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

Primary Purpose

Chagas Disease

Status
Unknown status
Phase
Phase 2
Locations
Colombia
Study Type
Interventional
Intervention
Nifurtimox
Benznidazole
Placebo
Sponsored by
Universidad Autónoma de Bucaramanga
About
Eligibility
Locations
Arms
Outcomes
Full info

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

20 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

Nifurtimox (NFX)

Benznidazole (BZN)

Placebo

Arm Description

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

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

T. cruzi positive serology status
Proportion of participants with positive T. cruyzi serology status
Mean change in T. cruzi antibody titers
Mean change (before-after) in antibody readings as measured with ELISA serology

Full Information

First Posted
February 17, 2015
Last Updated
July 18, 2017
Sponsor
Universidad Autónoma de Bucaramanga
Collaborators
Fundación Cardioinfantil Instituto de Cardiología, Instituto Nacional de Salud, Colombia, Instituto Nacional de Parasitologia Dr. Mario Fatala Chaben
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1. Study Identification

Unique Protocol Identification Number
NCT02369978
Brief Title
CHICAMOCHA 3 - Equivalence of Usual Interventions for Trypanosomiasis (EQUITY)
Acronym
CHICAMOCHA-3
Official Title
Cardiovascular Health Investigation and Collaboration From Countries of America to Assess the Markers and Outcomes of Chagas Disease (CHICAMOCHA-3) - EQUITY (Equivalence of Usual Interventions for Trypanosomiasis)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Unknown status
Study Start Date
August 2015 (Actual)
Primary Completion Date
August 2018 (Anticipated)
Study Completion Date
February 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad Autónoma de Bucaramanga
Collaborators
Fundación Cardioinfantil Instituto de Cardiología, Instituto Nacional de Salud, Colombia, Instituto Nacional de Parasitologia Dr. Mario Fatala Chaben

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
The specific aims of this multi-center randomized trial include: To evaluate the feasibility of conducting a multinational trial in terms of the ability to identify and recruit T. cruzi-infected individuals without clinical disease in a relatively short period the standardization of procedures to test the parasitic load using polymerase chain reaction (PCR) To evaluate, in the study population, the efficacy of a treatment with NFX using conventional (full) dose (8/mg/Kg/day) or half-dose for a variable duration (full-dose for 60 days versus half-dose for 120 days) in terms of the presence of positive PCR tests one year after treatment, as compared with placebo. To evaluate the equivalence (in terms of non-inferiority of its impact over the PCR testing) of two treatment schedules with NFX: a full-dose treatment for 60 days and a half-dose treatment for 120 days. To evaluate the equivalence of two treatment schedules with BZN: A conventional (full) dose of 5 mg/Kg/day) for 60 days, as compared with half-dose treatment for 120 days. To evaluate the equivalence of the treatment schedules with NFX as compared with those with BZN 5 To evaluate the safety (in terms of reporting of mild symptoms, limitation of daily activities or hospitalizations, biochemical or blood abnormalities commonly reported by individuals taking these treatments) and adherence to the allocated treatments among individuals receiving NFX or BZN for varying duration and dose, as compared with placebo To explore differences in the impact of active treatments on the PCR among four subgroups of interest (geographical origin, T. cruzi discrete type unit found, parasitic load at baseline and age of participants). To explore, among individuals treated with placebo, the level of agreement in the tests of parasitic load at baseline and during the follow up.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chagas Disease
Keywords
Trypanocidal therapy, Benznidazole, Nifurtimox, Polymerase chain reaction, Randomized trial

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
500 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Nifurtimox (NFX)
Arm Type
Experimental
Arm Description
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)
Arm Title
Benznidazole (BZN)
Arm Type
Active Comparator
Arm Description
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)
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
120 days of treatment with matching placebo
Intervention Type
Drug
Intervention Name(s)
Nifurtimox
Other Intervention Name(s)
Lampit (Bayer)
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Benznidazole
Other Intervention Name(s)
Radanil (Roche), Rochagan (Roche), Abarax (ELEA)
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Control group
Intervention Description
Two capsules of matching placebo (contaning Magnesium stearate and cellulose) B.I.D
Primary Outcome Measure Information:
Title
Quantitative Polymerase Chain Reaction (qPCR) for Trypanosoma cruzi
Description
Proportion of participants with at least one out of three positive tests (performed at least one week apart from each other)
Time Frame
12 - 18 months after starting therapy
Secondary Outcome Measure Information:
Title
T. cruzi positive serology status
Description
Proportion of participants with positive T. cruyzi serology status
Time Frame
12 months after starting therapy
Title
Mean change in T. cruzi antibody titers
Description
Mean change (before-after) in antibody readings as measured with ELISA serology
Time Frame
12 months after starting therapy
Other Pre-specified Outcome Measures:
Title
Reported adverse reactions
Description
Proportion of participants with at least one of the following a) Reporting hospitalization or inability to work b) Stopping study treatment because of adverse reactions /intolerance c) having abnormal levels of at least two biochemical or blood markers
Time Frame
60 days after starting therapy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Juan C Villar, MD, PhD
Phone
+5776436111
Ext
514
Email
jvillar@unab.edu.co
First Name & Middle Initial & Last Name or Official Title & Degree
Bernardo I Useche, PhD
Phone
+5776436111
Ext
539
Email
buseche@unab.edu.co
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Juan C Villar, MD, PhD
Organizational Affiliation
Universidad Autónoma de Bucaramanga
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fundación Oftalmológica de Santander - Clínica Ardila Lulle (FOSCAL)
City
Bucaramanga
State/Province
Santander
Country
Colombia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gustavo A Parra, MD
Email
guparra@unab.edu.co
First Name & Middle Initial & Last Name & Degree
Skarlet M Vásquez, RN, MSc
Email
svasquez196@unab.edu.co

12. IPD Sharing Statement

Citations:
PubMed Identifier
24867876
Citation
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.
Results Reference
background
PubMed Identifier
31307503
Citation
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. Erratum In: Trials. 2019 Aug 20;20(1):516.
Results Reference
derived

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

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