Congenital ToxoplasmosisTOXODIAGNCT03385499
New Diagnostic Approach for Congenital Toxoplasmosis
A study testing blood additional samples in people with Congenital Toxoplasmosis, run by Assistance Publique - Hôpitaux de Paris at 3 sites in France.
Trial summary
Caused by Toxoplasma gondii, toxoplasmosis is mostly asymptomatic except in immunocompromised individuals and infants infected in utero. Congenital toxoplasmosis (CT) results from the transplacental passage of the parasite, which occurs in 30% of cases of primary infection during pregnancy. Read more about this study
- Who is it for?
- Ages 18 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Congenital Toxoplasmosis
- What is being tested?
- blood additional samples
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 3 sitesFrance
- Study dates
- 20 Jun 2018to 25 Dec 2024
- Phase
- Interventional
- 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 18 to 55 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- In all cases, pregnant women whose age ≥ 18 years are concerned.
- Seroconversion group: a diagnosis of toxoplasmic seroconversion will be documented by a negative serology in early pregnancy which becomes positive during pregnancy, with the synthesis of specific IgG;
- Positive control group: known and documented positive toxoplasmosis serology;
- Negative control group: known and documented negative serology for toxoplasmosis at 7 months of pregnancy.
Who cannot join
- Non-inclusion criteria common to the three groups
- Expected delivery in another maternity that does not participate in the study;
- Positive serology for HIV;
- Contra-indication to additional tubes during the blood sampling corresponding to the usual follow-up of pregnancy (anemia, all other case according to the evaluation of the clinician in charge of the follow-up);
- Absence of social insurance or CMU or AME;
- Vulnerable pregnant woman (under guardianship or curatorship);
- No signature of consent to participate in research.
Trial locations and contacts
3 sites in 1 country.
France3 sites
Hopital Louis Mourier
Colombes, 92700
Hopital Bichat
Paris
Hopital Cochin
Paris
About this study
Official title: TOXODIAG: New Diagnostic Approach for Congenital Toxoplasmosis
Caused by Toxoplasma gondii, toxoplasmosis is mostly asymptomatic except in immunocompromised individuals and infants infected in utero. Congenital toxoplasmosis (CT) results from the transplacental passage of the parasite, which occurs in 30% of cases of primary infection during pregnancy. Neonatal biological diagnosis of toxoplasmosis is essential in the case of (i) suggestive clinical signs in the newborn with no information on the serological status of the mother, (ii) seroconversion diagnosed during pregnancy, (iii) not or poorly followed pregnancy, and (iiii) for enhanced effectiveness of treatments administered as soon as possible to the newborn. Given the limitations of current diagnostic tests, the characterization of specific immunoglobulin (Ig)G neo-synthesized by the newborn would be of great help for an early diagnosis of CT.
The main objective of the TOXODIAG project is to validate and evaluate the ELISPOT (Enzyme-Linked Immunosorbent SPOT assay) method for detecting, in the newborn, B lymphocytes (LyB) sensitized in utero to produce T. gondii specific immunoglobulins (Ig) following a primary infection of the mother during the pregnancy. More precisely, the detection and quantification of LyB secreting IgG and IgM specific for T. gondii using the ELISPOT method will be applied i) to mononuclear cells of women in seroconversion following a toxoplasmic primo-infection during pregnancy and ii) to cord blood mononuclear cells of newborns suspected of CT, in comparison to positive and negative infection controls.
To reach this goal, TOXODIAG is a diagnostic, multicentric, prospective, non-randomized, comparative and controlled study. It will be performed in 3 parallel groups of pregnant women performing prenatal follow-up and giving birth in the maternity wards of 3 hospitals of the AP-HP (Louis MOURIER, Bichat-Claude Bernard and Cochin) which ensure mother/child follow-up and biological sampling, with great gynecology and obstetrics expertise. Sixty women will be selected and included into 3 groups according to toxoplasmic seroconversion during pregnancy (n=30), positive (n=15) or negative (n=15) toxoplasma serology. The necessary biological material will consist in additional blood tubes which will be taken at the same time as those performed for the usual pregnancy follow-up examinations and will correspond to maternal peripheral blood at inclusion, seroconversion and delivery as well as cord blood.
