FilmArray Pneumonia Panel for Antimicrobial Treatment of HAP/VAP in Intensive Care Units (FilmArray)

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

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.

Study Overview

• Status: Terminated
• Conditions: Critically Ill; Pneumonia, Ventilator-Associated; Pneumonia, Hospital Acquired
• Intervention / Treatment: Diagnostic test: FilmArray Pneumonia panel

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.

• Study Type: Interventional
• Enrollment (Actual): 41
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 06351
    • Samsung Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Intervention; 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.	Diagnostic test: FilmArray Pneumonia panel; A rapid molecular diagnostic test designed to detect 27 bacterial and viral species and 6 major resistance genes from respiratory specimens.
No Intervention: Control; Microbiologic tests, including cultures, are performed as per routine practice. No intervention is made on the antimicrobial treatment in the control arm.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Kyungmin Huh
• Investigators: Principal Investigator: Kyungmin Huh, MD, Samsung Medical Center, Sungkyunkwan University School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): July 12, 2022
• Primary Completion (Actual): March 21, 2024
• Study Completion (Actual): March 21, 2024

Study Registration Dates

• First Submitted: December 30, 2021
• First Submitted That Met QC Criteria: January 27, 2022
• First Posted (Actual): January 31, 2022

Study Record Updates

• Last Update Posted (Actual): April 11, 2024
• Last Update Submitted That Met QC Criteria: April 9, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Disease Attributes; Cross Infection; Iatrogenic Disease; Healthcare-Associated Pneumonia; Pneumonia; Critical Illness; Pneumonia, Ventilator-Associated
• Other Study ID Numbers: 2021-11-103

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No