GonFAST: faster gonorrhoea diagnosis
Research type
Research Study
Full title
Direct from clinical sample gonorrhoea sequencing to combat antibiotic resistance
IRAS ID
256871
Contact name
David W Eyre
Contact email
Sponsor organisation
University of Oxford / Clinical Trials and Research Governance
Duration of Study in the UK
0 years, 6 months, 31 days
Research summary
Gonorrhoea is the second most common sexually transmitted infection in the United Kingdom. Control of antibiotic resistant gonorrhoea infection is a major public health priority. The bacteria that causes gonorrhoea, Neisseria gonorrhoeae, has developed widespread resistance to multiple antibiotics. Prompt effective treatment of gonorrhoea is important to help patients feel better and to reduce transmission of infection. However, existing laboratory methods involving growing bacteria in a lab, which takes several days to determine if an infection is resistant to the usual treatment given. If this treatment turns out not to be effective, this delays patients getting better, requires retreatment and increases the risk that resistant strains will spread.
We will investigate whether the recent scientific breakthroughs which make it possible to read the genetic code of bacteria present in patient samples can be used to make a really fast (same-day) test to identify antibiotic resistance in gonorrhoea infection and to track transmission.
We will recruit 250 men who come to sexual health clinics in Oxford and Brighton complaining of pain passing urine and discharge from the penis. Participants will be asked to provide a urine sample, a urethral swab and in those having throat and rectal swabs taken as part of routine testing, a second swab from each body site for research use.
Research samples will be tested anonymously using Oxford Nanopore Technologies sequencing of DNA extracted directly from the samples. We will investigate whether it is possible to 1) confirm whether Neisseria gonorrhoeae bacteria are present, 2) determine if the bacteria are resistant to any of six antibiotics, 3) identify the genetic type of gonorrhoea present. We will develop laboratory methods for extracting and sequencing high-quality DNA and tools for processing the data generated and reporting results.
Funded by the Centers for Disease Control and Prevention, United States.
REC name
East Midlands - Leicester Central Research Ethics Committee
REC reference
19/EM/0029
Date of REC Opinion
11 Feb 2019
REC opinion
Favourable Opinion