Study to Assess the Efficacy and Safety of Meropenem and Pralurbactam in CIAI
NCT ID: NCT06633718
Last Updated: 2024-10-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE3
786 participants
INTERVENTIONAL
2024-10-31
2027-05-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Meropenem and Pralurbactam
Meropenem and Pralurbactam (120min infusion)
Meropenem and Pralurbactam
3g，q8h，120min infusion
Saline
100mL，q8h，60min infusion
Ceftazidime-avibactam
Ceftazidime-avibactam (120min infusion) 、 Metronidazole(60min infusion)
Ceftazidime-avibactam
2.5g，q8h，120min infusion
Metronidazole
0.915g，q8h，60min infusion
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* 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
* Non-complicated abdominal infection (infection is limited to abdominal organs), such as simple appendicitis and simple cholecystitis.
* Abdominal wall infection or abscess (infection has not spread into abdominal cavity).
* The creatinine clearance rate in the screening period is ≤50mL/min.
* The estimated survival time is less than 4 weeks.
* Those who have a history of drug abuse or drug abuse within 6 months before screening.
* Those who participated in other clinical trials within 28 days before randomization and used any test drugs or medical devices.
* Any physiological or psychological disease or condition that may increase the risk of the experiment, affect the compliance of the subject with the protocol or affect the completion of the experiment as judged by the researcher.
* Subjects are directly related persons who participated in this research.
18 Years
75 Years
ALL
No
Sponsors
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Qilu Pharmaceutical Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Yunfei Ju, MM
Role: STUDY_CHAIR
Qilu Pharmaceutical Co., Ltd.
Locations
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Zhejiang Provincial People's Hospital
Hangzhou, Zhejiang, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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FL058-301
Identifier Type: -
Identifier Source: org_study_id
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