At a glance
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Etiologic Treatment With Benznidazole in Adult Patients With Chronic Chagas Disease. A Randomized Double Blind Clinical Trial
In Brief
A Phase 3 clinical trial evaluating Benznidazole and Placebo for Chagas Disease. Completed, enrolled 910 participants across 1 site.
Detailed Summary
The purpose of this study is: 1. -to determine whether benznidazole (BZN) will be able to modify the natural evolution of chronic Chagas disease in adult patients by means of a randomized, double-blind clinical trial (RCT). Also: 2. -to validate therapeutic efficacy with new methods, such as recombinant antigen F29 of Trypanosoma cruzi visualized by conventional ELISA, in the context of the RCT compared with conventional serology (CS) 3. -to develop the real-time polymerase chain-reaction (RT-PCR) to quantify the parasite load as an early therapeutic effect. 4. to determine the potential of such serological and parasitological methods as predictors of therapeutic effect or failure.
Study Details
Timeline
Interventions
Benznidazole at a dose 5 mg/Kg/day until 60 days have been completed or development of non-acceptable toxicity-
Placebo at a dose 5 m/Kg/day until 60 days