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NCT00004317 · ClinicalTrials.gov registry record · Phase 4
Pyrimethamine, Sulfadiazine, and Leucovorin in Treating Patients With Congenital Toxoplasmosis
A Phase 4 study of Toxoplasmosis, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Recruiting
- Registry status
- Phase 4
- Development phase
- 600
- Enrollment target
- 1
- Study location
NCT00004317: Recruiting Phase 4 study of Toxoplasmosis, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT00004317 is a Phase 4 study of Toxoplasmosis that is actively recruiting participants, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 600 participants, above the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (16% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00004317, a Phase 4 study of Toxoplasmosis, is actively recruiting participants, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- RECRUITING
- Registry status
- Phase 4
- Development phase
- 600 participants
- Enrollment target
- 1
- Study location
Study 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 Studied
Interventions
- DRUG Leucovorin calcium
- DRUG Pyrimethamine
- DRUG Spiramycin
- DRUG Sulfadiazine
Study Locations (1)
Illinois
- University of Chicago - Chicago
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 600 participants |
| Start Date | 2000-07 |
| Est. Completion | 2030-12 |
| Phase | Phase 4 |
What NCT00004317 shows while recruiting
NCT00004317 is an interventional study that assigns participants to a tested intervention. The registered 600 participants enrollment target is mid-sized for trials with a published cap, above the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (16% higher).
The record links to 1 condition, with Toxoplasmosis appearing as the primary indexed condition, and to 4 interventions - of which Leucovorin calcium is the first listed.
NCT00004317 reports a single indexed study location in Illinois.
Frequently Asked Questions
What is clinical trial NCT00004317 about?
NCT00004317 is a clinical study titled "Pyrimethamine, Sulfadiazine, and Leucovorin in Treating Patients With Congenital Toxoplasmosis". 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...
What is the current status of trial NCT00004317?
This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 600 participants. The study started on 2000-07. Estimated completion is 2030-12.
What conditions does trial NCT00004317 study?
This clinical trial studies the following conditions: Toxoplasmosis.
What interventions are being tested in trial NCT00004317?
The interventions under investigation include: Leucovorin calcium (DRUG), Pyrimethamine (DRUG), Spiramycin (DRUG), Sulfadiazine (DRUG).
Who is sponsoring clinical trial NCT00004317?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00004317 being conducted?
This trial has 1 study location across Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00004317's enrollment target sits among peer trials
600 137th of 2000 higher than 1,855 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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