Impact of Rapid Pathogen Detection in ICU Patients With Suspected Pneumonia on Antimicrobial Therapy
NCT Number: NCT06478953
Acronym: IRISPAT-1
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Pneumonia|Critically Ill
Interventions: DIAGNOSTIC_TEST: FA Pneumonia Panel
Sponsor: Chinese University of Hong Kong
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 40
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-06-26
Completion Date: 2025-12-31
Locations: Prince of Wales Hospital, Hong Kong, Hong Kong

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.

Primary Outcome Measures: Time interval to appropriate antimicrobial therapy, Defined as the time interval (hours) from time of randomization to earliest time that appropriate antimicrobial therapy is achieved as determined by the antimicrobial stewardship review panel., 7 days
Secondary Outcome Measures: Proportion of patients with appropriate antimicrobial therapy at 48 hours after randomization, Defined as the proportion of patients with appropriate antimicrobial therapy at 48 hours after randomization as determined by the antimicrobial stewardship review panel, 48 hours|Time interval to pathogen detection, Defined as the time interval (hours) between culture or FA Pneumonia Panel sampling time to reporting time that confirmed the presence (with sensitivity pattern) or absence any causative pathogens from the tracheal aspirate or BAL sample taken after randomization., 7 days|Duration of antimicrobial therapy between FA Pneumonia Panel guided and standard care group, Defined as the duration (hours) of antimicrobial therapy given after randomization until hospital discharge, 28 days|Proportion of patients on broad-spectrum antibiotics at 48 hours after randomization, Defined as the proportion of patients who are prescribed carbapenem, tigecycline, ceftolozane-tazobactam, ceftaroline, ceftazidime/avibactam, linezolid, vancomycin, daptomycin, aztreonam or cefiderocol at 48 hours after randomization., 48 hours|Ventilator free days, Defined as the number of days free from mechanical ventilation 28 days after randomization., 28 days|Vasopressor free days, Defined as the number of days free from vasopressor therapy 28 days after randomization., 28 days|ICU length of stay, Defined as the duration (days) of ICU length of stay, 28 days|28-day mortality, Defined as the all-cause mortality rate on or before 28 days after randomization, 28 days|Proportion of patients who require re-initiation or escalation of antimicrobial therapy after 48 hours of discontinuation or de-escalation, Defined as the proportion of patients who required restart or escalation of antimicrobial therapy after discontinuation or de-escalation after ≥ 48 hours, 7 days