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Anti-parasitic

Pyrimethamine + Sulfadiazine + Leucovorin for Congenital Toxoplasmosis

Phase 4

Recruiting

Research Sponsored by National Institute of Allergy and Infectious Diseases (NIAID)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Asymptomatic congenital toxoplasmosis

No treatment within the first year of life

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at pre-specified time points

Awards & highlights

Study Summary

This trial is studying two regimens of pyrimethamine to see which is more effective in treating patients with congenital toxoplasmosis.

Who is the study for?

This trial is for pregnant women with toxoplasma infection confirmed by clinical observation and amniotic fluid tests, infants diagnosed with congenital toxoplasmosis before 2.5 months old, and untreated older children as controls. It excludes those who've had over a month of prior therapy, are older than a year or weren't treated in their first year.Check my eligibility

What is being tested?

The study aims to find the most effective regimen of pyrimethamine when combined with sulfadiazine and leucovorin for treating congenital toxoplasmosis. Participants will be randomly assigned different dosages to determine which works best.See study design

What are the potential side effects?

Potential side effects may include allergic reactions, bone marrow suppression leading to anemia or low white blood cell counts, liver toxicity, nausea, vomiting, rash and potential harm to the fetus if taken during pregnancy.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have toxoplasmosis from birth but no symptoms.

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I did not receive any treatments during my first year of life.

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My infant was diagnosed with congenital toxoplasmosis before 2.5 months old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at pre-specified time points

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at pre-specified time points

This trial's timeline: 3 weeks for screening, Varies for treatment, and at pre-specified time points for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Decrease in IQ of greater than or equal to 15 points

Hearing

IQ less than 70

+3 more

Side effects data

From 2016 Phase 1 & 2 trial • 32 Patients • NCT01083667

44%

Nausea

41%

Headache

19%

Diarrhea

16%

Pain

13%

Upper respiratory infection

weight loss

decreased appetite

Pneumonia

100%

80%

60%

40%

20%

Study treatment Arm

Pyrimethamine

Trial Design

2Treatment groups

Experimental Treatment

Group I: 2Experimental Treatment4 Interventions

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.

Group II: 1Experimental Treatment4 Interventions

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Leucovorin

FDA approved

Pyrimethamine

FDA approved

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Institute of Allergy and Infectious Diseases (NIAID)Lead Sponsor

3,270 Previous Clinical Trials

5,484,637 Total Patients Enrolled

6 Trials studying Toxoplasmosis

951 Patients Enrolled for Toxoplasmosis

University of ChicagoOTHER

1,004 Previous Clinical Trials

819,177 Total Patients Enrolled

Rima McLeodStudy ChairUniversity of Chicago

Media Library

Pyrimethamine (Anti-parasitic) Clinical Trial Eligibility Overview. Trial Name: NCT00004317 — Phase 4

Toxoplasmosis Research Study Groups: 1, 2

Toxoplasmosis Clinical Trial 2023: Pyrimethamine Highlights & Side Effects. Trial Name: NCT00004317 — Phase 4

Pyrimethamine (Anti-parasitic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00004317 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Could you share any other studies that have utilized Pyrimethamine as a part of their research?

"Currently, there are 270 live trials of pyrimethamine in Phase 3 with 86 taking place at the Woolloongabba site. Moreover, there are a total 15 099 clinical trial centres operating studies that involve this drug."

Answered by AI

What is the size of this particular medical experiment?

"Affirmative. Data on clinicaltrials.gov indicate that this experiment is still in the recruitment process, having first been published on July 1st 2000 and last updated on May 13th 2009. The project seeks to find 600 participants at one medical centre."

Answered by AI

What potential risks should be considered when taking Pyrimethamine?

"Due to the fact that this is a Phase 4 trial, which signifies general approval of Pyrimethamine's efficacy and safety, our team at Power gave it a score of 3 on their scale."

Answered by AI

Is enrollment to this trial ongoing?

"Right. According to the information hosted on clinicaltrials.gov, this particular research endeavor is actively recruiting participants since its inception on July 1st 2000 and has been updated as recently as May 13th 2009. 600 patients need to be recruited from a single medical centre for this trial."

Answered by AI