Read the detailed description
Toxoplasmosis is a cosmopolitan parasitosis that affects one third of the world's population. This infection, caused by Toxoplasma gondii, is mostly asymptomatic except in immunocompromised individuals and infants infected in utero. Congenital toxoplasmosis (CT) results from the transplacental passage of the parasite, which occurs in 30% of cases of primary infection during pregnancy. The clinical consequences are all the more serious when fetal contamination is early (death in utero, premature delivery or term childbirth with perivisceral involvement) and result in mainly neuro-ocular attacks in case of later contamination. Pregnant women or women of childbearing age therefore constitute a group at risk and are exposed differently according to their geographical situation and food consumption. Neonatal biological diagnosis of toxoplasmosis is essential in the case of (i) suggestive clinical signs in the newborn with no information on the serological status of the mother, (ii) seroconversion diagnosed during pregnancy, (iii) not or poorly followed pregnancy, and (iiii) for enhanced effectiveness of treatments administered as soon as possible to the newborn. This diagnosis is based mainly on parasite research in the neonatal amniotic fluid or placenta by PCR and / or inoculation in mice, as well as on serological tests. Immunoglobulins (Ig) A and IgM do not cross the placental barrier and represent good markers of congenital infection in the newborn. Nevertheless, they are not specific to an acute infection and are no longer detectable at birth in cases of infections contracted by the mother before the 3rd trimester of pregnancy. The detection of IgG synthesized by the child has a diagnostic value only after 6 months of life, once the materno-transmitted IgG have been eliminated, and the techniques comparing the IgG response profiles of the mother and the child to a plurality of toxoplasmic antigens remain difficult to interpret (western blot, ELIFA). It is nevertheless a combination of these different tests that makes up the decision tree for a neonatal biological diagnosis of CT. The characterization of specific IgG neo-synthesized by the newborn would be of great help for an early diagnosis of congenital infection by T. gondii. The present project consists in determining the presence in the neonate of B lymphocytes (LyB) sensitized in utero to produce specific IgG in case of CT. This approach can be envisaged because of the maturity acquired by the fetal LyB from the end of the first trimester of pregnancy, demonstrated by their ability to produce high affinity Ig in the case of maternal infection or neonatal immunization.
This research is diagnostic, multicentric, prospective, non-randomized, comparative and controlled. It will be performed in 3 parallel groups of pregnant women performing prenatal follow-up and giving birth in the maternity wards of 3 hospitals of the AP-HP which ensure mother/child follow-up and biological sampling, with great gynecology and obstetrics expertise. Sixty patients will be selected and included according to the following distribution:
- Positive control group (women with positive toxoplasma serology): 15 patients;
- Negative control group (women with negative toxoplasma serology): 15 patients;
- Group of women diagnosed with toxoplasmic seroconversion during pregnancy: 30 patients.
Non-recruiting centers will be HUPC and HUPNVS biology laboratories for the realization of serological tests and expertise in biological diagnosis and IRD UMR 216 for coordination, laboratory experiments and expertise in immunology.
- Conditions
- Congenital Toxoplasmosis
- Being tested
- blood additional samples
- Keywords
- Congenital toxoplasmosis, Neonatal biological diagnosis of congenital toxoplasmosis, neonatal diagnosis, ELISPOT, IgG
- Medical subject headings
- Toxoplasmosis, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood additional samplesBiological
additional samples of mother's blood and umbilical cord at delivery
| Study group | Role | What they receive |
|---|---|---|
| negative control group | Other | blood additional samples on negative control group Receives: Biological: blood additional samples |
| positive control group | Other | blood additional samples on positive control group Receives: Biological: blood additional samples |
| seroconversion group | Other | blood additional samples on seroconversion group Receives: Biological: blood additional samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection/quantification of T. gondii IgG and IgM secreting LyB by ELISPOT on cord blood mononuclear cells (MNC) of newborns suspected of congenital toxoplasmosis.
