Gentamicin in the treatment of Gonorrhoea (G-TOG)

Not Applicable

Completed

• Conditions: Topic: Infectious diseases and microbiology; Subtopic: Infection (all Subtopics); Disease: Infectious diseases and microbiology; Infections and Infestations

• Registration Number: ISRCTN51783227
• Lead Sponsor: niversity Hospital Birmingham NHS Foundation Trust (UK)

Brief Summary

2016 Protocol article in https://www.ncbi.nlm.nih.gov/pubmed/27881151 protocol 2019 Results article in https://www.ncbi.nlm.nih.gov/pubmed/31056291 results (added 08/05/2019) 2019 Results article in https://www.ncbi.nlm.nih.gov/pubmed/31099330 results (added 20/05/2019) 2020 Results article in https://pubmed.ncbi.nlm.nih.gov/32732336/ results (added 03/08/2020) 2020 Results article in https://pubmed.ncbi.nlm.nih.gov/32829308/ (added 15/12/2021)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-09-18
• Study Completion: 2016-12-31
• Last Update Posted: 27 December 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 720

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
1. Clinical resolution of symptoms<br>2. Frequency of nausea/vomiting, hearing loss, dizziness and rash<br>3. Frequency of other adverse events<br>4. Tolerability of therapy<br>5. Relationship between clinical effectiveness and MIC to inhibit N. gonorrhoeae growth<br>6. Cost effectiveness