[Efficacy and safety of pristinamycin vs amoxicillin in community acquired pneumonia in adults]. [Comparative study of the effectiveness of enoxacin and amoxicillin in bacterial pneumonia by a double blind method]. [Oral levofloxacin versus intravenous ceftriaxone and amoxicillin/clavulanic acid in the treatment of community-acquired pneumonia that requires hospitalization]. [Effect and tolerance of ofloxacin in bronchopulmonary infections in comparison with amoxicillin]. Gemifloxacin once daily for 7 days compared to amoxicillin/clavulanic acid thrice daily for 10 days for the treatment of community-acquired pneumonia of suspected pneumococcal origin. Carbapenems in the treatment of severe community-acquired pneumonia in hospitalized elderly patients: a comparative study against standard therapy. A comparative study of levofloxacin and ceftriaxone in the treatment of hospitalized patients with pneumonia. Once-daily sparfloxacin versus high-dosage amoxicillin in the treatment of community-acquired, suspected pneumococcal pneumonia in adults. Sparfloxacin European Study Group. [Initial antibiotherapy in severe bacterial bronchopneumopathies. Randomized study of a new quinolone: pefloxacin]. [Comparison of DL-8280 and amoxicillin in the treatment of respiratory tract infections]. Evaluation of roxithromycin (RU-965) versus cephradine in pneumococcal pneumonia. Efficacy and safety of azithromycin versus benzylpenicillin or erythromycin in community-acquired pneumonia. Treatment of community-acquired pneumonia: a randomized comparison of sparfloxacin, amoxycillin-clavulanic acid and erythromycin. The use of oral temafloxacin compared with a parenteral cephalosporin in hospitalized patients with pneumonia. Efficacy and safety of temafloxacin versus those of amoxicillin in hospitalized adults with community-acquired pneumonia. Clarithromycin versus amoxicillin-clavulanic acid in the treatment of community-acquired pneumonia. Prospective study of lower respiratory tract infections in an extended-care nursing home program: potential role of oral ciprofloxacin. A randomized study of ciprofloxacin versus ceftriaxone in the treatment of nursing home-acquired lower respiratory tract infections. Trovafloxacin versus high-dose amoxicillin (1 g three times daily) in the treatment of community-acquired bacterial pneumonia. Efficacy and safety of ciprofloxacin in patients with respiratory infections in comparison with amoxycillin. An open, randomised, multi-centre study comparing the safety and efficacy of sitafloxacin and imipenem/cilastatin in the intravenous treatment of hospitalised patients with pneumonia. [A comparison of moxifloxacin and amoxicillin in the treatment of community-acquired pneumonia in Latin America: results of a multicenter clinical trial]. Comparison of pefloxacin with ceftazidime in severe bronchopulmonary infections.
Evaluation of efficacy and safety of pristinamycin (PRI), compared with amoxicillin (AMX), both at 3 g daily for 7 to 10 days in adults with community-acquired pneumonia (CAP).
                Multinational, randomized, double blind, double dummy clinical trial of non-inferiority was conducted in 399 patients with a CAP.
                At inclusion, the mean age was 47.8+/-18.3 years, 24.3% patients were 65 or older. The Fine score was < or =III in 85.4% patients. The bacterial etiology was documented in 34.8% of patients: Streptococcus pneumoniae (48.1%), Mycoplasma pneumoniae (18.6%), Haemophilus influenzae (14.7%), Chlamydia pneumoniae (13.2%), Legionella pneumophila (9.3%). In the clinical per-protocol population, the clinical success rate was 87.6% in each group: 149/170 patients (PRI) and 148/169 (AMX); The 95% confidence interval was [-6.61%; 7.23%]. In modified intend to treat population, the clinical success rate was 79.9% (151/189) in the PRI group and 83.0% (151/182) in the AMX group [CI 95% (-10.87%; 4.69%)]. A satisfactory bacteriological response was observed in 82.3% (51/62) of PRI patients and 88.1% (59/67) of AMX patients. Treatment related adverse events occurred similarly in both groups according to the expected tolerance profile of the two drugs. No serious adverse events in both groups were related to the study drugs.
