Comparison of spiramycin and doxycycline in the empirical treatment of acute sinusitis: preliminary results. Clinical comparison of cefuroxime axetil and amoxicillin/clavulanate in the treatment of patients with acute bacterial maxillary sinusitis. Once daily clarithromycin extended-release vs twice-daily amoxicillin/clavulanate in patients with acute bacterial sinusitis: a randomized, investigator-blinded study. Therapeutic efficacy and tolerability of brodimoprim in comparison with doxycycline in acute sinusitis in adults. Comparison of moxifloxacin and cefuroxime axetil in the treatment of acute maxillary sinusitis. Sinusitis Infection Study Group. Efficacy and safety of oral telithromycin once daily for 5 days versus moxifloxacin once daily for 10 days in the treatment of acute bacterial rhinosinusitis. Moxifloxacin vs amoxicillin/clavulanate in the treatment of acute sinusitis. Acute bacterial sinusitis. Minocycline vs amoxicillin. The comparative efficacy and safety of clarithromycin and amoxycillin in the treatment of outpatients with acute maxillary sinusitis. Efficacy and safety of oral levofloxacin compared with clarithromycin in the treatment of acute sinusitis in adults: a multicentre, double-blind, randomized study. The Canadian Sinusitis Study Group. Randomized double-blind study comparing 7- and 10-day regimens of faropenem medoxomil with a 10-day cefuroxime axetil regimen for treatment of acute bacterial sinusitis. Cefaclor vs amoxicillin in the treatment of acute, recurrent, and chronic sinusitis. An open label, randomized comparative study of levofloxacin and amoxicillin/clavulanic acid in the treatment of purulent sinusitis in adult Thai patients. Comparison of the effectiveness of levofloxacin and amoxicillin-clavulanate for the treatment of acute sinusitis in adults. Antibiotic treatment of patients with mucosal thickening in the paranasal sinuses, and validation of cut-off points in sinus CT. Efficacy and tolerability of ceftibuten versus amoxicillin/clavulanate in the treatment of acute sinusitis. Azithromycin extended release vs amoxicillin/clavulanate: symptom resolution in acute sinusitis. Loracarbef (LY 163892) vs amoxicillin/clavulanate in bacterial maxillary sinusitis. Treatment of acute maxillary sinusitis. A comparison of four different methods. Azithromycin versus placebo in acute infectious rhinitis with clinical symptoms but without radiological signs of maxillary sinusitis. A comparison of the safety and efficacy of moxifloxacin (BAY 12-8039) and cefuroxime axetil in the treatment of acute bacterial sinusitis in adults. The Sinusitis Study Group. Sparfloxacin versus cefuroxime axetil in the treatment of acute purulent sinusitis. Sinusitis Study Group. [Clarithromycin versus amoxicillin-clavulanic acid in the treatment of acute maxillary sinusitis in adults]. Efficacy and safety of azithromycin versus phenoxymethylpenicillin in the treatment of acute maxillary sinusitis. A comparison of the efficacy of telithromycin versus cefuroxime axetil in the treatment of acute bacterial maxillary sinusitis. Double-blind comparative trial of ciprofloxacin versus clarithromycin in the treatment of acute bacterial sinusitis. Sinusitis Infection Study Group. Efficacy and tolerability of telithromycin for 5 or 10 days vs amoxicillin/clavulanic acid for 10 days in acute maxillary sinusitis. Randomised, double blind, placebo controlled trial of penicillin V and amoxycillin in treatment of acute sinus infections in adults. Treatment of acute maxillary sinusitis--comparing cefpodoxime proxetil with amoxicillin. Comparison of roxithromycin with co-amoxiclav in patients with sinusitis. Cefuroxime axetil versus clarithromycin in the treatment of acute maxillary sinusitis. Randomized double-blind study comparing 3- and 6-day regimens of azithromycin with a 10-day amoxicillin-clavulanate regimen for treatment of acute bacterial sinusitis. Moxifloxacin versus amoxicillin clavulanate in the treatment of acute maxillary sinusitis: a primary care experience. Azithromycin versus amoxicillin/clavulanate in the treatment of acute sinusitis. Efficacy and tolerability of cefprozil versus amoxicillin/clavulanate for the treatment of adults with severe sinusitis. A multicenter, investigator-blinded, randomized comparison of oral levofloxacin and oral clarithromycin in the treatment of acute bacterial sinusitis. Cefdinir versus levofloxacin in patients with acute rhinosinusitis of presumed bacterial etiology: a multicenter, randomized, double-blind study. Efficacy and safety of cefdinir in the treatment of maxillary sinusitis. [Amoxycillin-clavulanic acid and cefuroxime axetil in the treatment of acute sinusitis. A clinical, radiological and bacteriological evaluation]. A multicenter, randomized, investigator-blinded study of 5- and 10-day gatifloxacin versus 10-day amoxicillin/clavulanate in patients with acute bacterial sinusitis. [Treatment of acute sinusal processes of adults with tetracycline and a combination of sulfamethopyrazine-trimethoprim]. Loracarbef versus doxycycline in the treatment of acute bacterial maxillary sinusitis. Scandinavian Study Group. A comparison of the efficacy, tolerability and safety of azithromycin and co-amoxiclav in the treatment of sinusitis in adults. [Efficiency of a four-day course of pristinamycin compared to a five-day course of cefuroxime axetil for acute bacterial maxillary sinusitis in adult outpatients]. Primary-care-based randomised placebo-controlled trial of antibiotic treatment in acute maxillary sinusitis. Are antibiotics beneficial for patients with sinusitis complaints? A randomized double-blind clinical trial. Clinical efficacy and time to symptom resolution of 5-day telithromycin versus 10-day amoxicillin-clavulanate in the treatment of acute bacterial sinusitis. Comparison of the efficacy and safety of faropenem daloxate and cefuroxime axetil for the treatment of acute bacterial maxillary sinusitis in adults. Comparative effectiveness and safety of cefdinir and amoxicillin-clavulanate in treatment of acute community-acquired bacterial sinusitis. Cefdinir Sinusitis Study Group. Efficacy and safety of a novel, single-dose azithromycin microsphere formulation versus 10 days of levofloxacin for the treatment of acute bacterial sinusitis in adults. Multicenter comparison of clarithromycin and amoxicillin in the treatment of acute maxillary sinusitis. An open comparative study of azithromycin versus cefaclor in the treatment of patients with upper respiratory tract infections. Efficacy of clarithromycin vs. amoxicillin/clavulanate in the treatment of acute maxillary sinusitis. Brodimoprim versus amoxicillin in the treatment of acute sinusitis.
In an open randomized comparative study, the clinical and bacteriological efficacy and safety of spiramycin were compared with those of doxycycline in patients with acute sinusitis. Spiramycin was given at a dose of 1 g bd for 10 days and doxycycline at 200 mg once a day on day 1 and 100 mg once a day from day 2 to day 10. Clinical and bacteriological evaluations of efficacy were carried out at the end of therapy. In case of clinical cure, a last follow-up visit was made 15 days after the end of therapy. Adverse effects were recorded. To date 12 assessable patients have been treated with spiramycin and 15 with doxycycline. In the spiramycin group, nine patients were clinically cured at the end of therapy (with no relapse at the last follow-up visit). In the doxycycline group, nine patients were clinically cured at the end of therapy (with no relapse at the last follow-up visit). The data so far available from this study suggest that spiramycin presents an alternative to doxycycline in the treatment of acute sinusitis. This multicenter study compared the clinical and bacteriologic efficacy of two oral antibiotics, cefuroxime axetil and amoxicillin/clavulanate, in the treatment of acute bacterial maxillary sinusitis.
                Three hundred seventeen patients with clinical and radiographic evidence of acute maxillary sinusitis were enrolled at nine centers and were randomly assigned to receive 10 days of treatment with cefuroxime axetil 250 mg twice daily (n = 157) or amoxicillin/clavulanate 500 mg three times daily (n = 160). Patients were assessed for both clinical and bacteriologic responses once during treatment (5 to 7 days) and twice after treatment (1 to 3 days and 4 weeks). Bacteriologic assessments were based on needle aspirates of the maxillary sinus obtained pretreatment and, when possible, at the first posttreatment visit.
                Organisms were isolated from the pretreatment sinus aspirates of 198 of 317 (62%) patients, with the primary isolates being Streptococcus pneumoniae (22%), Haemophilus spp. (17%), Staphylococcus aureus (13%), and Haemophilus influenzae (10%). A satisfactory clinical outcome (cure or improvement) was achieved in 85% (98 of 115) and 82% (102 of 124) of the clinically evaluable patients treated with cefuroxime axetil or amoxicillin/clavulanate, respectively (P = 0.446). With respect to the eradication of the bacterial pathogens, a satisfactory outcome (cure or presumed cure) was obtained in 84% (31 of 37) and 87% (34 of 39) of bacteriologically evaluable patients treated with cefuroxime axetil or amoxicillin/clavulanate, respectively (p = 0.567). Treatment with amoxicillin/clavulanate was associated with a significantly higher incidence of drug-related adverse events (13% versus 3%, p = 0.001), particularly diarrhea (8% versus 1%, p = 0.001). Two patients in the cefuroxime axetil group and three patients in the amoxicillin/clavulanate group withdrew from the study due to adverse events.
                Our results indicate that cefuroxime axetil twice a day is as effective as amoxicillin/clavulanate three times a day in the treatment of acute bacterial maxillary sinusitis but produces fewer adverse effects. To compare the efficacy and tolerability of clarithromycin extended-release (ER) to amoxicillin/ clavulanate in patients diagnosed with acute bacterial sinusitis.
                In a controlled, multicenter, investigator-blinded study, 437 ambulatory patients at least 12 years old with signs/symptoms and radiographic findings of acute sinusitis were randomized to receive clarithromycin ER 1000 mg once daily or amoxicillin/ clavulanate 875 mg/l25 mg twice daily for 14 days.
