Intramuscular bipenicillin vs. intravenous penicillin in the treatment of erysipelas in adults: randomized controlled study. Can cycloidal vibration plus standard treatment reduce lower limb cellulitis treatment times? Antibiotic and prednisolone therapy of erysipelas: a randomized, double blind, placebo-controlled study. Once-daily intravenous cefazolin plus oral probenecid is equivalent to once-daily intravenous ceftriaxone plus oral placebo for the treatment of moderate-to-severe cellulitis in adults. Once-daily oral gatifloxacin versus oral levofloxacin in treatment of uncomplicated skin and soft tissue infections: double-blind, multicenter, randomized study. Azithromycin, erythromycin and cloxacillin in the treatment of infections of skin and associated soft tissues. European Azithromycin Study Group. Ampicillin/sulbactam versus cefazolin or cefoxitin in the treatment of skin and skin-structure infections of bacterial etiology. Double-blind, double-dummy comparison of azithromycin and cephalexin in the treatment of skin and skin structure infections. Efficacy of two dosage schedules of cephalexin in dermatologic infections. Linezolid versus vancomycin in treatment of complicated skin and soft tissue infections. Oral pristinamycin versus standard penicillin regimen to treat erysipelas in adults: randomised, non-inferiority, open trial. Roxithromycin versus penicillin in the treatment of erysipelas in adults: a comparative study. Flucloxacillin alone or combined with benzylpenicillin to treat lower limb cellulitis: a randomised controlled trial. Current and future management of serious skin and skin-structure infections. Comparison of short-course (5 days) and standard (10 days) treatment for uncomplicated cellulitis. Sequential intravenous/oral moxifloxacin versus intravenous piperacillin-tazobactam followed by oral amoxicillin-clavulanate for the treatment of complicated skin and skin structure infection. Cefdinir versus cephalexin for the treatment of skin and skin-structure infections. The Cefdinir Adult Skin Infection Study Group. Randomized, double-blind, multicenter comparison of oral cefditoren 200 or 400 mg BID with either cefuroxime 250 mg BID or cefadroxil 500 mg BID for the treatment of uncomplicated skin and skin-structure infections. Meropenem versus imipenem-cilastatin for the treatment of hospitalized patients with complicated skin and skin structure infections: results of a multicenter, randomized, double-blind comparative study.
The objective of the study was to evaluate the efficacy of intramuscular penicillin: mixture of benzyl penicillin and procain penicillin (2 MU x 2 times daily) and intravenous benzyl penicillin (4 MU x 6 times daily) in the treatment of hospitalized adult patients with erysipelas. A prospective randomized unicentric trial was conducted. In total, 112 patients entered the study; 57 in the intramuscular group and 55 patients in the intravenous group completed the trial. The failure rate was 14% for intramuscular group and 20% for the intravenous group (P = 0.40). Local complications such as of the leg abscesses were observed in the two groups (intravenous 9.1%, intramuscular 7%; P = 0477). Of the patients treated with intravenous benzyl penicillin, 25.5% presented complications related to the route (venitis). Intramuscular penicillin should be considered an effective and well-tolerated treatment of erysipelas in adult patients. This single-centre non-blind randomised controlled trial aimed to compare clinical outcomes in terms of recovery time of standard treatment of lower limb cellulitis versus standard treatment combined with cycloidal vibration (Vibro-Pulse) therapy.
                Thirty-six patients (18 per group) with lower limb cellulitis were randomised to receive either standard treatment (intravenous or oral antibiotic therapy) and bed rest or standard treatment combined with cycloidal vibration treatment three times per day, 30 minutes per treatment. The outcome measure was the daily amount of reduction in erythema/cellulitis and oedema reduction against time for up to seven days of treatment and the resources required.
                There was a clinically significant difference between the two groups, with 66% of the study group fully recovering within the seven days compared with 11% of the control group.
