Clinical trial NCT06633718: Study to Assess the Efficacy and Safety of Meropenem and Pralurbactam in 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Intra-abdominal Infections
Lead sponsor: Qilu Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2024-10-09
Enrollment: 786
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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 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.

Primary outcomes:
measure: Percentage of Participants With a Clinical Response of "Cure" at the Test of Cure (TOC) Visit
timeFrame: Up to approximately 28 days
Secondary outcomes:
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Zhejiang Provincial People's Hospital
state: Zhejiang
Study officials:
affiliation: Qilu Pharmaceutical Co., Ltd.
name: Yunfei Ju, MM
role: STUDY_CHAIR
References: