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Not yet recruitingNCT06633718Updated Oct 9, 2024

Study to Assess the Efficacy and Safety of Meropenem and Pralurbactam in CIAI

A Phase 3 interventional study of Meropenem and Pralurbactam and Saline in Intra-abdominal Infections, sponsored by Qilu Pharmaceutical Co., Ltd.. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-10-09.

Sponsored by Qilu Pharmaceutical Co., Ltd. · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
786
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study 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).

Read the 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.

02

Conditions studied

  • Intra-abdominal Infections
03

In context

Infections

6,687 studies on the registry are indexed under Infections; 807 are open to participants now.

This study's planned enrollment of 786 is above the median of 120 across 4,200 interventional studies indexed under Infections.

Browse Infections studies →

Lead sponsor

Qilu Pharmaceutical Co., Ltd. is the lead sponsor of 193 studies on the registry; 119 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
786 participants (estimated)

Study arms

  • Experimental
    Meropenem and Pralurbactam

    Meropenem and Pralurbactam (120min infusion)

    Drug: Meropenem and Pralurbactam · Drug: Saline

  • Active comparator
    Ceftazidime-avibactam

    Ceftazidime-avibactam (120min infusion) 、 Metronidazole(60min infusion)

    Drug: Ceftazidime-avibactam · Drug: Metronidazole

Interventions

  • DrugMeropenem and Pralurbactam

    3g,q8h,120min infusion

  • DrugSaline

    100mL,q8h,60min infusion

  • DrugCeftazidime-avibactam

    2.5g,q8h,120min infusion

  • DrugMetronidazole

    0.915g,q8h,60min infusion

06

What researchers measure

Primary outcomes

  1. 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

07

Study locations

1 site
  • Zhejiang Provincial People's Hospital
    Hangzhou, Zhejiang 310014, China
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 9, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06633718
Lead sponsor
Qilu Pharmaceutical Co., Ltd.
Responsible party
Sponsor
First posted
Oct 9, 2024
Start date
Oct 31, 2024 (estimated)
Primary completion
May 30, 2027 (estimated)
Completion
May 30, 2027 (estimated)
Last update
Oct 9, 2024

Study contacts

Yunsong Yu, Professor
Contact
yvys119@zju.edu.cn
+86-0571-85893267
Yuanyu Wang, Professor
Contact
Lywyy1979@126.com
+86-0571-85893889
Yunfei Ju, MM
study chair · Qilu Pharmaceutical Co., Ltd.

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.

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