Study design and procedures
Chagas disease
BLOOD, CHAGAS DISEASE
In a phase 3, randomized, double-blind, parallel-group, historically controlled study (ClinicalTrials.gov NCT02625974), blood samples obtained from children diagnosed with Chagas disease were analyzed using ELISA F29. Blood samples were obtained for ELISA F29 immediately before nifurtimox treatment (baseline), on Days 7 (±1), 30 (±3), and 60 (±3) after the start of treatment and on Months 6 (±7 days), 12 (±7 days), 24 (±6 weeks), 36 (±6 weeks), and 48 (±6 weeks) after end of treatment.Details of the study design and outcomes have been published elsewhere [The design and all aspects of the conduct, evaluation, and documentation of the study conformed with good clinical practice guidelines and the guiding principles of the current version of the Declaration of Helsinki. The study also complied with applicable local law(s) and regulation(s), and all information identifying patients was collected, stored and analyzed in strict confidence and in accordance with local data protection laws.