Treating congenital toxoplasmosis with specific medications
Official title: Phase IV Randomized Study of Pyrimethamine, Sulfadiazine, and Leucovorin Calcium for Congenital Toxoplasmosis
Run by Office of Rare Diseases (ORD) · NCT00004317 · Data updated 2026-11-12
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 |
| Sex | All |
| Enrollment | 600 (estimated) |
| Sponsor | Office of Rare Diseases (ORD) NIH |
| Drugs / interventions | prednisone |
| Locations | 1 site (Chicago, Illinois) |
| Status | Recruiting |
| Started | July 2000 |
| Main results expected | December 2030 |
| Study ends | December 2030 |
| Registry record updated | May 14, 2009 |
| Trial ID | NCT00004317 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include infants diagnosed with congenital toxoplasmosis before 2.5 months of age and pregnant women with evidence of toxoplasma infection.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
-
University of Chicago
Chicago, Illinois, United States Recruiting
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Blood microRNAs to distinguish schizophrenia, depression, and bipolar disorder in women with chronic toxoplasmosis
This project will test whether specific blood microRNA levels can help tell apart schizophrenia, major depression, and bipolar disorder in women with long-term Toxoplasma gondii infection.
-
Evaluating the prognosis of severe toxoplasmosis in ICU patients
This study looks at how well different treatments work for patients with severe toxoplasmosis in the ICU, especially those with weakened immune systems, to understand their chances of recovery.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.