Treating male partners of women being treated for bacterial vaginosis (BV): randomised controlled trial

Phase 3

Completed

• Conditions: bacterial vaginosis; Infection - Other infectious diseases; Renal and Urogenital - Other renal and urogenital disorders; Reproductive Health and Childbirth - Other reproductive health and childbirth disorders

• Registration Number: ACTRN12619000196145
• Lead Sponsor: Monash University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2019-02-12
• Study Completion: 2023-11-28
• Last Update Posted: 21 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 328

Inclusion Criteria

Females will be included if they fulfil the following criteria:
i) Are aged 18 years to pre-menopausal (defined as still menstruating within the last 12 months); and
ii) have symptomatic BV defined as 3 or 4 Amsel’s criteria and a Nugent score (NS) of 4–10; and
iii) have a regular male partner for the prior 8 weeks who is willing and eligible to participate; and
iv) are being treated with a first line recommended antimicrobial therapy for BV (including the following 3 options: 7 days of oral metronidazole 400mg bd is the preferred option but if not tolerated or is contraindicated 7 days of topical vaginal clindamycin cream or 5 days of intravaginal metro gel are acceptable; and
v) have sufficient English language proficiency to understand the study requirements; and
vi) provide written informed consent; and
vii) are willing and able to comply with protocol requirements including clinic visits at 4 and 12 weeks ; and
viii) do not have any of the exclusion criteria listed below.

Males nominated as the regular partner of a woman fulfilling inclusion criteria will be eligible if they:
i) Are aged 18 years or above; and
ii) enrol within a week of their partner with confirmed BV; and
iii) have sufficient English language proficiency to understand the study requirements; and
iv) provide written informed consent; and
v) are able to comply with protocol requirements; and
vi) do not have any of the exclusion criteria or contraindications listed for metronidazole.

Exclusion Criteria

Participants will be deemed ineligible for the study if they meet any of the following exclusion criteria:
i) are a current sex worker; or
ii) have concurrent sexual partners; or
iii) are known to be HIV positive

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
BV recurrence defined as 3 or 4 Amsel’s criteria and a Nugent score (NS) of 4–10 within 12 weeks*<br><br>*The combination of at least 3 Amsel’s criteria (Amsel-BV) and a Nugent Score (NS) between 4 and 10 (Nugent-BV) will be used to diagnose BV in this trial. <br>The Amsel’s criteria include: <br>i)presence of a characteristic homogenous vaginal discharge;<br>ii)elevated vaginal pH >4.5; <br>iii)positive amine test (noticeable fishy odour on examination for non-laboratory sites); <br>iv)>=20% Clue cells on microscopy.<br>The Nugent method scores bacterial morphotypes on vaginal Gram stain: <br>i)a NS of 0–3 represents a lactobacillus dominant optimal” vaginal microbiota, <br>ii)a NS of 4–6 an intermediate state with few lactobacilli and increased anaerobes, <br>iii)a NS of 7–10 is classified as Nugent-BV. <br>Combining a NS of 4–10 with at least 3 Amsel’s criteria optimises diagnosis of symptomatic BV. [ 12 weeks post randomisation]

Secondary Outcome Measures

Name	Time	Method
BV recurrence defined as NS of 7-10 by vaginal Gram stain, within 12 weeks[ 12 weeks post randomisation];BV recurrence defined as 3 or 4 Amsel’s criteria (presence of a vaginal discharge; elevated vaginal pH >4.5, positive amine test, >=20% Clue cells on microscopy of vaginal Gram stain), within 4 weeks [ 4 weeks post randomisation];BV recurrence defined as NS of 7-10 by vaginal Gram stain, within 4 weeks [ 4 weeks post randomisation];Recurrence of a microbiota characterised by BV-associated bacteria using high throughput sequencing and/or quantitative PCR, within 12 weeks[ 12 weeks post randomisation];Recurrence of a microbiota characterised by BV-associated bacteria using high throughput sequencing and/or quantitative PCR, within 4 weeks[ 4 weeks post randomisation]