Early treatment with targeted antibiotics for severe infections using rapid diagnostics
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 (RAPID)
This study is testing if giving targeted antibiotics right away, based on quick test results, can help hospitalized patients with severe infections caused by tough-to-treat bacteria feel better faster than standard care.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 1900 (estimated) |
| Sex | All |
| Sponsor | National University of Singapore Academic / other |
| Locations | 4 sites (Kuala Lumpur and 3 other locations) |
| Trial ID | NCT05979545 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to improve treatment outcomes for patients with severe infections caused by multidrug-resistant bacteria by linking rapid bacterial identification and antibiotic resistance detection to timely antibiotic prescription. Patients will be randomized into two groups: one receiving standard care and the other receiving targeted treatment with ceftazidime-avibactam based on rapid diagnostic results. The trial focuses on hospitalized patients with bloodstream infections, hospital-acquired pneumonia, or ventilator-associated pneumonia due to specific resistant bacteria. The goal is to minimize the time between infection onset and appropriate treatment, potentially leading to better clinical outcomes.
Who should consider this trial
Good fit: Ideal candidates for this study are hospitalized patients exhibiting symptoms of bloodstream infections or pneumonia caused by carbapenem-resistant bacteria.
Not a fit: Patients with refractory shock or severe comorbid conditions that limit survival expectancy, or those whose infections are not intended to be cured, will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the time to effective treatment for patients with severe infections, improving survival rates and clinical outcomes.
How similar studies have performed: Other studies have shown promise in using rapid diagnostics for similar infections, indicating that this approach could be effective.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Kuala Lumpur and 3 other locations
- University Malaya Medical Centre — Kuala Lumpur, Malaysia (Not_yet_recruiting)
- Taichung Veterans General Hospital — Taichung, Xitun District, Taiwan (Recruiting)
- Kaohsiung Medical University Hospital — Kaohsiung City, Taiwan (Not_yet_recruiting)
- Sunpasitthiprasong Hospital — Ubon Ratchathani, Thailand (Not_yet_recruiting)
Study contacts
- Principal investigator: David Paterson, Professor — National University of Singapore
- Study coordinator: Kithalakshmi Vignesvaran
- Email: kitha@nus.edu.sg
- Phone: 90300178
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.