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.
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
None
Parallel
Leucovorin calcium
DrugSee arm descriptions
Pyrimethamine
DrugSee arm descriptions
Spiramycin
DrugSpiramycin is administered before the fetal diagnosis is made.
Sulfadiazine
DrugSee arm descriptions
Persistent motor abnormality
Vision
Hearing
New chorioretinal lesion
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National Institute of Allergy and Infectious Diseases (NIAID)
Lead sponsor
University of Chicago
Collaborator
