EaRly impAct theraPy With Ceftazidime-avibactam Via rapID Diagnostics

The goal of this clinical trial is to propose a seamless intervention linking rapid bacterial isolate identification and antibiotic resistance gene detection and targeted antibiotic prescription to minimise time between infection onset and appropriate treatment in patients with Pseudomonas aeruginosa or carbapenemase producing Enterobacterales infections. This is an investigator initiated trial. The primary hypothesis is that these interventions will lead to improved clinical outcomes amongst patients with hospital-acquired bloodstream infection, hospital-acquired pneumonia or ventilator-associated pneumonia due to carbapenem non-susceptible Pseudomonas aeruginosa or Enterobacterales, compared to standard antibiotic susceptibility testing. Patients will be randomised to either a control or intervention arm. Patients randomised to the intervention arm will have relevant specimens analysed by rapid microbiological diagnostics and will have early availability of ceftazidime-avibactam if appropriate. Patients randomised to the control arm, will have samples analysed by clinical microbiology laboratories using standard of care diagnostics. Antibiotics will be available to these patients as per usual institutional practice.

NCT Number	NCT05979545
Lead Sponsor	National University of Singapore Collaborators: Pfizer, Biomerieux inc
Conditions	Blood Stream Infections, Ventilator Associated Pneumonia, Healthcare Associated Infection, Carbapenem-Resistant Enterobacteriaceae Infection, Hospital-acquired Pneumonia
Enrollment	1,900 participants
Start Date	2023-12-12
Primary Completion	2026-10-31 (estimated)
Study Completion	2026-12-31 (estimated)
Updated on ClinicalTrials.gov	2024-03-06