Meropenem-FL058 Phase 2 Study in the Treatment of Complicated Urinary Tract Infections

• Status: Not yet recruiting
• Trial end date: 2022-08-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Qilu Pharmaceutical Co., Ltd.
• Treatments: Meropenem; Piperacillin; Piperacillin, Tazobactam Drug Combination; Tazobactam

Criteria

Inclusion Criteria:

1. Male or female patients, aged 18 ~ 75 years (inclusive);；

2. Acute pyelonephritis or other complicated urinary tract infection.

Exclusion Criteria:

1. Patients needing concomitant systemic antimicrobial agents in addition to those designated in the various study treatment groups;

2. Fungal urinary tract infection;

3. History of allergic to any carbapenem, cephalosporin, penicillin, other β -lactam drugs or other β -lactamase inhibitors;

4. Pregnant or breastfeeding women;

5. Inability to tolerate intravenous fluids, due to medical reasons, of 1050 mL per day required for study drug administration;

6. Unable or unwilling, in the judgment of the Investigator, to comply with the protocol.