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| Sponsors and Collaborators: |
National Institute of Allergy and Infectious Diseases (NIAID) University of Chicago |
|---|---|
| Information provided by: | Office of Rare Diseases (ORD) |
| ClinicalTrials.gov Identifier: | NCT00004317 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Toxoplasmosis |
Drug: Leucovorin calcium Drug: Pyrimethamine Drug: Spiramycin Drug: Sulfadiazine |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Single Blind (Outcomes Assessor), Dose Comparison, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | Phase IV Randomized Study of Pyrimethamine, Sulfadiazine, and Leucovorin Calcium for Congenital Toxoplasmosis |
| Estimated Enrollment: | 600 |
| Study Start Date: | July 2000 |
| Estimated Study Completion Date: | December 2030 |
| Estimated Primary Completion Date: | December 2030 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
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.
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Drug: Leucovorin calcium
See arm descriptions
Drug: Pyrimethamine
See arm descriptions
Drug: Spiramycin
Spiramycin is administered before the fetal diagnosis is made.
Drug: Sulfadiazine
See arm descriptions
|
|
2: Experimental
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.
|
Drug: Leucovorin calcium
See arm descriptions
Drug: Pyrimethamine
See arm descriptions
Drug: Spiramycin
Spiramycin is administered before the fetal diagnosis is made.
Drug: Sulfadiazine
See arm descriptions
|
PROTOCOL OUTLINE: Infants are randomly assigned to 1 of 2 treatment groups. 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.
Collaborating physicians will also refer historical controls, who have not been treated in the first year of life or who received one month or less therapy, and are older than one year. Absence of treatment in the first year of life will be due to parental preference, prior inadequate follow-up by the family physicians, or lack of detection or treatment of eye disease before the age of one year in otherwise asymptomatic children. These historical, untreated patients (who enter the study when they are older than one year) will be compared with treated children in the randomized study. These historical patients will not be randomized. Any abnormality requiring treatment (e.g., active chorioretinitis) in any child (including historical patients) will be treated. All infants are followed at birth, then at age 1, 3.5, 5, 7.5, 10, 15, and 20.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
PROTOCOL ENTRY CRITERIA:
Contacts and Locations| United States, Illinois | |
| University of Chicago | Recruiting |
| Chicago, Illinois, United States, 60637 | |
| Contact: Rima McLeod 773-834-4152 | |
| Study Chair: | Rima McLeod | University of Chicago |
More Information
| Responsible Party: | University of Chicago ( Rima McLeod, MD Professor ) |
| Study ID Numbers: | 199/11837, UCCRC-08796, MRH-850410, UCRCC-08796 |
| Study First Received: | October 18, 1999 |
| Last Updated: | February 20, 2009 |
| ClinicalTrials.gov Identifier: | NCT00004317 History of Changes |
| Health Authority: | United States: Federal Government |
|
immunologic disorders and infectious disorders rare disease toxoplasmosis |
|
Pyrimethamine Protozoan Infections Vitamin B Complex Rare Diseases Central Nervous System Diseases Leucovorin Trace Elements Toxoplasmosis, Congenital Spiramycin Folic Acid Antagonists Toxoplasmosis |
Folic Acid Anti-Bacterial Agents Antimalarials Calcium, Dietary Central Nervous System Infections Congenital Toxoplasmosis Vitamins Infant, Newborn, Diseases Parasitic Diseases Micronutrients Sulfadiazine |
|
Pyrimethamine Anti-Infective Agents Antiprotozoal Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Leucovorin Spiramycin Central Nervous System Parasitic Infections Anti-Bacterial Agents Antimalarials Antiparasitic Agents Therapeutic Uses Vitamins Infant, Newborn, Diseases Parasitic Diseases |
Micronutrients Coccidiostats Protozoan Infections Vitamin B Complex Coccidiosis Growth Substances Nervous System Diseases Central Nervous System Diseases Enzyme Inhibitors Toxoplasmosis, Congenital Folic Acid Antagonists Toxoplasmosis Pharmacologic Actions Central Nervous System Protozoal Infections Central Nervous System Infections |
