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EaRly impAct theraPy With Ceftazidime-avibactam Via rapID Diagnostics

Study acronym: RAPID
StatusRecruiting
PhasePhase 4
Started2023-12-12
View on ClinicalTrials.gov ↗

Amendment history

2024-03-03
notable
Not Yet Recruiting→Recruiting Study Identification, Study Status, Oversight, Outcome Measures, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2023-10-01→confirmed 2023-12-12
Secondary endpoints5 entries, revised
Implementation cost-Health Economics
Study title-229 characters
EaRly impAct theraPy With Ceftazidime-avibactam Via rapID Diagnostics Versus Standard of Care Antibiotics and Diagnostics in Patients With Bloodstream Infection, Hospital-acquired Pneumonia or Ventilator-associated Pneumonia Due to Pseudomonas Aeruginosa or Carbapenemase Producing Enterobacterales
2023-07-31
minor
Original filing
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.
Trial Details
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