                Cycloidal vibration combined with standard therapy can significantly reduce cellulitis treatment time. This can reduce both hospital bed days and the resources required. 112 patients admitted to hospital with a diagnosis of erysipelas, were randomized to 8 days treatment with prednisolone or placebo in addition to antibiotics. 108 patients received the study drugs and were evaluated for time to cure, which was the primary end-point. The median healing time was significantly shorter in the prednisolone group, 5 days, vs 6 days in the placebo group (p < 0.01). The 90th percentile healing time was 10.0 days in the prednisolone group vs 14.6 days in the control group. The prednisolone-treated patients had a median length of hospital stay (secondary end-point) of 5 days vs 6 for the placebo-treated (p < 0.01). The median treatment time with intravenous antibiotics (secondary end-point) was 4 days in the placebo group, which was 1 day longer than in the prednisolone group (p < 0.05). 13 patients, 7 of whom received placebo, relapsed during the observation period of 3 weeks. The frequency of side effects attributable to the study drug was not higher in the prednisolone group. A once-daily regimen of cefazolin (2 g intravenously [iv]) plus probenecid (1 g by mouth) was compared with a once-daily regimen of ceftriaxone (1 g iv) plus oral placebo in a randomized, double-blind equivalence trial of home-based therapy for moderate-to-severe cellulitis in adults. For the assessable recipients of cefazolin-probenecid (n=59) and ceftriaxone-placebo (n=57), clinical cure occurred at the end of treatment in 86% and 96% (P=.11), respectively, and was maintained at 1 month of follow-up in 96% and 91% (P=.55), respectively. The mean number of treatment doses (+/-standard deviation) given was similar in the 2 treatment arms (6.97+/-2.6 for cefazolin-probenecid and 6.12+/-2.1 for ceftriaxone-placebo; P=.06). The median antibiotic trough concentrations were 2.35 microgram/mL for cefazolin and 15.45 microgram/mL for ceftriaxone. Patients in the 2 treatment arms were similar with regard to overall rates of adverse reaction (P=.15), but nausea was more common among those in the cefazolin-probenecid arm (P=.048). The once-daily regimen of cefazolin-probenecid is a cheap, practical, and effective treatment option for moderate-to-severe cellulitis, and it avoids the need to use third-generation cephalosporins in most patients. This was a double-blind, multicenter study in which 410 adults (> or =18 years of age) with uncomplicated skin and soft tissue infections (SSTIs) were randomized to receive either 400 mg of gatifloxacin orally once daily or 500 mg of levofloxacin orally once daily for 7 to 10 days. The study protocol called for four assessments-before and during treatment, at the end of treatment, and posttreatment. Efficacy evaluations included clinical response and bacterial eradication rates. Of 407 treated patients, 202 (108 women, 94 men) received gatifloxacin and 205 (111 women, 94 men) received levofloxacin. For clinically evaluable patients, the cure rates were 91% for gatifloxacin and 84% for levofloxacin (95% confidence interval [CI] for the difference, -2.0 to 15.2%). Clinical cure rates for microbiologically evaluable patients were 93% for gatifloxacin and 88% for levofloxacin (95% CI for the difference, -6.5 to 16.8%). The bacterial eradication rate was 92% for each group, with gatifloxacin eradicating 93% of the methicillin-susceptible Staphylococcus aureus isolates and levofloxacin eradicating 91% of them. Both drugs were well tolerated. Most of the adverse events were mild to moderate, and nausea was the most common adverse event in each treatment arm. Once-daily oral gatifloxacin (400 mg) is clinically efficacious and well tolerated compared with once-daily levofloxacin (500 mg) for the treatment of patients with uncomplicated SSTIs. Azithromycin (total dose 1.5 g) given orally in five or six doses over 5 days was compared with erythromycin and cloxacillin both given orally as 500 mg four times daily for 7 days in two multicentre studies of patients with skin and associated soft-tissue infections. Azithromycin eradicated baseline pathogen(s), mainly Staphylococcus aureus, in 89% compared with in 78%, of erythromycin-treated patients (P = 0.501) and in 78% compared with in 59% of cloxacillin-treated patients (P = 0.421). No statistically