CompletedPhase IVInterventional

Dequalinium versus usual care antibiotics for the treatment of bacterial vaginosis

Bacterial vaginosis (BV) is the most common cause of unusual vaginal discharge, affecting up to one in three women at some point in their lives. It happens when the natural balance of bacteria in the vagina changes. Doctors usually treat BV with antibiotics, but the condition often returns, and repeated antibiotic use can cause side effects and lead to antibiotic resistance. This UK clinical study is testing a non-antibiotic treatment called dequalinium chloride against standard antibiotics. Dequalinium is an antiseptic vaginal tablet (pessary) that works locally to treat the infection without affecting bacteria in the rest of the body. The aim is to see whether dequalinium works just as well as routine antibiotics. Participants take one of the two treatments, provide swab samples, and complete two short online questionnaires over 12 weeks to report their symptoms and recovery.

At a glance

Status

Completed

Phase

Phase IV

Sponsor

Leeds Teaching Hospitals NHS Trust

Enrolment target

1,316

Start

20 Aug 2021

Estimated completion

20 Dec 2024

Bacterial vaginosis

What is this study about?

Bacterial vaginosis, often called BV, is a very common vaginal condition that causes an unusual discharge, often with an unpleasant or fishy smell. It happens when the natural balance of bacteria inside the vagina is disturbed. The numbers of 'good' bacteria drop, allowing other bacteria to grow. While BV is not usually dangerous, its symptoms can be distressing. Left untreated, it can also raise the risk of catching other infections or cause complications during pregnancy.

Currently, the standard treatment is a course of antibiotics, taken as tablets or used inside the vagina as a cream or gel. While these treatments can work, BV returns within a month for more than one in five women. Taking antibiotics again and again can cause side effects like nausea or thrush. Over time, frequent antibiotic use also increases the risk of bacteria becoming resistant to treatment, which is a major health concern worldwide.

The DEVA study is exploring whether a non-antibiotic medicine called dequalinium chloride is just as effective as standard antibiotics. Dequalinium is an antiseptic tablet inserted into the vagina at bedtime. Because it acts locally, it is less likely to upset the good bacteria in other parts of your body or contribute to antibiotic resistance. By comparing dequalinium directly with routine antibiotics, researchers hope to give women and healthcare providers better, safer treatment choices in the future.

Key takeaways

Tests an antiseptic vaginal tablet against standard antibiotics for bacterial vaginosis (BV).
Open to people with a vagina aged 16 and over living in the UK with confirmed BV.
Participation can be completed either in an NHS clinic or completely from home.
Follow-up involves simple home swabs and two short online surveys over 12 weeks.
Helps researchers find effective BV treatments that do not increase antibiotic resistance.

Who may be eligible?

You may be able to join this study if you were assigned female at birth, are aged 16 or older, and have symptoms of bacterial vaginosis (such as an unusual vaginal smell or discharge). A clinic or home swab test must confirm that your symptoms are caused by BV. You must also be happy to take whichever treatment you are given, avoid vaginal sex and vaginal douching during your treatment, and fill in follow-up forms.

You will not be able to take part if you have taken antibiotics or used any vaginal treatments (including douching) in the past 14 days, or if you plan to use them soon. People with known allergies to dequalinium or the standard BV antibiotics cannot join. You also cannot participate if you are pregnant and planning a termination, or if you are not willing to provide your GP's details if you are or become pregnant.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

I am aged 16 or over and was assigned female at birth.
I currently have symptoms of bacterial vaginosis, such as an unusual odour or discharge.
I have not used antibiotics or vaginal treatments in the last 14 days.
I am willing to avoid vaginal sex and douching while using the study medicine.
I am happy to complete two short online questionnaires over the next 12 weeks.

Answer every question to see your result.

What does participation involve?

You can take part either in person through a participating NHS sexual health clinic or entirely from home using online forms and postal swab kits. If you are eligible, a computer system will randomly assign you to one of two groups. One group uses dequalinium chloride vaginal tablets for six nights. The other group uses a standard antibiotic course chosen by a clinic doctor, which may be tablets swallowed by mouth or a gel or cream applied inside the vagina.

If you take part from home, you will be sent a kit to collect your own vaginal swabs at the start and after four weeks. All participants will complete short, secure online questionnaires at 4 weeks and 12 weeks to check whether symptoms have cleared and whether you noticed any side effects. Your total time in the study is about 12 weeks.

Potential risks and benefits

Taking part may not give you any extra personal health benefit compared to standard care, but it helps doctors discover better ways to manage BV and reduce antibiotic overuse. Participants who complete the follow-up surveys receive £10 shopping vouchers (up to £20 total) and entry into a prize draw. Both treatments carry a small risk of mild side effects; dequalinium can sometimes cause local itching, burning, or thrush, while antibiotic tablets may cause stomach upset or dizziness. If your BV does not clear up, your study team or GP can provide standard alternative treatments. You are completely free to leave the study at any time, and doing so will never affect your standard NHS care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Leeds Teaching Hospital NHS Trust
City only
Leeds, England

Common questions

What is the difference between an antiseptic and an antibiotic?

Antibiotics kill bacteria or stop them growing throughout the body, but bacteria can learn to resist them over time. Antiseptics work locally on a specific area to clear away bacteria and are far less likely to cause resistance.

Do I have to go to a clinic to take part?

Not necessarily. While some people join through an NHS sexual health clinic visit, you can also join remotely from home by registering online, speaking to the research team by phone or video, and using posted swab kits.

Can I choose which treatment I receive?

No. A computer system puts participants into a treatment group at random. This ensures the trial is fair and that the results can be trusted.

Can I have sex while using the treatment?

You will be asked to avoid vaginal sex while actively using your study treatment to allow the medicine to work properly and avoid irritating the area.

What happens if my BV symptoms do not go away?

If your symptoms do not improve or if they come back, you can contact the study team, your local sexual health clinic, or your GP to discuss standard alternative treatments.

How to find out more

Mickey Lewis

deva@nottingham.ac.uk 1157487105 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.