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Treatment of congenital toxoplasmosis with pyrimethamine/sulfadiazine

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

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs071180093
Enrollment
35
Registered
2019-03-29
Start date
2020-02-03
Completion date
Unknown
Last updated
2025-11-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Congenital toxoplasmosis

Interventions

Sponsors

Maruyama Haruhiko
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion 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

Design outcomes

Primary

MeasureTime frame
Incidence of psychomotor retardation

Secondary

MeasureTime frame
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)

Contacts

Public ContactKei Yamamoto

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

yamamoto.k@jihs.go.jp+81-3-3201-7181

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Feb 4, 2026