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

Toxoplasmosis research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Toxoplasmosis

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:Leucovorin calciumSee arm descriptions

Drug:PyrimethamineSee arm descriptions

Drug:SpiramycinSpiramycin is administered before the fetal diagnosis is made.

Drug:SulfadiazineSee arm descriptions

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

1This 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.

2This 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.

Study Status

Recruiting

Start Date: July 2000

Completed Date: December 2030

Phase: Phase 4

Type: Interventional

Design:

Primary Outcome: Persistent motor abnormality

Secondary Outcome:

Study sponsors, principal investigator, and references

Principal Investigator: Rima McLeod

Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Collaborator: University of Chicago

More information:https://clinicaltrials.gov/show/NCT00004317

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