                In this study, PRI 3 g daily was clinically as effective and well tolerated as AMX 3 g daily, for 7 to 10 days, in PPc, in the treatment of bacterial community-acquired pneumonia. nan Levofloxacin, an antibiotic from the quinolone family, which is used with success in the ambulatory treatment of patients with community-acquired pneumonia, has been recently introduced to the pharmaceutical market. The purpose of this study was to compare the effectiveness and tolerance of oral (v.o.) levofloxacin (LVF) versus intravenous (i.v.) amoxicillin/clavulanate (AMX/CL) and ceftriaxone (CTX) in the treatment of the community-acquired pneumonia that require hospitalization (CAPH).
                In this prospective and randomized study 84 patients were included, 28 per group, from both sex with CAPH. The patients were assigned randomly to receive one of the next treatments: AMX/CL, 1.02 g i.v. every 8 h, CTX, 1 g i.v. every 12 h or LVF, 500 mg v.o. every 24 h. At the beginning clinical, biochemical and radiological characteristics were recorded from each case and at the 72 h the effect of treatment was evaluated using the evolution of the thermal curve and radiological images. The quantitative variables were analyzed with ANOVA, the qualitatives parameters with *2 test and Yates correction. The level of signification was * = 0.05.
                Age, sex, clinical presentation, biochemical measurements and radiological images in the 3 groups were similar and no adverse effects were recorded in any of them. Number of patients with favorable outcome in the groups AMX/CL, CTX and LVF was 25 (89%), 25 (89%) and 26 (93%); p = 0,870.
                Levofloxacin can be a simple, effective and safe therapeutic option for patients with CAPH. Ofloxacin and amoxicillin in the treatment of 121 bronchopulmonary infections were compared in a randomized, open clinical trial. 64% of the infections were pneumonias. S. pneumoniae, H. influenzae and B. catarrhalis accounted for 76% of the etiologic agents. The clinical and bacteriological responses were positive in more than 90% of the patients and comparable in both groups. None of the isolated agents was resistant to ofloxacin, whereas 21% were amoxicillin-resistant. Ofloxacin was used without randomization in the treatment of 26 atypical pneumonias and opportunistic infections, all of which were cured or improved. Occurrence of side-effects was rarely observed in either treatment group. Community-acquired pneumonia (CAP) is common among adults and contributes considerably to morbidity and mortality.
                To compare the safety and efficacy of gemifloxacin to high-dose amoxicillin/clavulanate for the treatment of CAP of suspected pneumococcal origin.
                Randomized, multicentre, double-blind, double-dummy, parallel group Phase III study.
                From September 1998 to July 1999, 324 patients with CAP were randomized at 102 centers in France, Poland and the Republic of South Africa.
                Patients were double-blind randomized to receive either oral gemifloxacin 320 mg once daily for 7 days or oral amoxicillin/clavulanate 1 g/125 mg three times daily for 10 days.
                The main outcome measures were clinical, bacteriological, and radiological responses at the end of therapy (day 12-14) and follow-up (day 24-30) visits.
                In 228 PP patients, clinical resolution at follow-up was 88.7% for 7-day gemifloxacin and 87.6% for 10-day amoxicillin/clavulanate [95% CI, -7.3, 9.5]. In 249 PP patients, clinical resolution at end of therapy was 95.3% for 7-day gemifloxacin vs. 90.1% for 10-day amoxicillin/clavulanate [95% CI, -1.2, 11.7]. Bacteriologic response rates for the PP patients at end of therapy were 96.3% for 7-day gemifloxacin and 91.8% for the amoxicillin/clavulanate group [95% CI, -4.7, 13.6]. Bacteriologic response rates at follow-up were 87.2% for 7-day gemifloxacin and 89.1% for the amoxicillin/clavulanate group [95% CI, -15.0, 11.2]. Specifically gemifloxacin eradicated 95.7% of Streptococcus pneumoniae including penicillin and macrolide resistant strains. Radiological response rates for the PP patients at end of therapy were 89.1% for 7-day gemifloxacin and 87.6% for the amoxicillin/clavulanate group. The most frequently reported drug-related events were in the gemifloxacin group, diarrhea (6.0%) and rash (3.0%) and in the amoxicillin/clavulanate group, diarrhea (11.1%) and fungal infection, vaginitis and vomiting (each 2.0%). Overall there were statistically fewer withdrawals due to lack of therapeutic effect in the gemifloxacin group compared with the amoxicillin/clavulanate cohort, (95% CI, -8.8;0.6; P = 0.03).