                Clinical and bacteriological response rates were determined at a test-of-cure visit, which was conducted up to 10 days following the completion of treatment. Radiological response was assessed at a follow-up visit.
                The clinical cure rate in clinically evaluable patients was 98% (184/188) in the clarithromycin ER group and 97% (179/185) in the amoxicillin/clavulanate group (95% CI for the difference in rates [-2.4%, 4.7%]). Clinical cure was sustained at the follow-up visit (96% for each treatment group). The pathogen eradication rates were 94% (61/65) in the clarithromycin ER group and 98% (61/62) in the amoxicillin/clavulanate group (95% CI for difference in rates [-12.0%, 2.9%]). The radiological success rate was 94% (172/183) in both the clarithromycin ER and amoxicillin/clavulanate groups (95% CI for difference in rates [-4.9%, 4.9%]). Symptomatic improvement or relief was observed as early as 2 days-5 days after the initiation of study drug, with a statistically significantly higher resolution rate of sinus pressure (p = 0.027) and improvement/resolution rate of nasal congestion (p = 0.035) during treatment with clarithromycin ER. The resolution/improvement rate at the test-of-cure visit for each treatment group was > or = 94% for the primary acute sinusitis signs/symptoms, with a statistically significantly higher resolution/improvement rate of purulent nasal discharge with clarithromycin ER (p = 0.010). Both study drugs had a positive and rapid impact on quality of life. Patients reported a high level of satisfaction and probability of using either study antibiotic again, and health care resource use was low, with slightly fewer sinusitis-related physician and outpatient visits required by patients in the clarithromycin ER group (p = 0.055). The treatment groups were comparable with respect to incidence of drug-related adverse events.
                In this multinational population of patients with acute bacterial sinusitis, clarithromycin ER was comparable, and for selected measures superior, to amoxicillin/clavulanate based on clinical, bacteriological, and radiological responses as well as quality of life measures, satisfaction with antibiotic therapy, and health care resource utilization. To compare efficacy and tolerability of brodimoprim tablets with doxycycline tablets in adults with acute sinusitis.
                Open, randomized, controlled phase III study, with parallel groups.
                Of the 70 enrolled patients, 56 adults of both sexes with a mean age of 33 years were evaluable. STUDY DRUGS: One brodimoprim 200mg tablet or one doxycycline 100mg tablet was administered once daily for 8 to 12 days (on the first treatment day all patients received the loading dose consisting of 2 tablets of the corresponding compound).
                In the brodimoprim group 96.4% of the patients were judged cured/improved; in the doxycycline group 96.2%. BACTERIOLOGICAL OUTCOME: Eradication of the causative pathogen/s was achieved in 87.5% of the patients treated with brodimoprim and in 60% of the doxycycline group. SAFETY OUTCOME: Tolerability was judged as very good/good in 89.7% of the patients treated with brodimoprim and in all patients receiving doxycycline. Gastrointestinal skin, CNS and various other reactions were reported by 13 patients; 3 of them had to discontinue treatment. Discontinuation of therapy: 8 more patients withdrew from the study due to inactivity of the compound or reasons unrelated to the drugs.
                Brodimoprim was shown to be effective in the treatment of acute sinusitis in adults, its efficacy being equal to that of doxycycline. The assessments showed a positive clinical response to the medication in 96.4% of the patients treated with brodimoprim and 96.2% of the patients taking doxycycline. Both compounds were well tolerated and all side effects were of mild nature and reversible. The aim of this prospective, multicenter, randomized, double-masked clinical trial was to compare the efficacy and safety of moxifloxacin with those of cefuroxime axetil for the treatment of community-acquired acute sinusitis. Five hundred forty-two adult patients with symptoms and radiographic evidence of acute maxillary sinusitis received a 10-day oral regimen of either moxifloxacin (400 mg once daily) or cefuroxime axetil (250 mg twice daily). Acute signs and symptoms at presentation had lasted >7 days but <4 weeks. Clinical response at the end of therapy (7 to 14 days after treatment) was the primary efficacy variable. Four hundred fifty-seven of the patients (223 moxifloxacin, 234 cefuroxime axetil) were included in the clinical efficacy analysis. Moxifloxacin was found to be similar in effectiveness to cefuroxime axetil at the end-of-therapy visit (90% vs. 89%, respectively; 95% confidence interval, -5.1% to 6.2%). Clinical relapse at the follow-up visit was reported for only 8 patients (3 moxifloxacin, 5 cefuroxime axetil). No clinically significant differences were observed with respect to the number of patients experiencing a successful clinical response based on demographic or infection characteristics. Five of the 542 enrolled patients were lost to follow-up. Of the 537 patients in the intent-to-treat population, drug-related adverse events were reported in 37% of moxifloxacin-treated patients and in 26% of cefuroxime axetil-treated patients (P = 0.006). Adverse-event profiles were comparable in the 2 treatment groups, with the exception of nausea, which was reported by 11% of moxifloxacin-treated patients compared with 4% of cef uroxime axetil-treated patients (P = 0.003). In this study, moxifloxacin was as effective as cefuroxime axetil in the treatment of community-acquired acute sinusitis. To compare the clinical and bacteriologic efficacy and safety of short-duration treatment with telithromycin given for 5 days with moxifloxacin given for 10 days in adults with acute bacterial rhinosinusitis (ABRS).
                In this prospective, double-blind, parallel-group, randomized, multicenter study, adult patients (N = 349) with ABRS were randomized to oral telithromycin (800 mg once daily for 5 days) or to oral moxifloxacin (400 mg once daily for 10 days) and followed for 31 to 36 days. Clinical outcome was determined by the investigator at the posttherapy/test of cure (TOC) visit. Bacteriologic outcome was determined by comparing cultures taken at the pretreatment visit with cultures obtained at the posttherapy/TOC visit. The primary objective was to demonstrate equivalence of clinical cure rates in the per-protocol population between treatment groups at the posttherapy/TOC visit.
                Clinical success at TOC (primary endpoint) was achieved in 87.4% of patients in the telithromycin group compared with 86.9% for moxifloxacin (per-protocol patients; 0.5% difference between treatment groups; 95% confidence interval [CI], -8.1, 9.2; P = 0.8930). The bacteriologic success rates were 94.1% and 93.9%, respectively (0.2% difference between treatment groups; 95% CI, -14.2, 14.5; P = 0.9734). Overall treatment-emergent adverse events for both drugs (mostly gastrointestinal) were mild to moderate in intensity.
                The clinical and bacteriologic efficacy of telithromycin 800 mg once daily for 5 days was equivalent to that of moxifloxacin 400 mg once daily for 10 days, establishing telithromycin as an important treatment option for ABRS. The aim of this study was to compare the efficacy and safety of moxifloxacin with that of amoxicillin/clavulanate for the treatment of acute bacterial sinusitis in adults.
                Five hundred seventy-five patients from Latin American countries were randomized to receive oral moxifloxacin 400 mg once daily for 7 days, or oral amoxicillin/clavulanate 500/125 mg 3 times daily for 10 days, in a prospective, open study.
                At the test-of-cure visit (7-14 days after the end of therapy), the clinical success rate in the moxifloxacin group was 93.4% similar to that in the amoxicillin/clavulanate group (92.7%). Documented bacteriological eradication plus presumed eradication rates in the moxifloxacin (96.5%) and the amoxicillin/clavulanate (96.7%) groups were also similar. Drug-related adverse events were recorded in 32.2% of patients in the moxifloxacin group and 29.7% in the amoxicillin/clavulanate group. Patient discontinuation in the trial due to adverse events occurred for 10 patients in the moxifloxacin group and 6 in the amoxicillin/clavulanate group.
                Overall, in terms of clinical and bacteriological response, moxifloxacin was equivalent to amoxicillin/clavulanate for the treatment of acute bacterial sinusitis in adults. The efficacy and safety of minocycline were compared with that of amoxicillin in the treatment of 58 patients with acute bacterial sinusitis. The most frequently isolated pathogens were streptococci, staphylococci, and Haemophilus influenzae. After therapy for a mean time of 11 days, clinical cure or improvement and bacterial eradication were evident in 100% of the patients treated with minocycline and in 95% of the patients treated with amoxicillin. Roentgenographic results indicated clearing or improvement in 91% of the minocycline recipients and in 70% of those who received amoxicillin. These differences between treatments were not statistically significant. A low incidence of generally mild adverse clinical experiences occurred in both treatment groups. Thus, minocycline and amoxicillin were equally safe and effective in the treatment of these patients with acute bacterial sinusitis. The efficacy and safety of clarithromycin and amoxycillin in the treatment of acute maxillary sinusitis were compared in a single-blind, multicentre outpatient study. Fifty patients were randomly assigned to receive either clarithromycin 500 mg 12-hourly or amoxycillin 500 mg 8-hourly orally. Clinical signs and symptoms, sinus culture and blood and urine laboratory profiles were assessed prior to treatment, at four to six days during treatment, and within 48 h of the end of therapy (usually 9-11 days). Patients from whom beta-lactamase producing strains were isolated were excluded from the study. Both antibiotics achieved a clinical success rate of 91% within 48 h post-treatment; radiological resolution or improvement was observed in 91% of patients treated with clarithromycin and 89% of patients who received amoxycillin. Bacteriological cure was achieved in 88% and 91% of evaluable patients for clarithromycin and amoxycillin, respectively. Adverse events were reported for 16% of patients in the clarithromycin group compared to 26% in the amoxycillin group. Gastrointestinal disturbance was the most commonly occurring adverse event in both groups. The results of this study suggest that clarithromycin is as effective and well tolerated as amoxycillin in the treatment of acute maxillary sinusitis. Adult patients with acute sinusitis (n = 236) were randomized in a double-blind study to levofloxacin 500 mg orally once daily (n = 119) or clarithromycin 500 mg orally twice daily (n = 117) for 10-14 days. Between 2 and 5 days after therapy participants were evaluated as cured (no symptoms), improved (symptoms improved, no further therapy required), or failed (further therapy required). Clinical response rates (cured plus improved) for clinically evaluable patients were 93.9% for levofloxacin (n = 98) and 93.5% for clarithromycin (n = 93). The proportion of patients evaluated as cured was higher in the levofloxacin (40.8%) than in the clarithromycin arm (29.0%) and individual symptoms showed higher rates of resolution. Of patients receiving levofloxacin and clarithromycin, 22.5% and 39.3%, respectively, experienced adverse events related or possibly related to the study therapy. This study showed that, in the treatment of acute sinusitis, daily levofloxacin therapy is as effective as twice-daily clarithromycin therapy with more complete clearing of symptoms and a more tolerable side-effect profile. To compare the efficacy and safety of faropenem medoxomil, 300 mg twice daily for seven or ten days, with cefuroxime axetil 250 mg twice daily for ten days in adults with acute bacterial sinusitis (ABS).
