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Infectious Diseases in Obstetrics and Gynecology
Volume 2010, Article ID 705692, 6 pages
http://dx.doi.org/10.1155/2010/705692
Clinical Study

Treatment of Bacterial Vaginosis: A Multicenter, Double-Blind, Double-Dummy, Randomised Phase III Study Comparing Secnidazole and Metronidazole

1Institut Alfred Fournier, 25, Boulevard Saint-Jacques, 75014 Paris, France
2Hôpital Fernand Widal, 200 rue du Fbg Street Denis, 75010 Paris, France
3IPRAD 174, quai de Jemmapes, 75010 Paris, France

Received 23 April 2010; Accepted 14 July 2010

Academic Editor: José Tirán-Saucedo

Copyright © 2010 Jean-Marc Bohbot et al. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

Abstract

Objective. Multiple-dose metronidazole oral therapy is currently the reference treatment for bacterial vaginosis (BV). This double-blind, double-dummy, noninferiority study compared the efficacy of secnidazole, another nitroimidazole with pharmacokinetics allowing a single dose regimen, to this standard treatment. Methods. A total of 577 patients were randomized to receive metronidazole (500 mg, b.i.d for seven days) or secnidazole (2 g, once). Therapeutic cure at D28 was defined as the resolution of vaginal discharge, positive KOH whiff test, vaginal pH and Nugent score on Gram-stained vaginal fluid. Results. According to this primary endpoint, the single-dose secnidazole regimen was shown to be at least as effective as the multiple-dose metronidazole regimen ( % cured women vs % , 95% confidence interval with a noninferiority margin of 10%: ). Safety profiles were comparable in both groups. Conclusion. The secnidazole regimen studied represents an effective, convenient therapeutic alternative that clinicians should consider in routine practice.