Using rapid pathogen detection to improve antibiotic therapy for ICU patients with pneumonia
Impact of Rapid Pathogen Detection in ICU Patients With Suspected Pneumonia on Antimicrobial Therapy: a Pilot, Randomized, Controlled Open-label Feasibility Trial (IRISPAT-1)
This study is testing whether a quick test for pneumonia germs can help doctors give the right antibiotics faster to critically ill patients on ventilators.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Chinese University of Hong Kong Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Hong Kong) |
| Trial ID | NCT06478953 on ClinicalTrials.gov |
What this trial studies
This intervention focuses on evaluating the feasibility, safety, and potential impact of rapid pathogen detection using the BioFire FA Pneumonia Panel in critically ill patients on mechanical ventilation who are suspected of having pneumonia. Participants will be randomized to receive either the rapid diagnostic test or standard care to guide their antibiotic therapy. The study aims to determine if this molecular technique can shorten the time to appropriate antimicrobial treatment and reduce the unnecessary use of broad-spectrum antibiotics. By identifying pathogens more quickly and accurately, the study seeks to enhance antibiotic stewardship in the ICU setting.
Who should consider this trial
Good fit: Ideal candidates are adult ICU patients on mechanical ventilation who have received a new antibiotic prescription for suspected pneumonia.
Not a fit: Patients who are not expected to survive beyond 48 hours or have significant immunosuppression may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to more timely and targeted antibiotic therapy, improving outcomes for critically ill patients with pneumonia.
How similar studies have performed: Previous studies have shown that rapid molecular diagnostics can improve outcomes in similar settings, suggesting a promising avenue for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * adult (≥18 years old) ICU patients * mechanical ventilation * new antibiotic prescription within 24 hours for suspected community acquired, healthcare or ventilator associated pneumonia * suspected pneumonia is defined as any of purulent sputum, cough, fever, shortness of breath, hypoxia, hypercapnia or abnormal white cell count AND chest infiltrates on imaging * need for antibiotics other than suspected respiratory infection * aspiration pneumonia * suspected pneumonia due to tuberculosis * known respiratory pathogens within 7 days prior to randomization * given empirical antimicrobials for suspected Stenotrophomonas, Citrobacter infection * lack of sufficient respiratory samples for culture and FA Pneumonia Panel * not expected to survive beyond 48 hours * limitation of therapy prior to recruitment * prisoners * allergy to antibiotics * immunosuppression from long term steroid of at least 5 mg/day or chemotherapy or HIV or haematological disease * pregnancy
Where this trial is running
Hong Kong
- Prince of Wales Hospital — Hong Kong, Hong Kong (Recruiting)
Study contacts
- Study coordinator: Lowell Ling, MBBS
- Email: lowell.ling@cuhk.edu.hk
- Phone: +852 35052735
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.