Randomized Controlled Noninferiority Trial Comparing Daptomycin to Vancomycin for the Treatment of Complicated Skin and Skin Structure Infections in an Observation Unit

Shaw, George J.; Meunier, Jason M.; Korfhagen, Joseph J.; Wayne, Beth; Hart, Kimberly W.; Lindsell, Christopher J.; Fermann, Gregory J.

doi:10.1016/j.jemermed.2015.07.026

Cited by 9 publications

(15 citation statements)

References 15 publications

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“…One trial 21 was excluded because it used a high dose of daptomycin (10 mg/kg). In total, eight studies 11 , 12 , 22 – 27 were included in this meta-analysis ( Figure 1 ). Table 1 summarizes the characteristics of all the included studies, which were published in English.…”

Section: Resultsmentioning

confidence: 99%

“…All the included studies enrolled adult patients. The comparator drugs were vancomycin and semi-synthetic penicillin in two studies, 22 , 27 vancomycin and teicoplanin in one study, 25 vancomycin in four studies, 11 , 12 , 24 , 26 and telavancin in one study. 23…”

Section: Resultsmentioning

confidence: 99%

“…Seven trials 11 , 12 , 22 , 23 , 25 – 27 reported the clinical success rate of daptomycin versus comparator drugs in ITT and CE populations. In the ITT population, the overall success rate was 72.5% (1,372/1,892).…”

Section: Resultsmentioning

confidence: 99%

“…This result indicated that conclusive evidence was established and that further trials were not required. Six studies 11 , 12 , 22 , 25 – 27 reported the clinical success rates of daptomycin and vancomycin in the CE population. As there was significant heterogeneity among studies ( χ 2 =23.25, df =5, P =0.0003, I 2 =78%; Figure 4A ), a random effects model was used to conduct the meta-analysis, and the results showed no significant difference in the clinical success rate between the two groups (RR =1.03, 95% CI =0.95–1.13, P =0.47; Figure 4A ).…”

Section: Resultsmentioning

confidence: 99%

“…However, no significant differences were found between daptomycin and standard drugs. Recently, two related randomized controlled trials (RCTs) 11 , 12 were published. In the present study, the effect of daptomycin on the treatment of SSTIs was evaluated by conducting this meta-analysis with trial sequential analysis (TSA) to analyze whether the available sample size is large enough and conclusive.…”

Section: Introductionmentioning

confidence: 99%

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Efficacy and safety of daptomycin for skin and soft tissue infections: a systematic review with trial sequential analysis

Liu

Mao

Kang

et al. 2016

TCRM

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BackgroundSkin and soft tissue infections (SSTIs) are significant indications for antibiotic treatment. Daptomycin, a novel antibiotic, has been registered and licensed to be used in the treatment of these infections. However, its efficacy and safety remain controversial.ObjectiveThe objective of this study was to conduct a systematic review with trial sequential analysis (TSA) to evaluate the efficacy and safety of daptomycin for the treatment of SSTIs and to analyze whether the available sample size has been large enough and is conclusive.MethodsPubMed, the Cochrane Library, and EMBASE were searched for published randomized controlled trials (RCTs) that compared daptomycin with other antibiotics in adult patients with SSTIs up to February 2016.ResultsThis meta-analysis included eight randomized controlled trials (n=2,002). There was no difference in either the clinical success rate (intention-to-treat population: relative risk [RR] =1.04, 95% confidence interval [CI] =0.99–1.10, P=0.12; clinically evaluable population: RR =1.00, 95% CI =0.97–1.04, P=0.82) or the microbiological success rate (RR =1.00, 95% CI =0.95–1.06, P=0.92) between the daptomycin and comparator groups for treating SSTIs, which was confirmed by TSA. Compared with vancomycin, daptomycin exhibited no advantage in increasing the clinical success rate (RR =1.03, 95% CI =0.95–1.13, P=0.47), and this was also confirmed by TSA. All-cause mortality, overall treatment-related adverse events, and creatine phosphokinase events were similar between these two groups.ConclusionDaptomycin and comparator drugs are equally efficacious with regard to clinical and microbiological success for patients with SSTIs, and TSA showed that no additional randomized controlled trials are required. Although daptomycin is a good alternative when other antibiotics are contraindicated for patients with SSTIs and it can serve as a first-line treatment for SSTIs, clinicians should be aware of potential adverse events, such as daptomycin-induced acute eosinophilic pneumonia and creatine phosphokinase, when treating patients with daptomycin.

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Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

See 3 more Smart Citations

Efficacy and safety of daptomycin for skin and soft tissue infections: a systematic review with trial sequential analysis

Liu

Mao

Kang

et al. 2016

TCRM

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Comparative Efficacy and Safety of Vancomycin, Linezolid, Tedizolid, and Daptomycin in Treating Patients with Suspected or Proven Complicated Skin and Soft Tissue Infections: An Updated Network Meta-Analysis

et al. 2021

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Introduction: Skin and soft structure infections (SSTIs) caused by methicillin-resistant Staphylococcus aureus (MRSA) pose serious health risks and cause significant cost burdens, and a conclusive recommendation about antibiotics has not yet been generated. Therefore, we performed this updated network meta-analysis to determine the preferred drug for the treatment of MRSA-caused SSTIs. Methods: We searched PubMed, Embase, and Cochrane Library to identify any potentially eligible randomized controlled trials (RCTs) investigating the comparative efficacy and safety of any two of vancomycin, linezolid, tedizolid, and daptomycin in MRSA-caused SSTIs. All statistical analyses were conducted with RevMan, ADDIS, and STATA software. Results: Twenty eligible RCTs involving 7804 patients were included for the final analysis. Direct meta-analysis suggested that linezolid was superior to vancomycin in improving clinical (odds ratio [OR], 1.46; 95% confidence interval [CI], 1.07-1.99; P = 0.02) and microbiological (OR, 1.89; 95% CI, 1.24-2.86; P = 0.003) success, which were all confirmed by network meta-analyses. No statistical differences were identified regarding other comparisons. Meanwhile, there were no significant differences between any two antibiotics related to safety. Moreover, ranking probabilities indicated that linezolid had the highest probability of being ranked best in terms of clinical and microbiological success. Conclusion:Based on the limited evidence, linezolid may be a preferred antibiotic for the treatment of MRSA-caused SSTIs because it showed superiority in clinical and microbiological success without difference regarding safety.

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Descriptive evaluation of patients receiving one-time intravenous vancomycin doses at a large academic medical center emergency department

Schuchter,

Shuler Truoccolo,

Wilson

et al. 2024

The American Journal of Emergency Medicine

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Randomized Controlled Noninferiority Trial Comparing Daptomycin to Vancomycin for the Treatment of Complicated Skin and Skin Structure Infections in an Observation Unit

Cited by 9 publications

References 15 publications

Efficacy and safety of daptomycin for skin and soft tissue infections: a systematic review with trial sequential analysis

Efficacy and safety of daptomycin for skin and soft tissue infections: a systematic review with trial sequential analysis

Comparative Efficacy and Safety of Vancomycin, Linezolid, Tedizolid, and Daptomycin in Treating Patients with Suspected or Proven Complicated Skin and Soft Tissue Infections: An Updated Network Meta-Analysis

Descriptive evaluation of patients receiving one-time intravenous vancomycin doses at a large academic medical center emergency department

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