Critically Ill, Pneumonia, Hospital Acquired, Pneumonia, Ventilator-Associated
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DIAGNOSTIC_TESTFilmArray Pneumonia panel
A rapid molecular diagnostic test designed to detect 27 bacterial and viral species and 6 major resistance genes from respiratory specimens.
Sponsors
Kyungmin Huh
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Aged 19 years or older 2. Diagnosed with hospital-acquired or ventilator-associated pneumonia and being treated in an intensive care unit 3. Patient or his/her legal proxy agrees to participate and is able to provide informed consent
Exclusion criteria
1. Has been treated with antibiotic for HAP/VAP for 24 hr or longer 2. Requires antibiotic treatment for indications other than HAP/VAP 3. Bacteria has been isolated from respiratory specimens within 7 days prior to screening 4. Immunocompromised host whose major differential diagnosis includes Pneumocystis jirovecii or cytomegalovirus pneumonia 5. Expected to die within 2 days since screening due to underlying disease 6. Has an advance directive against mechanical ventilation or cardiopulmonary resuscitation 7. Does not want to participate or unable to provide consent 8. Determined to be unfit by the study investigator
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The proportion of appropriate/optimal early antibiotic regimen | within 24 hours | * 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 |
| The time to the administration of appropriate antibiotics | within 30 days | time interval between the first dose of antibiotics and the first dose of antibiotics confirmed active in vitro |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hospital and ICU length of stay | Through study completion, an average of 9 months | length of hospital and ICU stay |
| Ventilator-free day | within 30 days | the number of days that the patient was not on mechanical ventilation within 30 days since the initiation of antibiotic treatment |
| Dialysis-free day | within 30 days | 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 |
| Incidence of acute kidney injury | within 30 days | Acute kidney injury is defined using the RIFLE (Risk, Injury, Failure, Loss of kidney function, and End-stage kidney disease) criteria. |
| 30-day mortality (all-cause) | within 30 days | death of any cause within 30 days since the initiation of antibiotic treatment |
| Acquisition of multi-drug resistance organism during hospital stay | within 30 days | 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. |
| Duration of antibiotic treatment | within 30 days | 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 |
| Total medical cost in the ICU | within 30 days | total medical cost for the patient care in the ICU |
| Compliance to FilmArray guidance (intervention arm only) | within 30 days | The proportion of early antibiotic regimens that complied with the recommendation in the guidance. |
| Incidence of Clostridioides difficile infection | within 30 days | 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. |
| ICU mortality | within 30 days | death of any cause while staying in the ICU within 30 days since the initiation of antibiotic treatment |
Countries
South Korea
Outcome results
None listed