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

Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Oct 18, 1999

Keywords

ClinConnect Summary

This clinical trial is studying the best way to treat congenital toxoplasmosis, an infection that can be passed from a mother to her baby during pregnancy. The infection is caused by a parasite called Toxoplasma gondii, which can lead to serious health issues for the baby, including problems with the eyes, nervous system, and other organs. The trial will test different combinations of two medications, pyrimethamine and sulfadiazine, along with leucovorin, to find out which treatment works best.

To be part of this trial, participants must be infants under 2.5 months old who have been confirmed to have congenital toxoplasmosis, or pregnant women who show signs of the infection. Older children with untreated congenital toxoplasmosis can also join as comparison subjects. Participants will receive treatment and be monitored for their health outcomes. This study aims to improve the understanding of how to effectively treat this infection, which can have lasting effects on a child's development.

Gender

ALL

Eligibility criteria

• 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