Recruiting

Pyrimethamine, Sulfadiazine, Leucovorin

Sponsor:

National Institute of Allergy and Infectious Diseases (NIAID)

Code:

NCT00004317

Conditions

Toxoplasmosis

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

Leucovorin calcium

Pyrimethamine

Spiramycin

Sulfadiazine

Study Details

Brief 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.

Conditions

Toxoplasmosis

Study ID

NCT00004317

Start date

Jul, 2000

Status verified date

May, 2009

Completion date

Dec, 2030

Anticipated

Primary completion date

Dec, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

600 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 1

This 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.

experimental: 2

This 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.

Interventions

Leucovorin calcium

See arm descriptions

Pyrimethamine

See arm descriptions

Spiramycin

Spiramycin is administered before the fetal diagnosis is made.

Sulfadiazine

See arm descriptions

Primary outcome measure

  • Persistent motor abnormality [ Time Frame: At pre-specified time points ]
  • Vision [ Time Frame: At pre-specified time points ]
  • Hearing [ Time Frame: At pre-specified time points ]
  • New chorioretinal lesion [ Time Frame: At pre-specified time points ]
  • IQ less than 70 [ Time Frame: At pre-specified time points ]
  • Decrease in IQ of greater than or equal to 15 points [ Time Frame: At pre-specified time points ]

Central Contacts and Locations

Locations

University of Chicago

Recruiting

Chicago, Illinois, United States, 60637

Contacts

Rima McLeod

773-834-4152

More Information

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Last update posted

May 14, 2009

Last verified

May, 2009

Keywords

  • immunologic disorders and infectious disorders
  • rare disease
  • toxoplasmosis

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by National Institute of Allergy and Infectious Diseases (NIAID) on 2009-05-14.