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

Qilu Pharmaceutical

Status and phase: Unknown; Phase 2

Conditions: Acute Pyelonephritis; Complicated Urinary Tract Infection

Treatments: Drug: Meropenem- FL058; Drug: Saline; Drug: Piperacillin -tazobactam

Study type: Interventional

Funder types: Industry

Identifiers

NCT05060419

FL058-II-01

Details and patient eligibility

About

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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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150 participants in 2 patient groups

Meropenem-FL058 (180min infusion)

Experimental group

Treatment:

Drug: Saline

Drug: Meropenem- FL058

Drug: Saline

Piperacillin-Tazobactan (30min infusion)

Active Comparator group

Treatment:

Drug: Saline

Drug: Piperacillin -tazobactam

Drug: Saline