Metronidazole versus lactic acid for treating bacterial vaginosis (VITA): protocol for a randomised controlled trial to assess the clinical and cost effectiveness of topical lactic acid gel for treating second and subsequent episodes of bacterial vaginosis

Armstrong-Buisseret, Lindsay; Brittain, Clare; David, Miruna; Dean, Gillian; Griffiths, Frances; Hepburn, Trish; Jackson, Louise; Kai, Joe; Montgomery, Alan; Roberts, Tracy; Thandi, Sukhwinder; Ross, Jonathan D.C.

Abstract

Background: Bacterial vaginosis (BV) affects 30 – 50% of women at some time in their lives and is an embarrassing and distressing condition which can be associated with potentially serious comorbidities. Current antibiotic treatments such as metronidazole are effective but can result in side effects, and recurrence is common. This trial aims to investigate whether lactic acid gel is clinically effective and cost effective in the treatment of recurrent BV compared with metronidazole.

Methods: VITA is an open-label, multicentre, parallel group randomised controlled trial in women with a clinical diagnosis of BV and at least 1 previous BV episode in the past 2 years. Participants will be randomised 1:1 to intravaginal lactic acid gel 5ml once daily for 7 days or oral metronidazole tablets 400mg twice daily for 7 days. All participants will be followed-up for 6 months to assess health status and healthcare costs. A subgroup will be interviewed to further explore adherence, tolerability and acceptability of treatment. The estimated sample size is 1900 participants to detect a 6% absolute increase in response rate to 86% in those receiving lactic acid gel. The primary outcome is participant reported resolution of BV at Week 2.

Discussion: Results from this trial will help inform UK treatment guidelines for BV and may provide an alternative effective treatment for recurrent episodes of this condition which avoids repeated exposure to antibiotics.

Trial Registration : ISRCTN, ISRCTN14161293, registered on 8th September 2017, https://doi.org/10.1186/ISRCTN14161293

Citation

Armstrong-Buisseret, L., Brittain, C., David, M., Dean, G., Griffiths, F., Hepburn, T., Jackson, L., Kai, J., Montgomery, A., Roberts, T., Thandi, S., & Ross, J. D. (2019). Metronidazole versus lactic acid for treating bacterial vaginosis (VITA): protocol for a randomised controlled trial to assess the clinical and cost effectiveness of topical lactic acid gel for treating second and subsequent episodes of bacterial vaginosis. Trials, 20, Article 648. https://doi.org/10.1186/s13063-019-3731-7

• Journal Article Type: Article
• Acceptance Date: Sep 16, 2019
• Online Publication Date: Nov 27, 2019
• Publication Date: Nov 27, 2019
• Deposit Date: Nov 20, 2019
• Publicly Available Date: Dec 3, 2019
• Journal: Trials
• Electronic ISSN: 1745-6215
• Publisher: Springer Verlag
• Peer Reviewed: Peer Reviewed
• Volume: 20
• Article Number: 648
• DOI: https://doi.org/10.1186/s13063-019-3731-7
• Keywords: Bacterial vaginosis, lactic acid gel, metronidazole, recurrence, VITA, antibiotic usage, cost-benefit analysis.
• Public URL: https://nottingham-repository.worktribe.com/output/3343763
• Publisher URL: https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-019-3731-7
• Additional Information: Received: 6 June 2019; Accepted: 16 September 2019; First Online: 27 November 2019; : This trial was reviewed and given a favourable ethical opinion by the London - Harrow Research Ethics Committee (Ref CitationRef removed/LO/1245). The trial will be performed in accordance with the ethical principles of the Declaration of Helsinki and subsequent amendments. The trial will be conducted in accordance with the Research Governance Framework for Health and Social Care, the applicable UK Statutory Instruments, which include the Medicines for Human Use Clinical Trials 2004 and subsequent amendments, the Data Protection Act 1998, Human Tissue Act 2008 and Human Tissue (Scotland) Act 2006 (if applicable), EU Clinical Trials Directive, Medical Devices Regulations and amendment Regulations and Guidelines for Good Clinical Practice (GCP). This trial will be carried out under a Clinical Trial Authorisation in accordance with the Medicines for Human Use Clinical Trials regulations. The protocol will be submitted to and approved by the Research Ethics Committee prior to circulation.All participants will receive oral and written information about the trial and must give their written informed consent to take part in the trial. Participants are free to withdraw at any time.; : Not applicable.; : JDCR reports personal fees from GlaxoSmithKline (GSK) Pharma, Hologic Diagnostics, Mycovia and Janssen Pharma as well as ownership of shares in GSK Pharma and Astrazeneca Pharma. He is author of the UK and European Guidelines on Pelvic Inflammatory Disease; is a Member of the European Sexually Transmitted Infections Guidelines Editorial Board; is a Member of the National Institute for Health Research (NIHR) Funding Committee (Health Technology Assessment [HTA] programme); and was previously a Member of the NIHR HTA Primary Care, Community and Preventative Interventions Panel (2013–2016). He is an NIHR Journals editor and associate editor of the journal Sexually Transmitted Infections. He is an officer of the British Association for Sexual Health and HIV (vice-president) and the International Union against Sexually Transmitted Infections (treasurer), and he is a charity trustee of the Sexually Transmitted Infections Research Foundation. The other authors declare that they have no competing interests.