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...

Autores: Molina Morant, D.; Fernández, M. L.; Bosch Nicolau, P.; Sulleiro, E.; Bangher, M.; Salvador, F.; Sanchez Montalva, A.; Ribeiro, A.L.P.; De Paula, A.M.B.; Eloi, S.; Oliveira Correa, Ronaldo; Villar, J. C.; Sosa-Estani, Sergio Alejandro; Molina, I.
Año de publicación: 2020
Idioma: inglés
Tipo de recurso: artículo
Estado: versión publicada
Descripción: Background: Chagas disease (CD) continues to be a neglected infectious disease with one of the largest burdens globally. Despite the modest cure rates in adult chronic patients and its safety profile, benznidazole (BNZ) is still the drug of choice. Its current recommended dose is based on nonrandomized studies, and efficacy and safety of the optimal dose of BNZ have been scarcely analyzed in clinical trials.Methods/design: MULTIBENZ is a phase II, randomized, noninferiority, double-blind, multicenter international clinical trial. A total of 240 patients with Trypanosoma CD in the chronic phase will be recruited in four different countries (Argentina, Brazil, Colombia, and Spain). Patients will be randomized to receive BNZ 150 mg/day for 60 days, 400 mg/day for 15 days, or 300 mg/day for 60 days (comparator arm). The primary outcome is the efficacy of three different BNZ therapeutic schemes in terms of dose and duration. Efficacy will be assessed according to the proportion of patients with sustained parasitic load suppression in peripheral blood measured by polymerase chain reaction. The secondary outcomes are related to pharmacokinetics and drug tolerability. The follow-up will be 12 months from randomization to end of study participation. Recruitment was started in April 2018.Conclusion: This is a clinical trial conducted for the assessment of different dose schemes of BNZ compared with the standard treatment regimen for the treatment of CD in the chronic phase. MULTIBENZ may help to clarify which is the most adequate BNZ regimen in terms of efficacy and safety, predicated on sustained parasitic load suppression in peripheral blood.
Fil: Molina Morant, D.. Universidad Autónoma de Barcelona. Hospital Vall D' Hebron; España
Fil: Fernández, M. L.. Dirección Nacional de Instituto de Investigación. Administración Nacional de Laboratorio e Instituto de Salud “Dr. C. G. Malbrán”. Instituto Nacional de Parasitología "Dr. Mario Fatala Chaben”; Argentina
Fil: Bosch Nicolau, P.. Universidad Autónoma de Barcelona. Hospital Vall D' Hebron; España
Fil: Sulleiro, E.. Universidad Autónoma de Barcelona. Hospital Vall D' Hebron; España
Fil: Bangher, M.. Instituto de Cardiologia de Corrientes Juana Francisca Cabral.; Argentina
Fil: Salvador, F.. Universidad Autónoma de Barcelona. Hospital Vall D' Hebron; España
Fil: Sanchez Montalva, A.. Universidad Autónoma de Barcelona. Hospital Vall D' Hebron; España
Fil: Ribeiro, A.L.P.. Universidade Federal de Minas Gerais; Brasil
Fil: De Paula, A.M.B.. Universidad Federal de Montes Claros; Brasil
Fil: Eloi, S.. Universidade Federal de Minas Gerais; Brasil
Fil: Oliveira Correa, Ronaldo. Fundación Oswaldo Cruz; Brasil
Fil: Villar, J. C.. Instituto de Cardiología; Colombia
Fil: Sosa-Estani, Sergio Alejandro. Consejo Nacional de Investigaciones Científicas y Técnicas. Oficina de Coordinación Administrativa Parque Centenario. Centro de Investigaciones en Epidemiología y Salud Pública. Instituto de Efectividad Clínica y Sanitaria. Centro de Investigaciones en Epidemiología y Salud Pública; Argentina
Fil: Molina, I.. Universidad Autónoma de Barcelona. Hospital Vall D' Hebron; España
Materia: BENZNIDAZOLE
CHAGAS DISEASE
CLINICAL TRIAL
MULTICENTER STUDY
THERAPEUTIC
Nivel de accesibilidad: acceso abierto
Condiciones de uso: https://creativecommons.org/licenses/by/2.5/ar/
Repositorio
Institución: Consejo Nacional de Investigaciones Científicas y Técnicas
OAI Identificador: oai:ri.conicet.gov.ar:11336/142510

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repository_id_str	3498
network_name_str	CONICET Digital (CONICET)
