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New treatment option for Toxoplasmosis
Official title Pyrimethamine, Sulfadiazine, and Leucovorin in Treating Patients With Congenital Toxoplasmosis
ClinicalTrials.gov ID: NCT00004317
What this study is testing
What is Leucovorin calcium?
Leucovorin calcium is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for toxoplasmosis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Adults
You may be able to join if
- 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
See the full eligibility 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
The study team makes the final eligibility decision.
Where it's taking place
- Chicago, Illinois, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, not specified. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chicago, Illinois, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.