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Pyrimethamine, Sulfadiazine, and Leucovorin in Treating Patients With Congenital Toxoplasmosis
Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Summary
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.
Official title: Phase IV Randomized Study of Pyrimethamine, Sulfadiazine, and Leucovorin Calcium for Congenital Toxoplasmosis
Key Details
Gender
All
Age Range
Any - Any
Study Type
INTERVENTIONAL
Enrollment
600
Start Date
2000-07
Completion Date
2030-12
Last Updated
2009-05-14
Healthy Volunteers
No
Conditions
Interventions
Leucovorin calcium
See arm descriptions
Pyrimethamine
See arm descriptions
Spiramycin
Spiramycin is administered before the fetal diagnosis is made.
Sulfadiazine
See arm descriptions
Locations (1)
University of Chicago
Chicago, Illinois, United States