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Pyrimethamine, Sulfadiazine, and Leucovorin in Treating Patients With Congenital Toxoplasmosis

Phase IV Randomized Study of Pyrimethamine, Sulfadiazine, and Leucovorin Calcium for Congenital Toxoplasmosis

Who can join

All ages · All sexes

PROTOCOL ENTRY CRITERIA:

* Infants with congenital toxoplasmosis Toxoplasma gondii confirmed prior to age 2.5 months
* Pregnant women with evidence of toxoplasma infection by clinical observation and amniotic fluid sampling
* Acute infection acquired during gestation with evidence of fetal infection
* Untreated older children entered as controls
* Asymptomatic congenital toxoplasmosis
* Age more than 1 year
* No treatment within the first year of life
* No more than 1 month of prior therapy

About the study

RATIONALE: Congenital toxoplasmosis is an infection caused by the parasitic organism Toxoplasma gondii, and it may be passed from an infected mother to her unborn child. The mother may have mild symptoms or no symptoms; the fetus, however, may experience damage to the eyes, nervous system, skin, and ears. The newborn may have a low birth weight, enlarged liver and spleen, jaundice, anemia, petechiae, and eye damage. Giving the antiparasitic drugs pyrimethamine and sulfadiazine is standard treatment for congenital toxoplasmosis, but it is not yet known which regimen of pyrimethamine is most effective for the disease.

PURPOSE: Randomized phase IV trial to determine which regimen of pyrimethamine is most effective when combined with sulfadiazine and leucovorin in treating patients who have congenital toxoplasmosis.

What is being tested

• Leucovorin calcium (drug)
• Pyrimethamine (drug)
• Spiramycin (drug)
• Sulfadiazine (drug)

Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) · Participants: 600 · Started: 2000-07

Contact the study team

Official record on ClinicalTrials.gov — NCT00004317

Locations in the U.S.

Conditions

• Immune System and Disorders
• Infectious Diseases
• Rare Diseases

From ClinicalTrials.gov, data retrieved Oct 3, 2026. Each study sets its own eligibility; the study team decides who can join.