Treatment of Male Sexual Partners of Women With Bacterial Vaginosis: A Randomized, Double-Blind, Placebo-Controlled Trial.

BACKGROUND: We aimed to determine if treatment of male sexual partners of women with recurrent bacterial vaginosis (BV) with oral metronidazole 2×/day for 7 days (ie, multidose metronidazole) significantly decreased BV recurrence rates in the female. METHODS: This was a multicenter, 2-arm, double-blind, placebo-controlled study. Women with recurrent BV and current diagnosis of BV by Amsel and Nugent were enrolled. Multidose metronidazole for 7 days was dispensed to women. Male partners were randomized to placebo versus multidose metronidazole for 7 days and asked to refrain from unprotected sex for 14 days. Female follow-up visits were conducted at day 21 and 8 and 16 weeks. Male follow-up visits occurred at days 14-21. BV cure was defined as 0-2 Amsel criteria and Nugent score 0-6 in the female partner with the primary endpoint at 16 weeks. RESULTS: 214 couples were enrolled. In the intent-to-treat population, there was no significant difference between treatment arms for the primary outcome. BV treatment failure occurred in 81% and 80% of women in the metronidazole and placebo arms through the third follow-up visit, respectively (P > .999). However, women whose male partners adhered to study medication were less likely to fail treatment (adjusted relative risk, .85; 95% CI, .73-.99; P = .035). This finding persisted in post hoc comparisons in the metronidazole arm. CONCLUSIONS: Overall, this study did not find that male partner treatment with multidose metronidazole significantly reduces BV recurrence in female partners, although women whose partners adhered to multidose metronidazole were less likely to fail treatment. CLINICAL TRIALS REGISTRATION: (NCT02209519).

Use of a Novel Couples' Verification Tool in a Male Partner Treatment Study of Women With Recurrent Bacterial Vaginosis.

Verification of relationship status beyond self-report is an important aspect in sexually transmitted infection research, including partner treatment studies where primary sexual partners are targeted for enrollment. This exploratory study describes the use of a novel couples' verification tool in a male partner treatment study of women with recurrent bacterial vaginosis.

Conventional oral and secondary high dose vaginal metronidazole therapy for recurrent bacterial vaginosis: clinical outcomes, impacts of sex and menses.

PURPOSE: Oral metronidazole therapy is the standard of care for bacterial vaginosis (BV), yet it has alarming rates of recurrence and refractory responses among recurrent BV (RBV) patients. This study addresses whether high dose vaginal metronidazole therapy (HDM) is beneficial in RBV patients who fail after standard of care (SOC) therapy, whether diagnostic test scores proximal to the HDM predict clinical outcome, and whether menses, coitus, or race influences therapy outcome. PATIENTS AND METHODS: A total of 90 patients with RBV were given SOC and tracked 74 for up to 9 months. Refractory or recurrent patients (57) with symptomatic BV were given HDM and followed for up to 8 months. Patients were evaluated by Amsel criteria, Nugent score, and a qPCR assay that assesses the Lactobacillus content. RESULTS: HDM achieved at least short-term remission in 68% of the patients who were refractory to or recurred after SOC and provided a 10-day increase in the mean duration of remission among patients who eventually recurred (p=0.027). Patients with prolonged dysbiosis (pH >5 or Amsel 4) before symptomatic recurrence were more likely to recur after subsequent HDM. Most recurrence happened within 10 days of menses, but sex in this cohort was not associated with clinical outcome. Mean diagnostic BV scores of African American patients in remission were inferior to scores of a small cohort of Caucasian patients in remission. CONCLUSION: Encouraging results obtained with HDM justify a prospective, randomized study to determine if follow-up HDM is beneficial among a broader cohort of women failing conventional oral metronidazole therapy.

Prognostic Indicators of Recurrence of Bacterial Vaginosis.

Following all forms of therapy for bacterial vaginosis (BV), recurrence rates are extremely high. Many diagnostic tests are available that differentiate bacterial vaginosis from other types of vaginal disorders, but none predict recurrence after treatment, nor are any vetted for monitoring ongoing responses to treatment. Our goal was to determine which tests, and at what optimal times, have prognostic value in predicting recurrence. This prospective cohort study monitored 74 highly recurrent BV patients for up to 9 months. Symptomatic BV patients were treated with oral metronidazole and were evaluated at cessation of treatment and monthly. Index tests included Amsel, Nugent, BV Blue, and Affirm VPIII, as well as a quantitative PCR (qPCR)-based test under initial evaluation here. The qPCR-based LbRC ( LactobacillusRelative Composition) assay predicted BV recurrence when performed shortly after oral metronidazole treatment, with both 90% positive predictive values (PPV) and 74% negative predictive values (NPV); the Nugent scores had 93% PPV but poor NPV (57%). No test, at any other visit, was prognostic. The LbRC assay and, to a lesser extent, Nugent tests scored a week after oral metronidiazole predicted recurrence, suggesting that the recurrence in this cohort was predominantly by relapse due to incomplete restoration of eubiosis soon after therapy. This is the first study in an under evaluated population of recurrent BV patients that emphasizes the need for and a pathway to a possible prognostic modality. Given the high recurrence rates of BV, prognostic tests that could influence individualized treatment alternatives are urgently needed.