                Prospective, double-blinded, phase III trial with entry criteria consistent with FDA/IDSA guidelines for diagnosis of ABS. Primary efficacy parameter was clinical response at 7 to 21 days posttherapy.
                One thousand ninety-nine subjects were randomized and treated; 861 were efficacy valid. Clinical cure rates were 80.3% for seven days of faropenem, 81.8% for ten days of faropenem, and 74.5% for 10 days of cefuroxime axetil. The incidence of adverse events and premature discontinuations were similar for the three treatment regimens.
                Seven- and ten-day faropenem medoxomil regimens were similar (noninferior) to a ten-day cefuroxime axetil regimen based on clinical response in patients with ABS.
                A seven-day course of faropenem medoxomil 300 mg twice-daily regimen is a promising alternative for treatment of ABS. The treatment of acute, recurrent, and chronic sinusitis remains controversial because of the presence of a wide variety of aerobic and anaerobic bacteria in the sinuses.
                This double-blind, randomized trial compared cefaclor with amoxicillin in the treatment of acute, recurrent, and chronic maxillary sinusitis using clinical evaluation, roentgenography, and microbiologic evaluation of antral aspirates.
                Outpatient office of five otorhinolaryngologists in Salt Lake City, Utah.
                One hundred eight adult patients with acute, recurrent, or chronic maxillary sinusitis.
                Oral treatment with cefaclor (500 mg) twice daily or amoxicillin (500 mg) three times daily for 10 days.
                Clinical response to treatment with cefaclor vs amoxicillin.
                Fifty-six patients with acute sinusitis, 25 with recurrent sinusitis, and 15 with chronic sinusitis were evaluable. Although multiple organisms were common in each group, patients with acute sinusitis were more likely to have Haemophilus influenzae or Streptococcus pneumoniae, and patients with recurrent or chronic sinusitis were more likely to have anaerobes in sinus aspirate. Whether treated with cefaclor or amoxicillin, clinical improvement occurred in 86% of patients with acute sinusitis and 56% of patients with recurrent sinusitis. Patients with chronic sinusitis were too few to allow statistical analysis of the differences in outcome between them and patients with recurrent or acute sinusitis. Resistance of the cultured organisms to the study drug used was unrelated to treatment outcome.
                The rate of clinical improvement was high in patients with acute sinusitis but was less favorable in those with recurrent and chronic disease regardless of the study drug used. The susceptibility of organisms isolated to the study drugs was unrelated to outcome. The objective of the study was to compare the clinical efficacy and bacteriological response of levofloxacin and amoxicillin/clavulanic acid (co-amoxiclav) in the treatment of purulent maxillary sinusitis. Sixty patients randomly received either levofloxacin 300 mg orally once daily (LEV group) or co-amoxiclav 625 mg three times a day (COA group) for 14 days. Thirty four patients were in the LEV group and 26 patients were in the COA group. The mean total symptom score was significantly decreased after treatment and was comparable between both groups. Radiological improvement was 61.8% in the LEV group (41.2% resolution, 20.6% improvement) and 61.5% in the COA group (26.9% resolution, 34.6% improvement). Pretreatment maxillary antral aspiration cultures were positive in 28 patients (82.4%) in the LEV group and 20 patients (76.9%) in the COA group. Bacteriological eradication was 78.5% in the LEV group and 70.0% in the COA group, which was not significantly different. In the LEV group, the eradication rate for major pathogens of acute sinusitis was 100% for H. influenzae (both betalactamase +ve and -ve), 100% for S. pneumoniae and S. aureus, 100% for Neisseria species, and 66.7% for P. aeruginosa. The eradication rate in the COA group was 75% for H. influenzae (both betalactamase +ve and -ve), 100% for S. pnumoniae and S. aureus, 50% for Neisseria species, and 0% for P. aeruginosa. There were no significant changes in vital sign measurements or hemato-biochemical parameters at the end of treatment as compared to baseline values, in both groups. Adverse events were found in 8.8% of patient in the LEV group and in 7.7% of patients in the COA group. Adverse events included nausea, abdominal pain, and diarrhea. All the adverse events in both groups were mild and resolved spontaneously. This study demonstrated that levofloxacin 300 mg orally once daily was as effective and safe as amoxicillin/clavulanic acid 625 mg three times a day in the treatment of maxillary sinusitis, either acute or acute exacerbation. Both drugs showed bacteriological efficacy that was not significantly different. The once daily dosage regimen is more applicable, convenience and has better compliance. In this comparative trial, outpatients with acute sinusitis were randomly assigned to receive levofloxacin (500 mg orally once daily) or amoxicillin-clavulanate (500/125 mg orally 3 times daily) for 10 to 14 days. The success rates (cured and improved) 2 to 5 days after the end of treatment were 88.4% for the 267 clinically evaluable patients who received levofloxacin and 87.3% for the 268 clinically evaluable patients who received amoxicillin-clavulanate. Drug-related adverse events occurred in a smaller percentage of patients in the levofloxacin treatment group (7.4%) than in the amoxicillin-clavulanate treatment group (21.2%). The most common of these were nausea, diarrhea, vaginitis, and abdominal pain for levofloxacin-treated patients and diarrhea, vaginitis, nausea, genital moniliasis, abdominal pain, vomiting, and flatulence for amoxicillin-clavulanate-treated patients. The results of this study show that once-daily administration of levofloxacin is as effective and better tolerated than amoxicillin-clavulanate administered 3 times daily for treating acute sinusitis in adult outpatients. We compared the efficacy of penicillin V and amoxycillin treatment with placebo in 70 adult patients from Norwegian family practice with a clinical diagnosis of acute sinusitis and mucosal thickening on CT, but without fluid level or total opacification. The study was randomized and double-blind. Three different outcomes were evaluated; subjective status after 10 days of treatment, difference in clinical score between day 0 and day 10, and duration of the illness episode. Amoxycillin and penicillin V gave no better response to treatment than placebo, evaluated by all three outcome measures. The median duration of the sinusitis episode was 10 days in the amoxycillin- and placebo groups and 13 days in the penicillin-V group. In patients with a clinical diagnosis of acute sinusitis, fluid level and total opacification on CT are good criteria to differentiate between groups of patients that need or do not need antibiotic treatment. The efficacy and tolerability of ceftibuten 400 mg o.d. or 200 mg b.i.d. was compared with amoxicillin/clavulanate (AMX/CA, 500 mg/125 mg) t.i.d. in the treatment of acute sinusitis. This was a multicenter, open, randomized, parallel-group 8-day study. In total, 450 patients were evaluable for safety and 400 patients for efficacy. At day 10, clinical cure rates were 83% in the ceftibuten 400 mg o.d. group, 87% in the ceftibuten 200 mg b.i.d. group and 89% in the AMX/CA t.i.d. group; the clinical/radiological cure rates were 52, 44 and 56%, respectively. Clinical and clinical/radiological cure rates at day 40 for the ceftibuten 400 mg o.d. group, ceftibuten 200 mg b.i.d. group and the AMX/CA t.i.d. group were similar, with clinical cure rates of 81, 82 and 87%, and clinical/radiological cure rates of 62, 58 and 63%, respectively. Most adverse events were mild. Ceftibuten, 400 mg o.d. or 200 mg b.i.d., was equally effective and well tolerated as AMX/CA t.i.d. in the treatment of acute sinusitis. The aim of the study was to compare early symptom resolution with a single 2-g dose of azithromycin extended release or 10 days of amoxicillin/clavulanate 875 mg/125 mg every 12 hours in patients with acute sinusitis.
                This was a prospective, randomized, open-label, observational study to mimic "real-world" conditions, including patients with symptoms of acute bacterial sinusitis lasting between 7 and 30 days. Key symptoms were assessed twice daily by patient diary, and patients were interviewed by telephone at 12 and 28 days. The primary end point was symptom resolution at 5 days, defined as reporting "no problem" with at least 3 of 4 diary symptoms in 2 consecutive measures in the per-protocol population. Secondary end points included additional antibiotic use, sinusitis-related quality of life, and treatment satisfaction.
                Three hundred seventy-eight patients were randomized to a single dose of azithromycin extended release and 371 to 10 days of amoxicillin/clavulanate. In the per-protocol population at day 5, 70/236 patients (29.7%) in the azithromycin extended release arm and 45/238 patients (18.9%) in the amoxicillin/clavulanate arm had resolution of symptoms (difference = 10.8%; 95% confidence interval [CI], 3.1-18.4%). By day 28, 26/236 patients (11.0%) in the azithromycin extended release arm and 27/238 patients (11.3%) in the amoxicillin/clavulanate arm had used additional antibiotics (difference = -0.4%; 95% CI: -6.1% to 5.3%). Additional physician visits, quality of life, and overall satisfaction were similar between groups.
