A Study To Compare Gepotidacin & Nitrofurantoin For Acute Cystitis
Research type
Research Study
Full title
A Phase III, Randomized, Multicenter, Parallel-Group, Double-Blind, Double-Dummy Study in Adolescent and Adult Female Participants Comparing the Efficacy and Safety of Gepotidacin to Nitrofurantoin in the Treatment of Uncomplicated Urinary Tract Infection (Acute Cystitis)
IRAS ID
271588
Contact name
Prasad Godbole
Contact email
Sponsor organisation
GlaxoSmithKline Research & Development Limited
Eudract number
2018-001801-98
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 6 months, 1 days
Research summary
This is a phase III, randomised, multicenter, parallel-group, double-blind, double-dummy study in adolescent and adult female participants, comparing the efficacy and safety of gepotidacin to nitrofurantoin in the treatment of uncomplicated Urinary Tract Infections, also known as Acute Cystitis.
The study will compare gepotidacin with standard-of-care treatment, nitrofurantoin. Participants will be divided into 2 groups by chance: one group will take gepotidacin (by mouth) and the other group will take nitrofurantoin (by mouth); treatment will require twice daily dosing, for five days.
This study will include approximately 1000 to 1200 study participants globally, with 60 participants expected to be recruited from at least 5 sites across the UK. The study will run for about 18 months. Participation will only be for approximately 28 days.
Study procedures include physical examination, vital signs, ECG (measures heart rhythm), and 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
Yorkshire & The Humber - Sheffield Research Ethics Committee
REC reference
19/YH/0365
Date of REC Opinion
27 Feb 2020
REC opinion
Further Information Favourable Opinion