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Even if the study period was extended, it was expected that the target subjects would not be able to be registered, so the study was terminated early.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Active Comparator | Respiratory specimens from the subjects are tested by the FilmArray Pneumonia panel and the results are reported via an electronic health record system. Treating physicians may adjust empirical antibiotic regimens with assistance from the guidelines formulated by the study investigators. Other microbiologic tests, including cultures, are performed as per routine practice. |
|
| Control | No Intervention | Microbiologic tests, including cultures, are performed as per routine practice. No intervention is made on the antimicrobial treatment in the control arm. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FilmArray Pneumonia panel | Diagnostic Test | A rapid molecular diagnostic test designed to detect 27 bacterial and viral species and 6 major resistance genes from respiratory specimens. |
| Measure | Description | Time Frame |
|---|---|---|
| The proportion of appropriate/optimal early antibiotic regimen |
| 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 | within 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| 30-day mortality (all-cause) | death of any cause within 30 days since the initiation of antibiotic treatment | within 30 days |
| ICU mortality | death of any cause while staying in the ICU within 30 days since the initiation of antibiotic treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kyungmin Huh, MD | Samsung Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Samsung Medical Center | Seoul | 06351 | South Korea |
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| ID | Term |
|---|---|
| D053717 | Pneumonia, Ventilator-Associated |
| D000077299 | Healthcare-Associated Pneumonia |
| D016638 | Critical Illness |
| ID | Term |
|---|---|
| D003428 | Cross Infection |
| D007239 | Infections |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
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| within 30 days |
| Hospital and ICU length of stay | length of hospital and ICU stay | 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 | within 30 days |
| Dialysis-free day | 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 | 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. | 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. | 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. | 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 | within 30 days |
| Total medical cost in the ICU | total medical cost for the patient care in the ICU | within 30 days |
| Compliance to FilmArray guidance (intervention arm only) | The proportion of early antibiotic regimens that complied with the recommendation in the guidance. | within 30 days |
| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D007049 | Iatrogenic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |