Phase IV Randomized Study of Pyrimethamine, Sulfadiazine, and Leucovorin Calcium for Congenital Toxoplasmosis
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.
Description
PROTOCOL OUTLINE: Infants are randomly assigned to 1 of 2 treatment groups. Patients are stratified by disease severity, chorioretinitis, prenatal treatment, and certainty of diagnosis at birth. One group of infants is treated with a loading dose of oral pyrimethamine followed by a higher dose for the first two months then a lower dose for the remainder of the 12 months. Sulfadiazine and leucovorin calcium are also given orally for 12 months. The pyrimethamine loading dose is omitted if prior prenatal therapy was given. Another group of infants is treated with a higher dose of oral pyrimetha…
Eligibility
- Age range
- Not specified
- Sex
- All
- Healthy volunteers
- No
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
Interventions
- DrugLeucovorin calcium
See arm descriptions
- DrugPyrimethamine
See arm descriptions
- DrugSpiramycin
Spiramycin is administered before the fetal diagnosis is made.
- DrugSulfadiazine
See arm descriptions
Location
- University of ChicagoChicago, Illinois