CHICAMOCHA 3 - Equivalence of Usual Interventions for Trypanosomiasis (EQUITY)
Status:
Unknown status
Trial end date:
2019-02-01
Target enrollment:
Participant gender:
Summary
This randomized, blind, parallel-group trial will evaluate the efficacy and safety of
Nifurtimox (NFX) and Benznidazole (BZN), the two usual interventions to treat the parasite
Trypanosoma cruzi.
The investigators will test whether NFX is an effective trypanocidal agent (by comparison
with placebo) and equivalent to BZN (as active comparator) in terms of both parasite-related
and safety outcomes.
Individuals found seropositive and without clinical signs of dilated cardiomyopathy will
receive either of the active treatments or matching placebo. Participants allocated to NFX or
BZN will receive either a 60-day (full-dose) or a 120-day (half-dose) active treatment,
whereas the control group will receive placebo for 120 days. There will be thus four arms of
active treatment (NFX60, NFX120, BZN60 and BZN120), and a fifth control arm receiving placebo
(1:1:1:1:1 allocation ratio) where every participant in the trial will take 120 days of study
drug (the groups receiving full-dose will complete a 120-day masked treatment with placebo).
The study plans to enroll 500 participants from Colombia (in two different geographical
areas) and Argentina, in order to explore regional differences in the treatment effects.
Phase:
Phase 2/Phase 3
Details
Lead Sponsor:
Universidad Autónoma de Bucaramanga
Collaborators:
Fundación Cardioinfantil Instituto de Cardiología Instituto Nacional de Parasitologia Dr. Mario Fatala Chaben Instituto Nacional de Salud (Colombia) Instituto Nacional de Salud, Colombia