The DEVA trial: protocol for a randomised controlled trial of dequalinium chloride versus usual care antibiotics for the treatment of bacterial vaginosis

Haydock, Rebecca; Hepburn, Trish; Ross, Jonathan; Daniels, Jane; Brittain, Clare; Jackson, Louise; Ozolins, Mara; Wilson, Janet

Abstract

Background: Bacterial vaginosis (BV) is the most common cause of vaginal discharge in women of reproductive age, and it is estimated that up to a third of women will experience it at some point in their lives. BV produces an offensive vaginal odour and it is associated with serious sequelae. The most frequently prescribed treatment for BV in the UK is 7-day oral metronidazole but recurrences are common following it. Dequalinium chloride (Fluomizin©) is an anti-infective, antiseptic agent administered as a vaginal tablet. Small studies have shown this to be an effective alternative to antibiotics as a BV treatment. This trial aims to investigate whether dequalinium is as effective as current antibiotic treatments for the treatment of BV 1 month after treatment start.

Methods: DEVA is a multi-centre, randomised, open-label, parallel group, non-inferiority trial of dequalinium chloride versus usual care antibiotics for the treatment of BV. Recruitment will take place in 15 GUM clinics in the UK with Leeds Sexual Health also managing remote recruitment via the trial website. Women will be randomised 1:1 to receive dequalinium or usual care antibiotics. The primary outcome is to determine if the proportion of women reporting resolution of BV symptoms 4 weeks after treatment (without the need for additional treatment) is not worse in women treated with dequalinium chloride compared to usual care antibiotics. Questionnaire follow-up will take place 4 and 12 weeks after starting treatment, and remotely recruited patients will also provide a week 4 BV vaginal smear. The sample size is 904.

Discussion: This trial will provide high-quality evidence on the use of dequalinium chloride as a BV treatment, which could result in patients reducing the number of antibiotics they take.

Trial registration: ISRCTN ISRCTN91800263. Prospectively registered on 20 January 2020.

Citation

Haydock, R., Hepburn, T., Ross, J., Daniels, J., Brittain, C., Jackson, L., Ozolins, M., & Wilson, J. (2021). The DEVA trial: protocol for a randomised controlled trial of dequalinium chloride versus usual care antibiotics for the treatment of bacterial vaginosis. Trials, 23(1), Article 1040. https://doi.org/10.1186/s13063-022-06954-x

• Journal Article Type: Article
• Acceptance Date: Nov 22, 2022
• Online Publication Date: Dec 21, 2022
• Publication Date: Dec 21, 2021
• Deposit Date: Feb 8, 2023
• Publicly Available Date: Feb 8, 2023
• Journal: Trials
• Electronic ISSN: 1745-6215
• Publisher: Springer Verlag
• Peer Reviewed: Peer Reviewed
• Volume: 23
• Issue: 1
• Article Number: 1040
• DOI: https://doi.org/10.1186/s13063-022-06954-x
• Keywords: Study Protocol, Clinical trial, Randomised controlled trial, Protocol, Bacterial vaginosis, Antiseptic, Pessary, Metronidazole, Dequalinium
• Public URL: https://nottingham-repository.worktribe.com/output/15432333
• Publisher URL: https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-022-06954-x
• Additional Information: Received: 6 October 2022; Accepted: 22 November 2022; First Online: 21 December 2022; : ; : Ethical approval was granted by the North West—Liverpool Central Research Ethics Committee on 21 April 2020 (Ref: 20/NW/0113). Due to the COVID-19 pandemic, the trial set-up was paused and the protocol was amended to include the remote patient pathways. Approval for the amended study design was received on 04 May 2021. Written or electronic informed consent to participate will be obtained from all participants.; : Not applicable—no identifying images or other personal or clinical details of participants are presented here or will be presented in reports of the trial results. Informed consent materials are available from the corresponding author on request.; : Dr. Janet Wilson reports personal fees from Mundipharma Medical and co-authorship of the UK Guideline on Trichomonas vaginalis and the European guidelines on vaginal discharge and Mycoplasma genitalium. She is the President for the International Union against Sexually Transmitted Infections. Professor Jonathan Ross reports personal fees from GSK Pharma and Bayer Consumer Care and ownership of shares in GSK Pharma and AstraZeneca Pharma and is the lead author of the UK and European Guidelines on Pelvic Inflammatory Disease and a member of the European Sexually Transmitted Infections Guidelines Editorial Board. He is an NIHR Journals Editor and associate editor of the Sexually Transmitted Infections journal. He is a treasurer for the International Union against Sexually Transmitted Infections and chair of charity trustees for the Sexually Transmitted Infections Research Foundation. The other authors declare that they have no competing interests.