                More patients randomized to azithromycin extended release experienced symptom resolution at day 5 than those randomized to amoxicillin/clavulanate, without experiencing differences in second antibiotic use at 28 days. Loracarbef (LY 163892), a beta-lactam antibiotic (carbacephem), was compared with amoxicillin/clavulanate potassium in a 10-day, single-blind, randomized parallel trial in the treatment of acute bacterial maxillary sinusitis. Based on posttherapy aspirate and culture, there was a 95.2% bacteriologic cure rate in patients receiving loracarbef (400 mg twice daily) and an 86.7% cure rate in patients receiving amoxicillin/clavulanate (500/125 mg three times daily) (p = 0.359). Loracarbef was comparable in efficacy to amoxicillin/clavulanate with a more desirable safety profile. nan In this double-blind, parallel-group, multicenter study, 169 patients with symptoms of maxillary sinusitis but without radiographically confirmed empyema (pus) were randomly assigned to receive either 500 mg azithromycin once daily for 3 days (87 patients) or placebo daily for 3 days (82 patients). Nasal secretion, maxillary tenderness and pain, nasal obstruction, general malaise, and hyposmia were assessed at the start of the study and on days 4, 11, and 25 of treatment. After 11 days 58% of the patients in the azithromycin group were cured versus 31% in the placebo group; after 25 days the cure rate was 79% versus 67%, respectively. When both cure and improvement were considered, the corresponding figures after day 25 were 90% and 88%, respectively. Adverse events, predominantly gastrointestinal, occurred in 24 (27%) of the azithromycin-treated patients and in 15 (18%) of those treated with placebo, but the difference was not statistically significant. There was a difference in efficacy in favor of azithromycin in the treatment of rhinitis with symptoms of maxillary sinusitis but without radiological signs of empyema (pus). Antibiotics should only be used to alleviate symptoms in patients with moderate to severe symptoms, as the results after 25 days for both improvement and cure are equal. In the treatment of acute rhinitis with symptoms and signs of maxillary sinusitis but without empyema, treatment with azithromycin seems to result in a better cure rate after 10-12 days when compared with placebo. The aim of this multicentre, randomized study was to compare the efficacy and safety of moxifloxacin (BAY 12-8039), a new 8-methoxy fluoroquinolone, with that of cefuroxime axetil for the treatment of acute bacterial sinusitis in adults. Diagnosis was made on a range of clinical signs and symptoms combined with radiology and microbiology. A 400 mg dose of moxifloxacin was administered once daily for 7 days to 242 patients and 250 mg twice daily of cefuroxime axetil was administered to 251 patients for 10 days. The clinical success rate at the end of treatment in the evaluable population was significantly higher (96.7%) in the moxifloxacin group (204/211) than in the cefuroxime axetil group (204/225, 90.7%; 95% confidence intervals 1.5%; 10.6%). At follow-up the success rate in the moxifloxacin group was 90.7% and that for the cefuroxime axetil group was 89.2% (95% confidence intervals -4.3%; 5.4%). The predominant pathogens isolated were Streptococcus pneumoniae and Haemophilus influenzae, followed by Moraxella catarrhalis and Staphylococcus aureus. The bacteriological eradication rates were higher for moxifloxacin (94.5%, 103/109) than for cefuroxime axetil (83.5%, 96/115; 95% CI 3.6%; 19.7%). Only one S. pneumoniae infection persisted following moxifloxacin therapy in contrast with three in individuals on cefuroxime axetil. There were slightly more adverse events in the moxifloxacin group than in the cefuroxime axetil group, but there were fewer serious adverse events following moxifloxacin treatment (three vs. eight). The drug was discontinued because of adverse events in 14 moxifloxacin patients and in 11 cefuroxime axetil patients. Overall, in all assessments, moxifloxacin was at least as effective clinically and bacteriologically, and as well tolerated, as cefuroxime axetil in the treatment of acute sinusitis. In a double-blind, multicentre trial, 382 patients with a diagnosis of acute purulent sinusitis were randomised to receive sparfloxacin 200 mg once daily for 5 days following a loading dose of 400 mg on day 1 (n = 193) or cefuroxime axetil 250 mg twice daily for 8 days (n = 189). Patients were classified as success or failure according to clinical symptoms plus bacteriological and radiological data at the end of treatment and at a follow-up visit. In analyses of the intent-to-treat (n = 374) and evaluable populations (n = 304), the 5 day course of sparfloxacin was at least as effective and well tolerated as the 8 day course of cefuroxime axetil. The success rates at the end of treatment in the evaluable population were 82.6% and 83.2% in the sparfloxacin and cefuroxime axetil groups, respectively. The pathogens isolated most frequently were Haemophilus influenzae (33%) and Streptococcus pneumoniae (28%). Response rates according to the bacterial aetiology of the acute sinusitis were similar in the two treatment groups. Both drugs were well tolerated. The commonest adverse events were gastrointestinal and were reported in 2.6% and 3.8% of sparfloxacin- and cefuroxime axetil-treated patients, respectively. The efficacy and safety of clarithromycin and amoxicillin-clavulanate in the treatment of acute maxillary sinusitis was compared in an open multicenter outpatient study. Two hundred and eighty patients were randomly assigned to receive either clarithromycin 500 mg 12-hourly or amoxicillin-clavulanate 500 mg 8-hourly orally for 8 days. Clinical and radiologic signs and symptoms, and sinus culture were not significantly different in the two treatment groups. A clinical and radiological success or improvement was achieved after the end of treatment in 115/134 (85.8%) patients treated with clarithromycin and in 110/129 (85.3%) patients treated with amoxicillin-clavulanate. Adverse events were reported for 14.8% and 12.2% of patients for clarithromycin and amoxicillin-clavulanate, respectively. In this study clarithromycin was as effective and well tolerated as amoxicillin-clavulanate acid in the treatment of acute maxillary sinusitis. In the treatment of acute maxillary sinusitis, azithromycin offers an advantage over phenoxymethylpenicillin in that a complete course of treatment requires drug administration once daily for only three days. In this double-blind, parallel-group, multicenter study, 438 patients with radiographically verified maxillary sinusitis were randomly assigned to receive either 500 mg azithromycin once daily for three days (221 patients) or 1.3 g phenoxymethylpenicillin three times daily for ten days (217 patients). Nasal secretion, maxillary tenderness and pain, nasal obstruction, general malaise, and hyposmia, were assessed at the start of the study and on days 4, 11, and 25 of treatment. After 11 days 58% of the patients in the azithromycin group were cured versus 51% in the penicillin group; after 25 days the cure rate was 79% versus 76%, respectively. When both cure and improvement were considered, the corresponding figures after 11 days were 97% (azithromycin) and 95% (penicillin); after 25 days they were 92% and 88%, respectively. Adverse events, predominantly gastrointestinal, occurred in 73 (33%) of the azithromycin-treated patients and in 87 (40.1%) of those treated with penicillin. No difference in efficacy was found between the two drugs in the treatment of acute maxillary sinusitis, and the adverse effects were comparable. The short duration of treatment with azithromycin offers a significant advantage over treatment with phenoxymethylpenicillin. Telithromycin, a new ketolide, exhibits potent activity against respiratory pathogens, including resistant strains.
                Five days of telithromycin (800 mg once daily) was compared with 10 days of cefuroxime axetil (250 mg twice daily) in subjects (n = 593) with acute bacterial maxillary sinusitis (ABMS). Bacteriologic sampling was accomplished by sinus puncture or nasal endoscopy. The primary efficacy variable was clinical outcome at the posttherapy/test-of-cure evaluation in clinically evaluable patients.
                Clinical cure was achieved in 85.2% of telithromycin patients and 82.0% of cefuroxime axetil patients (difference in proportions, 3.2%; 95% confidence interval, -7.1-13.4%). Satisfactory bacteriologic response rates were comparable. Treatment-emergent adverse events for both drugs were mild or moderate. The most frequently reported treatment-emergent adverse events were nausea and diarrhea.
                Once-daily telithromycin for 5 days was equivalent in efficacy to twice-daily cefuroxime axetil for 10 days in patients with ABMS. Telithromycin is a suitable option for short-course therapy of ABMS. This multicenter, randomized, double-blind trial compared the efficacy and safety of ciprofloxacin (CIP; 500 mg twice daily for 10 days, placebo for 4 days) to those of clarithromycin (CLARI; 500 mg twice daily for 14 days) in 560 adults with clinically documented and radiologically confirmed acute sinusitis. Of 457 efficacy-valid adults (236 CIP, 221 CLARI), clinical resolution plus improvement at the end of therapy was 84% for CIP-treated patients compared to 91% of CLARI recipients (CI95 = -0.131, -0.013). At the 1-month follow-up, more than twice as many CLARI-treated patients, 18 (10%), experienced a relapse, compared to 7 (4%) CIP-treated patients. The combined clinical response analyses (end of therapy and 1 -month follow-up) demonstrated that CIP and CLARI were statistically equivalent (CI95 = -0.106, 0.044). Diarrhea, nausea, headache, and dizziness were the most frequently reported drug-related adverse events in both treatment groups; diarrhea and taste perversion were reported more frequently among CLARI recipients. In summary, the combined end of therapy and follow-up clinical evaluation analyses revealed that CIP and CLARI were equally effective in the management of acute sinusitis, although twice as many relapses were reported among CLARI recipients. Telithromycin (HMR 3647) is a new ketolide antimicrobial that was developed for the treatment of community-acquired respiratory tract injections. We conducted a randomized, double-blind, multicenter study to compare the clinical efficacy and safety of oral telithromycin, at 800 mg once daily for 5 or 10 days, with that of amoxicillin/clavulanic acid, at 500/125 mg three times daily for 10 days, in adults with acute maxillary sinusitis (AMS). A total of 754 patients with AMS of less than 28 days' duration were randomized to receive either telithromycin for 5 days followed by placebo for 5 days, telithromycin for 10 days, or amoxicillin/clavulanic acid for 10 days. Clinical outcome was assessed at a test-of-cure (TOC) visit between days 17 and 24 and at a late post-therapy visit between days 31 and 45. Analysis of clinical outcome on a per-protocol basis (n = 434) demonstrated therapeutic equivalence among the three regimens at the TOC visit; in each treatment group, the clinical cure rate was approximately 75%. Only a few patients (3 to 5 in each group) had relapsed by the late post-therapy follow-up visit. Telithromycin was generally safe and well tolerated. The most common adverse events were mild or moderate gastrointestinal effects, which occurred with similar frequency in all three groups. We conclude that 5 or 10 days of telithromycin at 800 mg once daily is as effective clinically and as well tolerated as 10 days of treatment with amoxicillin/clavulanic acid. Telithromycin, therefore, appears to be a valuable option for the treatment of AMS. To compare the effectiveness of penicillin V and amoxycillin with placebo in treatment of adult patients with acute sinusitis.
