臨床研究等提出・公開システム

Scientific Title	Efficacy and safety of injectable quinine in malaria patients (Injectable quinine for malaria)
Public Title	Treatment of severe malaria with injectable quinine (Injectable quinine for malaria)

Contact for Scientific Queries	Name	Maruyama Haruhiko
	Affiliation	University of Miyazaki Hospital
	Address	5200 Kihara, Kiyotake, Miyazaki 889-1692, JAPAN
	Telephone	+81-985-85-0990
	E-mail	hikomaru@med.miyazaki-u.ac.jp
Contact for Public Queries	Name	Maruyama Haruhiko
	Affiliation	University of Miyazaki
	Address	5200 Kihara, Kiyotake, Miyazaki 889-1692, JAPAN
	Telephone	+81-985-85-0990
	E-mail	hikomaru@med.miyazaki-u.ac.jp

Recruitment status	Recruiting

Anticipated date of first enrollment		June. 16, 2017
Actual date of first enrollment		July. 20, 2017
Target sample size		33
Study Type		Interventional
Study Design	allocation	single arm study
	masking	open(masking not used)
	control	uncontrolled control
	assignment	single assignment
	purpose	treatment purpose
Key inclusion & exclusion criteria	Inclusion Criteria	1) Severe malaria patient, or malaria patient who cannot take oral antimalarial medicines for absolute contraindication or other reasons 2) Patient who gives written informed consent on his/her own free will to participate the above described study, after having fully understood the explanations on it 3) Patient whose legal representative gives written informed consent on his/her own free will to let the patient participate the above described study, after having fully understood the explanations on it
	Exclusion Criteria	1) Patient who is allergic to quinine 2) Patient who refuses quinine injection 3) Patient principal investigator judged inappropriate
	Age Minimum	No limit
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		malaria
Intervention(s)		Treatment with un-licensed medicine
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome(s)		survival rate
Secondary Outcome(s)		1) Fever clearance time (h) 2) Parasite clearance time 3) Recrudescence before 28 days post-treatment

Primary Sponsor

Source of Monetary Support / Secondary Sponsor
Secondary Sponsor

Source of Monetary Support	Japan Agency for Medical Research and Development(AMED)
Secondary Sponsor	Not applicable

Name of Certified Review Board	Clinical Research Network Fukuoka Certified Review Board
Address	3-1-1 Maidashi,Higashi-ku,Fukuoka, Fukuoka
Telephone	+81-92-643-7171
E-Mail	mail@crnfukuoka.jp
Approval Status	Approval
Date of approval	Oct. 11, 2018

Plan to share IPD	No
Plan description

Secondary ID(s)	UMIN000027485
Issuing Authority	UMIN-CTR

Countries of Recruitment（Except Japan）	none

History of Changes

List of change history