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

NCT06633718 | Not Yet Recruiting Phase 3

• 1 other identifier: FL058-301
• Study Type: interventional
• Target: 786
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Intra-abdominal Infections

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Meropenem and Pralurbactam

EXPERIMENTAL

Meropenem and Pralurbactam (120min infusion)

Drug: Meropenem and Pralurbactam; Drug: Saline

Ceftazidime-avibactam

ACTIVE COMPARATOR

Ceftazidime-avibactam (120min infusion) 、 Metronidazole(60min infusion)

Drug: Ceftazidime-avibactam; Drug: Metronidazole

Interventions

Meropenem and Pralurbactam DRUG

3g，q8h，120min infusion

Meropenem and Pralurbactam

Saline DRUG

100mL，q8h，60min infusion

Meropenem and Pralurbactam

Ceftazidime-avibactam DRUG

2.5g，q8h，120min infusion

Ceftazidime-avibactam

Metronidazole DRUG

0.915g，q8h，60min infusion

Ceftazidime-avibactam

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 .

You may not qualify if:

• 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.

Sponsors & Collaborators

• Qilu Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Zhejiang Provincial People's Hospital

Hangzhou, Zhejiang, 310014, China

Location

MeSH Terms

Conditions

Intraabdominal Infections

Interventions

Meropenem; Sodium Chloride; avibactam, ceftazidime drug combination; Metronidazole

Condition Hierarchy (Ancestors)

Infections

Intervention Hierarchy (Ancestors)

Thienamycins; Carbapenems; beta-Lactams; Lactams; Amides; Organic Chemicals; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Nitroimidazoles; Nitro Compounds; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring

Study Officials

• Yunfei Ju, MM

  Qilu Pharmaceutical Co., Ltd.

  STUDY CHAIR

Central Study Contacts

Yunsong Yu, Professor

CONTACT

+86-0571-85893267; yvys119@zju.edu.cn

Yuanyu Wang, Professor

CONTACT

+86-0571-85893889; Lywyy1979@126.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2024
• First Posted: October 9, 2024
• Study Start: October 31, 2024
• Primary Completion (Estimated): May 30, 2027
• Study Completion (Estimated): May 30, 2027
• Last Updated: October 9, 2024

Record last verified: 2024-09

Locations

CN (1)