Toxoplasmosis, CongenitalNCT02936921
Lyon Cohort of Maternal and Congenital Toxoplasma Infections
An observational study of Toxoplasmosis, Congenital, run by Hospices Civils de Lyon at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Toxoplasmosis, Congenital
- How many people
- 4,030 participants
- Where
- 1 siteFrance
- Study dates
- Jan 1988to Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- Confirmation in our laboratory of a maternal infection estimated to have occurred during pregnancy or during the 12 weeks preceding conception.
Who cannot join
- maternal :infection that could not be confirmed in our reference laboratory
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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
- Conditions
- Toxoplasmosis, Congenital
- Keywords
- Toxoplasma gondii, Toxoplasmosis, congenital, prenatal, screening, treatment, diagnosis
- Medical subject headings
- Toxoplasmosis, Congenital, Toxoplasmosis, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 37 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2016 (estimated)
- Study startJan 1988
- Primary completionDec 2016 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Toxoplasmosis, CongenitalStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 4,030 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02936921
- Sponsor's protocol ID
- 69HCL16_0569
- Status last verified
- Sep 2016
- First submitted
- 6 Sep 2016
- Last updated
- 18 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02936921
- Acronym / sponsor ID
- 69HCL16_0569
- Conditions
- Toxoplasmosis, Congenital
- Keywords
- Toxoplasma gondii, Toxoplasmosis, congenital, prenatal, screening, treatment, diagnosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 4,030 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- Jan 1988
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 18 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Confirmation in our laboratory of a maternal infection estimated to have occurred during pregnancy or during the 12 weeks preceding conception.
Key exclusion criteria (1 listed)
- maternal :infection that could not be confirmed in our reference laboratory
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2016.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Toxoplasmosis, Congenital, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Martine Wallon, PU PH (4 72 07 18 72 ext. +33, martine.wallon@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Long term ophthalmological outcome of congenital infection (time frame: up to 37 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Oct 2016.