NCT05060419
Unknown
Phase 2
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
Overview
- Phase
- Phase 2
- Intervention
- Meropenem- FL058
- Conditions
- Complicated Urinary Tract Infection
- Sponsor
- Qilu Pharmaceutical Co., Ltd.
- Enrollment
- 150
- Primary Endpoint
- Proportion of patients in the Microbiological Modified Intent to Treat (m-MITT) Population who achieve overall treatment success at Test Of Cure (TOC).
- Last Updated
- 4 years ago
Overview
Brief 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Male or female patients, aged 18 \~ 75 years (inclusive);；
- •Acute pyelonephritis or other complicated urinary tract infection.
Exclusion Criteria
- •Patients needing concomitant systemic antimicrobial agents in addition to those designated in the various study treatment groups;
- •Fungal urinary tract infection;
- •History of allergic to any carbapenem, cephalosporin, penicillin, other β -lactam drugs or other β -lactamase inhibitors;
- •Pregnant or breastfeeding women;
- •Inability to tolerate intravenous fluids, due to medical reasons, of 1050 mL per day required for study drug administration;
- •Unable or unwilling, in the judgment of the Investigator, to comply with the protocol.
Arms & Interventions
Meropenem-FL058 (180min infusion)
Intervention: Meropenem- FL058
Meropenem-FL058 (180min infusion)
Intervention: Saline
Piperacillin-Tazobactan (30min infusion)
Intervention: Piperacillin -tazobactam
Piperacillin-Tazobactan (30min infusion)
Intervention: Saline
Outcomes
Primary Outcomes
Proportion of patients in the Microbiological Modified Intent to Treat (m-MITT) Population who achieve overall treatment success at Test Of Cure (TOC).
Time Frame: 5 to 9 days post-End of Treatment
Treatment success is defined as the composite of clinical outcome of Cure and the microbiological outcome of Eradication.
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