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Life sciences · Phase 4 Trial
ClinicalTrials.gov · October 22, 2026
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Phase 4 Trial.
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Registry record from ClinicalTrials.gov (NCT05979545). This is a study registration, not published results. Lead sponsor: National University of Singapore. Recruitment status: RECRUITING. Phase: PHASE4. Study type: INTERVENTIONAL. Enrollment: 1526 participants (ESTIMATED). Conditions: Blood Stream Infections, Ventilator Associated Pneumonia, Healthcare Associated Infection, Carbapenem-Resistant Enterobacteriaceae Infection, Hospital-acquired Pneumonia. Interventions: DIAGNOSTIC_TEST: Rapid Diagnostics. Primary outcome measures: Composite of All-Cause Mortality or Absence of SOFA Score Improvement at Day 14 , Day 14 following index culture.. Brief summary: RAPID is an investigator initiated Phase 4, multinational, multicentre, open-label, randomised controlled superiority trial evaluating the clinical impact of rapid microbiological diagnostics combined with antimicrobial stewardship and early targeted antibiotic therapy compared with standard-of-care diagnostics and antibiotics. Hospitalised adult patients with bloodstream infections, hospital-acquired pneumonia or ventilator-associated pneumonia are randomised in a 1:1 ratio to the intervention or control arm. The main analysis population comprises patients with infections caused by Pseudomonas aeruginosa or carbapenem-resistant Enterobacterales. A secondary analysis population includes patients with infections caused by other specified multidrug-resistant Gram-negative organisms. 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. The primary outcome is a composite of all-cause mortality or absence of improvement in Sequential Organ Failure Assessment (SOFA) score at Day 14 following the index culture.