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

Critically Ill Clinical Trial

— FilmArray  

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05214716
• Other study ID #: 2021-11-103
• Status: Terminated
• Phase: N/A
• Start date: July 12, 2022
• Est. completion date: March 21, 2024

Study information

• Verified date: April 2024
• Source: Samsung Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 patients treated for hospital-acquired or ventilator-associated pneumonia (HAP/VAP) in ICU.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 41
• Est. completion date: March 21, 2024
• Est. primary completion date: March 21, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Critical Illness
• Critically Ill
• Healthcare-Associated Pneumonia
• Pneumonia
• Pneumonia, Ventilator-Associated

Intervention

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.

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Kyungmin Huh

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	30-day mortality (all-cause)	death of any cause within 30 days since the initiation of antibiotic treatment	within 30 days
Secondary	ICU mortality	death of any cause while staying in the ICU within 30 days since the initiation of antibiotic treatment	within 30 days
Secondary	Hospital and ICU length of stay	length of hospital and ICU stay	Through study completion, an average of 9 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Total medical cost in the ICU	total medical cost for the patient care in the ICU	within 30 days
Secondary	Compliance to FilmArray guidance (intervention arm only)	The proportion of early antibiotic regimens that complied with the recommendation in the guidance.	within 30 days