Gentamicin in the treatment of Gonorrhoea (G-TOG)
| ISRCTN | ISRCTN51783227 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN51783227 |
| EudraCT/CTIS number | 2014-001823-56 |
| Secondary identifying numbers | 17433; HTA 12/127/10 |
- Submission date
- 18/09/2014
- Registration date
- 18/09/2014
- Last edited
- 15/12/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Plain English Summary
Background and study aims
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 which is an existing antibiotic, might be effective against gonorrhoea. Testing in the laboratory suggests that gentamicin could be used to treat gonorrhoea, and it has been used as a treatment in some developing countries with success. A review looking for previously published studies which assessed gentamicin found that the existing trials are of low quality and that there are no recent clinical trials. Therefore a randomised study to compare the efficacy of ceftriaxone and gentamicin has been designed. This will assess whether gentamicin is a safe and effective treatment for gonorrhoea.
Who can participate?
Patients diagnosed with gonorrhoea infection will be asked to join the study
What does the study involve?
and be randomised to receive either gentamicin or ceftriaxone. Both are given by injection. All patients will also receive azithromycin which is currently given in combination with ceftriaxone in the treatment of gonorrhoea. Patients will be asked to come back to clinic 2 weeks after their treatment to be tested to see if their gonorrhoea has cleared. The safety of both antibiotics will also be assessed.
What are the possible benefits and risks of participating?
There are no direct benefits for the participant of taking part in the study. However, the information we get from this study will help us to see if gentamicin is as good as ceftriaxone. This could benefit patients with gonorrhoea in the future. Although previous studies suggest that it is effective, there is a risk that gentamicin may not work as well as ceftriaxone and that participants may have to have further treatment. There is also a risk of side effects from both antibiotics, although we think this risk is low as they are only given once. Ceftriaxone can cause diarrhoea, anaemia, abnormalities in white blood cells and problems with kidney and liver function. Gentamicin can cause problems with hearing, balance and kidney function.
Where is the study run from?
Notitngham Clinical Trials Unit, UK
When is the study starting and how long is it expected to run for?
October 2014 to December 2016
Who is funding the study?
National Institute for Health Research (NIHR) UK
Who is the main contact?
Miss Clare Brittain
clare.brittain@nottingham.ac.uk
Contact information
Scientific
Queens Medical Centre
Derby Road
Nottingham
NG7 2UH
United Kingdom
| clare.brittain@nottingham.ac.uk |
Study information
| Study design | Randomised; Interventional; Design type: Not specified |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | A randomised controlled trial to compare the clinical effectiveness and safety of gentamicin and ceftriaxone in the treatment of gonorrhoea |
| Study acronym | G-TOG |
| Study hypothesis | The study is to trying to find out whether gentamicin is an acceptable alternative to ceftriaxone, in the treatment of gonorrhoea. This will be done by determining whether the clearance rate of gonorrheoa in participants receiving gentamicin is no worse than the rate in participants receiving ceftriaxone. In parallel, the safety of both treatments will be assessed. More details can be found at: http://www.nets.nihr.ac.uk/projects/hta/1212710 |
| Ethics approval(s) | South Central - Oxford C REC; ref: 14/SC/1030 |
| Condition | Topic: Infectious diseases and microbiology; Subtopic: Infection (all Subtopics); Disease: Infectious diseases and microbiology |
| Intervention | Gentamicin (240 mg), Gentamicin (240 mg) vs Ceftriaxone (500 mg) for the treatment of gonorrhoea. Participants will be randomised to receive a single intramuscular injection of gentamicin (240 mg) or ceftriaxone (500 mg). All participants will also receive a single oral dose of azithromycin (1 g) as standard care. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Gentamicin, ceftriaxone, azithromycin |
| Primary outcome measure | Clearance of N. gonorrhoeae at all the infected sites confirmed by a negative NAAT (Aptima Combo), two weeks post treatment (as recommended by the British Association for Sexual Health and HIV). |
| Secondary outcome measures | 1. Clinical resolution of symptoms 2. Frequency of nausea/vomiting, hearing loss, dizziness and rash 3. Frequency of other adverse events 4. Tolerability of therapy 5. Relationship between clinical effectiveness and MIC to inhibit N. gonorrhoeae growth 6. Cost effectiveness |
| Overall study start date | 01/10/2014 |
| Overall study end date | 31/12/2016 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | Planned Sample Size: 720; UK Sample Size: 720 |
| Total final enrolment | 720 |
| Participant inclusion criteria | 1. Aged 16-70 years 2. Diagnosis of uncomplicated untreated genital, pharyngeal or rectal gonorrhoea based on a positive gram stained smear on microscopy, or positive NAAT 3. Written informed consent provided |
| Participant exclusion criteria | 1. Known concurrent bacterial sexually transmitted infection (apart from chlamydia) 2. Known contraindications or allergy to gentamicin, ceftriaxone, azithromycin or lidocaine 3. Pregnant or breastfeeding 4. Current clinical diagnosis of complicated gonorrhoea infections eg pelvic inflammatory disease, epididymoorchitis 5. Weight less than 40kg at the time of randomisation 6. Currently receiving or have received ceftriaxone or gentamicin within the preceding 28 days 7. Previous participation in this study |
| Recruitment start date | 01/10/2014 |
| Recruitment end date | 31/12/2016 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
NG7 2UH
United Kingdom
Sponsor information
Hospital/treatment centre
Birmingham & Black Country
Research and Development
Queen Elizabeth Hospital
Edgbaston
Birmingham
B15 2TH
England
United Kingdom
"ROR" |
https://ror.org/014ja3n03 |
|---|
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- NIHR Health Technology Assessment Programme, HTA
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 31/03/2019 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan | The datasets analysed during the current study will be available upon request from the NCTU (ctu@nottingham.ac.uk), a minimum of 6 months after publication of the main results paper. Access to the data will be subject to review of a data sharing and use request by a committee including the CI and sponsor, and will only be granted upon receipt of a data sharing and use agreement. Any data shared will be pseudo anonymised which may impact on the reproducibility of published analyses. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 24/11/2016 | Yes | No | |
| Results article | results | 22/06/2019 | 08/05/2019 | Yes | No |
| Results article | results | 01/05/2019 | 20/05/2019 | Yes | No |
| Results article | results | 01/12/2020 | 03/08/2020 | Yes | No |
| Results article | 22/08/2020 | 15/12/2021 | Yes | No |
Editorial Notes
15/12/2021: Publication reference added.
03/08/2020: Publication reference added.
12/12/2019: The EudraCT number was added.
20/05/2019: Publication reference added.
08/05/2019: Total final enrolment and publication reference were added.
24/01/2019: the intention to publish date has been changed from 01/12/2018 to 31/03/2019
17/08/2018: IPD sharing statement added.
08/08/2018: The intention to publish date was changed from 01/01/2018 to 01/12/2018.
25/11/2016: Publication reference added.
