Trials / Unknown
UnknownNCT05060419
Meropenem-FL058 Phase 2 Study in the Treatment of Complicated Urinary Tract Infections
Phase Ⅱ, Randomized, Double-Blind,Double-Dummy Study Evaluating Safety,Tolerability,Efficacy of Meropenem-FL058 in Adult Patients With Complicated Urinary Tract Infections, Including Acute Pyelonephritis
- Status
- Unknown
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 150 (estimated)
- Sponsor
- Qilu Pharmaceutical Co., Ltd. · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Meropenem- FL058 | Meropenem-FL058(Meropenem 1000mg plus FL058 1000mg)q8h Meropenem-FL058(Meropenem 2000mg plus FL058 1000mg)q8h |
| DRUG | Piperacillin -tazobactam | Piperacillin-tazobactam (piperacillin 4 g plus tazobactam 0.5 g)q8h |
| DRUG | Saline | 180min |
| DRUG | Saline | 30min |
Timeline
- Start date
- 2021-10-08
- Primary completion
- 2022-04-29
- Completion
- 2022-08-31
- First posted
- 2021-09-29
- Last updated
- 2021-09-29
Source: ClinicalTrials.gov record NCT05060419. Inclusion in this directory is not an endorsement.