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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2010 by Centre Hospitalier Universitaire Dijon
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire Dijon
ClinicalTrials.gov Identifier:
NCT01202500
First received: September 15, 2010
Last updated: June 2, 2014
Last verified: September 2010
  Purpose

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.


Condition Intervention Phase
Congenital Toxoplasmosis
Procedure: reducing treatment to 3 months
Procedure: registered length of treatment
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Multicentre, Randomised Study to Determine the Relative Efficacy of Two Therapeutic Strategies in the Treatment of Children With Congenital Toxoplasmosis

Resource links provided by NLM:


Further study details as provided by Centre Hospitalier Universitaire Dijon:

Primary Outcome Measures:
  • episode of retinochoroiditis [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Time to the onset of a first episode of retinochoroiditis in the two years of the study (or the onset of a new episode in a child known to already have had at least one lesion), evaluated on a fundus examination using RetCam®.


Estimated Enrollment: 486
Study Start Date: July 2010
Estimated Study Completion Date: September 2016
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
12 months Procedure: registered length of treatment
The treatment procedure will follow the actual recommandation
Experimental: 3 months Procedure: reducing treatment to 3 months
The treatment will be stopped after 3 months

  Eligibility

Ages Eligible for Study:   3 Months to 6 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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®).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01202500

Contacts
Contact: Valérie JAVERLIAC 04 27 85 77 24 ext 33 valerie.javerliac@chu-lyon.fr

Locations
France
Hôpital d'Enfants Armand Trousseau Recruiting
Paris, France, 75015
Contact: François KIEFFER, MD    01 44 73 61 91 ext 33    francois.kieffer@trs.aphp.fr   
Principal Investigator: François KIEFFER, MD         
Sponsors and Collaborators
Centre Hospitalier Universitaire Dijon
Investigators
Study Director: Christine BINQUET, MD CHU Dijon
  More Information

No publications provided

Responsible Party: Centre Hospitalier Universitaire Dijon
ClinicalTrials.gov Identifier: NCT01202500     History of Changes
Other Study ID Numbers: 2009-016528-30
Study First Received: September 15, 2010
Last Updated: June 2, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on September 18, 2014