臨床研究等提出・公開システム

Scientific Title	Efficacy and safety of pyrimethamine/sulfadiazine/folinate combination therapy for the treatment of fetal toxoplasmosis (Treatment of fetal toxoplasmosis with pyrimethamine/sulfadiazine)
Public Title	Treatment of fetal toxoplasmosis with pyrimethamine/sulfadiazine (Treatment of fetal toxoplasmosis with pyrimethamine/sulfadiazine)

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		April. 01, 2019
Actual date of first enrollment		June. 18, 2019
Target sample size		35
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	Confirmed fetal toxoplasmosis (Toxoplasma DNA positive in amniotic fluid)
	Exclusion Criteria	#1 HIV positive patients #2 patients allergic to test compounds #3 patients with megaloblastic anemia due to folate deficiency #4 No consent is given from the patient him/herself nor a legally authorized representative/guardian of the patient #5 patients principal investigator judged inappropriate
	Age Minimum	16age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		Fetal toxoplasmosis
Intervention(s)		Treatment with un-licensed medicine
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome(s)		Incidence of infection at birth
Secondary Outcome(s)		1) incidence of intrauterine growth abnormality 2) incidence of congenital disorder 3) incidence of growth abnormality after birth 4) incidence of abdominal symptoms 5) incidence of pancytopenia 6) incidence of acute renal failure 7) incidence of hepatic dysfunction 8) incidence of skin eruption (e.g. erythema)

Primary Sponsor

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Primary Sponsor

Source of Monetary Support / Secondary Sponsor
Secondary Sponsor

Source of Monetary Support / Secondary Sponsor
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Source of Monetary Support / Secondary Sponsor
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Source of Monetary Support / Secondary Sponsor
Secondary Sponsor

Source of Monetary Support / Secondary Sponsor
Secondary Sponsor

Source of Monetary Support / Secondary Sponsor
Secondary Sponsor

Source of Monetary Support	Japan Agency for Medical Research and Development
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	Mar. 28, 2019

Plan to share IPD	No
Plan description

Secondary ID(s)	UMIN000029112
Issuing Authority	UMIN-CTR

Countries of Recruitment（Except Japan）	none

History of Changes

List of change history