BTZ116577-Treatment of Uncomplicated Urogenital Gonorrhoea
Research type
Research Study
Full title
A Phase III, Randomized, Multicenter, Open-Label Study in Adolescent and Adult Participants Comparing the Efficacy and Safety of Gepotidacin to Ceftriaxone Plus Azithromycin in the Treatment of Uncomplicated Urogenital Gonorrhea Caused by Neisseria gonorrhoeae
IRAS ID
260938
Contact name
Berlinda Cole
Contact email
Sponsor organisation
GlaxoSmithKline Research & Development Limited
Eudract number
2018-001780-23
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 2 months, 15 days
Research summary
Gonorrhoea caused by Neisseria gonorrhoeae (NG) is the second most widespread bacterial sexually transmitted infection and remains an important clinical and public health problem throughout the world.
Over the years, effective treatment options for gonorrhoea have reduced rapidly due to the resistance to many antibiotics recommended or used for treatment, highlighting the urgent need for new therapeutic options to treat gonorrhoea in the future.
This is a Phase III, Randomised, Multicenter, Open-Label Study in Adolescent and Adult Participants Comparing the Efficacy and Safety of Gepotidacin to Ceftriaxone Plus Azithromycin in the Treatment of Uncomplicated Urogenital Gonorrhoea Caused by Neisseria gonorrhoeae.
The study will compare gepotidacin with ceftriaxone plus oral azithromycin. Participants will be divided into 2 groups by chance: one group will take gepotidacin (by mouth) and the other group will take ceftriaxone (a shot in a muscle) plus azithromycin (by mouth).
This study will include approximately 500 to 600 study participants and the study will run for about 18 months. Participation for each participant will only be for approximately 21 days.
Study procedures include physical examination, vital signs, ECG (measures heart rhythm), swab specimens taken from the genital area, blood and urine tests.
This study is sponsored by GlaxoSmithKline (GSK). This project is funded in whole or in part with US Federal funds from the Biomedical Advanced Research and Development Authority (BARDA), under OTA Agreement No. HHSO100201300011C.REC name
South Central - Hampshire B Research Ethics Committee
REC reference
19/SC/0497
Date of REC Opinion
4 Dec 2019
REC opinion
Further Information Favourable Opinion