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The efficacy and safety of daptomycin vs. vancomycin for the treatment of cellulitis and erysipelas.

ABSTRACT: Results from previous trials suggest that daptomycin may result in faster clinical improvement than penicillinase-resistant penicillins or vancomycin for patients with complicated skin and skin structure infections.The objective was to evaluate whether daptomycin treatment of cellulitis or erysipelas would result in faster resolution compared with vancomycin.The study was a prospective, evaluator-blinded, multi-centre trial. Patients were randomised to receive daptomycin 4 mg/kg once daily or vancomycin according to standard of care for 7-14 days.Adults diagnosed with cellulitis or erysipelas requiring hospitalisation and intravenous antibiotic therapy were eligible for enrolment.The clinical success rates were 94.0% for daptomycin and 90.2% for vancomycin (95% confidence interval for the difference, -6.7%, 14.3%). There were no statistically significant differences between treatment arms in the time to resolution or improvement in any of the predefined clinical end-points. Both daptomycin and vancomycin were well tolerated.There was no difference in the rate of resolution of cellulitis or erysipelas among patients treated with daptomycin or vancomycin. Daptomycin 4 mg/kg once daily appeared to be effective and safe for treating cellulitis or erysipelas.

SUBMITTER: Pertel PE

PROVIDER: S-EPMC2705813 | biostudies-literature | 2009 Mar

REPOSITORIES: biostudies-literature

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The efficacy and safety of daptomycin vs. vancomycin for the treatment of cellulitis and erysipelas.

Pertel P E PE Eisenstein B I BI Link A S AS Donfrid B B Biermann E J A EJ Bernardo P P Martone W J WJ

International journal of clinical practice 20090301 3

<h4>Background</h4>Results from previous trials suggest that daptomycin may result in faster clinical improvement than penicillinase-resistant penicillins or vancomycin for patients with complicated skin and skin structure infections.<h4>Objective</h4>The objective was to evaluate whether daptomycin treatment of cellulitis or erysipelas would result in faster resolution compared with vancomycin.<h4>Design</h4>The study was a prospective, evaluator-blinded, multi-centre trial. Patients were rando ...[more]

PMID: 19222623

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Project description:BackgroundCellulitis and erysipelas are now usually considered manifestations of the same condition, a skin infection associated with severe pain and systemic symptoms. A range of antibiotic treatments are suggested in guidelines.ObjectivesTo assess the efficacy and safety of interventions for non-surgically-acquired cellulitis.Search strategyIn May 2010 we searched for randomised controlled trials in the Cochrane Skin Group Specialised Register, the Cochrane Central Register of Controlled Trials in The Cochrane Library, MEDLINE, EMBASE, and the ongoing trials databases.Selection criteriaWe selected randomised controlled trials comparing two or more different interventions for cellulitis.Data collection and analysisTwo authors independently assessed trial quality and extracted data.Main resultsWe included 25 studies with a total of 2488 participants. Our primary outcome 'symptoms rated by participant or medical practitioner or proportion symptom-free' was commonly reported. No two trials examined the same drugs, therefore we grouped similar types of drugs together.Macrolides/streptogramins were found to be more effective than penicillin antibiotics (Risk ratio (RR) 0.84, 95% CI 0.73 to 0.97). In 3 trials involving 419 people, 2 of these studies used oral macrolide against intravenous (iv) penicillin demonstrating that oral therapies can be more effective than iv therapies (RR 0.85, 95% CI 0.73 to 0.98).Three studies with a total of 88 people comparing a penicillin with a cephalosporin showed no difference in treatment effect (RR 0.99, 95% CI 0.68 to 1.43).Six trials which included 538 people that compared different generations of cephalosporin, showed no difference in treatment effect (RR 1.00, 95% CI 0.94 to1.06).We found only small single studies for duration of antibiotic treatment, intramuscular versus intravenous route, the addition of corticosteroid to antibiotic treatment compared with antibiotic alone, and vibration therapy, so there was insufficient evidence to form conclusions. Only two studies investigated treatments for severe cellulitis and these selected different antibiotics for their comparisons, so we cannot make firm conclusions.Authors' conclusionsWe 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.

Project description:ImportanceThe optimum antibiotic treatment for cellulitis and erysipelas lacks consensus. The available trial data do not demonstrate the superiority of any agent, and data are limited on the most appropriate route of administration or duration of therapy.ObjectiveTo assess the efficacy and safety of antibiotic therapy for non-surgically acquired cellulitis.Data sourcesThe following databases were searched to June 28, 2016: Cochrane Central Register of Controlled Trials (2016, issue 5), Medline (from 1946), Embase (from 1974), and Latin American and Caribbean Health Sciences Information System (LILACS) (from 1982). In addition, 5 trials databases and the reference lists of included studies were searched. Further searches of PubMed and Google Scholar were undertaken from June 28, 2016, to December 31, 2018.Study selectionRandomized clinical trials comparing different antibiotics, routes of administration, and treatment durations were included.Data extraction and synthesisFor data collection and analysis, the standard methodological procedures of the Cochrane Collaboration were used. For dichotomous outcomes, the risk ratio and its 95% CI were calculated. A summary of findings table was created for the primary end points, adopting the GRADE approach to assess the quality of the evidence.Main outcomes and measuresThe primary outcome was the proportion of patients cured, improved, recovered, or symptom-free or symptom-reduced at the end of treatment, as reported by the trial. The secondary outcome was any adverse event.ResultsA total of 43 studies with a total of 5999 evaluable participants, whose age ranged from 1 month to 96 years, were included. Cellulitis was the primary diagnosis in only 15 studies (35%), and in other studies the median (interquartile range) proportion of patients with cellulitis was 29.7% (22.9%-50.3%). Overall, no evidence was found to support the superiority of any 1 antibiotic over another, and antibiotics with activity against methicillin-resistant Staphylococcus aureus did not add an advantage. Use of intravenous antibiotics over oral antibiotics and treatment duration of longer than 5 days were not supported by evidence.Conclusions and relevanceIn this systematic review and meta-analysis, only low-quality evidence was found for the most appropriate agent, route of administration, and duration of treatment for patients with cellulitis; future trials need to use a standardized set of outcomes, including severity scoring, dosing, and duration of therapy.

