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

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05060419

Enrollment

150

Registered

2021-09-29

Start date

2021-10-08

Completion date

2022-08-31

Last updated

2021-09-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Pyelonephritis, Complicated Urinary Tract Infection

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.

Interventions

DRUGMeropenem- FL058

Meropenem-FL058(Meropenem 1000mg plus FL058 1000mg)q8h Meropenem-FL058(Meropenem 2000mg plus FL058 1000mg)q8h

DRUGPiperacillin -tazobactam

Piperacillin-tazobactam (piperacillin 4 g plus tazobactam 0.5 g)q8h

DRUGSaline

180min

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Masking description

Double-Blind,Double-Dummy

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

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.

Design outcomes

Primary

Measure	Time frame	Description
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.

Contacts

Primary ContactJu Yunfei, MM

yunfei.ju@qilu-pharma.com+86-0531-55821309

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026