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).
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
786
Zhejiang Provincial People's Hospital
Hangzhou, Zhejiang, China
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
Time frame: Up to approximately 28 days
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0.915g,q8h,60min infusion