Secnidazole Treatment of Bacterial Vaginosis: A Randomized Controlled Trial
| Autor: | Nikki Adetoro, Paul Nyirjesy, Carol J. Braun, Franklin G. Morgan, Arthur S. Waldbaum, Sharon L. Hillier, Jane R. Schwebke |
|---|---|
| Rok vydání: | 2017 |
| Předmět: |
Adult
medicine.medical_specialty Treatment outcome Antiprotozoal Agents Administration Oral Black People White People law.invention Single oral dose Placebos 03 medical and health sciences 0302 clinical medicine Randomized controlled trial Anti-Infective Agents Double-Blind Method law Internal medicine Metronidazole Medicine Humans 030212 general & internal medicine 030219 obstetrics & reproductive medicine business.industry Obstetrics and Gynecology Vaginosis Bacterial Middle Aged medicine.disease Surgery Anti-Bacterial Agents Treatment Outcome Female Bacterial vaginosis business Secnidazole medicine.drug |
| Zdroj: | Obstetrics and gynecology. 130(2) |
| ISSN: | 1873-233X |
| Popis: | To evaluate secnidazole as a single oral dose treatment for bacterial vaginosis in a phase 2 randomized, double-blind, placebo-controlled study.In 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.Between 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.Oral 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.ClinicalTrials.gov, NCT02147899. |
| Databáze: | OpenAIRE |
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