Umbilical cord blood will be collected at birth. A circuit is put in place to ensure a transfer to the research lab in order to assess the MNC isolation under 24 hours after blood drawing. Isolated MNC are thereafter frozen at -80°C until realization of the ELISPOT assay, using the adaptation of the test as validated under the Secondary Outcome Measures 1, 4 and 5 (test duration; multiple Ig detection; impact of the type of T. gondii capture antigen).
Measured: 6 months
Secondary outcomes (6)
Detection/quantification of T. gondii IgG and IgM secreting LyB by ELISPOT on mononuclear cells (MNC) of pregnant women with toxoplasma primary infection.
Peripheral blood will be collected in the maternities of the study. Isolated MNC will be frozen at -80°C until realization of the ELISPOT assay, with a focus on two main adjustments: lowering form 7 to 2 the number of days of duration of the test; simultaneous detection of IgM and IgG.
Measured: 6 months
Comparison of the number of T. gondii IgG and IgM secreting LyB revealed by ELISPOT between the three groups of mothers at delivery: positive control group, negative control group and seroconversion group.
Peripheral blood will be collected in the maternities of the study. Isolated MNC will be frozen at -80°C until realization of the ELISPOT assay, with expected results according to the T. gondii serological status at delivery.
Measured: 6 months
Comparison of the number of T. gondii IgG and IgM secreting LyB revealed by ELISPOT in mothers at time of the seroconversion biological diagnosis and at delivery.
Peripheral blood will be collected in the maternities of the study. Isolated MNC will be frozen at -80°C until realization of the ELISPOT assay, with an evaluation of the kinetics of anti-T. gondii IgM and IgG secreting cells.
Measured: 6 months
Comparison of the number of specific IgG and IgM secreting LyB revealed by ELISPOT in T. gondii primary infected-mothers at their delivery and in their newborns.
Maternal peripheral blood as well as cord blood will be collected in the maternities of the study. Isolated MNC will be frozen at -80°C until realization of the ELISPOT assay, with an evaluation of the maturity of the infant's immune system. This will be done by comparing the patterns of the LyB cell spots of a mother and her infant, with indication on both affinity and avidity.
Measured: 6 months
Comparison of the number of T. gondii IgG and IgM secreting LyB revealed by ELISPOT performed using either T. gondii type I or type II as capture antigen.
Demonstration of ubiquity of the ELISPOT assay applied to T. gondii IgM and IgG detection: ubiquity will be demonstrated if numbers of secreting B cells are not different.
Measured: 6 months
Comparison of the diversity of LyB cell populations between groups of women (toxoplasma infected or not during pregnancy) and infants (suspected of toxoplasma congenital infection or not).
Molecular study using the Ig spectratyping technique, in order to investigate the Ig variable region specialized in antigen recognition : it will allow to highlight the LyB populations which have been sensitized by T. gondii.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2017
- Study start20 Jun 2018
- Primary completion25 Dec 2023
- Study completion25 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital ToxoplasmosisStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Florence Migot Nabias, PhD, Principal investigator, university Paris Descarte
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03385499
- Sponsor's protocol ID
- 2017-A02208-45
- Acronym
- TOXODIAG
- Status last verified
- Jul 2026
- First submitted
- 3 Nov 2017
- Last updated
- 11 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TOXODIAG: New Diagnostic Approach for Congenital Toxoplasmosis
- ClinicalTrials.gov ID
- NCT03385499
- Acronym / sponsor ID
- TOXODIAG / 2017-A02208-45
- Conditions
- Congenital Toxoplasmosis
- Keywords
- Congenital toxoplasmosis, Neonatal biological diagnosis of congenital toxoplasmosis, neonatal diagnosis, ELISPOT, IgG
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 20 Jun 2018 (actual)
- Primary completion
- 25 Dec 2023 (actual)
- Study completion
- 25 Dec 2024 (actual)
- First posted
- 28 Dec 2017 (actual)
- 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.
Caused by Toxoplasma gondii, toxoplasmosis is mostly asymptomatic except in immunocompromised individuals and infants infected in utero. Congenital toxoplasmosis (CT) results from the transplacental passage of the parasite, which occurs in 30% of cases of primary infection during pregnancy. Neonatal biological diagnosis of toxoplasmosis is essential in the case of (i) suggestive clinical signs in the newborn with no information on the serological status of the mother, (ii) seroconversion diagnosed during pregnancy, (iii) not or poorly followed pregnancy, and (iiii) for enhanced effectiveness of treatments administered as soon as possible to the newborn. Given the limitations of current diagnostic tests, the characterization of specific immunoglobulin (Ig)G neo-synthesized by the newborn would be of great help for an early diagnosis of CT.
