Study to Assess the Efficacy and Safety of Meropenem and Pralurbactam in CIAI

A Phase 3,Multicenter, Randomized, Double-Blind, Positive Control，Study to Assess the Efficacy and Safety of Meropenem and Pralurbactam in Complicated Intra-abdominal Infections

This is a Phase 3, randomized, double-blind, multicenter, positive control study to assess the efficacy, safety, and pharmacokinetics of Meropenem and Pralurbactam compared with Ceftazidime-avibactam in combination with Metronidazole in the treatment of adult complicated intra-abdominal infections (cIAI).

Study Overview

• Status: Not yet recruiting
• Conditions: Intra-abdominal Infections
• Intervention / Treatment: Drug: Meropenem and Pralurbactam; Drug: Saline; Drug: Ceftazidime-avibactam; Drug: Metronidazole

Detailed Description

This is a Phase 3, randomized, double-blind, multicenter, positive control study to assess the efficacy, safety, and pharmacokinetics of Meropenem and Pralurbactam compared with Ceftazidime-avibactam in combination with Metronidazole in the treatment of adult complicated intra-abdominal infections (cIAI). Treatment duration for each cohort was 7 to 14 days.

• Study Type: Interventional
• Enrollment (Estimated): 786
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Yunsong Yu, Professor; Phone Number: +86-0571-85893267; Email: yvys119@zju.edu.cn
• Study Contact Backup: Name: Yuanyu Wang, Professor; Phone Number: +86-0571-85893889; Email: Lywyy1979@126.com

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310014
      • Zhejiang Provincial People's Hospital
      • Contact: Tingwei Liang; Phone Number: +86-18560013055; Email: tingwei.liang@qilu-pharma.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Male or female participants ≥18 and ≤75 years of age.
• Diagnosed or highly suspected cIAI.
• Evidence of a systemic inflammatory response with at least one of the following:a. Fever ( temperature ≥ 38°C); b. hypotension (systolic blood pressure < 90 mmhg); c. abdominal pain; d. nausea and/or vomiting; e. physical examination found abdominal mass; f. mental state change; g. other circumstances.
• Female subjects must meet the following conditions: a. menopause for at least 1 year, or b. Sterilization has been performed, or C. Those who are fertile must meet the following conditions at the same time: the random pre-blood/urine pregnancy test is negative, effective contraceptive measures are taken during the study period and within 30 days after the last application of experimental drugs, and eggs are not donated, and they are not breastfeeding.
• Male subjects are willing to take effective contraceptive measures and not donate sperm during the study period and within 30 days after the last application of experimental drugs.
• Understand and abide by the research procedures and methods, voluntarily participate in this research, and sign an informed consent form .

Exclusion Criteria:

• Allergic to any carbapenem, cephalosporin, penicillin, metronidazole disodium phosphate, other beta-lactam drugs or other beta-lactamase inhibitors and their auxiliary materials.
• Non-complicated abdominal infection (infection is limited to abdominal organs), such as simple appendicitis and simple cholecystitis.
• Abdominal wall infection or abscess (infection has not spread into abdominal cavity).
• The creatinine clearance rate in the screening period is ≤50mL/min.
• The estimated survival time is less than 4 weeks.
• Those who have a history of drug abuse or drug abuse within 6 months before screening.
• Those who participated in other clinical trials within 28 days before randomization and used any test drugs or medical devices.
• Any physiological or psychological disease or condition that may increase the risk of the experiment, affect the compliance of the subject with the protocol or affect the completion of the experiment as judged by the researcher.
• Subjects are directly related persons who participated in this research.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Meropenem and Pralurbactam; Meropenem and Pralurbactam (120min infusion)	Drug: Meropenem and Pralurbactam; 3g，q8h，120min infusion; Drug: Saline; 100mL，q8h，60min infusion
Active Comparator: Ceftazidime-avibactam; Ceftazidime-avibactam (120min infusion) 、 Metronidazole(60min infusion)	Drug: Ceftazidime-avibactam; 2.5g，q8h，120min infusion; Drug: Metronidazole; 0.915g，q8h，60min infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With a Clinical Response of "Cure" at the Test of Cure (TOC) Visit	Percentage of Participants With a Clinical Response of "Cure" at the Test of Cure (TOC) Visit	Up to approximately 28 days

Collaborators and Investigators

• Sponsor: Qilu Pharmaceutical Co., Ltd.
• Investigators: Study Chair: Yunfei Ju, MM, Qilu Pharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Estimated): October 31, 2024
• Primary Completion (Estimated): May 30, 2027
• Study Completion (Estimated): May 30, 2027

Study Registration Dates

• First Submitted: September 26, 2024
• First Submitted That Met QC Criteria: October 7, 2024
• First Posted (Estimated): October 9, 2024

Study Record Updates

• Last Update Posted (Estimated): October 9, 2024
• Last Update Submitted That Met QC Criteria: October 7, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Intraabdominal Infections; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Anti-Bacterial Agents; Antiprotozoal Agents; Antiparasitic Agents; beta-Lactamase Inhibitors; Third Generation Cephalosporins; Beta Lactam Antibiotics; Metronidazole; Meropenem; Avibactam; Ceftazidime; Avibactam, ceftazidime drug combination
• Other Study ID Numbers: FL058-301

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No