Treating male partners of women with bacterial vaginosis (StepUp): a protocol for a randomised controlled trial to assess the clinical effectiveness of male partner treatment for reducing the risk of BV recurrence

BMC Infectious Diseases

Christopher K. Fairley¹  Lenka A. Vodstrcil¹  Erica L. Plummer¹  Eric P. F. Chow¹  Catriona S. Bradshaw²  Jane S. Hocking³  Deborah Bateson⁴  Colette McGuiness⁵  Michelle Doyle⁵  Kathy Petoumenos⁶  Matthew G. Law⁶  Basil Donovan⁶ 

[1] Central Clinical School, Monash University, 3053, Carlton, VIC, Australia;Melbourne Sexual Health Centre, Alfred Health, 3053, Carlton, VIC, Australia;Central Clinical School, Monash University, 3053, Carlton, VIC, Australia;Melbourne Sexual Health Centre, Alfred Health, 3053, Carlton, VIC, Australia;Centre for Epidemiology and Biostatistics, Melbourne School of Population & Global Health, University of Melbourne, 3010, Parkville, Australia;Centre for Epidemiology and Biostatistics, Melbourne School of Population & Global Health, University of Melbourne, 3010, Parkville, Australia;Family Planning New South Wales, 2131, Ashfield, Australia;Discipline of Obstetrics, Gynaecology and Neonatology, University of Sydney, 2006, Camperdown, Australia;Melbourne Sexual Health Centre, Alfred Health, 3053, Carlton, VIC, Australia;The Kirby Institute, University of New South Wales, 2052, Sydney, Australia;

关键词: Bacterial vaginosis;    Antibiotic treatment;    Couple treatment;    Recurrence;    Metronidazole;    Clindamycin;    StepUp;   

DOI  :  10.1186/s12879-020-05563-w

来源: Springer

【 摘 要 】

BackgroundBacterial vaginosis (BV) is estimated to affect 1 in 3 women globally and is associated with obstetric and gynaecological sequelae. Current recommended therapies have good short-term efficacy but 1 in 2 women experience BV recurrence within 6 months of treatment. Evidence of male carriage of BV-organisms suggests that male partners may be reinfecting women with BV-associated bacteria (henceforth referred to as BV-organisms) and impacting on the efficacy of treatment approaches solely directed to women. This trial aims to determine the effect of concurrent male partner treatment for preventing BV recurrence compared to current standard of care.MethodsStepUp is an open-label, multicentre, parallel group randomised controlled trial for women diagnosed with BV and their male partner. Women with clinical-BV defined using current gold standard diagnosis methods (≥3 Amsel criteria and Nugent score (NS) = 4–10) and with a regular male partner will be assessed for eligibility, and couples will then be consented. All women will be prescribed oral metronidazole 400 mg twice daily (BID) for 7 days, or if contraindicated, a 7-day regimen of topical vaginal 2% clindamycin. Couples will be randomised 1:1 to either current standard of care (female treatment only), or female treatment and concurrent male partner treatment (7 days of combined antibiotics - oral metronidazole tablets 400 mg BID and 2% clindamycin cream applied topically to the glans penis and upper shaft [under the foreskin if uncircumcised] BID). Couples will be followed for up to 12 weeks to assess BV status in women, and assess the adherence, tolerability and acceptability of male partner treatment. The primary outcome is BV recurrence defined as ≥3 Amsel criteria and NS = 4–10 within 12 weeks of enrolment. The estimated sample size is 342 couples, to detect a 40% reduction in BV recurrence rates from 40% in the control group to 24% in the intervention group within 12 weeks.DiscussionCurrent treatments directed solely to women result in unacceptably high rates of BV recurrence. If proven to be effective the findings from this trial will directly inform the development of new treatment strategies to impact on BV recurrence.Trial registrationThe trial was prospectively registered on 12 February 2019 on the Australian and New Zealand Clinical Trial Registry (ACTRN12619000196145, Universal Trial Number: U1111–1228-0106, https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=376883&isReview=true).

【 授权许可】

CC BY