Assessment of Two Therapeutic Strategies in the Treatment of Children With Congenital Toxoplasmosis

NCT ID: NCT01202500

Last Updated: 2024-02-22

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 302 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-07-28
• Study Completion Date: 2022-04-07

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 severity of congenital infection varies, but in France, where maternal seroconversions during pregnancy are treated, the manifestations of the disease are often infraclinical at birth and only appear during the first years of life in the form of retinochoroiditis. In order to prevent long-term sequellae, children with confirmed congenital toxoplasmosis (TC) are treated with pyrimethamine combined with either sulfadiazine or sulfadoxine (Fansidar®). The relative efficacy of these two combinations has not yet been evaluated. Moreover, there is no consensus about the duration of the treatment, which varies, in France, from 12 to 24 months depending on the centre. Compared with the duration of parasitaemia in non-treated children, which can persist for up to 4 weeks, these treatments are very long. They are also far longer than the 3 months of treatment, which is in accordance with the World Health Organization (WHO) recommendations, given in Denmark to infants identified as being infected with the parasite during neonatal screening. A one-year treatment was developed in the United States, but it mainly concerns only symptomatic children, given the absence of generalised screening in the United States of America (USA). We have no arguments to justify the use of treatments lasting one year or more in children with asymptomatic or mildly-symptomatic TC. As these treatments carry certain risks, which may be severe, notably with regard to haematological or skin conditions, they have to be supervised closely with biological tests, which adds further constraints for both the children and their parents and increases the cost to health care systems.

Conditions

Congenital Toxoplasmosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

12 months

Group Type: OTHER

registered length of treatment

Intervention Type: PROCEDURE

The treatment procedure will follow the actual recommandation

3 months

Group Type: EXPERIMENTAL

reducing treatment to 3 months

Intervention Type: PROCEDURE

The treatment will be stopped after 3 months

Interventions

reducing treatment to 3 months

The treatment will be stopped after 3 months

Intervention Type: PROCEDURE

registered length of treatment

The treatment procedure will follow the actual recommandation

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

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 Criteria

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®).

• Minimum Eligible Age: 3 Months
• Maximum Eligible Age: 6 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire Dijon

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Christine BINQUET, MD

Role: STUDY_DIRECTOR

CHU Dijon

Locations

Hôpital d'Enfants Armand Trousseau

Paris, , France

Countries

France

Other Identifiers

2009-016528-30

Identifier Type: -

Identifier Source: org_study_id