“TRAENA” TRAtamiento EN pacientes Adultos. A preliminary evaluation from a randomized clinical trial with Benznidazole in Chagas disease chronicle

BACKGROUND: The objective of TRAENA was to determine whether a parasiticide drug such as Benznidazole (Bz) was capable of modifying the natural history of chronic Chagas disease (CHD) in adult patients. METHODS: A double-blind randomized clinical trial (RCT) was conducted in Phase III. The patients were selected from the urban population of the capital city and the province of Buenos Aires. Their clinical stage was characterized by medical evaluation, chest radiology, and electrocardiogram (Kuschnir). The sample was estimated at 750 with a power of 80% and an α error of 0.05; patients were randomized to Bz or Placebo (Pl); The administration dose was 5 mg/kg/d for 60 d. The post-treatment evolution (p.t) was performed by ELISA F29, conventional ELISA (ELISAc) and real-time PCR (qPCR). RESULTS: TRAENA was developed from May 1999 to March 2010. The serological and parasitological data refer to all patients, without discriminating their assignment to Bz or Pl since the RCT remains “blind”. The F29 ELISA detected serological negativization in 23.3% while the cELISA did so in 22.5% of the adult population. The qPCR was positive in 84.3% at time 0, while at 8-16 months p.t. It was 37.41% and at 8--11 years p.t. in 27.19% of the population. CONCLUSIONS: T.cruzi F29 antigen and qPCR appear to be early predictors of the impact of Bz treatment