Male-Partner Treatment to Prevent Recurrence of Bacterial Vaginosis

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 control group (recurrence rate, 4.2 per person-year; 95% CI, 3.2 to 5.7), which corresponded to an absolute risk difference of −2.6 recurrences per person-year (95% CI, −4.0 to −1.2; P<0.001). Adverse events in treated men included nausea, headache, and metallic taste.

Conclusions
The addition of combined oral and topical antimicrobial therapy for male partners to treatment of women for bacterial vaginosis resulted in a lower rate of recurrence of bacterial vaginosis within 12 weeks than standard care. (Funded by the National Health and Medical Research Council of Australia; StepUp Australian New Zealand Clinical Trials Registry number, ACTRN12619000196145.)

Author/s:

Lenka A Vodstrcil, Erica L Plummer, Christopher K Fairley, Jane S Hocking, Matthew G Law, Kathy Petoumenos, Deborah Bateson, Gerald L Murray, Basil Donovan, Eric P F Chow, Marcus Y Chen, John Kaldor, Catriona S Bradshaw, StepUp Team

Randomized Trial of Lactin-V to Prevent Recurrence of Bacterial Vaginosis

Brian Desmarais — Wed, 03 Jun 2020 14:42:13 +0000

Date Added:

June 3, 2020

Journal/Publication:

New England Journal of Medicine

Publication Date:

May 14, 2020

Issue:

Volume:

382

Pages:

1906-1915

URL:

Randomized Trial of Lactin-V to Prevent Recurrence of Bacterial Vaginosis

Type:

Clinical Research Results

Format:

Article

DOI (1):

10.1056/NEJMoa1915254

MeSH

Lactobacillus crispatus

Vaginosis, Bacterial

Societies, Medical

Administration, Intravaginal

risk factors

random allocation

Intention to Treat Analysis

follow-up studies

double-blind method

Confidence Intervals

anti-bacterial agents

incidence

Odds Ratio

RPR Commentary: This RCT suggest that intravaginal Lactin V (a probiotic) delayed recurrence of bacterial vaginosis in women following treatment with metronidazole. James W. Mold, MD, MPH

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Abstract

Background: Bacterial vaginosis affects 15 to 50% of women of reproductive age, and recurrence is common after treatment with an antibiotic agent. The high incidence of recurrence suggests the need for new treatments to prevent recurrent bacterial vaginosis.

Methods: We conducted a randomized, double-blind, placebo-controlled, phase 2b trial to evaluate the ability of Lactobacillus crispatus CTV-05 (Lactin-V) to prevent the recurrence of bacterial vaginosis. Women 18 to 45 years of age who had received a diagnosis of bacterial vaginosis and who had completed a course of vaginal metronidazole gel as part of the eligibility requirements were randomly assigned, in a 2:1 ratio, to receive vaginally administered Lactin-V or placebo for 11 weeks; follow-up occurred through week 24. The primary outcome was the percentage of women who had a recurrence of bacterial vaginosis by week 12.

Results: A total of 228 women underwent randomization: 152 to the Lactin-V group and 76 to the placebo group; of these participants, 88% in the Lactin-V group and 84% in the placebo group could be evaluated for the primary outcome. In the intention-to-treat population, recurrence of bacterial vaginosis by week 12 occurred in 46 participants (30%) in the Lactin-V group and in 34 participants (45%) in the placebo group (risk ratio after multiple imputation for missing responses, 0.66; 95% confidence interval [CI], 0.44 to 0.87; P = 0.01). The risk ratio for recurrence by week 24 (also calculated with multiple imputation for missing responses) was 0.73 (95% CI, 0.54 to 0.92). At the 12-week visit, L. crispatus CTV-05 was detected in 79% of participants in the Lactin-V group. The percentage of participants who had at least one adverse event related to Lactin-V or placebo by week 24 did not differ significantly between the groups. The percentage of participants with local or systemic adverse events was similar in the two groups.

Conclusions: The use of Lactin-V after treatment with vaginal metronidazole resulted in a significantly lower incidence of recurrence of bacterial vaginosis than placebo at 12 weeks. (Funded by the National Institutes of Health; ClinicalTrials.gov number, NCT02766023.).

Author/s:

Cohen, C.R., Wierzbicki, C.R., French, A.L., Morris, S., Newmann, S., Reno, H., Green, L., Miller, S., Powell, J., Parks, T., Hemmerling, S.