Treatment of disseminated toxoplasmosis/toxoplasma encephalitis with pyrimethamine/sulfadiazine

JRCT ID: jRCTs071180095

Registered date:29/03/2019

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Disseminated toxoplasmosis and toxoplasma encephalitis
• Date of first enrollment: 18/03/2020
• Target sample size: 35
• Study type: Interventional
• Intervention(s): Treatment with un-licensed medicine

Outcome(s)

• Primary Outcome: Survival rate 6 weeks after treatment initiation

Secondary Outcome

1) reduction ratio of affected brain area 4 weeks after treatment initiation
2) duration of medication
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)

Key inclusion & exclusion criteria

• Age minimum: >= 16age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

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