Early Treatment With Ceftazidime-avibactam Using Rapid Diagnostics Compared to Standard Antibiotics for Patients With Bloodstream Infection or Hospital-acquired Pneumonia Caused by Resistant Bacteria

What this Trial Is About

Researchers are evaluating the use of rapid bacterial identification and antibiotic resistance gene detection combined with targeted antibiotic treatment in patients with infections caused by Pseudomonas aeruginosa or carbapenemase producing Enterobacterales. This trial aims to reduce the time between infection onset and appropriate treatment in hospital-acquired bloodstream infections, hospital-acquired pneumonia, or ventilator-associated pneumonia. The study is an open-label, multinational, randomized trial comparing these rapid diagnostics and targeted therapy with standard antibiotic susceptibility testing. The goal is to see if this approach improves clinical outcomes compared to usual care. Participants are randomly assigned to either an intervention or control group. The intervention group will have specimens tested with the BioFire Blood Culture Identification 2 Panel for blood infections and the BioFire FilmArray Pneumonia or Pneumonia plus Panel for respiratory infections. Antibiotic guidelines will support treatment decisions and ceftazidime-avibactam will be available for targeted use when appropriate. The control group will receive standard microbiology testing and antibiotics as per usual hospital practice. The main population includes hospitalized patients with the specified infections, and a secondary group includes those with multidrug-resistant Gram-negative bacteria. Participants will be monitored for clinical and mortality outcomes up to 60 days after infection onset. Bacterial isolates will be collected for genetic analysis through whole genome sequencing. The primary outcome is a combination of all-cause mortality and lack of improvement in organ function score at 14 days post infection. Additional outcomes include clinical response, mortality at different time points, functional status, composite outcomes at 28 days, and health economic assessments. The study plans to enroll 1900 participants across 20 sites, with ongoing safety and clinical assessments throughout the trial.

EaRly impAct theraPy With Ceftazidime-avibactam Via rapID Diagnostics