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Lyon Cohort of Maternal and Congenital Toxoplasma Infections

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ClinicalTrials.gov Identifier: NCT02936921
Recruitment Status : Recruiting
First Posted : October 18, 2016
Last Update Posted : October 18, 2016
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

Brief Summary:

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

Condition or disease
Toxoplasmosis, Congenital

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Study Type : Observational
Estimated Enrollment : 4030 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Study Start Date : January 1988
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : December 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Toxoplasmosis

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.



Primary Outcome Measures :
  1. 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.



Biospecimen Retention:   Samples With DNA
samples with and without DNA are analyzed. blood samples taken during pregnancy to confirm maternal infection amniotic fluid analysed with PCR and inoculation to mice blood samples taken after birth for children born from a mother included in the cohort


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02936921


Contacts
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Contact: Martine Wallon, PU PH 4 72 07 18 72 ext +33 martine.wallon@chu-lyon.fr
Contact: François Peyron 4 72 07 18 68 ext +33 francois.peyron@chu-lyon.fr

Locations
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France
Croix Rousse Hospital Recruiting
Lyon, France
Contact: Martine Wallon         
Sponsors and Collaborators
Hospices Civils de Lyon

Additional Information:
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Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT02936921     History of Changes
Other Study ID Numbers: 69HCL16_0569
First Posted: October 18, 2016    Key Record Dates
Last Update Posted: October 18, 2016
Last Verified: September 2016
Keywords provided by Hospices Civils de Lyon:
Toxoplasma gondii
Toxoplasmosis
congenital
prenatal
screening
treatment
diagnosis
Additional relevant MeSH terms:
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Toxoplasmosis
Toxoplasmosis, Congenital
Coccidiosis
Protozoan Infections
Parasitic Diseases
Central Nervous System Protozoal Infections
Central Nervous System Parasitic Infections
Central Nervous System Infections
Central Nervous System Diseases
Nervous System Diseases
Infant, Newborn, Diseases