Study to Assess the Efficacy and Safety of Meropenem and Pralurbactam in CIAI (NCT06633718) | Clinical Trial Compass
Not Yet RecruitingPhase 3
Study to Assess the Efficacy and Safety of Meropenem and Pralurbactam in CIAI
China786 participantsStarted 2024-10-31
Plain-language 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).
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion Criteria:
* Male or female participants ≥18 and ≤75 years of age.
* Diagnosed or highly suspected cIAI.
* Evidence of a systemic inflammatory response with at least one of the following:a. Fever ( temperature ≥ 38°C); b. hypotension (systolic blood pressure \< 90 mmhg); c. abdominal pain; d. nausea and/or vomiting; e. physical examination found abdominal mass; f. mental state change; g. other circumstances.
* Female subjects must meet the following conditions: a. menopause for at least 1 year, or b. Sterilization has been performed, or C. Those who are fertile must meet the following conditions at the same time: the random pre-blood/urine pregnancy test is negative, effective contraceptive measures are taken during the study period and within 30 days after the last application of experimental drugs, and eggs are not donated, and they are not breastfeeding.
* Male subjects are willing to take effective contraceptive measures and not donate sperm during the study period and within 30 days after the last application of experimental drugs.
* Understand and abide by the research procedures and methods, voluntarily participate in this research, and sign an informed consent form .
Exclusion Criteria:
* Allergic to any carbapenem, cephalosporin, penicillin, metronidazole disodium phosphate, other beta-lactam drugs or other beta-lactamase inhibitors and their auxiliary materials.
* Non-complicated abdominal infection (infection is limited to abdominal organs), such as sim…
What they're measuring
1
Percentage of Participants With a Clinical Response of "Cure" at the Test of Cure (TOC) Visit