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

Study Status: Recruiting
Recruit Status: Unknown status
Study Type: Interventional

Official Title: Multicentre, Randomised Study to Determine the Relative Efficacy of Two Therapeutic Strategies in the Treatment of Children With Congenital Toxoplasmosis

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.

Detailed Summary:
Sponsor: Centre Hospitalier Universitaire Dijon

Current Primary Outcome: 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®.


Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Centre Hospitalier Universitaire Dijon

Dates:
Date Received: September 15, 2010
Date Started: July 2010
Date Completion: September 2016
Last Updated: June 2, 2014
Last Verified: September 2010