The main objective of the TOXODIAG project is to validate and evaluate the ELISPOT (Enzyme-Linked Immunosorbent SPOT assay) method for detecting, in the newborn, B lymphocytes (LyB) sensitized in utero to produce T. gondii specific immunoglobulins (Ig) following a primary infection of the mother during the pregnancy. More precisely, the detection and quantification of LyB secreting IgG and IgM specific for T. gondii using the ELISPOT method will be applied i) to mononuclear cells of women in seroconversion following a toxoplasmic primo-infection during pregnancy and ii) to cord blood mononuclear cells of newborns suspected of CT, in comparison to positive and negative infection controls.
To reach this goal, TOXODIAG is a diagnostic, multicentric, prospective, non-randomized, comparative and controlled study. It will be performed in 3 parallel groups of pregnant women performing prenatal follow-up and giving birth in the maternity wards of 3 hospitals of the AP-HP (Louis MOURIER, Bichat-Claude Bernard and Cochin) which ensure mother/child follow-up and biological sampling, with great gynecology and obstetrics expertise. Sixty women will be selected and included into 3 groups according to toxoplasmic seroconversion during pregnancy (n=30), positive (n=15) or negative (n=15) toxoplasma serology. The necessary biological material will consist in additional blood tubes which will be taken at the same time as those performed for the usual pregnancy follow-up examinations and will correspond to maternal peripheral blood at inclusion, seroconversion and delivery as well as cord blood.
Detailed description
Toxoplasmosis is a cosmopolitan parasitosis that affects one third of the world's population. This infection, caused by Toxoplasma gondii, is mostly asymptomatic except in immunocompromised individuals and infants infected in utero. Congenital toxoplasmosis (CT) results from the transplacental passage of the parasite, which occurs in 30% of cases of primary infection during pregnancy. The clinical consequences are all the more serious when fetal contamination is early (death in utero, premature delivery or term childbirth with perivisceral involvement) and result in mainly neuro-ocular attacks in case of later contamination. Pregnant women or women of childbearing age therefore constitute a group at risk and are exposed differently according to their geographical situation and food consumption. Neonatal biological diagnosis of toxoplasmosis is essential in the case of (i) suggestive clinical signs in the newborn with no information on the serological status of the mother, (ii) seroconversion diagnosed during pregnancy, (iii) not or poorly followed pregnancy, and (iiii) for enhanced effectiveness of treatments administered as soon as possible to the newborn. This diagnosis is based mainly on parasite research in the neonatal amniotic fluid or placenta by PCR and / or inoculation in mice, as well as on serological tests. Immunoglobulins (Ig) A and IgM do not cross the placental barrier and represent good markers of congenital infection in the newborn. Nevertheless, they are not specific to an acute infection and are no longer detectable at birth in cases of infections contracted by the mother before the 3rd trimester of pregnancy. The detection of IgG synthesized by the child has a diagnostic value only after 6 months of life, once the materno-transmitted IgG have been eliminated, and the techniques comparing the IgG response profiles of the mother and the child to a plurality of toxoplasmic antigens remain difficult to interpret (western blot, ELIFA). It is nevertheless a combination of these different tests that makes up the decision tree for a neonatal biological diagnosis of CT. The characterization of specific IgG neo-synthesized by the newborn would be of great help for an early diagnosis of congenital infection by T. gondii. The present project consists in determining the presence in the neonate of B lymphocytes (LyB) sensitized in utero to produce specific IgG in case of CT. This approach can be envisaged because of the maturity acquired by the fetal LyB from the end of the first trimester of pregnancy, demonstrated by their ability to produce high affinity Ig in the case of maternal infection or neonatal immunization.