                Randomised, double blind, placebo controlled trial.
                Norwegian general practice.
                130 adult patients with a clinical diagnosis of acute sinusitis confirmed by computed tomography.
                Subjective status after three and 10 days of treatment, difference in clinical severity score between day 0 and day 10 as evaluated by the general practitioner, difference in score from computed tomography on day 0 and day 10, and duration of sinusitis.
                Amoxycillin and penicillin V led to significantly faster and better recovery than placebo. By day 10, 71 patients receiving antibiotic treatment- (86%) considered themselves to be recovered or much better compared with 25 (57%) receiving placebo. The mean (95% confidence interval) reductions in clinical severity scores by day 10 were 5.4 (5.0 to 5.8) for penicillin V, 5.5 (4.9 to 6.0 for amoxycillin, and 3.4 (2.8 to 4.0) for placebo. For the antibiotic groups combined the number of patients with the greatest degree of improvement on computed tomography (scale 0-16)-that is, score 5-16 on day 10-was 31/83 (37%) compared with 10/44 (23%) receiving placebo. The median duration of the sinusitis was nine days in the amoxycillin group, 11 days in the penicillin V group, and 17 days in the placebo group.
                Penicillin V and amoxycillin are significantly more effective than placebo in the treatment of acute sinusitis. In order to evaluate the clinical efficacy and tolerance of cefpodoxime proxetil, compared with that of amoxicillin in the treatment of acute bacterial maxillary sinusitis, a randomized, double-blind, parallel group comparative study was performed. A total of 286 adults patients were included at 12 centres, each treatment group consisting of 143 patients. Each patient was treated for 10 days and observed before and after treatment. The observations included clinical, roentgenological, bacteriological and laboratory examinations. At inclusion, the most common pathogens were Haemophilus influenzae (24%) and Streptococcus pneumoniae (17%). In the per protocol analysis, 117 patients in the cefpodoxime group and 113 in the amoxicillin group were evaluable for clinical efficacy. The clinical response rates were 96% and 91%, respectively. The corresponding figures in the intent-to-treat analysis were 130 and 128 patients, with clinical response rates of 93% and 88%, respectively. Cefpodoxime proxetil proved clinically as effective as amoxicillin in the treatment of acute bacterial maxillary sinusitis. It was more effective in eradicating H. influenzae and was more efficient in improving the radiological score. Adverse events were reported in 20% of cefpodoxime cases and in 16% of amoxicillin cases. There was no statistically significant difference between the groups. In an open, randomized study of 60 patients with acute or recurrent sinusitis, the bacteriological and clinical efficacy of roxithromycin 150 mg bd were compared with those of po co-amoxiclav (625 mg) tds. Of 52 patients who underwent sinus puncture for isolation of causative organisms, 48 had pathogens sensitive to both antibiotics. Satisfactory clinical response was obtained in 93.1% (27/29) evaluable patients receiving roxithromycin and 88.8% (24/27) receiving co-amoxiclav. Tolerability was significantly better in the roxithromycin group, with 1/29 (3.4%) patients in this group experiencing gastrointestinal side-effects, compared with 7/27 (25.9%) patients in the co-amoxiclav group (P < 0.05). Although the study had limited power to detect differences, roxithromycin demonstrated clinical, bacteriological and overall efficacy similar to that of co-amoxiclav, but with better tolerability. Roxithromycin thus appears to be an effective and well-tolerated drug for the treatment of acute and recurrent sinusitis. Acute maxillary sinusitis is a common condition requiring broad-spectrum therapy to prevent development of chronic disease. A randomised, double-blind, multicentre study was performed to compare the efficacy and safety of cefuroxime axetil 250 mg twice daily (n = 185) and clarithromycin 250 mg twice daily (n = 185), both administered for 10 days, in the treatment of patients with acute sinusitis. Efficacy was determined by assessment of clinical response at post-treatment and follow-up, and by radiological assessment at pre-treatment and follow-up. Assessment of days absent from work due to illness was also made. In the cefuroxime axetil group, 169/185 (91%) patients were cured/improved at post-treatment, as were 172/185 (93%) patients receiving clarithromycin and, of these, 137/169 (81%) and 143/172 (83%) maintained their response at follow-up. Follow-up radiography showed a reduction in incidence of air fluid level and/or opacification from 96% to 15% (cefuroxime axetil) and from 96% to 11% (clarithromycin), and a decrease in frequency of mucosal thickening from 58% to 28% (cefuroxime axetil) and from 56% to 29% (clarithromycin). Only 10% of patients in either group experienced adverse events and days absent from work were comparable. This study demonstrated clinical equivalence between twice-daily cefuroxime axetil and clarithromycin, both treatments being effective and well tolerated. A randomized, double-blind, multicenter study of adults with acute bacterial sinusitis (ABS) compared the efficacy and safety of two azithromycin (AZM) regimens, 500 mg/day once daily for 3 days (AZM-3) or 6 days (AZM-6) to the efficacy and safety of an amoxicillin-clavulanate (AMC) regimen of 500-125 mg three times daily for 10 days. A total of 936 subjects with clinically and radiologically documented ABS were treated (AZM-3, 312; AZM-6, 311; AMC, 313). Clinical success rates were equivalent among per-protocol subjects at the end of therapy (AZM-3, 88.8%; AZM-6, 89.3%; AMC, 84.9%) and at the end of the study (AZM-3, 71.7%; AZM-6, 73.4%; AMC, 71.3%). Subjects treated with AMC reported a higher incidence of treatment-related adverse events (AE) (51.1%) than AZM-3 (31.1%, P < 0.001) or AZM-6 (37.6%, P < 0.001). More AMC subjects discontinued the study (n = 28) than AZM-3 (n = 7) and AZM-6 (n = 11) subjects. Diarrhea was the most frequent treatment-related AE. AZM-3 and AZM-6 were each equivalent in efficacy and better tolerated than AMC for ABS. In this prospective, multicentre, randomised, non-blinded phase III clinical trial, 475 adult patients with acute sinusitis received a 10-day oral regimen of either moxifloxacin (400 mg once daily) or amoxicillin clavulanate (875 mg twice daily). The primary measure of efficacy was clinical resolution. Secondary outcome measures included clinical relapse at follow-up and evaluation of patient reported outcomes. Of 471 adults comprising the intent-to-treat population (234 moxifloxacin, 237 amoxicillin/clavulanate), moxifloxacin treatment was statistically equivalent to amoxicillin/clavulanate at the test-of-cure visit (85% vs 82%; 95% CI -6%, 13%). Analysis of the efficacy evaluable population, confirmed statistical equivalence (86% vs 84%; 95% CI -7%, 13%). Of note, by day 3 of treatment, significantly more moxifloxacin-treated patients (n = 47; 24%), than amoxicillin/clavulanate-treated patients (n = 28; 14%), reported feeling better (p < 0.02). Frequency of drug-related adverse events were similar between groups: nausea (11% moxifloxacin, 5% amoxicillin/clavulanate) and diarrhoea (3% moxifloxacin, 10% amoxicillin clavulanate). In conclusion, once-daily moxifloxacin is as effective and safe as twice-daily amoxicillin/clavulanate in the treatment of acute sinusitis. Moxifloxacin is associated with more rapid symptomatic relief. To compare the efficacy and tolerability of a 3-day course of azithromycin with a 10-day course of amoxicillin/clavulanic acid in the treatment of acute sinusitis in adults.
                One hundred adult patients with acute sinusitis were included in an open, randomized study. Clinical diagnosis of sinusitis was confirmed by nasal endoscopy, sinus radiography, and (when possible) by culture of sinus aspirate. Patients were randomized to receive azithromycin (500 mg once daily for 3 days) or amoxicillin/clavulanate (625 mg every 8 hours for 10 days).
                A significantly faster resolution of signs and symptoms of sinusitis was observed in the azithromycin-treated patients. By the end of therapy (days 10-12), 95% of the patients in the azithromycin group and 74% in the amoxicillin/clavulanate group were cured. The remaining patients' conditions were improved. By the follow-up visit, cure was achieved in 98% of the azithromycin-treated patients, and 91% of the amoxicillin/clavulanate-treated patients. Treatment failure was observed in three patients from the amoxicillin/clavulanate group, and relapse occurred in one patient from each group. Bacteriologic eradication was achieved in 23 of 23 and 21 of 24 patients treated with azithromycin and amoxicillin/clavulanate, respectively. Both drugs were well tolerated. Two patients (4%) from the azithromycin group and five patients (10%) from the amoxicillin/clavulanate group reported mild gastrointestinal disturbances.
