Phase 4 Rare Disease Trial, Recruiting (NCT00004317)

Phase 4 Rare Disease Trial, Recruiting NCT00004317 Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) Condition: Rare Disease

Printed from Voxsanity (voxsanity.com.au) — NCT00004317 — Data sourced from ClinicalTrials.gov. Verify directly with the trial site before attending. Not medical advice.

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Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

Babies diagnosed with congenital toxoplasmosis (an infection called Toxoplasma gondii passed from mother to baby) before they are 2.5 months old
Pregnant women who show signs of toxoplasma infection, confirmed through clinical observation and testing of the fluid surrounding the baby in the womb
Pregnant women who caught this infection during pregnancy and where there is evidence that the baby has also been infected
Older children who have not received treatment for this infection, who may be enrolled as a comparison group
Children with congenital toxoplasmosis who do not currently show any symptoms of the disease, are older than 1 year, received no treatment during their first year of life, and have had no more than 1 month of prior treatment

Who may not be able to join:

Children who have received more than 1 month of treatment for this infection
Children under 1 year of age who are being considered for the untreated control group
Children who received treatment within their first year of life and are being considered for the untreated control group

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.

Last synced 19 July 2026

Phase 4 trials study a drug that has already been approved, monitoring long-term safety and effectiveness in real-world use.

GP referral letter

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Voxsanity

Clinical trials and treatments, explained plainly · voxsanity.com.au

Date:

To: My Doctor

Re: Clinical trial enquiry

I am writing to enquire about the following clinical trial which may be relevant to my care:

Trial: NCT00004317

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

Phase: Phase 4

Status: Recruiting

Condition: Rare Disease

More information: https://clinicaltrials.gov/study/NCT00004317

Eligibility summary (AI generated)

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

Babies diagnosed with congenital toxoplasmosis (an infection called Toxoplasma gondii passed from mother to baby) before they are 2.5 months old
Pregnant women who show signs of toxoplasma infection, confirmed through clinical observation and testing of the fluid surrounding the baby in the womb
Pregnant women who caught this infection during pregnancy and where there is evidence that the baby has also been infected
Older children who have not received treatment for this infection, who may be enrolled as a comparison group
Children with congenital toxoplasmosis who do not currently show any symptoms of the disease, are older than 1 year, received no treatment during their first year of life, and have had no more than 1 month of prior treatment

Who may not be able to join:

Children who have received more than 1 month of treatment for this infection
Children under 1 year of age who are being considered for the untreated control group
Children who received treatment within their first year of life and are being considered for the untreated control group

Important: Always verify eligibility with the trial site directly before applying.

Access in Australia: A treatment being studied in a clinical trial is generally not yet listed on the PBS. Where a medicine is not approved or not available through a trial, the TGA Special Access Scheme may allow a doctor to access unapproved therapeutic goods for individual patients. See voxsanity.com.au/sas-navigator/ for a plain English explainer.

This information was sourced from ClinicalTrials.gov via Voxsanity (data last synced 19 July 2026). It is not medical advice. Please verify the trial's current status directly with the trial site before acting.

Trial details

Status

Recruiting

Phase

Phase 4

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Registry

ClinicalTrials.gov

Start date

1 July 2000

Est. completion

1 December 2030

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Persistent motor abnormality; Vision; Hearing; New chorioretinal lesion; IQ less than 70; Decrease in IQ of greater than or equal to 15 points

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 19 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov