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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Hunan University Of Medicine General Hospital
  Huaihua, Hunan, China Recruiting

Study contacts

• Study coordinator: Bin Cao, PhD
• Email: caobin_ben@163.com
• Phone: 010 8420 6266

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.