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

Sponsored by National Institute of Allergy and Infectious Diseases (NIAID)

About this trial

Last updated 17 years ago

Study ID

199/11837

Status

Recruiting

Type

Interventional

Phase

Phase 4

Placebo

No

Accepting

All Ages
All Sexes

Trial Timing

Started 26 years ago

What is this trial about?

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 are the Participation Requirements?

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