The DEVA trial: protocol for a randomised controlled trial of dequalinium chloride versus usual care antibiotics for the treatment of bacterial vaginosis
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....
| Main Authors: | , , , , , , , |
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| Format: | Article |
| Language: | English |
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BMC
2022-12-01
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| Series: | Trials |
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| Online Access: | https://doi.org/10.1186/s13063-022-06954-x |
| _version_ | 1828086950590939136 |
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| author | Rebecca Haydock Trish Hepburn Jonathan Ross Jane Daniels Clare Brittain Louise Jackson Mara Ozolins Janet Wilson |
| author_facet | Rebecca Haydock Trish Hepburn Jonathan Ross Jane Daniels Clare Brittain Louise Jackson Mara Ozolins Janet Wilson |
| author_sort | Rebecca Haydock |
| collection | DOAJ |
| description | 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. |
| first_indexed | 2024-04-11T05:04:13Z |
| format | Article |
| id | doaj.art-70e1b7ec862d43b0a429f68fd435271e |
| institution | Directory Open Access Journal |
| issn | 1745-6215 |
| language | English |
| last_indexed | 2024-04-11T05:04:13Z |
| publishDate | 2022-12-01 |
| publisher | BMC |
| record_format | Article |
| series | Trials |
| spelling | doaj.art-70e1b7ec862d43b0a429f68fd435271e2022-12-25T12:28:20ZengBMCTrials1745-62152022-12-0123111110.1186/s13063-022-06954-xThe DEVA trial: protocol for a randomised controlled trial of dequalinium chloride versus usual care antibiotics for the treatment of bacterial vaginosisRebecca Haydock0Trish Hepburn1Jonathan Ross2Jane Daniels3Clare Brittain4Louise Jackson5Mara Ozolins6Janet Wilson7Nottingham Clinical Trials Unit (NCTU), Applied Health Research Building, University of Nottingham, University ParkNottingham Clinical Trials Unit (NCTU), Applied Health Research Building, University of Nottingham, University ParkDepartment of GU Medicine, University Hospitals Birmingham NHS Foundation TrustNottingham Clinical Trials Unit (NCTU), Applied Health Research Building, University of Nottingham, University ParkNottingham Clinical Trials Unit (NCTU), Applied Health Research Building, University of Nottingham, University ParkHealth Economics Unit, Institute of Applied Health Research, College of Medical and Dental Sciences, University of BirminghamNottingham Clinical Trials Unit (NCTU), Applied Health Research Building, University of Nottingham, University ParkGU Medicine Service, Leeds Teaching Hospitals NHS Trust, Leeds General InfirmaryAbstract 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.https://doi.org/10.1186/s13063-022-06954-xClinical trialRandomised controlled trialProtocolBacterial vaginosisAntisepticPessary |
| spellingShingle | Rebecca Haydock Trish Hepburn Jonathan Ross Jane Daniels Clare Brittain Louise Jackson Mara Ozolins Janet Wilson The DEVA trial: protocol for a randomised controlled trial of dequalinium chloride versus usual care antibiotics for the treatment of bacterial vaginosis Trials Clinical trial Randomised controlled trial Protocol Bacterial vaginosis Antiseptic Pessary |
| title | The DEVA trial: protocol for a randomised controlled trial of dequalinium chloride versus usual care antibiotics for the treatment of bacterial vaginosis |
| title_full | The DEVA trial: protocol for a randomised controlled trial of dequalinium chloride versus usual care antibiotics for the treatment of bacterial vaginosis |
| title_fullStr | The DEVA trial: protocol for a randomised controlled trial of dequalinium chloride versus usual care antibiotics for the treatment of bacterial vaginosis |
| title_full_unstemmed | The DEVA trial: protocol for a randomised controlled trial of dequalinium chloride versus usual care antibiotics for the treatment of bacterial vaginosis |
| title_short | The DEVA trial: protocol for a randomised controlled trial of dequalinium chloride versus usual care antibiotics for the treatment of bacterial vaginosis |
| title_sort | deva trial protocol for a randomised controlled trial of dequalinium chloride versus usual care antibiotics for the treatment of bacterial vaginosis |
| topic | Clinical trial Randomised controlled trial Protocol Bacterial vaginosis Antiseptic Pessary |
| url | https://doi.org/10.1186/s13063-022-06954-x |
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