Treatment of bacterial vaginosis: a multicenter, double-blind, double-dummy, randomised phase III study comparing secnidazole and metronidazole.

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 >4.5 and Nugent score >7 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 (60.1 % cured women vs 59.5% , 95% confidence interval with a noninferiority margin of 10%: [-0.082; 0.0094]). 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.

• Authors: Jean-Marc Bohbot, Eric Vicaut, Didier Fagnen, Michel Brauman
• Journal: Infectious diseases in obstetrics and gynecology (Infect Dis Obstet Gynecol) Vol. 2010 ( 2010) ISSN: 1098-0997 [Electronic] Egypt
• PMID: 20885970 (Publication Type: Clinical Trial, Phase III, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Anti-Infective Agents
• Metronidazole
• secnidazole

Topics

• Adolescent
• Adult
• Aged
• Anti-Infective Agents (adverse effects, therapeutic use)
• Chi-Square Distribution
• Double-Blind Method
• Female
• Humans
• Metronidazole (adverse effects, analogs & derivatives, therapeutic use)
• Middle Aged
• Prospective Studies
• Treatment Outcome
• Vaginosis, Bacterial (drug therapy)