RAPID trial is a multinational, open-label, phase 4, individually-randomised trial. Patients will be randomised to either a control or intervention arm. Patients randomised to the intervention arm will have relevant specimens analysed by rapid diagnostics with early availability of ceftazidime-avibactam, if appropriate.

Study Design & Objectives

The RAPID trial proposes a seamless intervention linking rapid bacterial isolate identification and antibiotic resistance gene detection and prompt administration of targeted antibiotic to minimise time between infection onset and appropriate treatment.

RAPID-Trial-diagram

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.

Enrolment, Sample Size and Sites

The main population that will be recruited in the study will be hospitalised patients with bloodstream infections, hospital-acquired pneumonia or ventilator-associated pneumonia due to Pseudomonas aeruginosa or carbapenemase producing Enterobacterales treated with ceftazidime-avibacatam, while the secondary population recruited will be those with multidrug resistant (MDR) Gram-negative bacilli. The total target sample size is 1900 participants in the main population over 20 study sites.

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