Meropenem plus pralurbactam versus ceftazidime–avibactam for hospital- and ventilator-associated bacterial pneumonia

A Multicenter, Randomized, Double-blind, Active-Controlled, Parallel, Phase Ⅲ Study to Evaluate the Efficacy and Safety of Meropenem and Pralurbactam for Injection Compared to Ceftazidime and Avibactam Sodium for Injection in Subjects With Hospital-acquired and Ventilator-associated Bacterial Pneumonia

This trial will test whether meropenem combined with pralurbactam works as well and is as safe as ceftazidime–avibactam in adults with hospital-acquired or ventilator-associated bacterial pneumonia.

Quick facts

• Phase: PHASE3
• Study type: Interventional
• Enrollment: 420 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Qilu Pharmaceutical Co., Ltd. (industry)
• Locations: 1 site (Huaihua, Hunan)
• Trial ID: NCT07327619 on ClinicalTrials.gov

What this trial studies

This is a Phase 3, randomized, double-blind, active-controlled non-inferiority trial comparing meropenem plus pralurbactam to ceftazidime–avibactam in adults with hospital-acquired or ventilator-associated bacterial pneumonia. Adult participants with new or worsening pulmonary infiltrates and systemic and respiratory signs are randomized to one of the two antibiotic regimens and followed for about 32 days including screening and follow-up. The primary focus is clinical efficacy (non-inferiority) and safety of the meropenem–pralurbactam combination versus the active comparator. Concomitant eligibility and exclusion criteria limit enrollment to patients without viral/atypical/chemical pneumonias, without very high illness severity (APACHE II >30), and without certain recent prolonged antibiotic exposures or beta-lactam allergies.

Who should consider this trial

Good fit: Adults aged 18–80 with a confirmed diagnosis of hospital-acquired or ventilator-associated bacterial pneumonia, new or worsening infiltrates on chest imaging, systemic and respiratory signs, and an expected survival of at least 28 days are the intended participants.

Not a fit: Patients with community-acquired, atypical, viral, or chemical pneumonia, with APACHE II scores over 30, with prolonged recent antibiotic exposure, or with known severe allergy to carbapenems/cephalosporins/other beta-lactams are unlikely to benefit from joining this trial.

Why it matters

Potential benefit: If successful, this regimen could offer an effective alternative antibiotic option for adults with serious hospital- or ventilator-associated pneumonia, potentially improving treatment choices against resistant Gram-negative bacteria.

How similar studies have performed: Previous studies of ceftazidime–avibactam and various beta-lactam/beta-lactamase inhibitor combinations have shown activity in serious Gram-negative pneumonia, but direct Phase 3 comparisons including meropenem–pralurbactam are limited, so the approach is partially supported but not yet fully established.

Eligibility criteria

Inclusion Criteria:

* 1\. Male or female participants ≥18 and ≤80 years of age

  2\. have a diagnosis of HAP/VAP.

  3\. have systemic signs and respiratory signs or symptoms of HAP/VAP.

  4\. New or worsening infiltrate on chest X-ray/CT obtained within 48 hours prior to screening.

  5\. The estimated survival time is at lest 28 days.

Exclusion Criteria:

* 1\. Diagnosed or suspected CAP, Atypical pneumonias, Viral pneumonia or Chemical pneumonia.

  2\. The total duration of antibiotic exposure for antibiotics whose administration begins in the 72 hours is longer than 24 hours.

  3\. Acute Physiology and Chronic Health Evaluation (APACHE) II score \>30.

  4\. Allergic to any carbapenem, cephalosporin, penicillin, metronidazole disodium phosphate, other beta-lactam drugs or other beta-lactamase inhibitors and their auxiliary materials.

  5\. Those who have a history of drug abuse or drug abuse within 6 months before screening.

  6\. Those who participated in other clinical trials within 28 days before randomization and used any test drugs or medical devices.

Where this trial is running

Huaihua, Hunan

• Hunan University Of Medicine General Hospital — Huaihua, Hunan, China (RECRUITING)

Study contacts

• Study coordinator: Bin Cao, PhD

Conditions: Hospital-acquired Bacterial Pneumonia and Ventilator-associated Bacterial Pneumonia