Microbiologic diagnosis of pneumonia is often limited by a long turnaround time of cultures. This randomized trial aims to evaluate the impact of BioFire FilmArray Pneumonia panel on (1) the proportion of appropriate/optimal early antibiotic regimen and (2) the time to the administration of appropriate antibiotics in patients treated for hospital-acquired or ventilator-associated pneumonia (HAP/VAP) in ICU.
The study subjects are adults treated for HAP/VAP in ICU, who should be enrolled within 24 hrs since the first administration of antibiotics. Informed consent are obtained from the subjects or their legal proxies. Due to the unique characteristics of ICU and the current COVID-19 pandemic, consent may be obtained via telephone when given by legal proxies; written consent should be obtained later. The subjects who meet the inclusion criteria are randomized into either intervention and control arms in 1:1 ratio. Respiratory specimens from the subjects in the intervention arm are tested with the FilmArray Pneumonia panel. Other routine microbiologic tests are performed for the subjects in both arms. The results are reported via electronic medical record, and the treating physicians may adjust antibiotic regimen with the assistance from the guidance formulated by the study investigators. No intervention is made on the antimicrobial treatment in the control arm. Primary outcomes are (1) the proportion of appropriate/optimal early antibiotic regimen and (2) the time to the administration of appropriate antibiotics.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
41
A rapid molecular diagnostic test designed to detect 27 bacterial and viral species and 6 major resistance genes from respiratory specimens.
Samsung Medical Center
Seoul, South Korea
The proportion of appropriate/optimal early antibiotic regimen
* "Appropriate" antibiotics: agents active in vitro * "Optimal" antibiotics: appropriate AND not overly broad. Spectrums of antibiotics are categorized with the following hierarchy: colistin \> carbapenem \> piperacillin-tazobactam/4th generation cephalosporins \> other beta-lactams/fluoroquinolones; for gram-positives, glycopeptides/linezolid \> no glycopeptides/linezolid) * Early antibiotic regimen is defined as antibiotics administered ≤24 hr since the initiation of antibiotic treatment
Time frame: within 24 hours
The time to the administration of appropriate antibiotics
time interval between the first dose of antibiotics and the first dose of antibiotics confirmed active in vitro
Time frame: within 30 days
30-day mortality (all-cause)
death of any cause within 30 days since the initiation of antibiotic treatment
Time frame: within 30 days
ICU mortality
death of any cause while staying in the ICU within 30 days since the initiation of antibiotic treatment
Time frame: within 30 days
Hospital and ICU length of stay
length of hospital and ICU stay
Time frame: Through study completion, an average of 9 months
Ventilator-free day
the number of days that the patient was not on mechanical ventilation within 30 days since the initiation of antibiotic treatment
Time frame: within 30 days
Dialysis-free day
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the number of days that the patient was not on hemodialysis (including continuous renal replacement therapy) within 30 days since the initiation of antibiotic treatment
Time frame: within 30 days
Incidence of acute kidney injury
Acute kidney injury is defined using the RIFLE (Risk, Injury, Failure, Loss of kidney function, and End-stage kidney disease) criteria.
Time frame: within 30 days
Incidence of Clostridioides difficile infection
C. difficile infection is defined as 3 or more defecations of unformed stool per day with a positive enzyme immunoassay or PCR for C. difficile toxin.
Time frame: within 30 days
Acquisition of multi-drug resistance organism during hospital stay
Multi-drug resistance (MDR) is defined as an in vitro resistance against 1 or more agents in 3 or more antibiotic classes. Methicillin (or oxacillin) resistance of Staphylococcus and vancomycin resistance of Enterococcus spp. are classified as MDR.
Time frame: within 30 days
Duration of antibiotic treatment
the number of days that the patient was administered with antibiotics for the treatment of pneumonia within 30 days since the initiation of antibiotic treatment
Time frame: within 30 days
Total medical cost in the ICU
total medical cost for the patient care in the ICU
Time frame: within 30 days
Compliance to FilmArray guidance (intervention arm only)
The proportion of early antibiotic regimens that complied with the recommendation in the guidance.
Time frame: within 30 days