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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 up to 5 years

Awards & highlights

Drug Has Already Been Approved

Approved for 5 Other Conditions

All Individual Drugs Already Approved

Pivotal Trial

No Placebo-Only Group

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.

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.

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 ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

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

Awards & Highlights

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

Approved for 5 Other Conditions

This treatment demonstrated efficacy for 5 other conditions.

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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