drugset / Trial / NCT05060419
Meropenem-FL058 Phase 2 Study in the Treatment of Complicated Urinary Tract Infections
RandomizedParallel-groupDouble-blindTreatment
Summary
Phase 2, randomised, double-blind,double-dummy study in hospitalised adults with complicated urinary tract infection (cUTI), including acute pyelonephritis.Treatment duration for each cohort was 7 to 14 days. Patients were not permitted to switch to oral therapy.
Timeline
- Start
- 2021-10-08
- Primary completion
- 2022-04-29
- Completion
- 2022-08-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | FL058 | Small molecule | 1000 mg | Other |
| Subject | Meropenem | Small molecule | 1000 mg | Other |
| Subject | Meropenem | Small molecule | 2000 mg | Other |
| Comparator | Piperacillin | Small molecule | 4 g | Other |
| Comparator | Tazobactam | Small molecule | 0.5 g | Other |