                Gemifloxacin 320 mg once daily for 7 days was found to be clinically, bacteriologically, and radiologically as effective as 10 days of amoxicillin/clavulanate 1 g/125 mg three times daily for the treatment of suspected pneumococcal CAP. In this open, prospective, study were enrolled 204 hospitalized elderly patients with severe (88 males, 116 females, age range 70-94). Patients were randomized to receive one of the following antibiotic treatment regimens: meropenem 500 mg i.v. t.i.d. (52); imipenem/cilastatin 500 mg i.v. t.i.d. (51), clarithromycin 500 mg + ceftriaxone 1 g i.v. b.i.d. (52), clarithromycin 500 mg + amikacin 250 mg i.v. b.i.d. (49). In 99 cases causative germs were isolated (24 meropenem, 26 imipenem, 23 clarithromycin + ceftriaxone, 26 ceftriaxone + amikacin). A satisfactory clinical, bacteriological response was achieved respectively in 86.5% 77% in meropenem; 86.3% 71% in imipenem/cilastatin; 69% 61% in ceftriaxone + clarithromycin and in 85.7% 77% in clarithromycin + amikacin. The mean total cost for each patient was $1,560; $1,620; $1,760 and $1,792 in meropenem, imipenem/cilastatin, clarithromycin + ceftriaxone and clarithromycin + amikacin respectively. This study shows that treatment with either meropenem or imipenem is as efficacious as conventional therapy in the treatment of community acquired pneumonia (CAP), and that meropenem is the most cost-effective. A multinational, multicentre, open, randomised study in hospitalised patients with pneumonia compared levofloxacin 500 mg twice daily with ceftriaxone 4 g i.v. once daily. Levofloxacin patients started on i.v. treatment and switched to oral on d 3-5 of therapy if signs and symptoms had improved. The minimum treatment duration was 5 d, except for treatment failure, and the median 8 d. The primary efficacy analysis was based on the per-protocol assessment of the clinical cure rate determined 2-5 d after the end of treatment in the per-protocol (PP) population (levofloxacin 127, ceftriaxone 139). Of 625 patients enrolled and randomized, 6 received no treatment, giving an intention-to-treat (ITT) population of 619 (levofloxacin 314, ceftriaxone 305). At the clinical endpoint, 2-5 d after the end of treatment, the cure rates for levofloxacin and ceftriaxone were similar in both the ITT (76% and 75%, respectively) and PP (87% and 86%, respectively) populations. Both drugs were well tolerated. Twice-daily levofloxacin 500 mg, either i.v. or as sequential i.v./oral therapy, was as effective as i.v. once-daily ceftriaxone 4 g in the treatment of hospitalized patients with pneumonia and offers the advantage of sequential therapy. The objective of this randomized, double-blind, multicenter study of 329 adult patients requiring hospitalization was to compare the safety and efficacy of sparfloxacin at a dosage of 200 mg once daily (following a 400-mg loading dose on day 1) with those of amoxicillin given as a 1-g oral dose three times daily for treatment of community-acquired pneumonia suspected to be due to Streptococcus pneumoniae. Success of treatment was determined by a combination of clinical assessment and chest radiography. Pneumococcal pneumonia was the confirmed diagnosis for 177 patients (54%). Overall rates of success among evaluable patients were equivalent between drugs, both at the end of treatment (sparfloxacin, 92%; amoxicillin, 87%) and at follow-up (sparfloxacin, 89%; amoxicillin, 84%). Sparfloxacin was well-tolerated and produced fewer gastrointestinal effects than amoxicillin. In conclusion, sparfloxacin is a safe and effective alternative to high-dose amoxicillin for the treatment of suspected pneumococcal community-acquired pneumonia. nan nan One hundred and sixty black South African gold miners with acute pneumococcal pneumonia were enrolled in a prospective randomized double-blind trial comparing roxithromycin (150 mg 2 X day) with cephradine (1.0 g 2 X day). Ninety patients with pneumonia caused by Streptococcus pneumoniae were treated for 5-10 days. Forty-three of 46 (93.4%) of the roxithromycin and all 44 (100%) of the cephradine treated groups had satisfactory clinical responses. In eight of the 46 (17%) roxithromycin treated patients and 10 of the 44 (23%) cephradine treated patients, Streptococcus pneumoniae was not eradicated from sputum cultures by the tenth day. Side effects in 18 patients (20%) were mild and were usually manifested by elevation of the transaminases; these were more common in the cephradine group (12) than in the roxithromycin group (5). Roxithromycin appears to be a safe and