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

Treatment of disseminated toxoplasmosis/toxoplasma encephalitis with pyrimethamine/sulfadiazine (Treatment of disseminated toxoplasmosis/toxoplasma encephalitis 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

Confirmed toxoplasmosis patients (DNA positive)
Suspected toxoplasmosis patients
#1 typical brain imaging
#2 serum anti-Toxoplasma IgG positive
#3 other diseases are 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

Disseminated toxoplasmosis and toxoplasma encephalitis

Treatment with un-licensed medicine

Survival rate 6 weeks after treatment initiation

1) improvement rate of imaging findings at 6 weeks after treatment initiation (+-1 week).
2) rate of PCR negativization by 6 weeks after treatment initiation among patients who were PCR-positive at enrollment, excluding brain tissue samples.
3) duration of medication
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

none