Toxoplasmosis, Congenital Clinical Trial
Official title:
Lyon Clinical Research Program on Maternal and Congenital Toxoplasmosis Based on the Toxo-Ly Cohort: Risks and Clinical Consequences, Prevention, Diagnosis and Treatment
Several decades ago, France has made the choice to implement a national prevention program
for congenital toxoplasmosis. The identification in their first trimester of pregnancy of
all pregnant women who are susceptible to Toxoplasma infection has been mandatory since
1985. In 1992, the decision was made to extent the program to the monthly retesting of all
women identified as not immune, in an attempt to reduce the number of severely infected
children.
The systematic detection of all maternal and congenital infections has generated many
questions from clinicians, biologists, parents and older patients, on the short and
long-term prognosis of congenital toxoplasmosis, on the best tests to use to diagnose
infections in mothers and children, on the efficacy of existing treatments, and on how to
manage patients in the long-term.
The need to answer these many questions has prompted the medical team working within the
laboratory and the outpatient department of the Parasitology Department at the Croix-Rousse
Hospital in Lyon to implement a clinical research program. It is based on the systematic
inclusion in our cohort of all pregnant women whose infection is confirmed, on their follow
up, in order to monitor the outcome of pregnancy 2) and on the follow up of their children
in order to confirm their infection or to rule it out. All congenitally infected subjects
undergo clinical examinations, serological tests and ocular examination at least once a year
without age limit.
The following data are prospectively collected in a dedicated database: gestational age at
maternal infection and corresponding serological profile; type and dates of maternal
treatment; findings of ultrasound tests and amniotic fluid analysis; serological and
clinical findings at birth; types and dates of postnatal treatment; postnatal serological
profiles; infection status at one year of age; long term clinical (ophthalmologic) et
serological findings.
These data have allowed producing original findings on the risk of maternal-foetal
transmission according to gestational age at maternal infection, on the long term
ophthalmological outcome of congenital toxoplasmosis and to offer guidelines for the
diagnosis, treatment and follow-up of maternal and congenital infections.
These efforts are still to be maintained in the future in order
- to further analyse the impact of puberty, pregnancy, or adult co-morbidities on the
risk of ophthalmological events
- to increase precision around our risk estimates for materno-foetal transmission,
- to continue innovating in terms of diagnostic strategy to improve tests performances
and reduce costs
- to explore new potential clinical outcomes such as neuropsychiatric disorders
associated with congenital and postnatal infection
- to determine if infections due to oocysts could have different clinical outcomes than
those due to the ingestion of cysts
- to assess the efficacy of treatments for maternal and congenital infections
| Status | Recruiting |
| Enrollment | 4030 |
| Est. completion date | December 2025 |
| Est. primary completion date | December 2016 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | N/A and older |
| Eligibility |
Inclusion Criteria: - Confirmation in our laboratory of a maternal infection estimated to have occurred during pregnancy or during the 12 weeks preceding conception. Exclusion Criteria: - maternal :infection that could not be confirmed in our reference laboratory |
Observational Model: Cohort, Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| France | Croix Rousse Hospital | Lyon |
| Lead Sponsor | Collaborator |
|---|---|
| Hospices Civils de Lyon |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Long term ophthalmological outcome of congenital infection | eye examinations are prospectively performed to detect lesions of retinochoroiditis or additional ocular lesions every three to six months in younger children and at least annually afterwards. A standardized form is used to report findings. Clinical examinations are performed at the same frequency. |
up to 37 years | No |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Not yet recruiting |
NCT04825600 -
Diagnosis of Toxoplasma Gondii Infection by Exploration of Cellular Immunity (TOXCELL)
|
N/A |