Actively Recruiting
Pyrimethamine, Sulfadiazine, and Leucovorin in Treating Patients With Congenital Toxoplasmosis
Led by National Institute of Allergy and Infectious Diseases (NIAID) · Updated on 2009-05-14
600
Participants Needed
1
Research Sites
1587 weeks
Total Duration
On this page
Sponsors
N
National Institute of Allergy and Infectious Diseases (NIAID)
Lead Sponsor
U
University of Chicago
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Pyrimethamine, Sulfadiazine, and Leucovorin in Treating Patients With Congenital Toxoplasmosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Infants with congenital toxoplasmosis confirmed before age 2.5 months
- Pregnant women with clinical and amniotic fluid evidence of toxoplasma infection
- Acute infection during pregnancy 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 or no more than one month of prior therapy
You will not qualify if you...
History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety
AI-Screening
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Trial Site Locations
Total: 1 location
1
University of Chicago
Chicago, Illinois, United States, 60637
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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