---
title: FilmArray Pneumonia Panel for Antimicrobial Treatment of HAP/VAP in Intensive Care Units
nct_id: NCT05214716
overall_status: TERMINATED
phase: NA
sponsor: Kyungmin Huh
study_type: INTERVENTIONAL
primary_condition: Pneumonia, Ventilator-Associated
countries: South Korea
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT05214716.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT05214716"
ct_last_update_post_date: 2024-04-11
last_seen_at: "2026-05-12T06:40:21.885Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# 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

**NCT ID:** [NCT05214716](https://clinicaltrials.gov/study/NCT05214716)

## Key Facts

- **Status:** TERMINATED
- **Why Stopped:** 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.
- **Phase:** NA
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 41
- **Lead Sponsor:** Kyungmin Huh
- **Conditions:** Pneumonia, Ventilator-Associated, Pneumonia, Hospital Acquired, Critically Ill
- **Start Date:** 2022-07-12
- **Completion Date:** 2024-03-21
- **CT.gov Last Update:** 2024-04-11

## 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

- **Minimum age:** 19 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
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
```

## Arms

- **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.

## 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.

## Primary Outcomes

- **The proportion of appropriate/optimal early antibiotic regimen** _(time frame: within 24 hours)_ — * "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
- **The time to the administration of appropriate antibiotics** _(time frame: within 30 days)_ — time interval between the first dose of antibiotics and the first dose of antibiotics confirmed active in vitro

## Secondary Outcomes

- **30-day mortality (all-cause)** _(time frame: within 30 days)_
- **ICU mortality** _(time frame: within 30 days)_
- **Hospital and ICU length of stay** _(time frame: Through study completion, an average of 9 months)_
- **Ventilator-free day** _(time frame: within 30 days)_
- **Dialysis-free day** _(time frame: within 30 days)_
- **Incidence of acute kidney injury** _(time frame: within 30 days)_
- **Incidence of Clostridioides difficile infection** _(time frame: within 30 days)_
- **Acquisition of multi-drug resistance organism during hospital stay** _(time frame: within 30 days)_
- **Duration of antibiotic treatment** _(time frame: within 30 days)_
- **Total medical cost in the ICU** _(time frame: within 30 days)_
- **Compliance to FilmArray guidance (intervention arm only)** _(time frame: within 30 days)_

## Locations (1)

- Samsung Medical Center, Seoul, South Korea

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.whyStopped` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.samsung medical center|seoul||south korea` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT05214716.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT05214716*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*