                In adults with acute sinusitis, a 3-day course of azithromycin was as effective and well tolerated as a 10-day course of amoxicillin/clavulanic acid. A significantly simpler dosage regimen and faster clinical effect were the advantages of azithromycin. Cefprozil is a beta-lactamase-stable oral cephalosporin with an antimicrobial spectrum that includes gram-positive and gram-negative pathogens commonly associated with acute bacterial sinusitis, one of the most common upper respiratory tract infections among adults. We conducted a multicenter, open-label study to compare the efficacy and safety of cefprozil and amoxicillin/clavulanate in the treatment of adults with severe acute bacterial sinusitis diagnosed by clinical and radiographic criteria. A total of 278 patients entered the study, 140 (59 males, 81 females) in the cefprozil group and 138 (69 males, 69 females) in the amoxicillin/clavulanate group. Patients were randomized to 10 days of treatment with either cefprozil 500 mg BID or amoxicillin/clavulanate 500 mg/125 mg TID. Clinical severity was assessed at study entry, and patients were stratified based on symptom grade. Efficacy was evaluated using a 10-point questionnaire administered during, at the end of, and 2 weeks after completing therapy. At the end of treatment, 84.5% (71/84) of patients with severe sinusitis treated with cefprozil had a satisfactory clinical response, which was not significantly different from the 89.9% (80/89) of patients in the amoxicillin/clavulanate group who had a satisfactory clinical response. Two weeks after completing treatment, 80.8% (63/78) of cefprozil-treated patients and 81.0% (64/79) of amoxicillin/clavulanate-treated patients with severe sinusitis had a satisfactory response. Relapse was more common among amoxicillin/clavulanate patients (6/70; 8.6%) than among cefprozil patients (2/65; 3.1%), but the difference was not statistically significant. Significantly more amoxicillin/clavulanate-treated patients experienced adverse events compared with cefprozil-treated patients (P < 0.001), including diarrhea (P < 0.001), nausea (P < 0.042), and rash (P < 0.035). Three times as many amoxicillin/clavulanate patients discontinued treatment because of adverse events. Cefprozil demonstrated comparable clinical efficacy to amoxicillin/clavulanate in the treatment of adults with severe sinusitis; however, cefprozil was associated with a significantly lower incidence of diarrhea, nausea, and rash. A multicenter, investigator-blinded, randomized, parallel-group study was conducted to compare oral levofloxacin 500 mg once/day for 14 days with clarithromycin 500 mg twice/day for 14 days in the treatment of acute bacterial sinusitis. Of 216 adult outpatients randomized to treatment, 190 were evaluable for efficacy. The primary efficacy measure was clinical response, based on resolution of signs and symptoms 2-5 days after therapy. A secondary efficacy measure was relapse rate 1 month after therapy. Among evaluable patients, clinical success rates (cured or improved) were 96.0% and 93.3% for levofloxacin (L) and clarithromycin (C), respectively (95% CI -9.2%, 3.7%). The confidence interval (CI) for treatment difference (C-L) included zero and its upper limit was less than 15%, indicating that levofloxacin was as effective as clarithromycin. In all, 4.1% of patients receiving levofloxacin and 7.2% receiving clarithromycin had a relapse of symptoms 1 month after therapy (95% CI-12.2%, 3.2%). Long-term success (initial success, absence of relapse at 1 month, no further antibacterial therapy 2-5 days after therapy) was 79.2% in the levofloxacin group and 76.4% in the clarithromycin group (95% CI -14.7%, 9.0%). Based on investigator-assessed treatment-emergent adverse events, overall tolerability of the drugs was similar, except for a higher frequency of taste perversion and diarrhea in the clarithromycin group. Levofloxacin had an advantage over clarithromycin based on two quality-of-life (QOL) parameters: number of times taking other drugs for targeted medical conditions and mean total cost of these drugs. No statistical significance was found in other QOL variables. These findings suggest that the efficacy and tolerability of levofloxacin 500 mg once/day are comparable with those of clarithromycin 500 mg twice/day in the treatment of acute bacterial sinusitis. Treatment guidelines for acute bacterial rhinosinusitis (ABRS) recommend 10 to 14 days of therapy with high-dose amoxicillin, amoxicillin/clavulanate, cefdinir, cefpodoxime, cefuroxime, a macrolide, or a newer fluoroquinolone, among other agents.
                This study compared the clinical efficacy and tolerability of cefdinir and levofloxacin in patients with a diagnosis of acute rhinosinusitis of presumed bacterial origin.
                In this multicenter, double-blind, noninferiority study, ambulatory adult patients who had signs and symptoms for >7 to 21 days before the screening visit and radiographic findings consistent with acute rhinosinusitis were randomized to receive cefdinir 600 mg or levofloxacin 500 mg, each once daily for 10 days. Clinical and radiologic response rates were determined at the test-of-cure (TOC) visit, which took place 9 to 14 days after the completion of treatment.
                Two hundred seventy-one patients (138 cefdinir, 133 levofloxacin) were enrolled and randomized to treatment at 27 study centers in the United States and Poland between November 2003 and March 2004. Of these, 241 (123 cefdinir, 118 levofloxacin) were clinically evaluable. The cefdinir group consisted of 75 women and 48 men, of whom 117 were white and 6 black; their mean (SD) age was 42.5 (14.3) years. The levofloxacin group consisted of 71 women and 47 men, of whom 111 were white and 7 black; their mean age was 40.4 (13.6) years. The 2 groups were similar in terms of presenting signs and symptoms and baseline radiographic findings. The most common presenting symptoms were sinus pain, sinus pressure, and purulent nasal discharge, each of which was reported by > or =89% of patients. Clinical cure rates at the TOC visit in the cefdinir and levofloxacin groups were 83% (102/123) and 86% (101/118), respectively (95% Cl for the difference in cure rates, -12.3 to 7.0). Cefdinir and levofloxacin were comparable in the treatment of infections classified as moderate to severe. The incidence of drug-related adverse events was generally comparable in the 2 treatment groups, although there were significant differences between cefdinir and levofloxacin in the incidence of vaginal moniliasis in women (11% vs 0%, respectively; P = 0.003), drug-related diarrhea (8% vs 1%; P = 0.005), and insomnia (0% vs 4%; P = 0.027). Only 2% of patients discontinued therapy prematurely as a result of a drug-related adverse event.
                In this population of patients with ABRS, the extended-spectrum cephalosporin cefdinir was as efficacious as the fluoroquinolone levofloxacin, suggesting that cefdinir may be a suitable alternative to the currently recommended fluoroquinolones. Cefdinir is a new, extended-spectrum, orally active, third-generation cephalosporin that is resistant to bacterial beta-lactamase production. To evaluate efficacy and safety of the antibiotic in maxillary sinusitis, its use was compared with amoxicillin/clavulanate (amox/clav), which is a well-accepted beta-lactamase-resistant antibiotic. In this investigator-blinded multicenter phase III clinical study, 569 patients were randomly assigned to one of three treatment regimens: one daily dose of cefdinir 600 mg (OD), cefdinir 300 mg every 12 h (BD), and amox/clav 500/125 mg every 8 h. All antibiotics were administered orally for 10 days. Maxillary sinusitis was documented by typical clinical signs and symptoms and was confirmed by X-ray imaging. Before treatment, the genus and species of any pathogens were determined from sinus aspirates. Cultures were tested for beta-lactmase production and in vitro resistance to cefdinir and amox/clav. The effectiveness of antibiotic treatment was evaluated 7-14 days after therapy and whether or not recurrent clinical symptoms or persistent infection was determined 21-35 days post-therapy. The appearance of any adverse events was classified as associated or not associated with the medication of the study. Present findings showed that the in vitro susceptibility of pathogens to cefdinir and amox/clav was similar. Cefdinir OD or BD was therapeutically as effective as or better than amox/clav, although cefdinir BD was not as useful as amox/clav clinically. Cefdinir OD and BD and amox/clav were well tolerated. The statistical incidence of adverse events was the same among the three treatment groups, although cefdinir OD treatment had significantly fewer treatment discontinuations due to adverse events than BD and amox/clav. Cefuroxime axetil (CAE), an orally absorbed product of cefuroxime, and amoxycillin/clavulanate (AAC), were evaluated for their efficacy and safety in the treatment of acute sinusitis. A total of 47 patients were enrolled in a randomized study to compare cefuroxime axetil 500 mg. b.d. for 8 days (25 patients) with amoxycillin/clavulanate 500 mg. t.d.s for 8 days (22 patients). All patients were evaluable for clinical, radiological and bacteriological response. Of 25 clinically assessable patients treated with CAE, 24 were cured, 1 improved and 1 relapsed (96% success rate). Of 22 assessable patients given AAC, 14 were cured and 8 improved (100% success rate). Two out of 25 (8%) patients treated with CAE experienced drug-related adverse events, including 4% with diarrhoea. In the AAC group, 3 out of 22 (13%) patients had a drug-related adverse event, including 13% with diarrhoea. In conclusion, CAE appears to be as safe and effective as AAC in the treatment of acute sinusitis. Treatment guidelines for acute bacterial sinusitis recommend 10 to 14 days of therapy with amoxicillin/clavulanate, high-dose amoxicillin, cefpodoxime, cefuroxime, or a newer fluoroquinolone. Objective: This study compared the clinical efficacy of short-course (5-day) gatifloxacin with standard 10-day regimens of amoxicillin/clavulanate or gatifloxacin in patients with a diagnosis of acute, uncomplicated maxillary sinusitis.
                This was a multicenter, investigator-blinded study in adult patients (age >18 years) with physical findings, signs and symptoms (for at least 7 days), and radiographic findings indicating acute, uncomplicated maxillary sinusitis. Patients were randomized to receive gatifloxacin 400 mg once daily for 5 days, gatifloxacin 400 mg once daily for 10 days, or amoxicillin/clavulanate 875 mg twice daily for 10 days. Clinical response was assessed once between days 3 and 5 of treatment, once I to 3 days after the completion of study treatment, once 7 to 14 days posttreatment (test-of-cure visit), and once 21 to 28 days posttreatment. Safety was assessed throughout the study.
