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
1 other identifier
interventional
150
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Oct 2021
Shorter than P25 for phase_2
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 18, 2021
CompletedFirst Posted
Study publicly available on registry
September 29, 2021
CompletedStudy Start
First participant enrolled
October 8, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 29, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
August 31, 2022
CompletedSeptember 29, 2021
September 1, 2021
7 months
September 18, 2021
September 18, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Proportion of patients in the Microbiological Modified Intent to Treat (m-MITT) Population who achieve overall treatment success at Test Of Cure (TOC).
Treatment success is defined as the composite of clinical outcome of Cure and the microbiological outcome of Eradication.
5 to 9 days post-End of Treatment
Study Arms (2)
Meropenem-FL058 (180min infusion)
EXPERIMENTALPiperacillin-Tazobactan (30min infusion)
ACTIVE COMPARATORInterventions
Meropenem-FL058(Meropenem 1000mg plus FL058 1000mg)q8h Meropenem-FL058(Meropenem 2000mg plus FL058 1000mg)q8h
Piperacillin-tazobactam (piperacillin 4 g plus tazobactam 0.5 g)q8h
Eligibility Criteria
You may qualify if:
- Male or female patients, aged 18 \~ 75 years (inclusive);；
- Acute pyelonephritis or other complicated urinary tract infection.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Huang Haihui, Professor
Huashan Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Masking Details
- Double-Blind,Double-Dummy
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 18, 2021
First Posted
September 29, 2021
Study Start
October 8, 2021
Primary Completion
April 29, 2022
Study Completion
August 31, 2022
Last Updated
September 29, 2021
Record last verified: 2021-09