Evaluation of compliance to congenital Chagas disease treatment: results of a randomised trial in Bolivia.

BACKGROUND: A randomised, unblinded, clinical trial comparing two benznidazole regimens for congenital Chagas disease was carried out to determine whether simplification and reduction in the length of treatment could lead to better treatment compliance. METHODS: This study was conducted in Santa Cruz, Bolivia. Serological screening was carried out in pregnant women, and parasites were sought in the blood of newborns from seropositive mothers. Infected infants were randomly assigned to two treatment groups. Recovery was assessed by parasite seeking at 1 month and 2 months as well as serological tests at 9 months. Assessment of treatment adherence was based on weekly home visits and use of electronic monitors. RESULTS: Benznidazole was given to 63 newborns in group A (5 mg/kg in two daily doses for 60 days) and 61 newborns in group B (7.5 mg/kg in a single daily dose for 30 days). There was no difference in compliance between the two groups. The study confirmed the efficacy and good tolerance of both benznidazole regimens in the treatment of congenital Chagas disease. CONCLUSIONS: The short treatment should be preferred as it allows reducing the dose of benznidazole as well as the cost of treatment.