Pyrimethamine, Sulfadiazine, and Leucovorin in Treating Patients With Congenital Toxoplasmosis
Recruiting
Phase 4
Interventional Study
Toxoplasmosis
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Sex
- Any
- Trial phase
- Phase 4
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 600 (estimated)
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID) · NIH
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About This Trial
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, petechi…
Trial Locations
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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 infectio…
Contacts
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