Treatment of ocular toxoplasmosis with pyrimethamine/sulfadiazine

JRCT ID: jRCTs071180092

Registered date:29/03/2019

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Ocular toxoplasmosis
• Date of first enrollment: 14/04/2020
• Target sample size: 35
• Study type: Interventional
• Intervention(s): Treatment with un-licensed medicine

Outcome(s)

• Primary Outcome: Improvement of visual acuity 24 weeks after treatment

Secondary Outcome

1) reduction ratio of affected retina area
2) duration until scar formation
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: Not applicable
• Age maximum: Not applicable
• Gender: Both

Include criteria

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

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