SynthesisClinical infectious diseases : an official publication of the Infectious Diseases Society of America2009
Antimicrobial agents for complicated skin and skin-structure infections: justification of noninferiority margins in the absence of placebo-controlled trials.
Synthesis in Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2009. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 19 papers, 1 of them a synthesis that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
19 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Systematic Review and Meta-Analysis To Estimate Antibacterial Treatment Effect in Acute Bacterial Skin and Skin Structure Infection.Antimicrobial agents and chemotherapy · 2015Pooled it
- Trial
- Trial
- A randomized trial of tigecycline versus ampicillin-sulbactam or amoxicillin-clavulanate for the treatment of complicated skin and skin structure infections.BMC infectious diseases · 2012Trial
- CANVAS 1 and 2: analysis of clinical response at day 3 in two phase 3 trials of ceftaroline fosamil versus vancomycin plus aztreonam in treatment of acute bacterial skin and skin structure infections.Antimicrobial agents and chemotherapy · 2012Trial
- Target attainment of intravenous lefamulin for treatment of acute bacterial skin and skin structure infections.The Journal of antimicrobial chemotherapy · 2024Article
- Antibacterial activity of ruthenium polypyridyl complexes against Staphylococcus aureus and biofilms.Journal of biological inorganic chemistry : JBIC : a publication of the Society of Biological Inorganic Chemistry · 2020Article
- Article
- Continuous cefazolin infusion versus cefazolin plus probenecid for the ambulatory treatment of uncomplicated cellulitis: A retrospective cohort study.Journal of the Association of Medical Microbiology and Infectious Disease Canada = Journal officiel de l'Association pour la microbiologie medicale et l'infectiologie Canada · 2019Article
- Early Response in Cellulitis: A Prospective Study of Dynamics and Predictors.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2016Article
- Noninferior Antibiotics: When Is "Not Bad" "Good Enough"?Open forum infectious diseases · 2016Article
- Beyond Antibiotics: New Therapeutic Approaches for Bacterial Infections.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2016Article
- The large scale antibacterial, antifungal and anti-phage efficiency of Petamcin-A: new multicomponent preparation for skin diseases treatment.Annals of clinical microbiology and antimicrobials · 2015Article
- Garenoxacin in Skin and Skin Structure Infections Sustained due to Road Traffic Accident.Journal of clinical and diagnostic research : JCDR · 2014Article
- Combating antimicrobial resistance: policy recommendations to save lives.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2011Article
- Design of clinical trials of antibacterial agents for community-acquired bacterial pneumonia.Clinical investigation · 2011Article
- Bactericidal kinetics of marine-derived napyradiomycins against contemporary methicillin-resistant Staphylococcus aureus.Marine drugs · 2011Article
- Skin and soft-tissue infections: modern evolution of an ancient problem.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2010Article
- Recommended design features of future clinical trials of antibacterial agents for hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2010Review
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9 authors.
Funding
Abstract
backgroundThe United States Food and Drug Administration requires clinical trial noninferiority margins to preserve a fraction (eg, 50%) of the established comparator drug's efficacy versus placebo. Lack of placebo-controlled trials for many infections complicates noninferiority margin justification for and, hence, regulatory review of new antimicrobial agents. Noninferiority margin clarification is critical to enable new antimicrobial development. In the absence of placebo-controlled trials, we sought to define the magnitude of efficacy of antimicrobial agents and resulting noninferiority margins for studies of complicated skin and skin-structure infection (SSSI).
methodsWe systematically reviewed literature on complicated SSSI published during 1900-1950 (before widespread penicillin resistance) to define treatment outcomes and confidence intervals (CIs). Antimicrobial efficacy was calculated as the lower limit CI of the cure rate with antimicrobials minus the upper limit CI of the cure rate without antimicrobials.
resultsWe identified 90 articles describing >28,000 patients with complicated SSSI. For cellulitis/erysipelas, cure rates were 66% (95% CI, 64%-68%) without antibiotics and 98% (95% CI, 96%-99%) for penicillin-treated patients, and penicillin reduced mortality by 10%. Cure rates for wound/ulcer infections were 36% (95% CI, 32%-39%) without antibiotics and 83% (95% CI, 81%-85%) for penicillin-treated patients. For major abscesses, cure rates were 76% (95% CI, 71%-80%) without antibiotics and 96% (95% CI, 94%-98%) for penicillin-treated patients; penicillin reduced mortality by 6%.
conclusionSystematic review of historical literature enables rational noninferiority margin justification in the absence of placebo-controlled trials and may facilitate regulatory review of noninferiority trials. Noninferiority margins of 14% for cellulitis/erysipelas, 21% for wound/ulcer infections, and 7% for major abscesses would preserve >or= 50% of antibiotic efficacy versus placebo for these complicated SSSI subsets.
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.