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

Study Description

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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.

Condition or disease	Intervention/treatment	Phase
Congenital Toxoplasmosis	Procedure: reducing treatment to 3 months; Procedure: registered length of treatment	Phase 3

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	486 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (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
Study Start Date :	July 2010
Actual Primary Completion Date :	July 2010
Estimated Study Completion Date :	September 2016

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
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

Outcome Measures

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Primary Outcome Measures :

1. episode of retinochoroiditis [ Time Frame: 2 years ]
   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®.

Eligibility Criteria

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Ages Eligible for Study:	3 Months to 6 Months (Child)
Sexes Eligible for Study:	All
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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Centre Hospitalier Universitaire Dijon
ClinicalTrials.gov Identifier:	NCT01202500 History of Changes
Other Study ID Numbers:	2009-016528-30
First Posted:	September 16, 2010
Last Update Posted:	June 3, 2014
Last Verified:	September 2010

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