NCT00004317 · National Institute of Allergy and Infectious Diseases (NIAID)
Pyrimethamine, Sulfadiazine, and Leucovorin in Treating Patients With Congenital Toxoplasmosis
What this study is about
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.
View original scientific description
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.
Interventions
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
Primary outcome measures
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
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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
Where
- Chicago, Illinois
Collaborators
University of Chicago
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 14, 2009 · Source of record for eligibility and locations