NCT06633718

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

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 786 (estimated)
• Sponsor: Qilu Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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).

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.

Conditions

• Intra-abdominal Infections

Interventions

Type	Name	Description
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

Timeline

• Start date: 2024-10-31
• Primary completion: 2027-05-30
• Completion: 2027-05-30
• First posted: 2024-10-09
• Last updated: 2024-10-09

Locations

1 site across 1 country: China