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
- Conditions
- Diseases of the respiratory system
- Registration Number
- KCT0007050
- Lead Sponsor
- Samsung Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Terminated
- Sex
- All
- Target Recruitment
- 160
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
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Appropriate” antibiotics: agents active in vitro;Optimal” antibiotics: appropriate AND not overly broad;Early antibiotic regimen is defined as antibiotics administered =24 hr since the initiation of antibiotic treatment
- Secondary Outcome Measures
Name Time Method 30-day mortality (all-cause);ICU mortality;Hospital and ICU length of stay