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Antimicrobial agents for complicated skin and skin-structure infections: justification of noninferiority margins in the absence of placebo-controlled trials.

Authors
Type
Published Article
Journal
Clinical Infectious Diseases
1537-6591
Publisher
Oxford University Press
Publication Date
Volume
49
Issue
3
Pages
383–391
Identifiers
DOI: 10.1086/600296
PMID: 19555285
Source
Medline
License
Unknown

Abstract

Systematic 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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