significant difference in clinical cure was reported between azithromycin (74%) and erythromycin (75%, P = 1.00) and between azithromycin (60%) and cloxacillin (47%, P = 0.301) treatment groups. The side-effects reported for azithromycin were mainly mild or moderate gastro-intestinal complaints and there were no major abnormalities in laboratory parameters. It is concluded that azithromycin was as effective as, but better tolerated than, either erythromycin or cloxacillin and short-course therapy may improve patient compliance. This randomized, double-blind study compared 1 g of ampicillin plus 0.5 g of sulbactam with 0.5 g of cefazolin in the treatment of cellulitis and with 1 g of cefoxitin in other skin and skin-structure infections. Study drugs were administered intravenously every 6 hours to 58 hospitalized patients. Each indication was evaluated separately. In cellulitis, ampicillin/sulbactam and cefazolin produced clinical cure or improvement in 100% and 91.7% of patients, respectively; duration of hospitalization was 7.7 and 7.2 days. In other skin and skin-structure infections, results for ampicillin/sulbactam and cefoxitin, respectively, were clinical cure or improvement, 80% and 64.7%; treatment failures, 0% and 11.8%; bacterial eradication, 40% and 53%; and duration of hospitalization, 7.7 and 9.4 days. No unusual or unexpected adverse experiences related to any study drug occurred. One patient treated with ampicillin/sulbactam died of a pulmonary embolism, and 1 patient treated with cefoxitin was discontinued from the study following amputation of an infected foot. These events were not considered drug-related. The treatment groups showed no statistically significant differences in efficacy or safety. In this double-blind, randomised trial conducted in 22 centres in the USA, azithromycin given over five days, as a once-a-day regimen, (500 mg on day 1, 250 mg on days 2-5) was compared with cephalexin (500 mg b.i.d.) given for ten days in the treatment of patients with skin and skin structure infections. A total of 366 patients entered the study and 179 of these were eligible for the efficacy analysis. The overall clinical response to azithromycin was 94.0%, compared with 95.8% for cephalexin. The clinical cure rates were 53.0% for azithromycin and 59.4% for cephalexin; the respective improvement rates were 41.0% and 36.5%. Distribution of response (cured, improved, failed) was similar in each group (p = 0.37). The bacteriological eradication rate for azithromycin-treated patients was 94.2% and for cephalexin-treated patients was 90.3% (p = 0.34). Clinical and bacteriological response was similar in each group for all primary diagnoses. The two antibiotics were well tolerated, the overall incidence of side effects being 13.7% with approximately 60% due to gastrointestinal disturbances. In all but one case (cephalexin) the severity of the reported side effects was mild or moderate. Six patients withdrew from the study due to treatment-related events; five had been treated with azithromycin and one with cephalexin. In summary, a five-day, once-daily regimen of azithromycin was as effective as a ten-day, twice-daily regimen of cephalexin in the treatment of patients with skin and skin structure infections. Is the administration of oral antibiotics four times a day as necessary as some pharmacokinetic studies indicate? The efficacy of cephalexin administered twice a day was compared to the same drug administered four times a day for the treatment of skin and skin structure infections due to staphylococcus and/or streptococcus. The 154 outpatients in this four-clinic study ranged in age from 1 month to more than 70 years. A random number table was used to assign patients to either the twice a day or the four times a day regimen. The total daily dosage was the same in each regimen. Administration twice a day proved equally effective to the four times a day regimen. Both regimens were more than 97 percent effective and side effects were minimal. Skin and soft tissue infections (SSTIs) are a common cause of morbidity in both the community and the hospital. An SSTI is classified as complicated if the infection has spread to the deeper soft tissues, if surgical intervention is necessary, or if the patient has a comorbid condition hindering treatment response (e.g., diabetes mellitus or human immunodeficiency virus). The purpose of this study was to compare