Chagas DiseasePhase 2/3CHICAMOCHA-3NCT02369978
CHICAMOCHA 3 - Equivalence of Usual Interventions for Trypanosomiasis (EQUITY)
A Phase 2/3 study testing Nifurtimox and Benznidazole in people with Chagas Disease, run by Universidad Autónoma de Bucaramanga at 1 site in Colombia.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 55 years
- Conditions the study is for
- Chagas Disease
- What is being tested?
- Nifurtimox and Benznidazole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 500 participants
- Where
- 1 siteColombia
- Study dates
- Aug 2015to Feb 2019
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Positive serology status to Trypanosoma cruzi
- No clinical signs of dilated cardiomyopathy
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Colombia1 site, 1 recruiting
- Recruiting
Fundación Oftalmológica de Santander - Clínica Ardila Lulle (FOSCAL)
Bucaramanga, Santander Department
Gustavo A Parra, MD, guparra@unab.edu.co
Skarlet M Vásquez, RN, MSc, svasquez196@unab.edu.co
About this study
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)
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.
Read more
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.
Read the 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.
- Conditions
- Chagas Disease
- Being tested
- Nifurtimox, Benznidazole, Placebo
- Keywords
- Trypanocidal therapy, Benznidazole, Nifurtimox, Polymerase chain reaction, Randomized trial
- Medical subject headings
- Chagas Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NifurtimoxDrug
Also called Lampit (Bayer)
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
BenznidazoleDrug
Also called Radanil (Roche), Rochagan (Roche), Abarax (ELEA)
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
PlaceboDrug
Also called Control group
Two capsules of matching placebo (contaning Magnesium stearate and cellulose) B.I.D
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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) Receives: Drug: Benznidazole |
| Placebo | Placebo comparator | 120 days of treatment with matching placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 12 - 18 months after starting therapy
Secondary outcomes (2)
T. cruzi positive serology status
Proportion of participants with positive T. cruyzi serology status
Measured: 12 months after starting therapy
Mean change in T. cruzi antibody titers
Mean change (before-after) in antibody readings as measured with ELISA serology
Measured: 12 months after starting therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2015 (estimated)
- Study startAug 2015
- Primary completionAug 2018 (estimated)
- Study completionFeb 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chagas DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad Autónoma de Bucaramanga
- Sponsor type
- University, hospital or other
- Collaborators
- Fundación Cardioinfantil Instituto de Cardiología, Instituto Nacional de Salud, Colombia, Instituto Nacional de Parasitologia Dr. Mario Fatala Chaben
- Responsible party
- Principal investigator, Juan Carlos Villar, MD, PhD, Universidad Autónoma de Bucaramanga
- Investigators
- Juan C Villar, MD, PhD, Principal investigator, Universidad Autónoma de Bucaramanga
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02369978
- Sponsor's protocol ID
- 124156935014
- Acronym
- CHICAMOCHA-3
- Status last verified
- Jul 2017
- First submitted
- 17 Feb 2015
- Last updated
- 21 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 24867876Villar 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.
PubMed 31307503
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT02369978
- Acronym / sponsor ID
- CHICAMOCHA-3 / 124156935014
- Conditions
- Chagas Disease
- Keywords
- Trypanocidal therapy, Benznidazole, Nifurtimox, Polymerase chain reaction, Randomized trial
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Universidad Autónoma de BucaramangaUniversity, hospital or other
- Collaborators
- Fundación Cardioinfantil Instituto de Cardiología, Instituto Nacional de Salud, Colombia, Instituto Nacional de Parasitologia Dr. Mario Fatala Chaben
- Study start
- Aug 2015 (actual)
- Primary completion
- Aug 2018 (estimated)
- Study completion
- Feb 2019 (estimated)
- First posted
- 24 Feb 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Nifurtimox (NFX) | Experimental | Drug: Nifurtimox60 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) |
| Benznidazole (BZN) | Active comparator | Drug: Benznidazole60 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) |
| Placebo | Placebo comparator | Drug: Placebo120 days of treatment with matching placebo |
Who may qualify
- Ages
- 20 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Positive serology status to Trypanosoma cruzi
- No clinical signs of dilated cardiomyopathy
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NifurtimoxAlso: Lampit (Bayer)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 | Nifurtimox (NFX) |
| BenznidazoleAlso: Radanil (Roche), Rochagan (Roche), Abarax (ELEA)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 | Benznidazole (BZN) |
| PlaceboAlso: Control groupTwo capsules of matching placebo (contaning Magnesium stearate and cellulose) B.I.D | Drug | Placebo |
Primary outcome
Quantitative Polymerase Chain Reaction (qPCR) for Trypanosoma cruzi
Time frame: 12 - 18 months after starting therapy
Proportion of participants with at least one out of three positive tests (performed at least one week apart from each other)
2 secondary outcomes
T. cruzi positive serology status
Time frame: 12 months after starting therapy
Mean change in T. cruzi antibody titers
Time frame: 12 months after starting therapy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2017.
- Background: PubMed 24867876Villar 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.
- Derived from this study: PubMed 31307503Villar 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Juan C Villar, MD, PhD principal investigator
Universidad Autónoma de Bucaramanga
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Nifurtimox and Benznidazole in people with Chagas Disease, run by Universidad Autónoma de Bucaramanga at 1 site in Colombia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Colombia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Juan C Villar, MD, PhD (+5776436111 ext. 514, jvillar@unab.edu.co), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quantitative Polymerase Chain Reaction (qPCR) for Trypanosoma cruzi (time frame: 12 - 18 months after starting therapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02369978, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2017; AzTrials last refreshed its copy on 7 Nov 2026.