Male-Partner Treatment to Prevent Recurrence of Bacterial Vaginosis
作者:Lenka A. Vodstrcil, Erica L. Plummer, Christopher K. Fairley, Jane S. Hocking, Matthew Law, Kathy Petoumenos, Deborah Bateson, Gerald L. Murray, Basil Donovan, Eric P. F. Chow, Marcus Y. Chen, John Kaldor, Catriona S. Bradshaw · 发表于:New England Journal of Medicine · 年份:2025 · DOI:10.1056/nejmoa2405404 · 被引用次数:83 · 研究领域:Reproductive tract infections research、Adolescent Sexual and Reproductive Health、Syphilis Diagnosis and Treatment
BACKGROUND: Bacterial vaginosis affects one third of reproductive-aged women, and recurrence is common. Evidence of sexual exchange of bacterial vaginosis-associated organisms between partners suggests that male-partner treatment may increase the likelihood of cure. METHODS: This open-label, randomized, controlled trial involved couples in which a woman had bacterial vaginosis and was in a monogamous relationship with a male partner. In the partner-treatment group, the woman received first-line recommended antimicrobial agents and the male partner received oral and topical antimicrobial treatment (metronidazole 400-mg tablets and 2% clindamycin cream applied to penile skin, both twice daily for 7 days). In the control group, the woman received first-line treatment and the male partner received no treatment (standard care). The primary outcome was recurrence of bacterial vaginosis within 12 weeks. RESULTS: A total of 81 couples were assigned to the partner-treatment group, and 83 couples were assigned to the control group. The trial was stopped by the data and safety monitoring board after 150 couples had completed the 12-week follow-up period because treatment of the woman only was inferior to treatment of both the woman and her male partner. In the modified intention-to-treat population, recurrence occurred in 24 of 69 women (35%) in the partner-treatment group (recurrence rate, 1.6 per person-year; 95% confidence interval [CI], 1.1 to 2.4) and in 43 of 68 women (63%) in the...