Nottingham Clinical Trials Unit
The University of Nottingham
University of Nottingham
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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 is comparing gentamicin with the current standard treatment ceftriaxone to assess whether gentamicin is a safe and effective alternative treatment for gonorrhoea. The primary outcome is clearance of gonorrhoeae at all infected sites confirmed by swab testing two weeks after treatment.

Recruitment commenced in October 2014 across a total of 15 sexual heath centres in the UK. The trial hit its recruitment target of 720 participants in November 2016. Publication of results are expected in early 2018.

Contact:  Sukhwinder Thandi

Funding:  NIHR Health Technology Assessment

Status:  Analysis and reporting

Publications:  2014-33, 2016-14

 Further Information:  Sukhwinder Thandi (Trial Manager)


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 is to determine if lactic acid gel is better than metronidazole for the symptomatic resolution of recurrent bacterial vaginosis by 'replacing' vaginal acidity in the vagina.

Some previous studies have suggested that this approach could be successful but they are not conclusive and current guidelines highlight a need for more data on the clinical effectiveness of lactic acid gel.

The VITA study will recruit 1900 women with recurrent BV over 27 months from 40 centres across the UK.

Recruitment commenced in October 2017 and will run for 26 months until November 2019.

Contact: Sukhwinder Thandi

Funding: NIHR Health Technology Assessment

Status: Recruiting



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