effective oral antibiotic for treatment of patients with mild to moderate pneumococcal pneumonia. Azithromycin, a recently introduced antibiotic, offers the potential advantages of short-course administration and lower toxicity compared to other macrolides. Approved for the treatment of mild pneumonia, this drug was investigated in a study of patients hospitalized for community-acquired pneumonia. In an open-labelled randomized study, oral azithromycin was compared with intravenous benzylpenicillin in patients suspected to have pneumococcal pneumonia. Azithromycin was also compared with erythromycin, both administered orally, in all other patients. Three hundred thirty-four patients with community-acquired pneumonia were hospitalized, 108 of whom were randomized; 104 could be evaluated. A need for intravenous therapy was the most common reason for exclusion. In the pneumococcal group, 35 patients received azithromycin and 29 benzylpenicillin. The clinical and radiological success rate achieved with azithromycin (83%) was considerably higher than that achieved with benzylpenicillin (66%), though the difference was not significant. In the non-pneumococcal group, 19 patients received azithromycin and 21 erythromycin; no differences in the success rate were found (79% and 76%, respectively). Eight patients on azithromycin had a blood culture positive for Streptococcus pneumoniae; in three of these patients therapy was changed. None of the five patients with pneumococcal bacteraemia who received benzylpenicillin required a change in therapy. It is concluded that oral azithromycin, administered as short-course therapy, is an appropriate antibiotic for treating patients with community-acquired pneumonia. However, it is not yet certain that azithromycin is a good choice for patients with pneumococcal bacteraemia. The treatment of community-acquired pneumonia is empirical in most cases and must cover a wide range of potential pathogens, such as Streptococcus pneumoniae, including penicillin-resistant strains, Haemophilus influenzae and intracellular microorganisms. The objective of this double-blind, randomized, parallel group study was to compare the efficacy and safety of sparfloxacin (400 mg loading dose, followed by 200 mg o.d.) with that of oral amoxycillin-clavulanic acid (500/125 mg t.i.d.) or oral erythromycin (1 g b.i.d.), during 7-14 days in 808 patients with confirmed community-acquired pneumonia. The overall success rates for sparfloxacin (87%), amoxycillin-clavulanic acid (80%) and erythromycin (85%) were similar in evaluable patients, and the equivalence hypothesis used for the statistical analysis showed at least an equivalent efficacy for the three antibiotics tested. The analysis of microbiologically documented infections (40% of the patients) showed that overall success rates were similar for S. pneumoniae and H. influenzae infections. Treatment withdrawal was necessary in 3.5, 2.5 and 7.7% of the patients treated with sparfloxacin, amoxycillin-clavulanic acid and erythromycin, respectively. This study indicates that sparfloxacin was at least as effective as amoxycillin-clavulanic acid or erythromycin in the treatment of mild-to-moderate community-acquired pneumonia and that the adverse effects were similar in the three groups. In a European open, multicentre, prospective clinical trial, 100 hospitalized adult patients (61 males; 18-91 years old (mean age 62] with bacterial pneumonia, diagnosed clinically and radiographically, were randomized to receive either oral temafloxacin 600 mg twice daily (n = 49) or intravenous cefotaxime 2 g thrice daily (n = 51). Signs, symptoms and chest radiographs were assessed during, at the end of therapy and at follow-up eight to ten days after the last dose. Patients were treated for a maximum of ten days. Sputum was obtained for culture before, during and after therapy. The clinical cure rate for the temafloxacin treatment group was 90%, the bacteriological cure rate was 91% and the radiological response rate was 95%. The respective rates for the cefotaxime-treated group were 92%, 96% and 100%. There were no significant differences between the treatment groups for clinical or microbiological outcome, premature study discontinuation, or adverse events. Oral temafloxacin was clinically and bacteriologically equivalent to intravenous cefotaxime in the treatment of hospitalized adults with bacterial pneumonia. Temafloxacin, a new fluoroquinolone, was compared with amoxicillin in the treatment of adult hospitalized patients with community-acquired pneumonia. In this