Back to resultsMeropenem-FL058 Phase 2 Study in the Treatment of Complicated Urinary Tract Infections
Primary Purpose
Complicated Urinary Tract Infection, Acute Pyelonephritis
Status
Unknown status
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Meropenem- FL058
Piperacillin -tazobactam
Saline
Saline
Sponsored by
About this trial
This is an interventional treatment trial for Complicated Urinary Tract Infection
Eligibility Criteria
Inclusion Criteria:
- Male or female patients, aged 18 ~ 75 years (inclusive);；
- Acute pyelonephritis or other complicated urinary tract infection.
Exclusion Criteria:
- 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Meropenem-FL058 (180min infusion)
Piperacillin-Tazobactan (30min infusion)
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT05060419
First Posted
September 18, 2021
Last Updated
September 18, 2021
Sponsor
Qilu Pharmaceutical Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT05060419
Brief Title
Meropenem-FL058 Phase 2 Study in the Treatment of Complicated Urinary Tract Infections
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Unknown status
Study Start Date
October 8, 2021 (Anticipated)
Primary Completion Date
April 29, 2022 (Anticipated)
Study Completion Date
August 31, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Qilu Pharmaceutical Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Complicated Urinary Tract Infection, Acute Pyelonephritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Masking Description
Double-Blind,Double-Dummy
Allocation
Randomized
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Meropenem-FL058 (180min infusion)
Arm Type
Experimental
Arm Title
Piperacillin-Tazobactan (30min infusion)
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Meropenem- FL058
Intervention Description
Meropenem-FL058(Meropenem 1000mg plus FL058 1000mg)q8h
Meropenem-FL058(Meropenem 2000mg plus FL058 1000mg)q8h
Intervention Type
Drug
Intervention Name(s)
Piperacillin -tazobactam
Intervention Description
Piperacillin-tazobactam (piperacillin 4 g plus tazobactam 0.5 g)q8h
Intervention Type
Drug
Intervention Name(s)
Saline
Intervention Description
180min
Intervention Type
Drug
Intervention Name(s)
Saline
Intervention Description
30min
Primary Outcome Measure Information:
Title
Proportion of patients in the Microbiological Modified Intent to Treat (m-MITT) Population who achieve overall treatment success at Test Of Cure (TOC).
Description
Treatment success is defined as the composite of clinical outcome of Cure and the microbiological outcome of Eradication.
Time Frame
5 to 9 days post-End of Treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male or female patients, aged 18 ~ 75 years (inclusive);；
Acute pyelonephritis or other complicated urinary tract infection.
Exclusion Criteria:
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ju Yunfei, MM
Phone
+86-0531-55821309
Email
yunfei.ju@qilu-pharma.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Huang Haihui, Professor
Organizational Affiliation
Huashan Hospital
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Meropenem-FL058 Phase 2 Study in the Treatment of Complicated Urinary Tract Infections
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