NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JRCT ID: jRCTs071180095

Registered date:29/03/2019

Treatment of disseminated toxoplasmosis/toxoplasma encephalitis with pyrimethamine/sulfadiazine

Basic Information

Recruitment status Recruiting
Health condition(s) or Problem(s) studiedDisseminated toxoplasmosis and toxoplasma encephalitis
Date of first enrollment18/03/2020
Target sample size35
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)Treatment with un-licensed medicine

Outcome(s)

Primary OutcomeSurvival rate 6 weeks after treatment initiation
Secondary Outcome1) reduction ratio of affected brain area 4 weeks after treatment initiation 2) duration of medication 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)

Key inclusion & exclusion criteria

Age minimum>= 16age old
Age maximumNot applicable
GenderBoth
Include criteriaConfirmed toxoplasmosis patients (DNA positive) Suspected toxoplasmosis patients #1 typical brain imaging #2 serum anti-Toxoplasma IgG positive #3 other diseases are excluded
Exclude 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

Related Information

Contact

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