Nottingham Clinical Trials Unit
The University of Nottingham
University of Nottingham
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INFECTION

G-TOG

 


Trial Name:  Gentamicin in the Treatment Of Gonorrhoea (G-TOG)

Chief Investigator:  Jonathan Ross, University Hospitals Birmingham NHS Foundation Trust

Trial Description:  Currently the antibiotic ceftriaxone is used to treat gonorrhoea, but there is increasing evidence that this antibiotic is becoming less effective over time and will stop curing patients with gonorrhoea within the next few years.

Many currently available antibiotics do not work against gonorrhoea, and there is an urgent need to find an alternative treatment which is effective and safe. Gentamicin was used in the past in the UK to treat gonorrhoea, and laboratory testing suggests that it remains effective against gonorrhoea. It is currently being used as a treatment in some developing countries.

This randomised trial compared gentamicin with the current standard treatment ceftriaxone to assess whether gentamicin is a safe and effective alternative treatment for gonorrhoea. The primary outcome was clearance of gonorrhoeae at all infected sites confirmed by swab testing two weeks after treatment.

Recruitment commenced in October 2014 across a total of 14 sexual heath centres in the UK. The trial hit its recruitment target of 720 participants in November 2016. Non-inferiority of gentamicin was not confirmed and the results of the trial were published in the Lancet in June 2019.

Contact:  Clare Brittain

Funding:  NIHR Health Technology Assessment

Status:  Published

Publications:  2014-33, 2016-14; 2019-9, 2019-10, 2019-19

 Further Information:  Clare Brittain (Senior Trial Manager) g-tog@nottingham.ac.uk

VITA

Trial Name: Metronidazole versus lactic acid for treating bacterial vaginosis (VITA)

Chief Investigator: Jonathan Ross, University Hospitals Birmingham NHS Foundation Trust

Trial Description: Bacterial vaginosis (BV) is a common condition in women which causes a discharge from the vagina, often with an unpleasant fishy smell.  The exact cause of BV is not known but it is associated with a change in the type of bacteria in the vagina; specifically a reduction in 'lactobacilli' and an increase in 'anaerobic bacteria'.

Oral metronidazole is currently recommended as first line therapy in the UK national BV treatment guidelines.  However, BV comes back again in about a third of women, who then require repeated courses of this antibiotic treatment.

The objective of this randomised control trial was to determine if lactic acid gel (a non-antibiotic treatment) is better than metronidazole for the symptomatic resolution of recurrent bacterial vaginosis.

The VITA study closed to recruitment in June 2019 with a total of 518 participants randomised.

Contact: Lindsay Armstrong-Buisseret/Clare Brittain

Funding: NIHR Health Technology Assessment

Status: Analysis and reporting

Publications: 2019-21

 

DEVA 2

Trial Name: Dequalinium versus usual care antibiotics for the treatment of bacterial vaginosis (DEVA): a multicentre randomised, open label, non-inferiority trial

Chief Investigator: Dr Janet Wilson, Leeds Teaching Hospital NHS Trust

Co-Chief Investigator: Professor Jonathan Ross, University Hospitals Birmingham NHS Foundation Trust

Trial Description: Bacterial vaginosis (BV) causes a vaginal discharge that has an unpleasant smell.  It is the most common cause of discharge and up to a third of women will get it at some time in their lives.  We do not know why BV occurs but there is a change in the balance of the vaginal bacteria with a reduction in the 'good' bacteria that protect against infections and an increase in many other bacteria.  Current treatments often do not cure BV completely, but treating BV is important as the symptoms are unpleasant.  Also, it can cause miscarriage, premature birth and it increases the risk of catching HIV and other sexually transmitted infections.

Oral or vaginal antibiotics are recommended for treating BV.  These can cause side-effects such as diziness, nausea and vaginal soreness.  Over 1 in 5 women get BV back within one month of treatment and have to take repeated courses of antibiotics.  Concern about bacteria becoming resistant to antibiotics and damage to the body's good bacteria means that non-antibiotic therapies are being considered for BV.

There is a new treatment available for BV called dequalinium which works as a vaginal antiseptic.  Its potential advantages are that it will not damage the good bacteria throughout the body or cause antibiotic resistance.  Two studies have suggested that it could be effective and safe but the number of women included were small so the results were not conclusive.

The aim of this study, called DEVA, is to see if dequalinium is as effective at treating BV as current BV antibiotics.

The trial aims to recruit 904 women with first episode or recurrent BV, with first participant first visit planned in 2020.

Contact: Rebecca Haydock

Funding: NIHR Health Technology Assessment

Status: Set-up

 

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