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NOT YET RECRUITING
NCT06633718
PHASE3

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

Sponsor: Qilu Pharmaceutical Co., Ltd.

View on ClinicalTrials.gov

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).

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

786

Start Date

2024-10-31

Completion Date

2027-05-30

Last Updated

2024-10-09

Healthy Volunteers

No

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

Locations (1)

Zhejiang Provincial People's Hospital

Hangzhou, Zhejiang, China