CHICAMOCHA 3 - Equivalence of Usual Interventions for Trypanosomiasis (EQUITY) (CHICAMOCHA-3)
Chagas Disease
About this trial
This is an interventional treatment trial for Chagas Disease focused on measuring Trypanocidal therapy, Benznidazole, Nifurtimox, Polymerase chain reaction, Randomized trial
Eligibility Criteria
Inclusion Criteria:
- Positive serology status to Trypanosoma cruzi
- No clinical signs of dilated cardiomyopathy
Exclusion Criteria:
- Unacceptable risk of re-infection, based on the investigators judgment
- Previous treatment with NFX or BZN
- History of peripheral neuropathy
- Health condition limiting the mobility, cognitive function or life expectancy within two years of the enrollment visit
- Pregnancy / Unwilling to use reliable contraceptive methods during childbearing age
Sites / Locations
- Fundación Oftalmológica de Santander - Clínica Ardila Lulle (FOSCAL)Recruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Active Comparator
Placebo Comparator
Nifurtimox (NFX)
Benznidazole (BZN)
Placebo
60 days of active treatment with full-dose, or 120 days of active treatment with half-dose (allocation ratio 1:1). The 60-day group will receive active treatment in the first or second half of a 120-day treatment window, as per random allocation. The active treatment period will be followed/preceded by matching placebo (see placebo arm below)
60 days of active treatment with full-dose, or 120 days of active treatment with half-dose (allocation ratio 1:1). The 60-day group will receive active treatment in the first or second half of a 120-day treatment window, as per random allocation. The active treatment period will be followed/preceded by matching placebo (see placebo arm below)
120 days of treatment with matching placebo