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

NCT02369978 · Status: UNKNOWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 500

Last updated 2017-07-21

No results posted yet for this study

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.

Conditions

  • Chagas Disease

Interventions

DRUG

Nifurtimox

Full dose: 8 mg/Kg/day, assuming an average weight of 60 Kg: 240 mg B.I.D Half-dose: 120 mg B.I.D

DRUG

Benznidazole

Full dose: 5 mg/Kg/day, assuming an average weight of 60 Kg: 150 mg B.I.D Half dose: 75 mg B.I.D

DRUG

Placebo

Two capsules of matching placebo (contaning Magnesium stearate and cellulose) B.I.D

Sponsors & Collaborators

  • Fundación Cardioinfantil Instituto de Cardiología

    collaborator OTHER

  • Instituto Nacional de Salud, Colombia

    collaborator OTHER_GOV

  • Instituto Nacional de Parasitologia Dr. Mario Fatala Chaben

    collaborator OTHER_GOV

  • Universidad Autónoma de Bucaramanga

    lead OTHER

Principal Investigators

  • Juan C Villar, MD, PhD · Universidad Autónoma de Bucaramanga

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-08-31
Primary Completion
2018-08-31
Completion
2019-02-28

Countries

  • Colombia

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02369978 on ClinicalTrials.gov