臨床研究等提出・公開システム

Japanese

Date of registration	Dec. 02, 2024
Last modified on	April. 08, 2026
Trial ID	jRCT1031240517

Scientific Title	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)
Public Title	Utility of BioFire Pneumonia Panel and Gram stain for ventilator-associated pneumonia in Japan (FASTVAP trial)

Contact for Scientific Queries	Name	Fujitani Shigeki
	Affiliation	St. Marianna University School of Medicine
	Address	2-16-1 Sugao Miyamae-ku Kawasaki-city, Kanagawa
	Telephone	+81-44-977-8111
	E-mail	shigekifujitani@marianna-u.ac.jp
Contact for Public Queries	Name	Hosoyama Akiko
	Affiliation	St. Marianna University School of Medicine
	Address	2-16-1 Sugao Miyamae-ku Kawasaki-city, Kanagawa
	Telephone	+81-44-977-8111
	E-mail	kyukyuigaku-001@marianna-u.ac.jp

Recruitment status	Recruiting

Anticipated date of first enrollment		Dec. 02, 2024
Actual date of first enrollment		Jan. 23, 2025
Target sample size		175
Study Type		Interventional
Study Design	allocation	randomized controlled trial
	masking	open(masking not used)
	control	no treatment control/standard of care control
	assignment	parallel assignment
	purpose	treatment purpose
Key inclusion & exclusion 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	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).
	Age Minimum	18age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		Ventilator Associated Pneumonia (VAP)
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.
Health Condition(s) Keyword		Ventilator Associated Pneumonia
Intervention(s) Keyword		FilmArray, BioFire, Gram stain, Multiplex PCR
Health Condition(s) Code		D053717
Intervention(s) Code		D060885
Primary Outcome(s)		Clinical cure of pneumonia at 14 days post-randomisation
Secondary Outcome(s)		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

Secondary Sponsor

Source of Monetary Support	Japan society for the promotion of science
Secondary Sponsor

Name of Certified Review Board	St. Marianna University Medical Ethics Committee, Clinical Research Section at St. Marianna University
Address	2-16-1 Sugao Miyamae-ku Kawasaki-city, Kanagawa, Kanagawa
Telephone	+81-44-977-8111
E-Mail	k-sienbu.mail@marianna-u.ac.jp
Approval Status	Approval
Date of approval	June. 06, 2024

Plan to share IPD	No

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
3	April. 08, 2026	(this page)	Changes
2	Aug. 15, 2025	Detail	Changes
1	Dec. 02, 2024	Detail

List of change history