Treating congenital toxoplasmosis with specific medications
Phase IV Randomized Study of Pyrimethamine, Sulfadiazine, and Leucovorin Calcium for Congenital Toxoplasmosis
This study is testing the best way to use a combination of medications to treat congenital toxoplasmosis in infants and also looks at treating infected fetuses in pregnant women.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 600 (estimated) |
| Sex | All |
| Sponsor | Office of Rare Diseases (ORD) NIH |
| Drugs / interventions | prednisone |
| Locations | 1 site (Chicago, Illinois) |
| Trial ID | NCT00004317 on ClinicalTrials.gov |
What this trial studies
This phase IV trial aims to determine the most effective regimen of pyrimethamine when combined with sulfadiazine and leucovorin for treating congenital toxoplasmosis in infants. Participants are randomly assigned to one of two treatment groups, with variations in the dosing schedule of pyrimethamine over a 12-month period. The study also includes nonrandomized treatment for infected fetuses of pregnant women after the first trimester. Historical controls will be referred for comparison, focusing on untreated cases or those with minimal prior therapy.
Who should consider this trial
Good fit: Ideal candidates include infants diagnosed with congenital toxoplasmosis before 2.5 months of age and pregnant women with evidence of toxoplasma infection.
Not a fit: Patients who have already received extensive treatment for congenital toxoplasmosis or those without a confirmed diagnosis may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment protocols for congenital toxoplasmosis, potentially reducing the risk of severe complications in affected infants.
How similar studies have performed: Other studies have explored treatments for congenital toxoplasmosis, but this specific regimen and its effectiveness are being evaluated for the first time in this context.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Chicago, Illinois
- University of Chicago — Chicago, Illinois, United States (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.