Chagas DiseasePhase 2MULTIBENZNCT03191162
Evaluation of Different Benznidazole Regimens for the Treatment of Chronic Chagas Disease.
A Phase 2 study testing Benznidazole in people with Chagas Disease and Trypanosoma Cruzi Infection, run by Hospital Universitari Vall d'Hebron Research Institute at 7 sites in 4 countries.
Trial summary
A phase 2 clinical trial to evaluate the the efficacy of different benznidazole regimens (300mg/day for 60 days, 150mg/day for 60 days, and 400mg/day for 15 days) for the treatment of chronic Chagas disease in adult patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chagas Disease, Trypanosoma Cruzi Infection
- What is being tested?
- Benznidazole
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 238 participants
- Where
- 7 sitesin 4 countries
- Study dates
- 21 Apr 2017to 16 Mar 2021
- Phase
- Phase 2
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Over 18 years old.
- Diagnosis of Chagas disease through two different serological tests.
- Positive T. cruzi PCR in peripheral blood.
- Signed informed consent.
Who cannot join
- Previous treatment with Benznidazole or Nifurtimox.
- Alcohol consumption.
- Acute or chronic health problems that could interfere in the assessment of the efficacy or safety of the drug (acute infections, HIV infection, liver or renal impairment, etc).
- Nitroimidazole hipersensitivity.
- Concomitant or previous treatment with allopurinol or antifungal drugs.
- Pregnancy.
Trial locations and contacts
7 sites in 4 countries.
7 sites in 4 countries
Argentina2 sites
Instituto Nacional de Parasitología Dr. Mario Fatala Chaben (ANLIS)
Buenos Aires
Instituto de Cardiología de Corrientes Juana Francisca Cabral
Corrientes
Brazil2 sites
Centro de Pesquisas René Rachou - Fundação Oswaldo Cruz. (FIOCRUZ)
Belo Horizonte
Hospital Universitário Clemente de Faria
Montes Claros
Colombia2 sites
Fundación Cardioinfantil - Instituto de Cardiología
Bogotá
Centro Atencion y Diagnóstico de Enfermedades Infecciosas
Bucaramanga
About this study
Official title: Phase II Clinical Trial for the Evaluation of Different Benznidazole Regimens for the Treatment of Chronic Chagas Disease in Adult Patients. Berenice Project
A phase 2 clinical trial to evaluate the the efficacy of different benznidazole regimens (300mg/day for 60 days, 150mg/day for 60 days, and 400mg/day for 15 days) for the treatment of chronic Chagas disease in adult patients. The efficacy is assessed through the proportion of patients with negative parasitaemia measured by Polymerase Chain Reaction (PCR) during the first 12 months after starting treatment. The study will be performed in Spain, Brazil, Argentina and Colombia.
- Conditions
- Chagas Disease, Trypanosoma Cruzi Infection
- Being tested
- Benznidazole
- Keywords
- Benznidazole, PCR
- Medical subject headings
- Chagas Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BenznidazoleDrug
Also called Abarax
To evaluate different regimens of Benznidazole for the treatment of chronic Chagas disease
| Study group | Role | What they receive |
|---|---|---|
| B300/60 | Active comparator | Benznidazole 300mg/day p.o. divided in two doses for 60 days Receives: Drug: Benznidazole |
| B150/60 | Experimental | Benznidazole 150mg/day p.o. divided in two doses for 60 days Receives: Drug: Benznidazole |
| B400/15 | Experimental | Benznidazole 400mg/day p.o. divided in two doses for 15 days Receives: Drug: Benznidazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with negative parasitaemia measured by PCR during the first 12 months after starting treatment
The treatment efficacy is assessed through the proportion of patients with negative parasitaemia measured by PCR during the first 12 months after starting treatment
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2017
- Study start21 Apr 2017
- Primary completion21 Sep 2020
- Study completion16 Mar 2021
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.
- More trials run by Hospital Universitari Vall d'Hebron Research InstituteThe sponsor's other registered studies.
- 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 238 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Israel Molina, PhD, Principal investigator, Hospital Universitario Vall d'Hebron Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03191162
- Sponsor's protocol ID
- 2016-003789-21
- Other IDs
- 2016
- Acronym
- MULTIBENZ
- Status last verified
- Dec 2023
- First submitted
- 8 Jun 2017
- Last updated
- 19 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Bosch-Nicolau P, Fernandez ML, Sulleiro E, Villar JC, Perez-Molina JA, Correa-Oliveira R, Sosa-Estani S, Sanchez-Montalva A, Del Carmen Bangher M, Moreira OC, Salvador F, Mota Ferreira A, Eloi-Santos SM, Serre-Delcor N, Ramirez JC, Silgado A, Oliveira I, Martin O, Aznar ML, Ribeiro ALP, Almeida PEC, Chamorro-Tojeiro S, Espinosa-Pereiro J, de Paula AMB, Vaquiro-Herrera E, Tur C, Molina I; MULTIBENZ Study Group. Efficacy of three benznidazole dosing strategies for adults living with chronic Chagas disease (MULTIBENZ): an international, randomised, double-blind, phase 2b trial. Lancet Infect Dis. 2024 Apr;24(4):386-394. doi: 10.1016/S1473-3099(23)00629-1. Epub 2024 Jan 11.
