RATIONALE: Congenital toxoplasmosis is an infection caused by the parasitic organism Toxoplasma gondii, and 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 II trial to determine which regimen of pyrimethamine is most effective when combined with sulfadiazine and leucovorin in treating patients who have congenital toxoplasmosis.

Condition	Treatment or Intervention	Phase
Toxoplasmosis	Drug: leucovorin calcium  Drug: pyrimethamine  Drug: spiramycin  Drug: sulfadiazine	Phase II

Further Study Details: 

Expected Total Enrollment:  110

PROTOCOL OUTLINE: Infants are randomly assigned to 1 of 2 treatment groups; patients treated prenatally are randomized separately. Patients are stratified by disease severity, chorioretinitis, prenatal treatment, and certainty of diagnosis at birth. One group of infants is treated with a loading dose of oral pyrimethamine followed by a higher dose for the first two months then a lower dose for the remainder of the 12 months. Sulfadiazine and leucovorin calcium are also given orally for 12 months. The pyrimethamine loading dose is omitted if prior prenatal therapy was given. Another group of infants is treated with a higher dose of oral pyrimethamine for the first 6 months and then the lower dose for the remainder of the 12 months. Sulfadiazine and leucovorin calcium are administered concurrently. Infected fetuses of pregnant women are nonrandomly assigned to treatment with pyrimethamine, sulfadiazine, and leucovorin calcium after the first trimester. Spiramycin is administered before the fetal diagnosis is made. Concurrent prednisone for active retinal inflammation or elevated cerebrospinal fluid protein is allowed. All infants are followed at birth, then at age 1, 3.5, 5, 7.5, 10, 15, and 20.

Genders Eligible for Study:  Both

Criteria

PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- 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

Illinois
      University of Chicago, Chicago,  Illinois,  60637,  United States; Recruiting

Study chairs or principal investigators

Rima McLeod,  Study Chair,  University of Chicago   

Study ID Numbers:  199/11837; UCCRC-08796; MRH-850410; UCRCC-08796
Record last reviewed:  January 2005
Last Updated:  January 21, 2005
Record first received:  October 18, 1999
ClinicalTrials.gov Identifier:  NCT00004317
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08