This research is diagnostic, multicentric, prospective, non-randomized, comparative and controlled. It will be performed in 3 parallel groups of pregnant women performing prenatal follow-up and giving birth in the maternity wards of 3 hospitals of the AP-HP which ensure mother/child follow-up and biological sampling, with great gynecology and obstetrics expertise. Sixty patients will be selected and included according to the following distribution:
- Positive control group (women with positive toxoplasma serology): 15 patients;
- Negative control group (women with negative toxoplasma serology): 15 patients;
- Group of women diagnosed with toxoplasmic seroconversion during pregnancy: 30 patients.
Non-recruiting centers will be HUPC and HUPNVS biology laboratories for the realization of serological tests and expertise in biological diagnosis and IRD UMR 216 for coordination, laboratory experiments and expertise in immunology.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| negative control group | Other | Biological: blood additional samplesblood additional samples on negative control group |
| positive control group | Other | Biological: blood additional samplesblood additional samples on positive control group |
| seroconversion group | Other | Biological: blood additional samplesblood additional samples on seroconversion group |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- In all cases, pregnant women whose age ≥ 18 years are concerned.
- Seroconversion group: a diagnosis of toxoplasmic seroconversion will be documented by a negative serology in early pregnancy which becomes positive during pregnancy, with the synthesis of specific IgG;
- Positive control group: known and documented positive toxoplasmosis serology;
- Negative control group: known and documented negative serology for toxoplasmosis at 7 months of pregnancy.
Key exclusion criteria (7 listed)
- Non-inclusion criteria common to the three groups
- Expected delivery in another maternity that does not participate in the study;
- Positive serology for HIV;
- Contra-indication to additional tubes during the blood sampling corresponding to the usual follow-up of pregnancy (anemia, all other case according to the evaluation of the clinician in charge of the follow-up);
- Absence of social insurance or CMU or AME;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| blood additional samplesadditional samples of mother's blood and umbilical cord at delivery | Biological | negative control group, positive control group, seroconversion group |
Primary outcome
Detection/quantification of T. gondii IgG and IgM secreting LyB by ELISPOT on cord blood mononuclear cells (MNC) of newborns suspected of congenital toxoplasmosis.
Time frame: 6 months
Umbilical cord blood will be collected at birth. A circuit is put in place to ensure a transfer to the research lab in order to assess the MNC isolation under 24 hours after blood drawing. Isolated MNC are thereafter frozen at -80°C until realization of the ELISPOT assay, using the adaptation of the test as validated under the Secondary Outcome Measures 1, 4 and 5 (test duration; multiple Ig detection; impact of the type of T. gondii capture antigen).
6 secondary outcomes
Detection/quantification of T. gondii IgG and IgM secreting LyB by ELISPOT on mononuclear cells (MNC) of pregnant women with toxoplasma primary infection.
Time frame: 6 months
Comparison of the number of T. gondii IgG and IgM secreting LyB revealed by ELISPOT between the three groups of mothers at delivery: positive control group, negative control group and seroconversion group.
Time frame: 6 months
Comparison of the number of T. gondii IgG and IgM secreting LyB revealed by ELISPOT in mothers at time of the seroconversion biological diagnosis and at delivery.
Time frame: 6 months
Comparison of the number of specific IgG and IgM secreting LyB revealed by ELISPOT in T. gondii primary infected-mothers at their delivery and in their newborns.
Time frame: 6 months
Comparison of the number of T. gondii IgG and IgM secreting LyB revealed by ELISPOT performed using either T. gondii type I or type II as capture antigen.
Time frame: 6 months
Comparison of the diversity of LyB cell populations between groups of women (toxoplasma infected or not during pregnancy) and infants (suspected of toxoplasma congenital infection or not).
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Congenital Toxoplasmosis
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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.
Florence Migot Nabias, PhD principal investigator
university Paris Descarte
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing blood additional samples in people with Congenital Toxoplasmosis, run by Assistance Publique - Hôpitaux de Paris at 3 sites 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 4 inclusion and 7 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: finished, as of the sponsor's last update on 11 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detection/quantification of T. gondii IgG and IgM secreting LyB by ELISPOT on cord blood mononuclear cells (MNC) of newborns suspected of congenital toxoplasmosis. (time frame: 6 months). 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 11 Aug 2026.