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

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

Yamamoto Kei

Japan Institute for Health Security National Center for Global Health and Medicine

1-21-1 Toyama Shinjyuku-ku Tokyo

yamamoto.k@jihs.go.jp

Yamamoto Kei

Japan Institute for Health Security National Center for Global Health and Medicine

1-21-1 Toyama Shinjyuku-ku Tokyo

+81-3-3201-7181

yamamoto.k@jihs.go.jp

Recruiting

April. 01, 2019

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

treatment purpose

Patients with active uveitis and one of the following findings
#1 Toxoplasma DNA positive
#2 high anti-Toxoplasma IgG concentration in vitreous humor
#3 serum anti-Toxoplasma IgG positive

#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

Ocular toxoplasmosis

Treatment with un-licensed medicine

Improvement in fundus imaging findings 6 weeks after treatment or 4-6 weeks after completion of treatment

1) presence or absence of visual acuity improvement
2) relapse status up to 24 weeks of treatment
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)

+81-92-643-7171

Mar. 28, 2019

none