linezolid to vancomycin in the treatment of suspected or proven methicillin-resistant gram-positive complicated SSTIs (CSSTIs) requiring hospitalization. This was a randomized, open-label, comparator-controlled, multicenter, multinational study that included patients with suspected or proven methicillin-resistant Staphylococcus aureus (MRSA) infections that involved substantial areas of skin or deeper soft tissues, such as cellulitis, abscesses, infected ulcers, or burns (<10% of total body surface area). Patients were randomized (1:1) to receive linezolid (600 mg) every 12 h either intravenously (i.v.) or orally or vancomycin (1 g) every 12 h i.v. In the intent-to-treat population, 92.2% and 88.5% of patients treated with linezolid and vancomycin, respectively, were clinically cured at the test-of-cure (TOC) visit (P=0.057). Linezolid outcomes (124/140 patients or 88.6%) were superior to vancomycin outcomes (97/145 patients or 66.9%) at the TOC visit for patients with MRSA infections (P<0.001). Drug-related adverse events were reported in similar numbers in both the linezolid and the vancomycin arms of the trial. The results of this study demonstrate that linezolid therapy is well tolerated, equivalent to vancomycin in treating CSSTIs, and superior to vancomycin in the treatment of CSSTIs due to MRSA. To assess the efficacy and safety of oral pristinamycin versus intravenous then oral penicillin to treat erysipelas in patients in hospital.
                Multicentre, parallel group, open labelled, randomised non-inferiority trial.
                22 French hospitals.
                289 adults admitted to hospital with erysipelas.
                At follow up (day 25-45) the cure rate (primary efficacy end point) for the per protocol populations was 81% (83/102) for pristinamycin and 67% (68/102) for penicillin. The planned interim analysis (global one sided type I error 5%) showed that the one sided 97.06% confidence interval of the observed difference (pristinamycin-penicillin) between cure rates (3.3% to infinity ) exceeded the -10% non-inferiority threshold. For the intention to treat populations the cure rate at follow up was 65% (90/138) for pristinamycin and 53% (79/150) for penicillin, with the one sided 97.06% confidence interval of the observed difference between cure rates (1.7% to infinity ) exceeding the -10% non-inferiority threshold. That the lower limit of the confidence interval exceeded the -10% threshold and was also >0 supports the hypothesis that pristinamycin is significantly superior at the 5% level. More adverse events related to treatment, as assessed by the investigators, were reported in the pristinamycin group than in the penicillin group. Most adverse events involved the gastrointestinal tract (nausea, vomiting, and diarrhoea) but were minor and usually did not require discontinuation of treatment.
                Pristinamycin could be an alternative to the standard intravenous then oral penicillin regimen used to treat erysipelas in adults in hospital, with the advantages of oral first line therapy. A prospective, randomized, multicentre trial was conducted to evaluate the efficacy and safety of roxithromycin (150 mg b.i.d. orally) and penicillin (2.5 MU x 8 daily intravenously, then 6 MU daily orally) in the treatment of hospitalized adult patients with erysipelas. Seventy-two patients entered the study. Thirty-one patients in the roxithromycin group and 38 patients in the penicillin group completed the trial. The overall efficacy rates (cure without additional antibiotics) were 84% (26/31) in the roxithromycin group and 76% (29/38) in the penicillin group (P = 0.43). No side-effects were observed in the roxithromycin-treated patients whereas rashes occurred in two cases in the penicillin group, leading to exclusion from the study. Oral roxithromycin can thus be considered an effective and well-tolerated treatment for erysipelas in adult hospitalized patients. To determine whether using intravenous benzylpenicillin in addition to intravenous flucloxacillin would result in a more rapid clinical response in patients with lower limb cellulitis.
                This was a randomised controlled trial set in an inner city teaching hospital, comprising 81 patients with lower limb cellulitis requiring intravenous antibiotics. The main outcome measure was the mean number of doses of antibiotic required until clinical response.
