Evaluation of Different Benznidazole Regimens for the Treatment of Chronic Chagas Disease.
NCT ID: NCT03191162
Last Updated: 2023-12-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
238 participants
INTERVENTIONAL
2017-04-21
2021-03-16
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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B300/60
Benznidazole 300mg/day p.o. divided in two doses for 60 days
Benznidazole
To evaluate different regimens of Benznidazole for the treatment of chronic Chagas disease
B150/60
Benznidazole 150mg/day p.o. divided in two doses for 60 days
Benznidazole
To evaluate different regimens of Benznidazole for the treatment of chronic Chagas disease
B400/15
Benznidazole 400mg/day p.o. divided in two doses for 15 days
Benznidazole
To evaluate different regimens of Benznidazole for the treatment of chronic Chagas disease
Interventions
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Benznidazole
To evaluate different regimens of Benznidazole for the treatment of chronic Chagas disease
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Diagnosis of Chagas disease through two different serological tests.
* Positive T. cruzi PCR in peripheral blood.
* Signed informed consent.
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Hospital Universitari Vall d'Hebron Research Institute
OTHER
Responsible Party
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Principal Investigators
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Israel Molina, PhD
Role: PRINCIPAL_INVESTIGATOR
Hospital Universitario Vall d'Hebron Research Institute
Locations
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Instituto Nacional de Parasitología Dr. Mario Fatala Chaben (ANLIS)
Buenos Aires, , Argentina
Instituto de Cardiología de Corrientes Juana Francisca Cabral
Corrientes, , Argentina
Centro de Pesquisas René Rachou - Fundação Oswaldo Cruz. (FIOCRUZ)
Belo Horizonte, , Brazil
Hospital Universitário Clemente de Faria
Montes Claros, , Brazil
Fundación Cardioinfantil - Instituto de Cardiología
Bogotá, , Colombia
Centro Atencion y Diagnóstico de Enfermedades Infecciosas
Bucaramanga, , Colombia
Infectious Disease Department Vall d'Hebron Hospital
Barcelona, , Spain
Countries
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References
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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.
Molina-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.
Other Identifiers
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2016-003789-21
Identifier Type: -
Identifier Source: org_study_id