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

NCT05214716 | Terminated

• 1 other identifier: 2021-11-103
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

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.

Conditions

Pneumonia, Ventilator-Associated; Pneumonia, Hospital Acquired; Critically Ill

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (11)

• 30-day mortality (all-cause)

  within 30 days

• ICU mortality

  within 30 days

• Hospital and ICU length of stay

  Through study completion, an average of 9 months

• Ventilator-free day

  within 30 days

• Dialysis-free day

  within 30 days

Study Arms (2)

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.

Diagnostic Test: FilmArray Pneumonia panel

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.

Interventions

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.

Intervention

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 19 years or older
• Diagnosed with hospital-acquired or ventilator-associated pneumonia and being treated in an intensive care unit
• Patient or his/her legal proxy agrees to participate and is able to provide informed consent

You may not qualify if:

• Has been treated with antibiotic for HAP/VAP for 24 hr or longer
• Requires antibiotic treatment for indications other than HAP/VAP
• Bacteria has been isolated from respiratory specimens within 7 days prior to screening
• Immunocompromised host whose major differential diagnosis includes Pneumocystis jirovecii or cytomegalovirus pneumonia
• Expected to die within 2 days since screening due to underlying disease
• Has an advance directive against mechanical ventilation or cardiopulmonary resuscitation
• Does not want to participate or unable to provide consent
• Determined to be unfit by the study investigator

Sponsors & Collaborators

• Kyungmin Huh: lead

Study Sites (1)

Samsung Medical Center

Seoul, 06351, South Korea

Location

MeSH Terms

Conditions

Pneumonia, Ventilator-Associated; Healthcare-Associated Pneumonia; Critical Illness

Condition Hierarchy (Ancestors)

Cross Infection; Infections; Pneumonia; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases; Iatrogenic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Kyungmin Huh, MD

  Samsung Medical Center, Sungkyunkwan University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: December 30, 2021
• First Posted: January 31, 2022
• Study Start: July 12, 2022
• Primary Completion: March 21, 2024
• Study Completion: March 21, 2024
• Last Updated: April 11, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)