臨床研究等提出・公開システム

Date of registration	Feb. 29, 2024
Last modified on	Nov. 10, 2025
Trial ID	jRCT1030230666

Scientific Title	The Respiratory Syncytial Virus Hospitalization Surveillance Network Pilot in Japan (RSV-NET Japan Pilot )
Public Title	The Respiratory Syncytial Virus Hospitalization Surveillance Network Pilot in Japan (RSV-NET Japan Pilot )

Contact for Scientific Queries	Name	Tajima Kentaro
	Affiliation	GlaxoSmithKline K.K.
	Address	Akasaka Intercity AIR, 1-8-1 Akasaka, Minato-ku, Tokyo, Japan
	Telephone	+81-120-561-007
	E-mail	jp.gskjrct@gsk.com
Contact for Public Queries	Name	Tajima Kentaro
	Affiliation	GlaxoSmithKline K.K.
	Address	Akasaka Intercity AIR, 1-8-1 Akasaka, Minato-ku, Tokyo, Japan
	Telephone	+81-120-561-007
	E-mail	jp.gskjrct@gsk.com

Recruitment status	Not Recruiting

Anticipated date of first enrollment		April. 15, 2024
Target sample size		500
Study Type		Observational
Key inclusion & exclusion criteria	Inclusion Criteria	Participants are eligible to be included in the study only if all of the following criteria apply: -Aged >- 50 years at onset of hospitalized ARI. -Hospitalized patients with two or more symptoms/signs of an ARI that meet the ARI definitions (see Section 6.1) lasting more than 12 hours -Patients agree to provide nasal/throat swab samples to detect RSV by multiplex-nested PCR and a combination RAT -Participants who are able to provide written IC. If a participant is unable to provide the IC at the time of Day1, a legal representative (family member who live together with the participant) can provide written IC on their behalf. In case of a legal representative will provide, a consent form can be provided remotely via an electronic form.
	Exclusion Criteria	Participants are excluded from the study if any of the following criteria apply: Hospitalized ARI participants -Re-enrolment if new ARI symptoms/signs are reported within 14 days from the study conclusion contact of the previous ARI. -Participants' ARI symptoms/signs are attributed to aspiration pneumonia diagnosed. -Participant who does not have a digital device such as a smartphone, computer or tablet -Participant is deemed to be ineligible for the study for any other reason by the investigator or sub investigator, eg. cognitive dysfunction, symptom severity that they cannot follow the procedures for study participation.
	Age Minimum	50age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		Acute respiratory infections
Primary Outcome(s)		To evaluate operational system for RSV-NET Japan surveillance
Secondary Outcome(s)		To describe positivity rate, trend, clinical symptoms/signs, complication of RSV-ARI or other respiratory virus/bacteria in hospitalized ARI participants by site, age group, comorbidity and overall.

Primary Sponsor	GlaxoSmithKline K.K.

Name of Certified Review Board	Institutional Review Board of National Center for Global Health and Medicine
Address	1-21-1 Toyama, Shinjuku-ku, Tokyo
Telephone	+81-3-3202-7181
E-Mail	rinrijm@hosp.ncgm.go.jp
Approval Status	Approval
Date of approval	Feb. 20, 2024

Plan to share IPD	No

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
3	Nov. 10, 2025	(this page)	Changes
2	July. 20, 2024	Detail	Changes
1	Feb. 29, 2024	Detail

List of change history