Status:
TERMINATED
Assessment of Two Therapeutic Strategies in the Treatment of Children With Congenital Toxoplasmosis
Lead Sponsor:
Centre Hospitalier Universitaire Dijon
Conditions:
Congenital Toxoplasmosis
Eligibility:
All Genders
3-6 years
Phase:
PHASE3
Brief Summary
Toxoplasmosis is a benign disease in healthy adults, but can be serious in the case of contamination during pregnancy: the parasite can pass through the placental barrier and infect the foetus. The se...
Eligibility Criteria
Inclusion
- Children meeting the following criteria can be included:
- Non-severe congenital toxoplasmosis diagnosed in utero or in the first 3 months of life, whether or not in utero treatment was given
- Treated for 3 months with pyrimethamine combined with sulfamides.
- age from 3 to 6 months (\> 2 months and \< 7 months)
- Diagnostic criteria for congenital toxoplasmosis:
- antenatal period: positive Polymerase Chain Reaction (PCR) on the amniotic fluid or positive mouse inoculation for the amniotic fluid
- postnatal period: presence of specific Immunoglobuline M (IgM) and/or Immunoglobuline A (IgA), positive Western Blot Chemistry (WBC), increase in Immunoglobuline G (IgG).
- Severe congenital toxoplasmosis is defined by the presence at birth of at least one of the following signs: \> or egal 3 cerebral calcifications, hydrocephaly, microcephaly, convulsions, microphtalmy.
- Informed consent must be provided by both parents.
Exclusion
- Children with the following cannot be included:
- a severe form of congenital toxoplasmosis
- inflammatory retinal disease at inclusion or in whom the treatment is contra-indicated (history of hypersensitivity to one of the components, severe renal or hepatic insufficiency, a history of hepatitis linked to treatment with Fansidar®).
Key Trial Info
Start Date :
July 28 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 7 2022
Estimated Enrollment :
302 Patients enrolled
Trial Details
Trial ID
NCT01202500
Start Date
July 28 2010
End Date
April 7 2022
Last Update
February 22 2024
Active Locations (1)
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1
Hôpital d'Enfants Armand Trousseau
Paris, France, 75015