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Krishan P Singh, Gang Li, Fanny S Mitrani-Gold, Milena Kurtinecz, Jeffrey Wetherington, John F Tomayko, Linda M Mundy
Noninferiority trial design and analyses are commonly used to establish the effectiveness of a new antimicrobial drug for treatment of serious infections such as complicated urinary tract infection (cUTI). A systematic review and meta-analysis were conducted to estimate the treatment effects of three potential active comparator drugs for the design of a noninferiority trial. The systematic review identified no placebo trials of cUTI, four clinical trials of cUTI with uncomplicated urinary tract infection as a proxy for placebo, and nine trials with reports of treatment effect estimates for doripenem, levofloxacin, or imipenem-cilastatin...
November 2013: Antimicrobial Agents and Chemotherapy
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