Journal article
Secnidazole Treatment of Bacterial Vaginosis: A Randomized Controlled Trial
Obstetrics and gynecology (New York. 1953), v 130(2), pp 379-386
01 Aug 2017
PMID: 28697102
Featured in Collection : UN Sustainable Development Goals @ Drexel
Abstract
OBJECTIVETo evaluate secnidazole as a single oral dose treatment for bacterial vaginosis in a phase 2 randomized, double-blind, placebo-controlled study. METHODSIn a phase 2, randomized, double-blind, dose-ranging, placebo-controlled study, women with bacterial vaginosis who met all Amsel criteria (discharge; pH 4.7 or greater; 20% or greater clue cells; positive whiff test) were randomized one to one to one at 24 U.S. centers to 1 or 2 g secnidazole compared with placebo. The primary endpoint was clinical cure (normalization of discharge, amine odor, and clue cells) 21-30 days after treatment. Secondary endpoints included microbiologic cure, defined as a Nugent score of 0-3, and therapeutic cure, defined as meeting criteria for both clinical and microbiologic cure. The modified intent to treat was used for efficacy analyses and included all randomized patients who met the enrollment criteria. Assuming a clinical cure rate of 40% in the active groups and 15% in the placebo group, a sample size of 52 patients per group provided approximately 80% power to detect a significant difference between groups (.05 level [two-sided]) using a Cochran-Mantel-Haenszel test. RESULTSBetween May and September 2014, 215 patients were enrolled. In the intent-to-treat population, the clinical cure rate was 65.3% for the 2-g group, 49.3% for the 1-g group, and 19.4% for the placebo group. The modified intent-to-treat population included 188 women (median age 33 years; 32% with four or more bacterial vaginosis episodes in the previous year; 54% black) with baseline Nugent scores 4 or greater. Clinical, microbiologic, and therapeutic cure rates were 67.7%, 40.3%, and 40.3% for 2 g secnidazole and 51.6%, 23.4%, and 21.9% for 1 g secnidazole compared with 17.7%, 6.5%, and 6.5% for placebo, respectively (P<.05 for secnidazole compared with placebo; all endpoints). Both doses were well-tolerated. CONCLUSIONOral granules containing 1 and 2 g secnidazole were superior to placebo in bacterial vaginosis treatment (P<.001 for both groups). These data support the development of secnidazole for bacterial vaginosis treatment. CLINICAL TRIAL REGISTRATIONClinicalTrials.gov, NCT02147899.
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Details
- Title
- Secnidazole Treatment of Bacterial Vaginosis: A Randomized Controlled Trial
- Creators
- Sharon L Hillier - University of Alabama at BirminghamPaul Nyirjesy - Drexel UniversityArthur S Waldbaum - Downtown Women's Health CareJane R Schwebke - University of Alabama at BirminghamFranklin G Morgan - Clinical Research Associates of TidewaterNikki A Adetoro - Product Innovation and Engineering (United States) (United States, Saint James) - LLCCarol J Braun
- Publication Details
- Obstetrics and gynecology (New York. 1953), v 130(2), pp 379-386
- Publisher
- Lippincott
- Resource Type
- Journal article
- Language
- English
- Web of Science ID
- WOS:000406240500024
- Scopus ID
- 2-s2.0-85023187598
- Other Identifier
- 991019350682804721
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- Collaboration types
- Domestic collaboration
- Web of Science research areas
- Obstetrics & Gynecology