DEqualinium versus usual care antibiotics for the treatment of bacterial VAginosis (DEVA): a multicentre randomised, open label, non-inferiority trial
Bacterial vaginosis
Participants will be assigned to treatment groups using a remote internet-based randomization system to one of the following the intervention or control arm. The intervention arm will receive dequalinium chloride 10mg vaginal tablet for 6 nights. This is the formulation and course that is licensed for use in the UK. The control arm will receive usual care antibiotics. Clinician-chosen usual care antibiotic treatment selected from UK guideline recommended or alternative oral or topical antibiotic BV treatments which (at the time of writing the protocol) will be one of the following treatments: 1. Metronidazole 400 mg orally twice daily for 5-7 days 2. Metronidazole 2 g single dose orally 3. Intravaginal metronidazole gel (0.75%) once daily for 5 days 4. Intravaginal clindamycin cream (2%) once daily for 7 days 5. Tinidazole 2 g single dose orally 6. Clindamycin 300 mg orally twice daily for 7 days A subgroup of women in each arm, who provide informed consent to take their own vaginal swabs at home and post them to us at 4 weeks, will also be assessed for clinical diagnosis of bacterial vaginosis. For both arms, participants will be sent confidential online questionnaires at 4 weeks and 12 weeks to ask about if symptoms have cleared, the amount of treatment used, the side effects and the acceptability of the treatment
Current inclusion criteria as of 06/10/2023: 1. People with a vagina (assigned female at birth) aged 16 years and over 2. Diagnosis of BV confirmed by microscopy with symptoms of vaginal odour plus or minus vaginal discharge requiring treatment with usual care (BV guideline recommended) antibiotics 3. Willing to use either intravaginal dequalinium chloride tablets (pessaries) or the clinician selected usual care antibiotic BV treatment 4. Willing to avoid vaginal sex whilst taking/using trial treatment 5. Willing to avoid vaginal douching whilst taking/using trial treatment 6. Willing to complete follow up _____ Previous inclusion criteria: 1. Cisgender women aged 16 years and over 2. Diagnosis of BV confirmed by on-site microscopy (Ison-Hay Grade 3) with symptoms of vaginal odour plus or minus vaginal discharge requiring treatment with usual care (BV guideline recommended) antibiotics 3. Willing to use either intravaginal dequalinium chloride tablets (pessaries) or the clinician selected usual care antibiotic BV treatment 4. Willing to avoid vaginal sex whilst taking/using trial treatment 5. Willing to avoid vaginal douching whilst taking/using trial treatment 6. Willing to complete follow up questionnaires in English 7. Written informed consent to participation given
Current exclusion criteria as of 06/10/2023: 1. Contra-indications or allergy to dequalinium chloride or clinician selected usual care antibiotic BV treatment 2. Use of antibiotics concurrently, within the 14 days prior to randomisation or planned use over the 14 days from randomisation 3. Use of intravaginal therapies (including vaginal douching) concurrently, within the 14 days prior to randomisation or planned use over the 14 days from randomisation 4. Pregnant females who are seeking a termination 5. Unwilling to provide GP information (only to be used for pregnant females or females who become pregnant in the first 4 weeks of the trial) 6. Current use of gender affirming hormones (androgens and anti-oestrogens) 7. Previous participation in this trial 8. Resident outside the UK (for shipment of trial medication and sample kits only) ______ Previous exclusion criteria: 1. Contra-indications or allergy to dequalinium chloride or clinician selected usual care antibiotic bacterial vaginosis (BV) treatment 2. Concurrent use of oral antibiotics, within the past 14 days or planned use over the next 14 days 3. Concurrent use of intravaginal therapies (including vaginal douching), within the past 14 days or planned use over the next 14 days 4. Diagnosis of any infection at the baseline visit that requires immediate antibiotic treatment 5. Pregnant women who are seeking a termination 6. Pregnant women or women who become pregnant in the first 4 weeks of the trial who are unwilling to provide GP information 7. Previous participation in this trial Added 11/05/2021: 8. Resident outside the UK (for shipment of trial medication and sample kits only)