double-blind, multicenter study, patients were randomly assigned to treatment with temafloxacin at 600 mg twice daily (n = 125) or amoxicillin at 500 mg three times daily (n = 121); the average duration of treatment was 10 days. Clinical recovery rates were similar for patients treated with temafloxacin and amoxicillin (89 and 85%), as were bacterial eradication rates (99 and 97%). This was also true for subgroups of patients with pneumococcal pneumonia (n = 100), nonpneumococcal pneumonia (n = 122), or atypical pneumonia (n = 12). Outcomes for temafloxacin- and amoxicillin-treated patients were also similar in terms of defervescence, improvement in leukocytosis, and radiographic evidence of infection. The frequency and severity of adverse events were similar in both groups, consisting primarily of digestive disorders and skin manifestations. We conclude that temafloxacin may be recommended as an alternative antibacterial drug for patients with suspected pneumococcal pneumonia who fail to respond to benzylpenicillin or amoxicillin when the incidence of multiresistant pneumococcal strains is low. In countries where the incidence of these strains is high, temafloxacin may also be recommended. In an open, prospective, randomised study, the clinical and bacteriological efficacy of intravenously administered clarithromycin was compared with that of amoxicillin-clavulanic acid in 112 patients with community-acquired pneumonia requiring hospitalisation. Clinical cure or improvement occurred in 86% (48/56) of the clarithromycin-treated patients and 84% (47/56) of the amoxicillin-clavulanic acid-treated patients. The rate of bacteriologic eradication was similar for the two drugs as were the rapidity of a clinical response and the rate of improvement of radiological signs. Clarithromycin had a slightly higher rate of side-effects mainly due to phlebitis caused by the intravenous treatment, but treatment could be continued in all cases. Clarithromycin should be used with caution in patients being treated with digoxin because of a significant risk of bradycardia resulting from drug interaction. Infections of the lower respiratory tract pose an important problem in nursing homes. Despite the magnitude of this problem, few, if any, antibiotic studies have been targeted specifically at nursing home-acquired bronchopulmonary infections. Following the establishment of a teaching Extended-Care Nursing Home Program, which facilitated the early diagnosis and therapy of bronchopulmonary infections, a comparative trial of oral ciprofloxacin and intramuscular cefamandole was initiated in elderly patients with lower respiratory tract infections. In addition to assessing the relative efficacy and safety of ciprofloxacin and cefamandole, our goals were to identify problems and pitfalls associated with conducting clinical research in this nursing home setting, evaluate selected clinical and laboratory features of lower respiratory tract infection in this patient population, and measure outcomes in all study groups. PATIENTS and
                During a 20-month period, 40 patients with pneumonia and 20 patients with acute bronchitis were enrolled in this randomized study. Sixty-three patients with pneumonia who were ineligible for the randomized study were also followed prospectively. The mean age of the 111 participants (123 cases) was 80.8 years; all patients had at least one chronic medical condition.
                Although Streptococcus pneumoniae was the single most common isolate, gram-negative bacteria were cultured from 81 percent of the cases that yielded pathogens from a satisfactory sputum specimen. The in-hospital mortality rate was strikingly low (6.5 percent), and a large majority of patients in all study groups were discharged safely back to their nursing homes well within the Diagnosis-Related Group length of stay.
                Ciprofloxacin appeared to be as safe and effective as cefamandole in this nursing home program; however, additional studies are needed to determine its role in the treatment of elderly patients with bronchopulmonary infections. To compare the efficacy and safety of ciprofloxacin and ceftriaxone in patients with nursing home-acquired lower respiratory tract infections requiring initial hospitalization.
                Prospective, randomized trial.
                Extended care nursing homes affiliated with a teaching hospital.
                Fifty patients aged 60 years or older with normal or mildly impaired renal function admitted to the hospital for treatment of lower respiratory tract infections.
