Clinical trial NCT05214716: FilmArray Pneumonia Panel for Antimicrobial Treatment of HAP/VAP in Intensive Care Units
Official title: Single Center, Randomized, Open Label, Prospective Clinical Trial of BioFire FilmArray Assay for Antimicrobial Treatment of Hospital-acquired or Ventilator-associated Pneumonia in Intensive Care Units
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Pneumonia, Ventilator-Associated
Pneumonia, Hospital Acquired
Critically Ill
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2022-01-31
Enrollment: 41
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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

Primary outcomes:
measure: The proportion of appropriate/optimal early antibiotic regimen
timeFrame: within 24 hours
measure: The time to the administration of appropriate antibiotics
timeFrame: within 30 days
Secondary outcomes:
measure: 30-day mortality (all-cause)
timeFrame: within 30 days
measure: ICU mortality
timeFrame: within 30 days
measure: Hospital and ICU length of stay
timeFrame: Through study completion, an average of 9 months
measure: Ventilator-free day
timeFrame: within 30 days
measure: Dialysis-free day
timeFrame: within 30 days
measure: Incidence of acute kidney injury
timeFrame: within 30 days
measure: Incidence of Clostridioides difficile infection
timeFrame: within 30 days
measure: Acquisition of multi-drug resistance organism during hospital stay
timeFrame: within 30 days
measure: Duration of antibiotic treatment
timeFrame: within 30 days
measure: Total medical cost in the ICU
timeFrame: within 30 days
measure: Compliance to FilmArray guidance (intervention arm only)
timeFrame: within 30 days
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
affiliation: Samsung Medical Center, Sungkyunkwan University School of Medicine
name: Kyungmin Huh, MD
role: PRINCIPAL_INVESTIGATOR
References: