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 ocular toxoplasmosis (Treatment of ocular toxoplasmosis with pyrimethamine/sulfadiazine)
Public Title	Treatment of ocular toxoplasmosis with pyrimethamine/sulfadiazine (Treatment of ocular 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		April. 14, 2020
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	Patients with active uveitis and one of the following findings #1 Toxoplasma DNA positive #2 high anti-Toxoplasma IgG concentration in vitreous humor #3 serum anti-Toxoplasma IgG positive
	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	No limit
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		Ocular 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)		Improvement of visual acuity 24 weeks after treatment
Secondary Outcome(s)		1) reduction ratio of affected retina area 2) duration until scar formation 3) incidence of abdominal symptoms 4) incidence of pancytopenia 5) incidence of acute renal failure 6) incidence of hepatic dysfunction 7) incidence of skin eruption (e.g. erythema)

Primary Sponsor

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	Certified Review Board, University of Miyazaki
Address	5200 Kihara, Kiyotake, Miyazaki-shi, Miyazaki
Telephone	+81-985-85-9403
E-Mail	crb_staff@med.miyazaki-u.ac.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