NCT05979545 EaRly impAct theraPy With Ceftazidime-avibactam Via rapID Diagnostics
| NCT ID | NCT05979545 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | National University of Singapore |
| Condition | Blood Stream Infections |
| Study Type | INTERVENTIONAL |
| Enrollment | 1,526 participants |
| Start Date | 2023-12-12 |
| Primary Completion | 2027-10-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 1,526 participants in total. It began in 2023-12-12 with a primary completion date of 2027-10-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
Inclusion Criteria: 1. Adult patients aged 18 years or older (21 years or older in Singapore) who meet at least one of the following criteria: * At risk of developing bloodstream infection, hospital-acquired pneumonia (HAP), or ventilator-associated pneumonia (VAP) due to Pseudomonas aeruginosa or carbapenem-resistant Enterobacterales; OR * Blood culture bottles showing Gram-negative bacilli on Gram stain; OR * Suspected HAP or VAP with respiratory specimens showing Gram-negative bacteria on Gram stain. 2. For randomisation, all of the following criteria must be fulfilled: * Written informed consent obtained from the participant or their authorised representative. * An appropriate blood or respiratory specimen received by the participating microbiology laboratory, with Gram-negative bacilli detected on Gram stain. * Patients with HAP or VAP must fulfil the US Centers for Disease Control and Prevention National Healthcare Safety Network (CDC NHSN) criteria. * No exclusion criteria are met. Exclusion Criteria: 1. Refractory shock or comorbid condition such that the patient is not expected to survive more than 48 hours. 2. Suspected catheter-related bloodstream infection where the implicated vascular catheter cannot be removed. 3. Treatment is not intended to cure the infection. 4. Infection requiring prolonged antibiotic treatment (more than two weeks). 5. Incarceration in a correctional facility. 6. Previous enrolment in the RAPID trial within the preceding 60 days. 7. Patients younger than 18 years (younger than 21 years in Singapore).
Contact & Investigator
David Paterson, Professor
PRINCIPAL INVESTIGATOR
National University of Singapore
Frequently Asked Questions
Who can join the NCT05979545 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Blood Stream Infections. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05979545 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT05979545 currently recruiting?
Yes, NCT05979545 is actively recruiting participants. Contact the research team at kitha@nus.edu.sg for enrollment information.
Where is the NCT05979545 trial being conducted?
This trial is being conducted at Vellore, India, George Town, Malaysia, Ipoh, Malaysia, Kuala Lumpur, Malaysia and 11 additional locations.
Who is sponsoring the NCT05979545 clinical trial?
NCT05979545 is sponsored by National University of Singapore. The principal investigator is David Paterson, Professor at National University of Singapore. The trial plans to enroll 1,526 participants.