spelling	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 trialMolina Morant, D.Fernández, M. L.Bosch Nicolau, P.Sulleiro, E.Bangher, M.Salvador, F.Sanchez Montalva, A.Ribeiro, A.L.P.De Paula, A.M.B.Eloi, S.Oliveira Correa, RonaldoVillar, J. C.Sosa-Estani, Sergio AlejandroMolina, I.BENZNIDAZOLECHAGAS DISEASECLINICAL TRIALMULTICENTER STUDYTHERAPEUTIChttps://purl.org/becyt/ford/3.2https://purl.org/becyt/ford/3Background: Chagas disease (CD) continues to be a neglected infectious disease with one of the largest burdens globally. Despite the modest cure rates in adult chronic patients and its safety profile, benznidazole (BNZ) is still the drug of choice. Its current recommended dose is based on nonrandomized studies, and efficacy and safety of the optimal dose of BNZ have been scarcely analyzed in clinical trials.Methods/design: MULTIBENZ is a phase II, randomized, noninferiority, double-blind, multicenter international clinical trial. A total of 240 patients with Trypanosoma CD in the chronic phase will be recruited in four different countries (Argentina, Brazil, Colombia, and Spain). Patients will be randomized to receive BNZ 150 mg/day for 60 days, 400 mg/day for 15 days, or 300 mg/day for 60 days (comparator arm). The primary outcome is the efficacy of three different BNZ therapeutic schemes in terms of dose and duration. Efficacy will be assessed according to the proportion of patients with sustained parasitic load suppression in peripheral blood measured by polymerase chain reaction. The secondary outcomes are related to pharmacokinetics and drug tolerability. The follow-up will be 12 months from randomization to end of study participation. Recruitment was started in April 2018.Conclusion: This is a clinical trial conducted for the assessment of different dose schemes of BNZ compared with the standard treatment regimen for the treatment of CD in the chronic phase. MULTIBENZ may help to clarify which is the most adequate BNZ regimen in terms of efficacy and safety, predicated on sustained parasitic load suppression in peripheral blood.Fil: Molina Morant, D.. Universidad Autónoma de Barcelona. Hospital Vall D' Hebron; EspañaFil: Fernández, M. L.. Dirección Nacional de Instituto de Investigación. Administración Nacional de Laboratorio e Instituto de Salud “Dr. C. G. Malbrán”. Instituto Nacional de Parasitología "Dr. Mario Fatala Chaben”; ArgentinaFil: Bosch Nicolau, P.. Universidad Autónoma de Barcelona. Hospital Vall D' Hebron; EspañaFil: Sulleiro, E.. Universidad Autónoma de Barcelona. Hospital Vall D' Hebron; EspañaFil: Bangher, M.. Instituto de Cardiologia de Corrientes Juana Francisca Cabral.; ArgentinaFil: Salvador, F.. Universidad Autónoma de Barcelona. Hospital Vall D' Hebron; EspañaFil: Sanchez Montalva, A.. Universidad Autónoma de Barcelona. Hospital Vall D' Hebron; EspañaFil: Ribeiro, A.L.P.. Universidade Federal de Minas Gerais; BrasilFil: De Paula, A.M.B.. Universidad Federal de Montes Claros; BrasilFil: Eloi, S.. Universidade Federal de Minas Gerais; BrasilFil: Oliveira Correa, Ronaldo. Fundación Oswaldo Cruz; BrasilFil: Villar, J. C.. Instituto de Cardiología; ColombiaFil: Sosa-Estani, Sergio Alejandro. Consejo Nacional de Investigaciones Científicas y Técnicas. Oficina de Coordinación Administrativa Parque Centenario. Centro de Investigaciones en Epidemiología y Salud Pública. Instituto de Efectividad Clínica y Sanitaria. Centro de Investigaciones en Epidemiología y Salud Pública; ArgentinaFil: Molina, I.. Universidad Autónoma de Barcelona. Hospital Vall D' Hebron; EspañaBioMed Central2020-04info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionhttp://purl.org/coar/resource_type/c_6501info:ar-repo/semantics/articuloapplication/pdfapplication/pdfhttp://hdl.handle.net/11336/142510Molina Morant, D.; Fernández, M. L.; Bosch Nicolau, P.; Sulleiro, E.; Bangher, M.; et al.; 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; BioMed Central; Trials; 21; 1; 4-2020; 1-101745-6215CONICET DigitalCONICETenginfo:eu-repo/semantics/altIdentifier/url/https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-020-4226-2info:eu-repo/semantics/altIdentifier/doi/10.1186/s13063-020-4226-2info:eu-repo/semantics/openAccesshttps://creativecommons.org/licenses/by/2.5/ar/reponame:CONICET Digital (CONICET)instname:Consejo Nacional de Investigaciones Científicas y Técnicas2025-10-15T15:43:46Zoai:ri.conicet.gov.ar:11336/142510instacron:CONICETInstitucionalhttp://ri.conicet.gov.ar/Organismo científico-tecnológicoNo correspondehttp://ri.conicet.gov.ar/oai/requestdasensio@conicet.gov.ar; lcarlino@conicet.gov.arArgentinaNo correspondeNo correspondeNo correspondeopendoar:34982025-10-15 15:43:46.48CONICET Digital (CONICET) - Consejo Nacional de Investigaciones Científicas y Técnicasfalse
