Pneumonia, Ventilator-AssociatedFilmArrayNCT05214716
FilmArray Pneumonia Panel for Antimicrobial Treatment of HAP/VAP in Intensive Care Units
A study testing FilmArray Pneumonia panel in people with Pneumonia, Ventilator-Associated and Pneumonia, Hospital Acquired, run by Kyungmin Huh at 1 site in South Korea.
Trial 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… Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Pneumonia, Ventilator-Associated, Pneumonia, Hospital Acquired, Critically Ill
- What is being tested?
- FilmArray Pneumonia panel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteSouth Korea
- Study dates
- 12 Jul 2022to 21 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Being tested
- FilmArray Pneumonia panel
- Medical subject headings
- Pneumonia, Ventilator-Associated, Healthcare-Associated Pneumonia, Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FilmArray Pneumonia panelDiagnostic test
A rapid molecular diagnostic test designed to detect 27 bacterial and viral species and 6 major resistance genes from respiratory specimens.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: within 30 days
Secondary outcomes (11)
30-day mortality (all-cause)
death of any cause within 30 days since the initiation of antibiotic treatment
Measured: within 30 days
ICU mortality
death of any cause while staying in the ICU within 30 days since the initiation of antibiotic treatment
Measured: within 30 days
Hospital and ICU length of stay
length of hospital and ICU stay
Measured: 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
Measured: 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
Measured: 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.
Measured: within 30 days
Incidence of Clostridioides difficile infection
- 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.
Measured: 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.
Measured: 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
Measured: within 30 days
Total medical cost in the ICU
total medical cost for the patient care in the ICU
Measured: within 30 days
Compliance to FilmArray guidance (intervention arm only)
The proportion of early antibiotic regimens that complied with the recommendation in the guidance.
Measured: within 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2022
- Study start12 Jul 2022
- Primary completion21 Mar 2024
- Study completion21 Mar 2024
Why it 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.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pneumonia, Ventilator-AssociatedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kyungmin Huh
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Kyungmin Huh, Samsung Medical Center
- Investigators
- Kyungmin Huh, MD, Principal investigator, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05214716
- Sponsor's protocol ID
- 2021-11-103
- Acronym
- FilmArray
- Status last verified
- Apr 2024
- First submitted
- 30 Dec 2021
- Last updated
- 11 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05214716
- Acronym / sponsor ID
- FilmArray / 2021-11-103
- Study type
- Interventional
- Recruitment status
- TerminatedReason 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.
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Kyungmin HuhUniversity, hospital or other
- Study start
- 12 Jul 2022 (actual)
- Primary completion
- 21 Mar 2024 (actual)
- Study completion
- 21 Mar 2024 (actual)
- First posted
- 31 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Active comparator | Diagnostic Test: FilmArray Pneumonia panelRespiratory 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. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FilmArray Pneumonia panelA rapid molecular diagnostic test designed to detect 27 bacterial and viral species and 6 major resistance genes from respiratory specimens. | Diagnostic test | Intervention |
Primary outcome
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
11 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
Results and safety
The study was stopped early (reason given: 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.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kyungmin Huh, MD principal investigator
Samsung Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FilmArray Pneumonia panel in people with Pneumonia, Ventilator-Associated and Pneumonia, Hospital Acquired, run by Kyungmin Huh at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 11 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: 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.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of appropriate/optimal early antibiotic regimen (time frame: within 24 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2024.