G-TOG - Gentamicin in the Treatment of Gonorrhoea

Phase 1

• Conditions: Gonorrhoea; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]; MedDRA version: 18.0 Level: PT Classification code 10018612 Term: Gonorrhoea System Organ Class: 10021881 - Infections and infestations

• Registration Number: EUCTR2014-001823-56-GB
• Lead Sponsor: niversity Hospitals Birmingham NHS Foundation Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-06-26
• Last Update Posted: 30 April 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 720

Inclusion Criteria

Individuals must meet ALL of the following to be included in the study
•Individuals aged 16-70 years.
•Diagnosis of uncomplicated untreated* genital, pharyngeal or rectal gonorrhoea based on a positive gram stained smear on microscopy, or positive NAAT within the last 4 weeks.
•Written informed consent provided.

*patient has not received any antibiotic in previous 28 days which could have treated gonorrhoea (either partially or completely)

Are the trial subjects under 18? yes
Number of subjects for this age range: 72
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 612
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 36

Exclusion Criteria

Individuals will be excluded from the study if they meet ANY of the following
•Known concurrent bacterial sexually transmitted infection (apart from chlamydia).
Known bacterial vaginosis or Trichomonas vaginalis
•Known contra-indications or allergy to gentamicin, ceftriaxone, azithromycin or lidocaine.
• Pregnant or breast-feeding.
• Current clinical diagnosis of complicated gonorrhoea infections eg pelvic inflammatory disease, epididymo-orchitis.
• Weight less than 40kg at the time of randomisation
• Currently receiving or have received ceftriaxone, gentamicin or azithromycin within the preceding 28 days.
• Previous participation in this study

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified