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Gentamicin versus ceftriaxone for the treatment of gonorrhoea (G-TOG trial): study protocol for a randomised trial

Brittain, Claire; Childs, Margaret; Duley, Lelia; Harding, Jan; Hepburn, Trish; Meakin, Garry; Montgomery, Alan A.; Tan, Wei Ghen; Ross, Jonathan D.C.

Authors

Margaret Childs

Lelia Duley

Jan Harding

ALAN MONTGOMERY ALAN.MONTGOMERY@NOTTINGHAM.AC.UK
Director, nottingham Clinical Trials Unit

WEI TAN Wei.Tan@nottingham.ac.uk
Medical Statistician

Jonathan D.C. Ross



Abstract

Background: Gonorrhoea is a common sexually transmitted infection which causes genital pain and discomfort; in women it can also lead to pelvic inflammatory disease and infertility, and in men to epididymo-orchitis. Current treatment is with ceftriaxone, but there is increasing evidence of antimicrobial resistance which is reducing its effectiveness against gonorrhoea. A small, but increasing, number of patients have already been found to have highly resistant strains of gonorrhoea which has been associated with clinical failure. This trial aims to determine whether gentamicin is not clinically worse than ceftriaxone in the treatment of gonorrhoea.

Methods/design: This is a blinded, two-arm, multicentre, noninferiority randomised trial. Patients are eligible if they are aged 16–70 years with a diagnosis of genital, pharyngeal and/or rectal gonorrhoea. Exclusion criteria are: known concurrent sexually transmitted infection(s) (excluding chlamydia); bacterial vaginosis and/or Trichomonas vaginalis infection; contraindications or an allergy to gentamicin, ceftriaxone, azithromycin or lidocaine; pregnancy or breastfeeding; complicated gonorrhoeal infection; weight under 40 kg; use of ceftriaxone, gentamicin or azithromycin within the preceding 28 days. Randomisation is to receive a single intramuscular injection of either gentamicin or ceftriaxone, all participants receive 1 g oral azithromycin as standard treatment. The estimated sample size is 720 participants (noninferiority limit 5%).

The primary outcome is clearance of Neisseria gonorrhoeae at all infected sites by a negative Nucleic Acid Amplification Test, 2 weeks post treatment. Secondary outcomes include clinical resolution of symptoms, frequency of adverse events, tolerability of therapy, relationship between clinical effectiveness and antibiotic minimum inhibitory concentration for N. gonorrhoeae, and cost-effectiveness.

Discussion: The options for future treatment of gonorrhoea are limited. Results from this randomised trial will demonstrate whether gentamicin is not clinically worse than ceftriaxone for the treatment of gonorrhoea. This will inform clinical practice and policy for the treatment of gonorrhoea when current therapy with cephalosporins is no longer effective, or is contraindicated.

Journal Article Type Article
Publication Date Nov 24, 2016
Journal Trials
Electronic ISSN 1745-6215
Publisher Springer Verlag
Peer Reviewed Peer Reviewed
Volume 17
Article Number 558
APA6 Citation Brittain, C., Childs, M., Duley, L., Harding, J., Hepburn, T., Meakin, G., …Ross, J. D. (2016). Gentamicin versus ceftriaxone for the treatment of gonorrhoea (G-TOG trial): study protocol for a randomised trial. Trials, 17, https://doi.org/10.1186/s13063-016-1683-8
DOI https://doi.org/10.1186/s13063-016-1683-8
Keywords Randomised trial, Gonorrhoea, Gentamicin, Ceftriaxone, Resistance, Treatment, Noninferiority
Publisher URL http://trialsjournal.biomedcentral.com/articles/10.1186/s13063-016-1683-8
Related Public URLs http://creativecommons.org/licenses/by/4.0/
Copyright Statement Copyright information regarding this work can be found at the following address: http://creativecommons.org/licenses/by/4.0

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Copyright Statement
Copyright information regarding this work can be found at the following address: http://creativecommons.org/licenses/by/4.0





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