Health TrialsbyHealthPanel

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

ConditionIntra-abdominal Infections
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorQilu Pharmaceutical Co., Ltd.

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Meropenem and Pralurbactam

    Drug

    3g，q8h，120min infusion

  • Saline

    Drug

    100mL，q8h，60min infusion

  • Ceftazidime-avibactam

    Drug

    2.5g，q8h，120min infusion

  • Metronidazole

    Drug

    0.915g，q8h，60min infusion

Treatment groups

786 Participants
are divided into 2 treatment groups
Group A: Meropenem and PralurbactamExperimental treatment 2 interventions
Group B: Ceftazidime-avibactamActive comparator 2 interventions

Trial outcomes

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

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Qilu Pharmaceutical Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: