Assessment of Two Therapeutic Strategies in the Treatment of Children With Congenital Toxoplasmosis (TOSCANE)
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ClinicalTrials.gov Identifier: NCT01202500 |
Recruitment Status
: Unknown
Verified September 2010 by Centre Hospitalier Universitaire Dijon.
Recruitment status was: Recruiting
First Posted
: September 16, 2010
Last Update Posted
: June 3, 2014
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Congenital Toxoplasmosis | Procedure: reducing treatment to 3 months Procedure: registered length of treatment | Phase 3 |
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 |

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
|
- 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®.

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Ages Eligible for Study: | 3 Months to 6 Months (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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®).

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01202500
Contact: Valérie JAVERLIAC | 04 27 85 77 24 ext 33 | valerie.javerliac@chu-lyon.fr |
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 |
Study Director: | Christine BINQUET, MD | CHU Dijon |
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 Key Record Dates |
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 |