Impact of Rapid Pathogen Detection in ICU Patients With Suspected Pneumonia on Antimicrobial Therapy: a Pilot, Randomized, Controlled Open-label Feasibility Trial (IRISPAT-1)

Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

The goal of this intervention trial is to determine the feasibility, safety, and potential impact of rapid respiratory pathogen detection by FA Pneumonia Panel on antibiotic therapy in mechanically ventilated critically ill patients with suspected pneumonia. Participants will randomized to either have an urgent BioFire FA Pneumonia Panel assay performed or recieve standard of care to guide antimicrobial therapy and treatment of pneumonia.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Hong Kong Special Administrative Region
Prince of Wales Hospital
RECRUITING
Hong Kong
Contact Information
Primary
Lowell Ling, MBBS
lowell.ling@cuhk.edu.hk
+852 35052735
Time Frame
Start Date: 2024-06-26
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 40
Treatments
Experimental: FA Pneumonia Panel Guided Group
Patients in the FA Pneumonia Panel guided group will have a BioFire® FilmArray® Pneumonia Panel assay performed as soon as possible but within 24 hours of new antibiotic prescription for suspected respiratory infection in addition to all the investigations performed in standard care. Based on the rapid test results, antimicrobial therapy will be adjusted according to a pre-determined treatment algorithm and antimicrobial guidelines. The treatment algorithm and antimicrobial guidelines were based on the latest hospital antibiogram, procalcitonin protocol, and consensus recommendations from microbiologists, infectious disease experts and intensive care physicians at our hospital. The treating clinical team will also be given the standard microbiological culture with sensitivity results when available. The treating clinical team may override the pre-determined antimicrobial algorithm for any clinical reason at any time and the rationale will be recorded.
No_intervention: Standard Care Group
Patients in the standard care group will receive antimicrobial therapy guided by conventional microbiological cultures and standardized procalcitonin protocol. Choice of antimicrobial agent is based on use of the narrowest-spectrum antimicrobial agent possible according to culture sensitivity. Current standard investigations for any patient mechanically ventilated for suspected pneumonia in our ICU includes two sets of blood cultures, daily procalcitonin, respiratory specimen of tracheal aspirate or bronchoalveolar lavage for bacterial gram stain and cultures, respiratory viral PCR and urine streptococcus and legionella antigen. FA Pneumonia Panel will be performed from concurrent respiratory samples in the standard care group at the end of the study and the results will not be used by the treating clinical team for treatment decisions. Blinded results will only be available to the antimicrobial review panel for outcome assessment.
Related Therapeutic Areas
Sponsors
Leads: Chinese University of Hong Kong

This content was sourced from clinicaltrials.gov