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

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.

NCT Number	NCT00004317
Lead Sponsor	National Institute of Allergy and Infectious Diseases (NIAID) Collaborators: University of Chicago
Conditions	Toxoplasmosis
Enrollment	600 participants
Start Date	2000-07
Primary Completion	2030-12 (estimated)
Study Completion	2030-12 (estimated)
Updated on ClinicalTrials.gov	2009-05-14