UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029112 |
|---|---|
| Receipt number | 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 | 2021/03/11 12:16:16 |
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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 | Obstetrics 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 | Maruyama |
| Middle name | |
| Last name | Haruhiko |
Organization
University of Miyazaki, Faculty of Medicine
Division name
Department of Infectious Diseases
Zip code
889-1692
Address
Kihara 5200, Kiyotake-cho, Miyazaki City, Miyazaki, Japan
TEL
0985-85-0990
hikomaru@med.miyazaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Maruyama |
| Middle name | |
| Last name | Haruhiko |
Organization
University of Miyazaki, Faculty of Medicine
Division name
Department of Infectious Diseases
Zip code
889-1692
Address
Kihara 5200, Kiyotake-cho, Miyazaki City, Miyazaki, Japan
TEL
0985-85-0990
Homepage URL
hikomaru@med.miyazaki-u.ac.jp
Sponsor or person
Institute
University of Miyazaki
Institute
Department
Personal name
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
Hospital of University of Miyazaki Clinical Research Support Center
Address
Kihara 5200, Kiyotake-cho, Miyazaki, Miyazaki
Tel
0985-85-9403
rinken@med.miyazaki-u.ac.jp
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
Completed
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
| 2019 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2019 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2021 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 09 | Month | 12 | Day |
Last modified on
| 2021 | Year | 03 | Month | 11 | Day |
Link to view the page
Value
https://center6.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 |
