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

NCT06633718 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 786

Last updated 2024-10-09

No results posted yet for this study

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

Interventions

DRUG

Meropenem and Pralurbactam

3g，q8h，120min infusion

DRUG

Saline

100mL，q8h，60min infusion

DRUG

Ceftazidime-avibactam

2.5g，q8h，120min infusion

DRUG

Metronidazole

0.915g，q8h，60min infusion

Sponsors & Collaborators

  • Qilu Pharmaceutical Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Yunfei Ju, MM · Qilu Pharmaceutical Co., Ltd.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-10-31
Primary Completion
2027-05-30
Completion
2027-05-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06633718 on ClinicalTrials.gov