Dequalinium versus usual care antibiotics for the treatment of bacterial vaginosis (DEVA): a multicentre randomised, open label, non-inferiority trial

Research question: Is dequalinium effective in resolving the symptoms of bacterial vaginosis (BV) compared to usual care antibiotics? Background: BV is the commonest cause of vaginal discharge. Usual care antibiotics produce resolution rates of 61-94% 30-days after treatment but recurrences are common. Dequalinium is a broad-spectrum antiseptic which has good activity against BV bacteria. Aim: To determine if dequalinium is effective in the management of BV compared to usual care antibiotics Objectives: To determine: • The efficacy of dequalinium in resolving BV compared with usual care antibiotics • The side effects, acceptability of, and adherence to, dequalinium compare with usual care antibiotics • The cost to the NHS of using dequalinium versus usual care antibiotics Methods Design: Multi-centre, randomised, open-label, parallel, non-inferiority trial Setting: 15 UK Genitourinary Medicine (GUM) clinics Population: Women with symptomatic BV either first or recurrent episode Intervention: Dequalinium chloride 10mg vaginal tablet for 6 nights Control: Any UK guideline recommended oral or topical antibiotic treatment for BV. Clinicians will choose the comparator treatment prior to randomisation Outcomes Primary: Patient reported resolution of symptoms 30 days after starting treatment Secondary: Time to resolution of symptoms Microscopic resolution of BV at 30-days (in a subgroup of participants) Adherence to treatment Side effects and acceptability of treatment Patient reported recurrence of symptoms within 3-months Time to recurrence of BV symptoms Costs of treatment Sample size: Assuming 78% of participants have BV symptom resolution at 30-days in both control and intervention groups, a total sample size of 722 for analysis (361 in each group) will achieve 90% power to detect non-inferiority with a lower confidence limit for the absolute risk difference of 10%, with a 1-sided significance level of 0.025. To allow a loss of primary outcome data of up to 20% the trial will recruit 904 women. A 10% lower confidence interval for the risk of difference was acceptable to 68% of a sample of women attending two GUM clinics and 81% of clinicians experienced in treating BV. Cost comparison: The costs associated with dequalinium will be compared with usual care antibiotics. The primary objective is to determine the non-inferiority of dequalinium so the economic analysis will focus on whether using dequalinium rather than usual care antibiotics is cost-neutral. Resource use and costs will be collected in both arms of the trial. Timelines for delivery (42 months): 9 months setup, 21 months recruitment, 3 month follow-up, 2 month data cleaning, 7 months analysis and write up. An internal pilot at 9 months post first participants randomised will review the number of participants recruited and completing the 30-day assessment, and adherence, against pre-specified targets. Following staggered site set up recruitment will be 4 participants per month per site. In 2016 Leeds GUM clinic diagnosed 90 cases of BV per month so this target is realistic for 15 sites of varying size and research capacity. Anticipated impact and dissemination: If dequalinium is effective in treating BV it will result in reduced antibiotic use for this common condition. The results will be presented at medical conferences, published in medical journals and highlighted to the authors of national and international BV management guidelines.