Lyon Cohort of Maternal and Congenital Toxoplasma Infections

October 14, 2016 updated by: Hospices Civils de Lyon

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

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Anticipated)

4030

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Lyon, France
        • Recruiting
        • Croix Rousse Hospital
        • Contact:
          • Martine Wallon

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Systematic inclusion of all cases of pergravidic Toxoplasma infections identified through the French monthly retesting program and confirmed in our reference center.

Systematic follow up of the outcome of pregnancy and systematic clinical and biological follow up of live born children, until the age of one year at least (to rule congenital toxoplasmosis in or out) or without limit for those who are recognized to have a congenital toxoplasmosis.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Pergravidic maternal infections
proven maternal infections: true seroconversions of profiles of recent infections
Subjects free of congenital infection
children who whom all tests performed before birth, at birth and after birth confirmed the absence of congenital toxoplasmosis.
Congenitally infected subjects
children for whom at least one test performed before birth, at birth or after birth demonstrated a congenital infection.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Long term ophthalmological outcome of congenital infection
Time Frame: up to 37 years

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospices Civils de Lyon

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 1988

Primary Completion (Anticipated)

December 1, 2016

Study Completion (Anticipated)

December 1, 2025

Study Registration Dates

First Submitted

September 6, 2016

First Submitted That Met QC Criteria

October 14, 2016

First Posted (Estimate)

October 18, 2016

Study Record Updates

Last Update Posted (Estimate)

October 18, 2016

Last Update Submitted That Met QC Criteria

October 14, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 69HCL16_0569

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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