Outcome measures.
cardiomyopathy
CHAGAS, CARDIOMYOPATHY
The primary outcome was the incidence rate of seronegative conversion measured and confirmed by recombinant ELISA (Secondary outcomes investigated included: the incidence rate of seronegative conversion confirmed by recombinant ELISA and IHA in patients who were randomized and received at least one dose of nifurtimox in the 30-day treatment regimen; the proportion of responders who showed seronegative conversion by two types of assay and no evidence of established Chagas disease-related cardiomyopathy measured by ECG; and seroreduction (as reduction of ELISA OD) measured by recombinant ELISA and total purified antigen ELISA.Exploratory analyses performed included the incidence rate of seroconversion by age at randomization according to the following age groups: ≤2 years, 3 to ≤6 years, 7 to ≤12 years, and 13 to <18 years.Safety evaluations included the occurrence of AEs considered possibly related to nifurtimox treatment, AEs caused by protocol-required procedures, physical examination abnormalities, cardiac assessment by 12-lead ECG, and assessment of vital signs.