NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JRCT ID: jRCTs071180093

Registered date:29/03/2019

Treatment of congenital toxoplasmosis with pyrimethamine/sulfadiazine

Basic Information

Recruitment status Recruiting
Health condition(s) or Problem(s) studiedCongenital toxoplasmosis
Date of first enrollment03/02/2020
Target sample size35
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)Treatment with un-licensed medicine

Outcome(s)

Primary OutcomeIncidence of psychomotor retardation
Secondary Outcome1) incidence of new ocular lesions 2) incidence of auditory disorder 3) incidence of hydrocephalus 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)

Key inclusion & exclusion criteria

Age minimumNot applicable
Age maximumNot applicable
GenderBoth
Include criteria1. Confirmed toxoplasmosis fulfilling one of the followings #1 Toxoplasma DNA detected in placenta or other tissues #2 pathological identification of Toxoplasma #3 anti-Toxoplasma IgM in cord blood or sera within 6 months after birth #4 increase of anti-Toxoplasma IgG within 1 year after birth #5 positive anti-Toxoplasma IgG after 12 months after birth 2. Suspected toxoplasmosis with all of the followings #1 typical symptoms (e.g. intra-cranial calcification) #2 positive anti-Toxoplasma IgG #3 other congenital infections 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