Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05138822 | Safety, Tolerability, Pharmacokinetic and Microbiological Investigation of GSK3882347 in Female Participants With Urinary Tract Infections | PHASE1 | COMPLETED | 140 | — | — | May 18, 2022 | Dec 3, 2024 | Mar 13, 2026 | 15 | United States |
Microbiological response (success/failure) is used to measure microbiological efficacy. Microbiological success was defined as a reduction in E. coli count to less than (\<) 10\^3 colony-forming units (CFU) per milliliter (CFU/mL) for any E. coli at the ToC visit. Microbiological failure included all other microbiological outcomes (for example but not limited to \>=10\^3 CFU/mL for any E. coli identified at ToC visit, use of rescue medication prior to ToC, lost to follow-up before ToC, missing/unevaluable samples at ToC, etc).
| Arm | Type | Description |
|---|---|---|
| GSK3882347+ Placebo | EXPERIMENTAL | Participants received GSK3882347 oral capsules plus placebo oral capsules from Day 1 to Day 5. |
| Nitrofurantoin + Placebo | ACTIVE_COMPARATOR | Participants received 100 milligrams (mg) of nitrofurantoin oral capsules plus placebo oral capsules from Day 1 to Day 5. |
| Name | Type | Description |
|---|---|---|
| GSK3882347 | DRUG | GSK3882347 was administered. |
| Nitrofurantoin | DRUG | Nitrofurantoin was administered. |
| Placebo | DRUG | Placebo matching GSK3882347 or Nitrofurantoin was administered. |
Inclusion Criteria: * Participants must be greater than or equal to (\>=)18 years of age and less than or equal to (\<=)70 years * The participant has 2 or more of the following clinical signs and symptoms of uncomplicated urinary tract infections (uUTI) with onset less than (\<) 96 hours of the sc...