P-1092. Re-analysis of Pivmecillinam Randomized Clinical Trial Data According to 2019 US Food and Drug Administration Guidance for the Treatment of Uncomplicated Urinary Tract Infection
Abstract
Abstract Background Due to increasing prevalence of resistant uropathogens, there is urgent need in the USA for effective new oral antibiotics for treatment of uncomplicated urinary tract infection (uUTI). Pivmecillinam has been used to treat uUTI in Canada and Europe for > 40 years, is recommended as a first-line agent by the Infectious Diseases Society of America, and has high microbiologic activity against most antibiotic-resistant Enterobacterales. We present a re-analysis of clinical trial data, as per 2019 US Food and Drug Administration (FDA) guidance, that supported the recent US approval of pivmecillinam for treatment of uUTI.Table 1. Composite response rates at test-of-cure (micro-ITT population) 185 mg of pivmecillinam is equivalent to 200 mg of pivmecillinam hydrochloride. CI, confidence interval; micro-ITT, microbiological intent-to-treat; QID, four times daily; TID, three times daily. 1. Ferry SA et al. Scand J Prim Health Care. 2007;25:49–57. 2. Menday AP. Intl J Antimicrob Agents. 2000;13:183–187. 3. Vik I et al. PLoS Med. 2018;15:e1002569. Methods Detailed subject-level clinical data were retrieved from three historic randomized controlled trials (RCTs) including subjects treated with pivmecillinam 185 mg, three times daily for 3–7 days, and re-analyzed in accordance with the 2019 FDA guidance for uUTI. Efficacy endpoints were composite (clinical and microbiologic) response rates, clinical response rates, and microbiologic response rates, analyzed in the…
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Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 385 participants or records.
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