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 | 1,900 participants |
| Start Date | 2023-12-12 |
| Primary Completion | 2026-10-31 |
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 1,900 participants in total. It began in 2023-12-12 with a primary completion date of 2026-10-31.
⚠ 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
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.
Eligibility Criteria
Inclusion Criteria: 1. patient developed clinical symptoms compatible with bloodstream infection, hospital-acquired or ventilator-associated pneumonia (hospital-acquired and ventilator-associated pneumonia should fulfil US CDC NHSN criteria) AND, 2. an appropriate specimen has been received by the participating laboratory - that is, a blood culture bottle showing Gram negative bacilli or a respiratory sample collected for clinical purposes showing Gram negative bacilli on Gram stain; Exclusion Criteria: 1. Refractory shock or comorbid condition such that patient not expected to survive more than 48 hours; OR, 2. where the bloodstream infection is thought to be related to a vascular catheter and the catheter is unable to be removed; OR, 3. treatment is not with the intent to cure the infection; OR, 4. patient is incarcerated in a correctional facility; OR, 5. patients previously randomised in this trial within the last 60 days.
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, 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 Kuala Lumpur, Malaysia, Taichung, Taiwan, Kaohsiung City, Taiwan, Ubon Ratchathani, Thailand.
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 1,900 participants.