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Study to Assess the Efficacy and Safety of Meropenem and Pralurbactam in CIAI
Sponsor: Qilu Pharmaceutical Co., Ltd.
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
Conditions
Interventions
Meropenem and Pralurbactam
3g,q8h,120min infusion
Saline
100mL,q8h,60min infusion
Ceftazidime-avibactam
2.5g,q8h,120min infusion
Metronidazole
0.915g,q8h,60min infusion
Locations (1)
Zhejiang Provincial People's Hospital
Hangzhou, Zhejiang, China