Overview

CHICAMOCHA 3 - Equivalence of Usual Interventions for Trypanosomiasis (EQUITY)

Status:
Unknown status
Trial end date:
2019-02-01
Target enrollment:
0
Participant gender:
All
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
Accepts Healthy Volunteers?
No
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
Treatments:
Benzonidazole
Nifurtimox
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