Utility of BioFire Pneumonia Panel and Gram stain for ventilator-associated pneumonia in Japan

JRCT ID: jRCT1031240517

Registered date:02/12/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Ventilator Associated Pneumonia (VAP)
• Date of first enrollment: 02/12/2024
• Target sample size: 175
• Study type: Interventional
• Intervention(s): In the intervention group, antimicrobials are administered based on the protocol that decide the antimicrobials from the Gram stain and the BioFire Pneumonia Panel test result of respiratory secretion specimens.

Outcome(s)

• Primary Outcome: Clinical cure of pneumonia at 14 days post-randomisation

Secondary Outcome

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

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both
• Include criteria: 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.
• Exclude criteria: 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).

Related Information

• Primary Sponsor: Fujitani Shigeki
• Source(s) of Monetary Support: Japan society for the promotion of science