RecruitingPhase 4NCT00004317

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

Phase IV Randomized Study of Pyrimethamine, Sulfadiazine, and Leucovorin Calcium for Congenital Toxoplasmosis


Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Enrollment

600 participants

Start Date

Jul 1, 2000

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Inclusion Criteria9

  • 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

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Interventions

DRUGLeucovorin calcium

See arm descriptions

DRUGPyrimethamine

See arm descriptions

DRUGSpiramycin

Spiramycin is administered before the fetal diagnosis is made.

DRUGSulfadiazine

See arm descriptions


Locations(1)

University of Chicago

Chicago, Illinois, United States

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NCT00004317


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