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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 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. The trial reports 1 study location across 1 state.

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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

FieldValue
Enrollment Target 600 participants
Start Date 2000-07
Est. Completion 2030-12
Phase Phase 4

What the Registry Record Tells You About NCT00004317

The ClinicalTrials.gov registry entry for NCT00004317 describes a study currently listed as recruiting, categorized as Phase 4. The registered enrollment target is 600 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total studies on file at ClinicalTrials.gov.

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 1 study location spanning 1 distinct geographic area - top geographies include 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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.