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

NCT ID: NCT05214716

Last Updated: 2024-04-11

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 41 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-07-12
• Study Completion Date: 2024-03-21

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

FilmArray Pneumonia panel

Intervention Type: DIAGNOSTIC_TEST

A rapid molecular diagnostic test designed to detect 27 bacterial and viral species and 6 major resistance genes from respiratory specimens.

Control

Microbiologic tests, including cultures, are performed as per routine practice. No intervention is made on the antimicrobial treatment in the control arm.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

FilmArray Pneumonia panel

A rapid molecular diagnostic test designed to detect 27 bacterial and viral species and 6 major resistance genes from respiratory specimens.

Intervention Type: DIAGNOSTIC_TEST

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

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kyungmin Huh

OTHER

Sponsor Role: lead

Responsible Party

Kyungmin Huh

Assistant Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Kyungmin Huh, MD

Role: PRINCIPAL_INVESTIGATOR

Samsung Medical Center, Sungkyunkwan University School of Medicine

Locations

Samsung Medical Center

Seoul, , South Korea

Countries

South Korea

Other Identifiers

2021-11-103

Identifier Type: -

Identifier Source: org_study_id