                The study enrolled 445 patients. The treatment groups were similar in terms of history of sinusitis, presenting signs and symptoms, and radiographic findings. The most common presenting symptoms were nasal congestion, sinus tenderness, and purulent nasal discharge (>90% of patients); 99% of patients had abnormal radiographic findings. At the test-of-cure visit, clinical cure rates for clinically evaluable patients in the 3 treatment groups were 74% (102/137) for 5-day gatifloxacin, 80% (101/127) for 10-day gatifloxacin, and 72% (101/ 141) for 10-day amoxicillin/clavulanate (95% CI for the difference in cure rates: 5-day gatifloxacin vs amoxicillin/clavulanate, -7.6 to 13.2; 5- vs 10-day gatifloxacin, -15.2 to 5.1; 10-day gatifloxacin vs amoxicillin/clavulanate, -2.3 to 18.1). The distribution and incidence of drug-related adverse events (AEs) were comparable between treatment groups, and the majority (>95%) were mild or moderate in severity. The most common drug-related AEs included vaginitis, diarrhea, and nausea.
                In this population of patients with acute, uncomplicated sinusitis of presumed bacterial origin, a short course (5 days) of gatifloxacin therapy was associated with comparable clinical cure rates and tolerability to those of standard 10-day therapy with gatifloxacin or amoxicillin/clavulanate. nan In a double-blind, multicentre study, 662 patients with acute maxillary sinusitis were randomly assigned to receive either loracarbef 400 mg bd (332 patients) or doxycycline, 200 mg for the first dose followed by 100 mg od, (330 patients) for ten days. One hundred and sixty-eight patients in the loracarbef group and 164 in the doxycycline group were evaluable for efficacy. Streptococcus pneumoniae and/or Haemophilus influenzae were isolated from approximately 75% of patients. The clinical response rate (cure or improvement) was significantly higher for patients receiving loracarbef (98.2%) than for those who received doxycycline (92.2%). There was no significant difference between the two groups with respect to bacteriological outcome, although more of the pre-treatment isolates were resistant to doxycycline (35 strains) than to loracarbef (five strains). Adverse events related to the gastrointestinal tract occurred in 11.7% and 10.6% of loracarbef- and doxycycline-treated patients respectively; therapy was terminated prematurely in ten patients in the loracarbef group and in nine in the doxycycline group. The results indicate that loracarbef is effective and safe treatment for acute maxillary sinusitis. The efficacy, tolerability and safety of azithromycin and co-amoxiclav in the treatment of non-severe acute maxillary/ethmoidal sinusitis were compared in a randomized, open clinical trial in 254 adult patients. The predominant pathogens were Streptococcus pneumoniae and Haemophilus influenzae (83 patients). Azithromycin was administered orally to 165 patients at a single daily dose of 500 mg for 3 days, and co-amoxiclav (4:1) to 89 patients, at a dose of 500 mg three times daily for 10 days. The overall clinical response rates were 87.5% for azithromycin and 83.7% for co-amoxiclav at follow-up (day 21-28). Microbiological responses to both drugs were good, with only five patients in each group having a persistent infection after treatment. Both drugs were well tolerated and produced similar incidences of adverse events, which were mostly gastrointestinal. Azithromycin was as effective, and as well tolerated as co-amoxiclav, and its shorter simpler dosing regime may offer advantages in compliance and cost. The aim of this multicentric, randomized, double blind study was to demonstrate that a 4-day treatment with pristinamycin 1 g bid was as efficient as a 5-day treatment with cefuroxime axetil 250 mg bid in adults presenting with an acute maxillary sinusitis.
                The clinical diagnosis was based on the association of sub-orbital pain, purulent rhinorrhea and purulent discharge on the middle nasal meatus and was confirmed radiologically. A rhinoscopic bacteriologic sampling was made on the middle nasal meatus.
                Four hundred and eighty five patients were included in the study: in France (n = 301), Tunisia (n = 48), Poland (n = 69) and Argentina (n = 67) between January 2001 and February 2002. Cultures were positive in 199/434 patients (46%), mainly S. pneumoniae (34.2%), H. influenzae (21.5%), S. aureus (15.4%), and M. catharralis (7.9%). The clinical cure rate at day 12-19 in the per protocol population, the main study criterion, was equal to 91.4% (201/220) and 91.1% (195/214) respectively in the pristinamycin and cefuroxime axetil groups; delta = 0.14%; 95%CI: [-5.1%; 5.3%]. The non-inferiority of 4-day pristinamycin versus 5-day cefuroxime axetil was demonstrated. The efficacy at follow up after treatment (day 26-31) was 88.6% and 85.8% respectively, confirming the non-inferiority. The bacteriological cure rate at day 12-19 was 87% (87/100) and 87.9% (87/99) respectively. Both treatments were well tolerated.
                A 4-day course with pristinamycin 1 g bid is as effective as a 5-day course of cefuroxime axetil 250 mg bid in the treatment of acute maxillary sinusitis in adults. The value of antibiotics in acute rhinosinusitis is uncertain. Although maxillary sinusitis is commonly diagnosed and treated in general practice, no effectiveness studies have been done on unselected primary-care patients. We used a randomised, placebo-controlled design to test the hypothesis that there would be an improvement associated with amoxycillin treatment for acute maxillary sinusitis patients presenting to general practice.
                Adult patients with suspected acute maxillary sinusitis were referred by general practitioners for radiographs of the maxillary sinus. Those with radiographic abnormalities (n = 214) were randomly assigned treatment with amoxycillin (750 mg three times daily for 7 days; n = 108) or placebo (n = 106). Clinical course was assessed after 1 week and 2 weeks, and reported relapses and complications were recorded during the following year.
                After 2 weeks, symptoms had improved substantially or disappeared in 83% of patients in the study group and 77% of patients taking placebo. Amoxycillin did not influence the clinical course of maxillary sinusitis nor the frequency of relapses during the 1-year follow-up. Radiographs had no prognostic value, nor were they an effect modifier. Side-effects were recorded in 28% of patients given amoxycillin and in 9% of those taking placebo (p < 0.01). The occurrence of relapses was similar in both groups (21 vs 17%) during the follow-up year.
                Antibiotic treatment did not improve the clinical course of acute maxillary sinusitis presenting to general practice. For these patients, an initial radiographic examination is not necessary and initial management can be limited to symptomatic treatment. Whether antibiotics are necessary in more severe cases warrants further study. Sinusitis is the fifth most common reason for patients to visit primary care physicians, yet clinical outcomes relevant to patients are seldom studied.
                To determine whether patients with purulent rhinitis, "sinusitis-type symptoms," improved with antibiotics. Second, to examine a clinical prediction rule to provide preliminary validation data.
                Prospective clinical trial, with double-blinded placebo controlled randomization. The setting was a suburb of Washington, DC, from Oct 1, 2001, to March 31, 2003. All participants were 18 years or older, presenting to a family practice clinic with a complaint of sinusitis and with pus in the nasal cavity, facial pressure, or nasal discharge lasting longer than 7 days. The main outcome measures were resolution of symptoms within a 14-day follow-up period and the time to improvement (days).
                After exclusion criteria, 135 patients were randomized to either placebo (n=68) or amoxicillin (n=67) for 10 days. Intention-to-treat analyses showed that 32 (48%) of the amoxicillin group vs 25 (37%) of the placebo group (P=.26) showed complete improvement by the end of the 2-week follow-up period (relative risk=1.3; 95% confidence interval [CI], 0.87-1.94]). Although the rates of improvement were not statistically significantly different at the end of 2 weeks, the amoxicillin group improved significantly earlier, in the course of treatment, a median of 8 vs 12 days, than did the placebo group (P=.039).
                For most patients with sinusitis-type complaints, no improvement was seen with anti-biotics over placebo. For those who did improve, data suggested there is a subgroup of patients who may benefit from antibiotics. This study compared the clinical efficacy, time to symptom resolution, and tolerability of a 5-day regimen of telithromycin with a 10-day regimen of high-dose amoxicillin-clavulanate in acute bacterial sinusitis (ABS).
                In this multinational (41 centers in Canada, Germany, Greece, Portugal, and Turkey), open-label, noninferiority study, patients >/=18 years old (n=298) with a clinical (>7 days' symptoms) and radiological (air/fluid level, total opacification, mucosal thickening >/=10 mm) diagnosis of ABS were randomized to receive telithromycin 800 mg once daily for 5 days or amoxicillin-clavulanate 875/125 mg twice daily for 10 days. Clinical efficacy and tolerability were assessed at the test-of-cure visit (days 17-21). Time to symptom resolution was based on patients' daily diary assessment of individual symptoms.
                The per-protocol clinical success rate (primary endpoint) with telithromycin (88.6% (109/123)) was noninferior to that with amoxicillin-clavulanate (88.8% (111/125)) (95% confidence interval: -8.9 to 8.5). In the modified intention-to-treat (mITT) population, the median time for 50% reduction of total symptom scores was significantly shorter for telithromycin (4 days) vs. amoxicillin-clavulanate (5 days; p=0.044); median times for 75% reduction of total symptom scores were: telithromycin, 7 days; amoxicillin-clavulanate, 8 days (p=0.115). The median time for reduction of total symptom scores to the absent/very mild category (mITT population) was 6 days for telithromycin vs. 8 days for amoxicillin-clavulanate (p=0.04). All treatment-emergent adverse events (TEAEs) were mostly gastrointestinal and occurred in 20.7% (30/145) of telithromycin-treated patients vs. 31.8% (47/148) of amoxicillin-clavulanate-treated patients (p=0.034). One serious AE was reported in the telithromycin group, but it was considered not to be related to treatment.