                The mean number of doses required was 8.47 (95% confidence interval (CI) 7.09 to 9.86) in the benzylpenicillin and flucloxacillin combined group. In the flucloxacillin only group it was 8.71 doses (95% CI 6.90 to 10.5), a mean difference of -0.24 doses (95% CI -2.48 to 2.01, p = 0.83). Other markers of treatment efficacy showed no difference between groups at review the following day; temperature decrease (mean difference -0.07 degrees C, 95% CI -0.76 to 0.62, p = 0.84), or diameter decrease of affected area (mean difference -34 mm, 95% CI -99 to 31, p = 0.30). Patient subjective assessments were also similar between the different drug regimen; improvement on a visual analogue scale of pain/discomfort from admission to first review (mean difference 10 mm, 95% CI -12.6 to 14.2, p = 0.91) and on second review (mean difference 15 mm, 95% CI -18.6 to 21.6, p = 0.88). Patient overall subjective feelings of improvement on first review (p = 0.32) and on second review (p = 0.64) were also similar.
                This study provides no evidence to support the addition of intravenous benzylpenicillin to intravenous flucloxacillin in the treatment of lower limb cellulitis. The purpose of this study was to compare in a randomized, open-label clinical study, the efficacy and safety of cefepime (1 g every 12 hours) with that of ceftazidime (1 g every 8 hours) in patients with serious skin and skin-structure infections. Of 298 patients enrolled in the study, 130 with serious skin and skin-structure infections were evaluable. Demographics and underlying medical conditions were comparable in both groups. The most common infections were cellulitis, abscesses, ulcers, and postoperative wound infections. The most common pathogens isolated were Staphylococcus aureus, group A streptococci, Enterobacteriaceae, and Pseudomonas aeruginosa. Duration of therapy in the 93 patients treated with cefepime was 3-18 days and in the 37 ceftazidime-treated patients was 4-16 days. Pathogen bacteriologic response rates were high: 92% (124 of 135) of pathogens were eradicated by cefepime and 95% (55 of 58) by ceftazidime. Clinical response rates were satisfactory in 88% (82 of 93) of cefepime-treated patients and in 89% (33 of 37) of ceftazidime-treated patients. Adverse events occurred with similar frequency in both groups. Events probably related to study drugs affected 3% (6 of 198) of patients treated with cefepime and 4% (4 of 100) of ceftazidime-treated patients. Cefepime, a new parenteral cephalosporin administered every 12 hours, is an extremely well tolerated and effective alternative to ceftazidime given every 8 hours for the treatment of serious skin and skin-structure infections. Cellulitis is a condition routinely encountered in the primary care setting. No previous study has compared a short (5 days) vs standard (10 days) course of therapy of the same antibiotic in patients with uncomplicated cellulitis.
                We performed a randomized, double-blind, placebo-controlled trial to determine if 5 days of therapy has equal efficacy to 10 days of therapy for patients with cellulitis. Of 121 enrolled subjects evaluated after 5 days of therapy for cellulitis, 43 were randomized to receive 5 more days of levofloxacin therapy (10 days total antibiotic treatment), and 44 subjects to receive 5 more days of placebo therapy (5 days of total antibiotic treatment). Levofloxacin was given at a dose of 500 mg/d. Subjects were not randomized if they had worsening cellulitis, a persistent nidus of infection, a lack of any clinical improvement, or abscess formation within the first 5 days of therapy. The main outcome measure was resolution of cellulitis at 14 days, with absence of relapse by 28 days, after study enrollment.
                Eighty-seven subjects were randomized and analyzed by intention to treat. There was no significant difference in clinical outcome between the 2 courses of therapy (success in 42 [98%] of 43 subjects receiving 10 days of antibiotic, and 43 [98%] of 44 subjects receiving 5 days of antibiotic) at both 14 and 28 days of therapy.
