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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000029112
Receipt No. R000032227
Scientific Title Efficacy and safety of pyrimethamine/sulfadiazine/folinate combination therapy for the treatment of toxoplasmosis
Date of disclosure of the study information 2017/09/13
Last modified on 2019/04/03

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Basic information
Public title Efficacy and safety of pyrimethamine/sulfadiazine/folinate combination therapy for the treatment of toxoplasmosis
Acronym Efficacy and safety of pyrimethamine/sulfadiazine/folinate for the treatment of toxoplasmosis
Scientific Title Efficacy and safety of pyrimethamine/sulfadiazine/folinate combination therapy for the treatment of toxoplasmosis
Scientific Title:Acronym Efficacy and safety of pyrimethamine/sulfadiazine/folinate for the treatment of toxoplasmosis
Region
Japan

Condition
Condition toxoplasmosis
Classification by specialty
Infectious disease Obsterics and gynecology Pediatrics
Ophthalmology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To demonstrate efficasy and safety of the combination therapy with pyrimethamine, sulfadiazine, and folinate, for treating toxoplasmosis in Japan.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Ocular toxoplasmosis: improvement of visual disorder 24 weeks after the end of therapy
Encephalitis/disseminated toxoplasmosis: survival rate 4-6 weeks after the therapy
Toxoplasmosis in pregnancy: congenital infection of the newborn
Congenital toxoplasmosis: mental/motor retardation 3 years after birth
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Treatment of toxoplasmosis patients with pyrimethamine/sulfadiazine/folinate.
1. active ocular toxoplasmosis: 2-6 weeks
2. toxoplasma encephalitis/disseminated toxoplasmosis: 6~4 to 6 weeks after symptom disappeared (52 weeks maximum)
3. pregnant toxoplasmosis: 18 gestation week to delivery
4. congenic toxoplasmosis: 52 weeks
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Toxoplasmosis of the following disease type
1. active ocular toxoplasmosis
2. toxoplasma encephalitis/disseminated toxoplasmosis
3. pregnant toxoplasmosis
4. congenic toxoplasmosis
Key exclusion criteria 1. HIV positive patients
2. patients who are allergic to pyrimethamine and/or sulfadiazine
3. patients with megacytic anemia due to folic acid deficiency
4. patients who did not agree to join the study
Target sample size 122

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Haruhiko Maruyama
Organization University of Miyazaki, Faculty of Medicine
Division name Department of Infectious Diseases
Zip code
Address Kihara 5200, Kiyotake-cho, Miyazaki City, Miyazaki, Japan
TEL 0985-85-0990
Email hikomaru@med.miyazaki-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Haruhiko Maruyama
Organization University of Miyazaki, Faculty of Medicine
Division name Department of Infectious Diseases
Zip code
Address Kihara 5200, Kiyotake-cho, Miyazaki City, Miyazaki, Japan
TEL 0985-85-0990
Homepage URL
Email hikomaru@med.miyazaki-u.ac.jp

Sponsor
Institute University of Miyazaki
Institute
Department

Funding Source
Organization The Japan Agency for Medical Research and Development (AMED)
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2017 Year 09 Month 13 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Open public recruiting
Date of protocol fixation
2007 Year 07 Month 03 Day
Date of IRB
2017 Year 06 Month 05 Day
Anticipated trial start date
2017 Year 09 Month 13 Day
Last follow-up date
2019 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 09 Month 12 Day
Last modified on
2019 Year 04 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032227

Research Plan
Registered date File name
2017/09/12 1 トキソプラズマ症:研究実施計画書_20170703.docx

Research case data specifications
Registered date File name
2017/09/12 7+キニマックス:症例報告書_v2_final.docx

Research case data
Registered date File name


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