臨床研究等提出・公開システム

Date of registration	July. 25, 2023
Last modified on	Nov. 20, 2024
Trial ID	jRCT1030230252

Scientific Title	A prospective observational study in child patients under under the age of 3 with RSV infection in Japan
Public Title	A prospective observational study in child patients with RSV infection

Contact for Scientific Queries	Name	Ishiwada Naruhiko
	Affiliation	Department of Infectious Diseases Medical Mycology Research Center, Chiba University
	Address	1-8-1 Inohana, Chuo-ku, Chiba City, Chiba
	Telephone	+81-43-222-7171
	E-mail	ishiwada@faculty.chiba-u.jp
Contact for Public Queries	Name	Ishiwada Naruhiko
	Affiliation	Department of Infectious Diseases Medical Mycology Research Center, Chiba University
	Address	1-8-1 Inohana, Chuo-ku, Chiba City, Chiba
	Telephone	+81-43-222-7171
	E-mail	ishiwada@faculty.chiba-u.jp

Recruitment status	Not Recruiting

Anticipated date of first enrollment		July. 24, 2023
Target sample size		100
Study Type		Observational
Key inclusion & exclusion criteria	Inclusion Criteria	Patients 0 to 3 years old at the time of informed consent. Patients within 5 days after the onset of RSV infection at the time of informed consent.
	Exclusion Criteria	Those who have been infected with viruses or bacteria other than RSV within 14 days before obtaining consent, or who are known to be currently infected.
	Age Minimum	0age over
	Age Maximum	3age old not
	Gender	Both
Health Condition(s) or Problem(s) Studied		RSV infection
Primary Outcome(s)		RSV viral RNA load and titer ReSVinet Scale (for clinician)

Primary Sponsor	Medical Mycology Research Center, Chiba University

Secondary Sponsor

Source of Monetary Support	SHIONOGI & CO., LTD
Secondary Sponsor	Applicable

Name of Certified Review Board	Institutional Review Board, Medical Mycology Research Center, Chiba University
Address	1-8-1 Inohana, Chuo-ku, Chiba-city, Chiba Prefecture, Chiba, Chiba, Chiba
Telephone	+81-43-226-2462
E-Mail	inohana-shien@chiba-u.jp
Approval Status	Approval
Date of approval	July. 31, 2023

Plan to share IPD	No

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
4	Nov. 20, 2024	(this page)	Changes
3	Aug. 02, 2023	Detail	Changes
2	July. 28, 2023	Detail	Changes
1	July. 25, 2023	Detail

List of change history