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

September 18, 2021 updated by: Qilu Pharmaceutical Co., Ltd.

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

150

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Meropenem-FL058 (180min infusion)
Drug: Meropenem- FL058

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

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

Drug: Saline
180min
Drug: Saline
30min
Active Comparator: Piperacillin-Tazobactan (30min infusion)
Drug: Saline
180min
Drug: Saline
30min
Drug: Piperacillin -tazobactam
Piperacillin-tazobactam (piperacillin 4 g plus tazobactam 0.5 g)q8h

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of patients in the Microbiological Modified Intent to Treat (m-MITT) Population who achieve overall treatment success at Test Of Cure (TOC).
Time Frame: 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.
5 to 9 days post-End of Treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Qilu Pharmaceutical Co., Ltd.

Investigators

  • Principal Investigator: Huang Haihui, Professor, Huashan Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

October 8, 2021

Primary Completion (Anticipated)

April 29, 2022

Study Completion (Anticipated)

August 31, 2022

Study Registration Dates

First Submitted

September 18, 2021

First Submitted That Met QC Criteria

September 18, 2021

First Posted (Actual)

September 29, 2021

Study Record Updates

Last Update Posted (Actual)

September 29, 2021

Last Update Submitted That Met QC Criteria

September 18, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FL058-II-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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