Treatment of congenital toxoplasmosis with pyrimethamine/sulfadiazine

JRCT ID: jRCTs071180093

Registered date:29/03/2019

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Congenital toxoplasmosis
• Date of first enrollment: 03/02/2020
• Target sample size: 35
• Study type: Interventional
• Intervention(s): Treatment with un-licensed medicine

Outcome(s)

• Primary Outcome: Incidence of psychomotor retardation

Secondary Outcome

1) 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 minimum: Not applicable
• Age maximum: Not applicable
• Gender: Both

Include criteria

1. 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

• Primary Sponsor: Maruyama Haruhiko
• Source(s) of Monetary Support: Japan Agency for Medical Research and Development
• Secondary ID(s): UMIN000029112