None listed
Conditions
Brief summary
Bacterial vaginosis (BV) is the most common cause of abnormal vaginal discharge in women of reproductive age affecting between 12-30% of women, suggesting it may currently affect at least 1 million Australian women. We have shown that 1 in 2 women will get BV back again after recommended treatment. BV-associated bacteria are present in male partners of women with BV on the male genitals. We believe that these bacteria may be exchanged during sex and that this may be contributing to the high rates of women getting their BV back again. Currently only women are treated for BV and their male partners are not. Our research study “StepUp RCT” aims to determine whether the combined antibiotic treatment of male partners of women receiving therapy for BV significantly reduces the risk of BV recurrence compared to no male treatment, in the 12 weeks after randomisation. We aim to recruit 342 couples in Melbourne and Sydney and we are using a randomised study design: half of men will receive antibiotic treatment (dual couple treatment) and the other half will not (female treatment only). We will collect genital specimens from all participants before and after treatment and then at weeks 4,8 and 12 to see if the female gets her BV back again or not.
Interventions
All female participants will receive first line recommended treatment, which is oral metronidazole (MTZ) 400mg tablets twice daily for 7 days, or if contraindicated, either alternate first line therapy: 7-day regimen of topical vaginal 2% clindamycin cream (intravaginally once daily at night) or 5 days of vaginal metronidazole gel (0.75% intravaginally once daily at night). Her male partner is then randomised to either the Intervention or Control group.
Male partners randomised to the Intervent
All female participants will receive first line recommended treatment, which is oral metronidazole (MTZ) 400mg tablets twice daily for 7 days, or if contraindicated, either alternate first line therapy: 7-day regimen of topical vaginal 2% clindamycin cream (intravaginally once daily at night) or 5 days of vaginal metronidazole gel (0.75% intravaginally once daily at night). Her male partner is then randomised to either the Intervention or Control group. Male partners randomised to the Intervention Group will receive oral MTZ 400mg tablets twice daily and topical 2% clindamycin cream to be applied to the glans penis and upper shaft (under the foreskin if uncircumcised) twice daily for 7 days. For all participants, adherence and adverse effects will be captured in post-antibiotic questionnaires (to be completed the day after treatment has been completed).
Sponsors
Monash University
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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
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
Outcome results
None listed