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

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.

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.