Impact of BioFire FilmArray Pneumonia Panel and Gram stain for ventilator-associated pneumonia on antimicrobial stewardship and patient outcomes in Japan: A multicenter randomized controlled open-label noninferiority trial (FASTVAP trial) (FASTVAP trial)

未提供0 个研究点目标入组 175 人开始时间: 待定最近更新: 2024年12月2日

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•18 years of age or older who have been on invasive mechanical ventilation for at least 48 hours and are considered to have newly developed VAP, and who are admitted to the ICU or a general ward in which a patientis under care of an Intensive Care Specialist, or who are going to be admitted due to the newly developed VAP.

•Patients who were started on a new antimicrobial agent between "72 hours prior" to the collection of the endotracheal suctioning sputum or BAL specimen for the suspected VAP condition under this study and the collection of the specimen (continuation of antimicrobials started more than 72 hours prior to specimen collection is not included in exclusion criteria).

Clinical cure of pneumonia at 14 days post-randomisation

Proportion of participants on antibiotics active against the causative pathogens(24 and 72 hours post-randomisation)
Proportion of participants on broad-spectrum antibiotics(24 and 72 hours post-randomisation)
ICU length of stay
Number of ventilator-free days(within 28 days post-randomisation)
Mortality(within 28 days post-randomisation or hospital discharge)
Mortality at the discharge from ICU
Incidence of new infections(within 28 days post-randomisation)
Incidence of specific adverse events associated with antibiotics(within 28 days post-randomisation)
Days of therapy (DOT)(14 days and 28 days post-randomisation)
Days of antibiotic spectrum coverage (DASC)(14 days and 28 days post-randomisation)
Number of antibiotics-free days(within 28 days post-randomisation)
Detection of new multidrug-resistant organisms
Hospital length of stay

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