                In patients with uncomplicated cellulitis, 5 days of therapy with levofloxacin appears to be as effective as 10 days of therapy. In this prospective, double-blind, multicentre trial, adult patients with complicated skin and skin structure infection (cSSSI) randomly received sequential intravenous (i.v.)/oral (p.o.) moxifloxacin (400 mg once a day) or a control regimen of i.v. piperacillin-tazobactam (3.0/0.375 g every 6 h) followed by p.o. amoxicillin-clavulanate (800 mg every 12 h), each for 7-14 days. Clinical cure rates at the test-of-cure visit (10-42 days post therapy) for the efficacy-valid population were 79% (143/180) for the moxifloxacin-treated group and 82% (153/187) for the control group (95% confidence interval, -12.04, 3.29). Bacteriological eradication rates for Staphylococcus aureus, the most prevalent organism, were 78% and 80%, respectively. The incidence of drug-related adverse events was similar for both groups (31% moxifloxacin, 30% control). Sequential i.v./p.o. moxifloxacin was as effective and well tolerated as i.v. piperacillin-tazobactam followed by p.o. amoxicillin-clavulanate in treating patients with cSSSI. Because of increasing resistance to older antimicrobial agents, newer drugs need to be evaluated for the treatment of skin and skin-structure infections (SSSIs). This double-masked, randomized, comparative, multicenter study enrolled patients aged 13 years or older with SSSIs to receive either cefdinir 300 mg BID or cephalexin 500 mg QID for 10 days. Nine hundred fifty-two patients (474 in the cefdinir group and 478 in the cephalexin group) took part, primarily white males between 18 and 65 years of age. There were two follow-up visits, with efficacy determined at the test-of-cure visit, 7 to 16 days posttherapy. Many patients were not microbiologically assessable, primarily because of negative cultures at study admission. Patients who required surgical intervention (e.g., incision and drainage) at the site of infection more than 24 hours after the initiation of drug therapy were defined as treatment failures. Significantly more isolated pathogens were resistant to cephalexin than to cefdinir. In the 178 efficacy-assessable cefdinir-treated patients, the rate of pathogen eradication was 93% (200/215), and the rate of successful clinical response was 88% (157/178), compared with 89% (221/247) and 87% (177/204), respectively, in the 204 efficacy-assessable cephalexin-treated patients. Using confidence-interval analysis, the microbiologic and clinical response rates of the cefdinir-treated patients were statistically equivalent to those of the cephalexin-treated patients. At the follow-up visits, patients were questioned about any adverse events occurring since their previous visit. Any untoward symptom occurring during or within 2 days after completion of drug treatment was considered an adverse reaction if the investigator judged it to be definitely, probably, or possibly related to the study drug. One hundred twenty-three (26%) cefdinir-treated patients and 77 (16%) cephalexin-treated patients experienced at least one adverse reaction, a statistically significant difference. Study drug was discontinued for adverse reactions in 20 (4%) cefdinir-treated patients and 13 (3%) cephalexin-treated patients; in the two groups, 10 and 7 patients, respectively, were discontinued for diarrhea. Cefdinir taken BID was as effective as cephalexin taken QID in the treatment of mild-to-moderate SSSIs and was well tolerated by most patients. The increased antibacterial activity of cefdinir must be balanced against the higher rate of diarrhea seen in patients treated with this drug. Uncomplicated skin and skin-structure infections are commonly observed in medical practice. Because these infections typically are confined to the superficial layers and seldom lead to the destruction of skin structures and resultant systemic dissemination, in general they can be treated with an oral antibiotic with potent microbiologic activity against gram-positive pathogens.
                This paper compares the efficacy and tolerability of 3 beta-lactam antibiotics in patients with uncomplicated skin and skin-structure infections.
