臨床研究等提出・公開システム

Scientific Title	Randomized study comparing Baloxavir Marboxil to Peramivir in pediatric patients with Influenza
Public Title	Randomized study comparing Baloxavir Marboxil to Peramivir in pediatric patients with Influenza

Contact for Scientific Queries	Name	Kato Kentaro
	Affiliation	Kitano Hospital, Tazuke Kofukai Medical Research Institute
	Address	2-4-20 Ohgimachi Kitaku Osaka Japan
	Telephone	+81-6-6312-1221
	E-mail	kenkato100@gmail.com
Contact for Public Queries	Name	Kato Kentaro
	Affiliation	Kitano Hospital, Tazuke Kofukai Medical Research Institute
	Address	2-4-20 Ohgimachi Kitaku Osaka Japan
	Telephone	+81-6-6312-1221
	E-mail	kenkato100@gmail.com

Recruitment status	Pending

Anticipated date of first enrollment		Dec. 12, 2018
Actual date of first enrollment
Target sample size		40
Study Type		Interventional
Study Design	allocation	randomized controlled trial
	masking	open(masking not used)
	control	active control
	assignment	single assignment
	purpose	treatment purpose
Key inclusion & exclusion criteria	Inclusion Criteria	1)axillary temperature more than 37.5 degree 2)a positive rapid antigen test for influenza virus 3)a symptom duraiton of no more than 36 hours 4)hospitalized patient 5)body weight more than 10kg
	Exclusion Criteria	1)patients who have suffered from bacterial infection or other viral infection within one week from the start of the study 2)patients who received recipes of Baloxavir marboxil, Oseltamivir, Zanavivir, Laninavir, Peramivir within 4 weeks from the start of the study
	Age Minimum	none
	Age Maximum	15 years old
	Gender	Both
Health Condition(s) or Problem(s) Studied		Influenza
Intervention(s)		Interventions 1 Baloxavir marboxil Interventions 2 Peramivir
Health Condition(s) Keyword		Influenza
Intervention(s) Keyword		Medicine
Health Condition(s) Code		D007251
Intervention(s) Code		D008511
Primary Outcome(s)		The time to alleviation of influenza symptoms The time to resolution of fever
Secondary Outcome(s)		The changes from baseline in infectious virus and viral RNA titers

Primary Sponsor

Primary Sponsor

Source of Monetary Support / Secondary Sponsor
Secondary Sponsor

Source of Monetary Support / Secondary Sponsor
Secondary Sponsor

Source of Monetary Support
Secondary Sponsor

Name of Certified Review Board	The Tazuke Kofukai Medical Research Institute Kitano Hospital Research Ethics Committee
Address	2-4-20 Ohgimachi Kitaku Osaka Japan, Osaka
Telephone	+81-6-6312-1221
E-Mail
Approval Status	Approval
Date of approval	Dec. 10, 2018

Plan to share IPD
Plan description

Secondary ID(s)
Issuing Authority

Countries of Recruitment（Except Japan）	none