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

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

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT1031240517

Enrollment

175

Registered

2024-12-02

Start date

2025-01-23

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ventilator Associated Pneumonia (VAP) Ventilator Associated Pneumonia

Interventions

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

D060885

FilmArray, BioFire, Gram stain, Multiplex PCR

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion 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.

Exclusion criteria

Exclusion 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).

Design outcomes

Primary

Measure	Time frame
Clinical cure of pneumonia at 14 days post-randomisation	—

Secondary

Measure	Time frame
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	—

Measure

Time frame

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

—

Contacts

Public ContactAkiko Hosoyama

St. Marianna University School of Medicine

kyukyuigaku-001@marianna-u.ac.jp+81-44-977-8111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026