                Two double-blind, multicenter, parallel-group studies were conducted, in which patients aged > or = 12 years with uncomplicated skin and skin-structure infections were randomized to receive cefditoren 200 or 400 mg, cefuroxime 250 mg, or cefadroxil 500 mg, each BID for 10 days. Study 1 compared cefditoren with cefuroxime; Study 2 compared cefditoren with cefadroxil. Clinical and microbiologic responses were assessed at a posttreatment visit (within 48 hours of treatment completion) and test-of-cure visit (7-14 days after treatment completion). Patients were monitored closely throughout the study with the use of physical examinations, clinical laboratory tests, and assessment of adverse events.
                A total of 1,685 patients (855 males, 830 females; mean age, 41.1 years [range, 12-95 years]) were enrolled. Within both studies, the 3 treatment groups were similar at baseline based on demographic characteristics and types of infection. Cellulitis (26%), wound infection (25%), and simple abscess (15%) were the most common infections. Clinical cure rates at the test-of-cure visit were 85% (443/523) for cefditoren 200 mg, 83% (427/516) for cefditoren 400 mg, 88% (234/265) for cefuroxime, and 85% (211/248) for cefadroxil. At the test-of-cure visit, cefditoren 200 mg had eradicated significantly fewer of the causative pathogens isolated before treatment in microbiologically evaluable patients than did cefuroxime in Study 1 (P = 0.043) but significantly more of the pathogens than did cefadroxil in Study 2 (P = 0.018). Eradication rates for the most commonly isolated pathogens were generally similar in the 3 treatment groups in both studies, with the only significant difference favoring cefditoren 200 and 400 mg over cefadroxil for Peptostreptococcus species in Study 2 (P = 0.016 and P = 0.003, respectively). A minority of patients (< or = 5% in any treatment group) discontinued study-drug treatment prematurely due to a treatment-related adverse event, with statistically higher rates for cefditoren 400 mg than for cefditoren 200 mg and the comparator cephalosporins (each P < 0.05). All 3 cephalosporins were generally well tolerated. Most adverse events (>93%) were categorized as mild to moderate, with the most common being diarrhea, nausea, and headache.
                In this population of patients with uncomplicated skin and skin-structure infections, including those due to Staphylococcus aureus or Streptococcus pyogenes, the clinical cure rate and tolerability of cefditoren were comparable to those of cefuroxime and cefadroxil. Meropenem, a broad-spectrum carbapenem with potent in vitro activity, is postulated to be an effective monotherapy for the treatment of complicated skin and skin structure infections (cSSSI).
                This multicenter, international, double-blind, randomized, prospective study of hospitalized patients with cSSSI evaluated the efficacy, safety, and tolerability of meropenem (500 mg IV q8h) versus imipenem-cilastatin (500 mg IV q8h). The primary efficacy endpoint was clinical outcome at follow-up in the clinically evaluable (CE) and modified intent-to-treat populations (MITT; patients who met eligibility criteria and received at least one dose of study drug). The study aimed to demonstrate non-inferiority (delta of 10%, 95% confidence intervals) in clinical response in the CE population. Clinical responses for all pathogens at follow-up were assessed in the fully evaluable population (CE population with baseline pathogen and follow-up cultures).
                In total, 1,076 patients were enrolled. Of these, 692 patients comprised the MITT population (334 and 358 patients randomized to meropenem and imipenem-cilastatin, respectively) and 548 the CE population (261 and 287 patients randomized to meropenem and imipenem-cilastatin, respectively). Cure rates were 86.2% (meropenem) and 82.9% (imipenemcilastatin; 95% CI, -2.8, 9.3) in the CE population and 73.1% (meropenem) and 74.9% (imipenem-cilastatin; 95% CI, -8.4, 4.7) in the MITT population. The frequencies of adverse events and drug-related adverse events were similar between treatment groups.
                In one of the largest studies conducted to date of hospitalized patients with cSSSI, meropenem, 500 mg IV q8h had comparable safety and efficacy to imipenem-cilastatin, 500 mg IV q8h.
We cannot define the best treatment for cellulitis and most recommendations are made on single trials. There is a need for trials to evaluate the efficacy of oral antibiotics against intravenous antibiotics in the community setting as there are service implications for cost and comfort.