臨床研究等提出・公開システム

Efficacy and safety of pyrimethamine/sulfadiazine/folinate combination therapy for the treatment of congenital toxoplasmosis (Treatment of congenital toxoplasmosis with pyrimethamine/sulfadiazine)

Treatment of congenital toxoplasmosis with pyrimethamine/sulfadiazine (Treatment of congenital toxoplasmosis with pyrimethamine/sulfadiazine)

Maruyama Haruhiko

University of Miyazaki Hospital

5200 Kihara, Kiyotake, Miyazaki 889-1692, JAPAN

hikomaru@med.miyazaki-u.ac.jp

Maruyama Haruhiko

University of Miyazaki

5200 Kihara, Kiyotake, Miyazaki 889-1692, JAPAN

+81-985-85-0990

hikomaru@med.miyazaki-u.ac.jp

Recruiting

April. 01, 2019

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

treatment purpose

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

#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

Both

Congenital toxoplasmosis

Treatment with un-licensed medicine

Incidence of psychomotor retardation

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)

+81-92-643-7171

Mar. 28, 2019

No

none