PubMed 38218195Molina-Morant D, Fernandez ML, Bosch-Nicolau P, Sulleiro E, Bangher M, Salvador F, Sanchez-Montalva A, Ribeiro ALP, de Paula AMB, Eloi S, Correa-Oliveira R, Villar JC, Sosa-Estani S, Molina I. Efficacy and safety assessment of different dosage of benznidazol for the treatment of Chagas disease in chronic phase in adults (MULTIBENZ study): study protocol for a multicenter randomized Phase II non-inferiority clinical trial. Trials. 2020 Apr 15;21(1):328. doi: 10.1186/s13063-020-4226-2.
PubMed 32293523
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Clinical Trial for the Evaluation of Different Benznidazole Regimens for the Treatment of Chronic Chagas Disease in Adult Patients. Berenice Project
- ClinicalTrials.gov ID
- NCT03191162
- Acronym / sponsor ID
- MULTIBENZ / 2016-003789-21
- Conditions
- Chagas Disease, Trypanosoma Cruzi Infection
- Keywords
- Benznidazole, PCR
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 238 participants (actual)
- Lead sponsor
- Hospital Universitari Vall d'Hebron Research InstituteUniversity, hospital or other
- Study start
- 21 Apr 2017 (actual)
- Primary completion
- 21 Sep 2020 (actual)
- Study completion
- 16 Mar 2021 (actual)
- First posted
- 19 Jun 2017 (actual)
- 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.
A phase 2 clinical trial to evaluate the the efficacy of different benznidazole regimens (300mg/day for 60 days, 150mg/day for 60 days, and 400mg/day for 15 days) for the treatment of chronic Chagas disease in adult patients. The efficacy is assessed through the proportion of patients with negative parasitaemia measured by Polymerase Chain Reaction (PCR) during the first 12 months after starting treatment. The study will be performed in Spain, Brazil, Argentina and Colombia.
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 |
|---|---|---|
| B300/60 | Active comparator | Drug: BenznidazoleBenznidazole 300mg/day p.o. divided in two doses for 60 days |
| B150/60 | Experimental | Drug: BenznidazoleBenznidazole 150mg/day p.o. divided in two doses for 60 days |
| B400/15 | Experimental | Drug: BenznidazoleBenznidazole 400mg/day p.o. divided in two doses for 15 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Over 18 years old.
- Diagnosis of Chagas disease through two different serological tests.
- Positive T. cruzi PCR in peripheral blood.
- Signed informed consent.
Key exclusion criteria (6 listed)
- Previous treatment with Benznidazole or Nifurtimox.
- Alcohol consumption.
- Acute or chronic health problems that could interfere in the assessment of the efficacy or safety of the drug (acute infections, HIV infection, liver or renal impairment, etc).
- Nitroimidazole hipersensitivity.
- Concomitant or previous treatment with allopurinol or antifungal drugs.
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 |
|---|---|---|
| BenznidazoleAlso: AbaraxTo evaluate different regimens of Benznidazole for the treatment of chronic Chagas disease | Drug | B150/60, B300/60, B400/15 |
Primary outcome
Proportion of patients with negative parasitaemia measured by PCR during the first 12 months after starting treatment
Time frame: 12 months
The treatment efficacy is assessed through the proportion of patients with negative parasitaemia measured by PCR during the first 12 months after starting treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2023.
- Derived from this study: PubMed 38218195Bosch-Nicolau P, Fernandez ML, Sulleiro E, Villar JC, Perez-Molina JA, Correa-Oliveira R, Sosa-Estani S, Sanchez-Montalva A, Del Carmen Bangher M, Moreira OC, Salvador F, Mota Ferreira A, Eloi-Santos SM, Serre-Delcor N, Ramirez JC, Silgado A, Oliveira I, Martin O, Aznar ML, Ribeiro ALP, Almeida PEC, Chamorro-Tojeiro S, Espinosa-Pereiro J, de Paula AMB, Vaquiro-Herrera E, Tur C, Molina I; MULTIBENZ Study Group. Efficacy of three benznidazole dosing strategies for adults living with chronic Chagas disease (MULTIBENZ): an international, randomised, double-blind, phase 2b trial. Lancet Infect Dis. 2024 Apr;24(4):386-394. doi: 10.1016/S1473-3099(23)00629-1. Epub 2024 Jan 11.
- Derived from this study: PubMed 32293523Molina-Morant D, Fernandez ML, Bosch-Nicolau P, Sulleiro E, Bangher M, Salvador F, Sanchez-Montalva A, Ribeiro ALP, de Paula AMB, Eloi S, Correa-Oliveira R, Villar JC, Sosa-Estani S, Molina I. Efficacy and safety assessment of different dosage of benznidazol for the treatment of Chagas disease in chronic phase in adults (MULTIBENZ study): study protocol for a multicenter randomized Phase II non-inferiority clinical trial. Trials. 2020 Apr 15;21(1):328. doi: 10.1186/s13063-020-4226-2.
- Individual participant dataSharing planned: Undecided
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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.
Israel Molina, PhD principal investigator
Hospital Universitario Vall d'Hebron Research Institute
7 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Benznidazole in people with Chagas Disease and Trypanosoma Cruzi Infection, run by Hospital Universitari Vall d'Hebron Research Institute at 7 sites in 4 countries.
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 4 inclusion and 6 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: finished, as of the sponsor's last update on 19 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Argentina, Brazil, Colombia, Spain. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients with negative parasitaemia measured by PCR during the first 12 months after starting treatment (time frame: 12 months). 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 NCT03191162, 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 19 Dec 2023.