Dequalinium versus usual care antibiotics for the treatment of bacterial vaginosis

Phase 4

• Conditions: Bacterial vaginosis; Urological and Genital Diseases

• Registration Number: ISRCTN91800263
• Lead Sponsor: eeds Teaching Hospitals NHS Trust

Brief Summary

2022 Protocol article in https://pubmed.ncbi.nlm.nih.gov/36544202/ (added 27/01/2023)

Detailed Description

Not available

Study Timeline

• Study Start: 2020-01-20
• Last Update Posted: 24 June 2024
• Study Completion: 2025-02-28

Recruitment & Eligibility

• Status: Ongoing
• Sex: Female
• Target Recruitment: 1316

Inclusion Criteria

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

Exclusion Criteria

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)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Participant-reported resolution of bacterial vaginosis (BV) symptoms without the need for additional treatment assessed by online questionnaire at 4 weeks.