                Twenty-four patients received initial therapy with intravenous ciprofloxacin, 200 mg every 12 hours (19 patients) or 400 mg every 12 hours (5 patients) during the acute phase followed by 750 mg orally every 12 hours during the convalescence phase. Twenty-six patients received initial therapy with intravenous ceftriaxone, 2 g every 24 hours during the acute phase followed by 1 g administered intramuscularly every 24 hours during the convalescent phase. The total duration of therapy was 14 days.
                Successful outcome was defined as resolution or marked improvement in clinical signs and symptoms of lower respiratory tract infection upon completion of the treatment course.
                Twelve (50%) of the ciprofloxacin-treated and 14 (54%) of ceftriaxone-treated patients had successful outcomes. Recurrent oropharyngeal aspiration was the reason for treatment failure in most patients refractory to either antibiotic. Mortality during therapy was 8% in each group. From 21 satisfactory sputum specimens collected, S. pneumoniae was the most common isolate, followed by H. influenzae and other Gram-negative bacteria. Ciprofloxacin therapy was well tolerated; ceftriaxone therapy was discontinued in two patients (8%) due to adverse reactions (intramuscular pain and drug fever).
                Sequential intravenous/oral ciprofloxacin appears to be as safe and effective as sequential intravenous/intramuscular ceftriaxone. The optimal dosage of intravenous ciprofloxacin in this patient population appears to be 400 mg every 12 hours; however, additional clinical and pharmacokinetic studies with this regimen are warranted. Once-daily trovafloxacin 200 mg was compared with high-dose amoxicillin, 1 g three times daily, given for 7 to 10 days. At end of treatment (day 10), the response was clinically successful (cure + improvement) in 93% of 152 clinically evaluable trovafloxacin patients and in 89% of 160 amoxicillin patients. At study end (day 35), respective rates were 91% and 81% (95% confidence interval: 1.6, 17.6; P=0.01). In evaluable patients with positive baseline radiographs, 93% of trovafloxacin and 88% of amoxicillin patients demonstrated radiological resolution at end of treatment. Streptococcus pneumoniae and Haemophilus influenzae eradication rates were comparable at end of treatment in both treatment groups, but at study end Streptococcus pneumoniae eradication rates were higher in trovafloxacin patients (100% vs 81%). At study end, all four trovafloxacin patients with baseline penicillin-resistant Streptococcus pneumoniae were clinically cured with pathogen eradication, whereas two of five amoxicillin patients with baseline penicillin-resistant Streptococcus pneumoniae were clinical failures with pathogen persistence. For patients in whom no pathogen was identified, trovafloxacin was significantly more effective at end of treatment (P=0.096) and study end (P=0.013). Treatment-related adverse events were comparable; the most common were headache, vomiting and dizziness in trovafloxacin patients, and diarrhoea. headache and abdominal pain in amoxicillin patients. Ciprofloxacin and amoxycillin were compared in the treatment of respiratory infections (pneumonia, acute bronchitis, exacerbation of chronic lung disease) in a study of 48 patients randomly assigned to ten days treatment with standard doses of either drug. Forty-eight patients were evaluated, 26 in the ciprofloxacin group and 22 in the amoxycillin group. The response to therapy was judged by clinical and bacteriological criteria. Ciprofloxacin was as effective as amoxycillin with a successful outcome in 81% and 82% of cases respectively. A specific bacterial cause was determined in just over half the cases (28 patients) and eradication rates were higher for ciprofloxacin than for amoxycillin, 87% and 64% respectively. In particular, amoxycillin was unsuccessful in two patients infected with Branhamella catarrhalis. Both regimens were safe and produced little, if any, adverse effect (one possible episode in each treatment group). Ciprofloxacin was found to be as effective in bacterial respiratory tract infections as amoxycillin. This was a phase II, randomised, open-label, multi-centre study to assess the safety, tolerability, and efficacy of sitafloxacin (DU-6859a, 400 mg once daily) compared with imipenem (imipenem/cilastatin, 500 mg three times daily) in the treatment of hospitalised patients with pneumonia. Patients (n=69) were entered into the study in the intent-to-treat group, 35 in the sitafloxacin and 34 in the imipenem group. Patients (n=65) were included in the clinically evaluable population and 42 in the bacteriologically evaluable population. Baseline demographic data and clinical characteristics were similar for both treatment groups and across all patient