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

StatusRecruiting
PhasePhase 4
Started
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Record History

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  1. Re-verified, no change to tracked fieldsv8
  2. Study description expanded, about 115 words
    • Eligibility criteria shortened, about 2 words
    v7
  3. Phase: Phase 2 to Phase 4v6 Show 4 more changesShow less
    • Enrollment target: 110 to 600
    • Primary and study completion dates: Dec 2030
    • Interventions: leucovorin calcium (Drug), pyrimethamine (Drug), spiramycin (Drug), sulfadiazine (Drug) to Leucovorin calcium (Drug), Pyrimethamine (Drug), Spiramycin (Drug), Sulfadiazine (Drug)
    • Study arms: 0 to 2
  4. Trial status: Suspended to Recruiting
    • Site details revised
    v5
  5. Trial status: Recruiting to Suspended
    • Site details revised
    v4
  6. 2 versions Re-verified since Sep 1, 2005, no change to tracked fieldsv2-v3
  7. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT00004317
Lead Sponsor National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators: University of Chicago
Conditions
(from sponsor)		 Toxoplasmosis
Related terms Communicable Diseases, Immune System Diseases, Rare Diseases, Toxoplasmosis
Enrollment 600 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov