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

Phase 2

• Conditions: Complicated Urinary Tract Infection; Acute Pyelonephritis
• Interventions: Drug: Piperacillin -tazobactam; Drug: Meropenem- FL058; Drug: Saline

• Registration Number: NCT05060419
• Lead Sponsor: Qilu Pharmaceutical Co., Ltd.

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2021-09
• Study First Submitted: 2021-09-18
• Study First Submitted QC: 2021-09-18
• Last Update Submitted: 2021-09-18
• Study First Posted: 2021-09-29
• Last Update Posted: 2021-09-29
• Study Start: 2021-10-08
• Primary Completion: 2022-04-29
• Study Completion: 2022-08-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

1. Male or female patients, aged 18 ~ 75 years (inclusive);；
2. Acute pyelonephritis or other complicated urinary tract infection.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Piperacillin-Tazobactan (30min infusion)	Piperacillin -tazobactam	-
Piperacillin-Tazobactan (30min infusion)	Saline	-
Meropenem-FL058 (180min infusion)	Saline	-
Meropenem-FL058 (180min infusion)	Meropenem- FL058	-

Primary Outcome Measures

Name	Time	Method
Proportion of patients in the Microbiological Modified Intent to Treat (m-MITT) Population who achieve overall treatment success at Test Of Cure (TOC).	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.