Project description:BackgroundLinezolid, which has bacteriostatic activity, is approved for the treatment of vancomycin-resistant enterococci (VRE) infections. Meanwhile, daptomycin exerts bactericidal activity against VRE, but is not approved for the treatment of VRE bacteremia. Only a few studies with small sample sizes have compared the effectiveness of these drugs for treatment of VRE bacteremia.MethodsPubMed, EMBASE, and the Cochrane Library were searched for studies of VRE bacteremia treatment published before January 1, 2014. All studies reporting daptomycin and linezolid treatment outcomes simultaneously were included. The endpoints were mortality and microbiological cure. The adjusted odds ratios (aORs) of mortality in daptomycin- and linezolid-treated patients were extracted if available. Pooled odds ratios (ORs) and 95% confidence intervals (CIs) were calculated for all outcomes using a random-effects model.ResultsThirteen studies (532 patients receiving daptomycin, 656 patients receiving linezolid) met the selection criteria. All studies had retrospective cohort designs and relatively small sample sizes. Eight studies compared the aORs of mortality in daptomycin- and linezolid-treated patients. Four studies were published as conference papers and there was significant heterogeneity among these studies (I2 = 63%, p = 0.04). Daptomycin use was not associated with better microbiological cure (daptomycin vs. linezolid, OR: 0.67, 95% CI: 0.42-1.06, p = 0.09). However, mortality was higher in patients receiving daptomycin (OR: 1.43, 95% CI: 1.09-1.86, p = 0.009). Subgroup analysis of studies that reported aORs indicated that daptomycin was associated with higher mortality (OR: 1.59, 95% CI: 1.02-2.50, p = 0.04). There was no evidence of publication bias, but all enrolled studies were retrospective, had small sample sizes, and had substantial limitations.ConclusionsAlthough limited data is available, the current meta-analysis shows that linezolid treatment for VRE bacteremia was associated with a lower mortality than daptomycin treatment. However, the results should be interpreted cautiously because of limitations inherent to retrospective studies and the high heterogeneity among studies. A large randomized trial is needed to confirm the present results.

Project description:Importance:Methicillin-resistant Staphylococcus aureus (MRSA) bacteremia is associated with mortality of more than 20%. Combining standard therapy with a ?-lactam antibiotic has been associated with reduced mortality, although adequately powered randomized clinical trials of this intervention have not been conducted. Objective:To determine whether combining an antistaphylococcal ?-lactam with standard therapy is more effective than standard therapy alone in patients with MRSA bacteremia. Design, Setting, and Participants:Open-label, randomized clinical trial conducted at 27 hospital sites in 4 countries from August 2015 to July 2018 among 352 hospitalized adults with MRSA bacteremia. Follow-up was complete on October 23, 2018. Interventions:Participants were randomized to standard therapy (intravenous vancomycin or daptomycin) plus an antistaphylococcal ?-lactam (intravenous flucloxacillin, cloxacillin, or cefazolin) (n?=?174) or standard therapy alone (n?=?178). Total duration of therapy was determined by treating clinicians and the ?-lactam was administered for 7 days. Main Outcomes and Measures:The primary end point was a 90-day composite of mortality, persistent bacteremia at day 5, microbiological relapse, and microbiological treatment failure. Secondary outcomes included mortality at days 14, 42, and 90; persistent bacteremia at days 2 and 5; acute kidney injury (AKI); microbiological relapse; microbiological treatment failure; and duration of intravenous antibiotics. Results:The data and safety monitoring board recommended early termination of the study prior to enrollment of 440 patients because of safety. Among 352 patients randomized (mean age, 62.2 [SD, 17.7] years; 121 women [34.4%]), 345 (98%) completed the trial. The primary end point was met by 59 (35%) with combination therapy and 68 (39%) with standard therapy (absolute difference, -4.2%; 95% CI, -14.3% to 6.0%). Seven of 9 prespecified secondary end points showed no significant difference. For the combination therapy vs standard therapy groups, all-cause 90-day mortality occurred in 35 (21%) vs 28 (16%) (difference, 4.5%; 95% CI, -3.7% to 12.7%); persistent bacteremia at day 5 was observed in 19 of 166 (11%) vs 35 of 172 (20%) (difference, -8.9%; 95% CI, -16.6% to -1.2%); and, excluding patients receiving dialysis at baseline, AKI occurred in 34 of 145 (23%) vs 9 of 145 (6%) (difference, 17.2%; 95% CI, 9.3%-25.2%). Conclusions and Relevance:Among patients with MRSA bacteremia, addition of an antistaphylococcal ?-lactam to standard antibiotic therapy with vancomycin or daptomycin did not result in significant improvement in the primary composite end point of mortality, persistent bacteremia, relapse, or treatment failure. Early trial termination for safety concerns and the possibility that the study was underpowered to detect clinically important differences in favor of the intervention should be considered when interpreting the findings. Trial Registration:ClinicalTrials.gov Identifier: NCT02365493.

Dataset Information

The efficacy and safety of daptomycin vs. vancomycin for the treatment of cellulitis and erysipelas.

Publications

The efficacy and safety of daptomycin vs. vancomycin for the treatment of cellulitis and erysipelas.

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