                This open-label, randomized study demonstrated that treatment of ABS with telithromycin resulted in comparable clinical efficacy, shorter times to symptom resolution, and fewer total TEAEs than treatment with amoxicillin-clavulanate. In this multicentre, multinational, comparative, double-blind clinical trial, outpatients with both clinical signs and symptoms and radiographic evidence of acute sinusitis were randomly assigned to receive for 7 days either a twice-daily oral regimen of faropenem daloxate (300 mg) or a twice daily oral regimen of cefuroxime axetil (250 mg). Among 452 patients considered valid for clinical efficacy, faropenem daloxate treatment was found to be statistically equivalent to cefuroxime axetil (89.0% vs. 88.4%-95% CI=-5.2%; +6.4%) at the 7-16 days post-therapy assessment. At 28-35 days post-therapy, the continued clinical cure rate in the faropenem daloxate group was 92.6% and that for the cefuroxime axetil group was 94.9% (95% CI: -6.8%; +1.2%). A total of 148 organisms was obtained in 136 microbiologically valid patients (30.1%). The predominant causative organisms were Streptococcus pneumoniae (47.1%), Haemophilus influenzae (30.1%), Staphylococcus aureus (14.7%) and Moraxella catarrhalis (8.8%). The bacteriological success rate at the 7-16 days post-therapy evaluation was similar in both treatment groups: 91.5% and 90.8% in the faropenem daloxate and cefuroxime axetil groups, respectively (95% CI=-9.2%; +9.5%). Eradication or presumed eradication was detected for 97.3% and 96.3% of S. pneumoniae, 85.0% and 90.5% of H. influenzae, 88.9% and 90.9% of S. aureus and 100.0% and 83.3% of M. catarrhalis in faropenem daloxate and cefuroxime axetil recipients, respectively. At least one drug-related event was reported by 9.5% of the faropenem daloxate-treated patients and by 10.3% of those who received cefuroxime axetil. The most frequently reported drug-related events were diarrhoea (2.2% versus 2.9%), nausea/vomiting (1.5% vs. 0.7%), abdominal pain (0.7% vs 1.5%) and skin reactions (1.5% vs. 1.1%). Overall, faropenem daloxate was at least as effective clinically and bacteriologically as cefuroxime axetil and was well tolerated. Cefdinir is an extended-spectrum oral cephalosporin that is active against pathogens commonly seen in acute community-acquired bacterial sinusitis (ACABS), including Streptococcus pneumoniae, Haemophilus influenzae, and Moraxella catarrhalis. Two randomized, investigator-blind, multicenter trials (one in the United States and one in Europe) compared two dosage regimens of cefdinir (600 mg once a day for 10 days and 300 mg twice a day for 10 days) to amoxicillin-clavulanate (A-C) (500 mg three times a day for 10 days) for adult and adolescent patients with ACABS. Twelve hundred twenty-nine patients entered the U.S. study, 698 with antral puncture; 569 patients entered the European study, all with antral puncture. Clinical response (cure or improvement) was determined 7 to 14 days and 3 to 5 weeks posttherapy. Microbiologic eradication rates were determined 10 to 30 days posttherapy in a subset of patients who underwent pre- and posttherapy sinus aspirate culture. Rates of adverse events and treatment discontinuations due to adverse events were examined. Cefdinir, given once or twice daily, was as effective clinically (approximately 90% cure rate) as amoxicillin-clavulanate given three times daily in the treatment of ACABS. Microbiologic eradication rates were also similar in the three groups. The major side effect was mild diarrhea, occurring in approximately 20% of each group. Cefdinir caused fewer adverse events requiring treatment discontinuation. To compare the efficacy and safety of a single 2.0-g dose of a novel azithromycin microsphere formulation with that of 10 days of levofloxacin, 500 mg/d, when used to treat adults with uncomplicated acute bacterial maxillary sinusitis (ABS).
                An international, multicenter, randomized, double-blind, double-dummy trial. Eligible outpatients > or =18 years of age with clinical and radiographic evidence of ABS underwent maxillary sinus aspiration before randomization. Primary endpoint was clinical efficacy at the test-of-cure visit (day 17-24).
                Clinical success rates were 94.5% (242/256) in azithromycin-microspheres-treated patients and 92.8% (233/251) in the levofloxacin group. In patients with documented Streptococcus pneumoniae, Haemophilus influenzae, or Moraxella catarrhalis, clinical cure rates were 97.3% (36/37), 96.3% (26/27), and 100% (8/8), respectively, for the azithromycin group and 92.3% (36/39), 100% (30/30), and 90.9% (10/11), respectively, for the levofloxacin group.
                Single-dose azithromycin microspheres provided clinical and bacteriologic efficacy and safety comparable to 10 days of levofloxacin.
                A novel microsphere formulation of azithromycin given as a single dose was safe and effective for the treatment of ABS. To compare the safety and efficacy of orally administered clarithromycin, a new macrolide antimicrobial, and amoxicillin in the treatment of patients with acute maxillary sinusitis.
                One hundred forty-two consecutive outpatients treated at four primary care centers for acute maxillary sinusitis were randomly assigned to receive oral clarithromycin (500 mg twice daily) or oral amoxicillin (500 mg three times daily) for 7 to 14 days. Clinical and roentgenographic responses to the antibiotic therapy were determined within 48 hours after the last dose and 6 weeks later.
                The success rates of clarithromycin and amoxicillin were comparable. A clinical success rate of 91% and a roentgenographic success rate of 78% were achieved in the clarithromycin group at the final visit; comparable results for the amoxicillin group were 89% and 92%, respectively. Differences between the two groups were not statistically significant (P = .766 and .064, respectively). No serious adverse events were reported, although both drugs caused mild gastrointestinal distress. Dropout rates were low in both groups: 3% for clarithromycin and 4% for amoxicillin. No clinically significant changes in laboratory studies were observed in either group.
                Clarithromycin twice daily is effective and well tolerated in patients with acute maxillary sinusitis. Azithromycin and cefaclor were compared for the treatment of acute otitis media, streptococcal pharyngitis/tonsillitis, or sinusitis in an open multicentre study conducted in 530 adults. At the end of therapy (day 11-15), 228/245 (93%) patients treated with azithromycin 500 mg once daily for 3 days and 233/241 (97%) treated with cefaclor 250 mg given three times daily for 10 days were considered to have responded satisfactorily (cured or improved). In bacteriologically evaluable patients with pharyngitis/ tonsillitis, Streptococcus pyogenes was eradicated in 116/117 (99%) azithromycin- and in 115/119 (97%) cefaclor-treated patients at day 11-15; one patient in each group had become reinfected after initial eradication of the pathogen. When followed up on day 25-30, S. pyogenes infection had recurred in 5/105 (5%) azithromycin and 4/108 (3%) cefaclor patients who had responded satisfactorily at day 11-15, and whose baseline pathogen had been eradicated. Of these patients, two in the azithromycin and one in the cefaclor group also relapsed clinically; the others remained asymptomatic. Patients tolerated both treatments well; treatment-related adverse events were recorded in 11% of the 267 azithromycin- and 10% of the 263 cefaclor-treated patients assessed for safety. One azithromycin patient and five cefaclor patients withdrew because of adverse events. The results of the study show that a 3-day regimen of azithromycin, given once daily, is as effective and well tolerated as a multiple-daily, 10-day cefaclor regimen for the treatment of upper respiratory tract infections in adults. A new macrolide drug, clarithromycin (Biaxin) was compared with amoxicillin/clavulanate (Augmentin) in a single-blind (investigator-blind), randomized, multicenter study of 497 outpatients with acute maxillary sinusitis; treatment was 500 mg clarithromycin bid (n = 246) or 500 mg amoxicillin/clavulanate tid (n = 251). Pathogens included Streptococcus pneumoniae in 22% of patients, Staphylococcus aureus in 16%, Haemophilus influenzae in 10%, and Moraxella catarrhalis in 7%. For evaluable patients, clinical success (cure or improvement) was noted for 97% (128/132) of clarithromycin recipients and 93% (119/128) amoxicillin/clavulanate recipients. Clinically significant improvement in signs and symptoms was comparable between groups. Bacteriologic cure rates were 87% (115/132) and 90% (115/128), respectively. Respective pathogen eradication rates were 87% (125/143) and 90% (125/139). Adverse events not due to concurrent conditions occurred in 41% of the former and 46% of the latter group; most were mild to moderate gastrointestinal upsets (21% and 38%, respectively; P < 0.001). We conclude that clarithromycin appears to be as effective as amoxicillin/clavulanate in acute maxillary sinusitis and may cause fewer gastrointestinal upsets. A new dihydrofolate inhibitor, brodimoprim, was compared with amoxicillin in the treatment of acute sinusitis in a general practice controlled study. Eighty adult outpatients with acute sinusitis were randomly assigned to receive 200 mg of brodimoprim once daily or 750 mg of amoxicillin thrice daily for seven to 10 days. The mean duration of treatment was 9.2 days in the brodimoprim group and 9.1 days in the amoxicillin group. In most patients the symptoms of sinusitis had disappeared by day 5 of treatment. The reduction in symptom scores was more marked in the brodimoprim-treated patients than in the amoxicillin-treated patients. Bacteriologic examinations after treatment were performed in 20 patients of each treatment group. At completion of treatment, the causative pathogen had been eradicated in 14 of 20 patients treated with brodimoprim and in 12 of 20 patients treated with amoxicillin. Treatment side effects were reported by two brodimoprim-treated patients (skin reactions) and by six amoxicillin-treated patients (gastrointestinal distrubances or skin reactions). The results indicate that brodimoprim is safe and effective in the treatment of acute sinusitis in adults.
There is moderate evidence that antibiotics provide a small benefit for clinical outcomes in immunocompetent primary care patients with uncomplicated acute sinusitis. However, 80% of participants treated without antibiotics improved within two weeks. Clinicians need to weigh the small benefits of antibiotic treatment against the potential for adverse effects at both the individual and general population level.