Phase IV Randomized Study of Pyrimethamine, Sulfadiazine, and Leucovorin Calcium for Congenital Toxoplasmosis

What this Trial Is About

Congenital toxoplasmosis is an infection caused by the parasite Toxoplasma gondii, which can be passed from an infected mother to her unborn child. While the mother may have mild or no symptoms, the unborn baby may suffer damage to the eyes, nervous system, skin, and ears. Newborns may also have low birth weight, enlarged liver and spleen, jaundice, anemia, petechiae, and eye damage. This phase IV randomized study aims to determine which dosing regimen of the drug pyrimethamine, combined with sulfadiazine and leucovorin calcium, is most effective in treating congenital toxoplasmosis in infants. Infants diagnosed with congenital toxoplasmosis are randomly assigned to one of two treatment groups. One group receives a loading dose of oral pyrimethamine, followed by a higher dose for two months and then a lower dose for the remaining 10 months, along with sulfadiazine and leucovorin calcium for 12 months. The loading dose is skipped if the infant had prior prenatal therapy. The second group receives a higher dose of oral pyrimethamine for the first six months, then a lower dose for the rest of the 12 months, with sulfadiazine and leucovorin calcium given at the same time. Pregnant women with fetal infection receive treatment after the first trimester, including spiramycin before diagnosis. Prednisone may be used for active eye inflammation or certain brain fluid abnormalities. Historical control children older than one year who were untreated or treated for less than one month are also included for comparison. Participants are assessed at birth and then followed up at ages 1, 3.5, 5, 7.5, 10, 15, and 20 years. Researchers monitor motor function abnormalities, vision, hearing, new eye lesions, and cognitive ability measured by IQ scores. Any child requiring treatment for active conditions will receive it. This long-term monitoring helps evaluate the effects of the different pyrimethamine regimens on congenital toxoplasmosis outcomes.

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