populations. The incidence, severity and type of adverse events were similar in both treatment groups. The frequency of adverse events, which were considered to be related to the study of drugs was low and generally similar between the two groups. Mild transient increases in alanine aminotransferase and alkaline phosphatase occurred in the sitafloxacin treatment group, but there were no apparent trends in the other serum enzyme levels. The clinical response at the first and second follow-up assessments indicated that 94-97% of patients in the clinically evaluable population and 91% of patients in the intent-to-treat population were classified as cured in both treatment groups. The bacteriological response was classified as satisfactory for all patients (100%) in the bacteriologically evaluable population in the imipenem treatment group and satisfactory for 90 and 95% of cases at the first and second follow-up assessments in the bacteriologically evaluable population in the sitafloxacin treatment group, respectively. In conclusion, for the treatment of pneumonia, sitafloxacin was considered as safe and as tolerable as imipenem and preliminary data from this study suggest that it may have similar efficacy. Since community-acquired pneumonia (CAP) is a common disease with a high morbidity rate, it is important to obtain information concerning its etiology and susceptibility to antibiotics across different geographic areas. This study presents data obtained in 5 Latin American counties in the course of an international clinical trial that evaluated the efficacy and safety of treatment with either moxifloxacin or amoxicillin administered for 10 days to patients suspected of having CAP caused by a pneumococcal infection. Details are given of the pathogens identified, the patterns of sensitivity to antibiotics observed, and the clinical and microbiological results obtained.A total of 84 patients were studied, of whom 70 (83.3%) were evaluated at the end of the trial to determine the efficacy and safety of the treatment received. Gram-positive bacteria were found in samples from 29 patients (80.5%). The pathogen was Streptococcus pneumoniae in 28 of those cases (77.7%). Gram-negative bacteria were found in 7 patients (19.4%), the most common being Haemophilus influenzae in 3 patients (8.3%). The presence of atypical microorganisms was detected in 18 of the 70 patients (25%), mainly Mycobacterium pneumoniae (n=11), and in 6 cases (8.5%) the infection was mixed. Ten strains of S. pneumoniae (35.7%) were shown to be susceptible to penicillin, 2 (7.1%) were highly resistant, and 16 (57.1%) showed moderate resistance. The clinical success rate at the final visit after treatment was 94.1% for moxifloxacin and 91.7% for amoxicillin. The results of this trial demonstrate a high prevalence of S. pneumoniae with reduced susceptibility to penicillin in patients with CAP in Latin America. It also revealed a high incidence of atypical pathogens and mixed infection in 8.6% of patients. This information should be taken into account when establishing protocols for empirical treatment of CAP in Latin America. In a prospective open randomized multicentre trial pefloxacin (400 mg twice daily, orally) or ceftazidime (2 g twice daily iv) were given to 82 and 88 patients, respectively, with serious bronchopulmonary infection, defined as: infection occurring in high risk patients, or infection that had failed to respond to previous antimicrobials, or infection by a multiresistant pathogen. An additional nitroimidazole was allowed if the culture demonstrated the presence of anaerobes considered pathogenic. Efficacy analysis was possible in 139 patients, 70 in the ceftazidime group, 69 in the pefloxacin group. In the efficacy population, 93 bacterial strains were isolated in the pefloxacin group and 89 in the ceftazidime group. There were more Streptococcus spp. in the ceftazidime group (21) than in the pefloxacin group (14) (P = 0.06). A successful clinical response was observed in 45 patients give pefloxacin (65.2%) and 51 patients given ceftazidime (72.9%). The difference was not statistically significant. There were two relapses with pefloxacin and six with ceftazidime. In the pefloxacin group 86 pathogens (91%) and in the ceftazidime group 78 pathogens (88%) were eradicated. There were 18 and 13 adverse reactions with ceftazidime and pefloxacin, respectively. In this study, pefloxacin was as effective and as safe as ceftazidime in the treatment of severe bronchopulmonary infections.
No benefit of survival or clinical efficacy was shown with empirical atypical coverage in hospitalized patients with CAP. This conclusion relates mostly to the comparison of quinolone monotherapy to beta-lactams. Further trials, comparing beta-lactam monotherapy to the same combined with a macrolide, should be performed.