NCT02369978

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Aug 2015

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 17, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 24, 2015

Completed
5 months until next milestone

Study Start

First participant enrolled

August 1, 2015

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2018

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2019

Completed
Last Updated

July 21, 2017

Status Verified

July 1, 2017

Enrollment Period

3 years

First QC Date

February 17, 2015

Last Update Submit

July 18, 2017

Conditions

Chagas Disease

Keywords

Trypanocidal therapyBenznidazoleNifurtimoxPolymerase chain reactionRandomized trial

Outcome Measures

Primary Outcomes (1)

  • Quantitative Polymerase Chain Reaction (qPCR) for Trypanosoma cruzi

    Proportion of participants with at least one out of three positive tests (performed at least one week apart from each other)

    12 - 18 months after starting therapy

Secondary Outcomes (2)

  • T. cruzi positive serology status

    12 months after starting therapy

  • Mean change in T. cruzi antibody titers

    12 months after starting therapy

Other Outcomes (1)

  • Reported adverse reactions

    60 days after starting therapy

Study Arms (3)

Nifurtimox (NFX)

EXPERIMENTAL

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)

Drug: Nifurtimox

Benznidazole (BZN)

ACTIVE COMPARATOR

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)

Drug: Benznidazole

Placebo

PLACEBO COMPARATOR

120 days of treatment with matching placebo

Drug: Placebo

Interventions

NifurtimoxDRUG

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

Also known as: Lampit (Bayer)
Nifurtimox (NFX)
BenznidazoleDRUG

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

Also known as: Radanil (Roche), Rochagan (Roche), Abarax (ELEA)
Benznidazole (BZN)
PlaceboDRUG

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

Also known as: Control group
Placebo

Eligibility Criteria

Age20 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Positive serology status to Trypanosoma cruzi
  • No clinical signs of dilated cardiomyopathy

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fundación Oftalmológica de Santander - Clínica Ardila Lulle (FOSCAL)

Bucaramanga, Santander Department, Colombia

RECRUITING

Related Publications (2)

  • Villar JC, Perez JG, Cortes OL, Riarte A, Pepper M, Marin-Neto JA, Guyatt GH. Trypanocidal drugs for chronic asymptomatic Trypanosoma cruzi infection. Cochrane Database Syst Rev. 2014 May 27;2014(5):CD003463. doi: 10.1002/14651858.CD003463.pub2.

    PMID: 24867876BACKGROUND

  • Villar JC, Herrera VM, Perez Carreno JG, Vaquiro Herrera E, Castellanos Dominguez YZ, Vasquez SM, Cucunuba ZM, Prado NG, Hernandez Y. Nifurtimox versus benznidazole or placebo for asymptomatic Trypanosoma cruzi infection (Equivalence of Usual Interventions for Trypanosomiasis - EQUITY): study protocol for a randomised controlled trial. Trials. 2019 Jul 15;20(1):431. doi: 10.1186/s13063-019-3423-3.

    PMID: 31307503DERIVED

MeSH Terms

Conditions

Chagas Disease

Interventions

NifurtimoxbenzonidazoleControl Groups

Condition Hierarchy (Ancestors)

TrypanosomiasisEuglenozoa InfectionsProtozoan InfectionsParasitic DiseasesInfectionsVector Borne Diseases

Intervention Hierarchy (Ancestors)

NitrofuransNitro CompoundsOrganic ChemicalsThiazinesSulfur CompoundsFuransHeterocyclic Compounds, 1-RingHeterocyclic CompoundsEpidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • Juan C Villar, MD, PhD

    Universidad Autónoma de Bucaramanga

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Juan C Villar, MD, PhD

CONTACT

+5776436111jvillar@unab.edu.co

Bernardo I Useche, PhD

CONTACT

+5776436111buseche@unab.edu.co

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, Department of Medicine

Study Record Dates

First Submitted

February 17, 2015

First Posted

February 24, 2015

Study Start

August 1, 2015

Primary Completion

August 1, 2018

Study Completion

February 1, 2019

Last Updated

July 21, 2017

Record last verified: 2017-07

Locations

CO(1)