dc.title.none.fl_str_mv	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
title	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
spellingShingle	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 Molina Morant, D. BENZNIDAZOLE CHAGAS DISEASE CLINICAL TRIAL MULTICENTER STUDY THERAPEUTIC
title_short	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
title_full	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
title_fullStr	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
title_full_unstemmed	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
title_sort	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
dc.creator.none.fl_str_mv	Molina Morant, D. Fernández, M. L. Bosch Nicolau, P. Sulleiro, E. Bangher, M. Salvador, F. Sanchez Montalva, A. Ribeiro, A.L.P. De Paula, A.M.B. Eloi, S. Oliveira Correa, Ronaldo Villar, J. C. Sosa-Estani, Sergio Alejandro Molina, I.
author	Molina Morant, D.
author_facet	Molina Morant, D. Fernández, M. L. Bosch Nicolau, P. Sulleiro, E. Bangher, M. Salvador, F. Sanchez Montalva, A. Ribeiro, A.L.P. De Paula, A.M.B. Eloi, S. Oliveira Correa, Ronaldo Villar, J. C. Sosa-Estani, Sergio Alejandro Molina, I.
author_role	author
author2	Fernández, M. L. Bosch Nicolau, P. Sulleiro, E. Bangher, M. Salvador, F. Sanchez Montalva, A. Ribeiro, A.L.P. De Paula, A.M.B. Eloi, S. Oliveira Correa, Ronaldo Villar, J. C. Sosa-Estani, Sergio Alejandro Molina, I.
author2_role	author author author author author author author author author author author author author
dc.subject.none.fl_str_mv	BENZNIDAZOLE CHAGAS DISEASE CLINICAL TRIAL MULTICENTER STUDY THERAPEUTIC
topic	BENZNIDAZOLE CHAGAS DISEASE CLINICAL TRIAL MULTICENTER STUDY THERAPEUTIC
purl_subject.fl_str_mv	https://purl.org/becyt/ford/3.2 https://purl.org/becyt/ford/3
dc.description.none.fl_txt_mv	Background: Chagas disease (CD) continues to be a neglected infectious disease with one of the largest burdens globally. Despite the modest cure rates in adult chronic patients and its safety profile, benznidazole (BNZ) is still the drug of choice. Its current recommended dose is based on nonrandomized studies, and efficacy and safety of the optimal dose of BNZ have been scarcely analyzed in clinical trials.Methods/design: MULTIBENZ is a phase II, randomized, noninferiority, double-blind, multicenter international clinical trial. A total of 240 patients with Trypanosoma CD in the chronic phase will be recruited in four different countries (Argentina, Brazil, Colombia, and Spain). Patients will be randomized to receive BNZ 150 mg/day for 60 days, 400 mg/day for 15 days, or 300 mg/day for 60 days (comparator arm). The primary outcome is the efficacy of three different BNZ therapeutic schemes in terms of dose and duration. Efficacy will be assessed according to the proportion of patients with sustained parasitic load suppression in peripheral blood measured by polymerase chain reaction. The secondary outcomes are related to pharmacokinetics and drug tolerability. The follow-up will be 12 months from randomization to end of study participation. Recruitment was started in April 2018.Conclusion: This is a clinical trial conducted for the assessment of different dose schemes of BNZ compared with the standard treatment regimen for the treatment of CD in the chronic phase. MULTIBENZ may help to clarify which is the most adequate BNZ regimen in terms of efficacy and safety, predicated on sustained parasitic load suppression in peripheral blood. Fil: Molina Morant, D.. Universidad Autónoma de Barcelona. Hospital Vall D' Hebron; España Fil: Fernández, M. L.. Dirección Nacional de Instituto de Investigación. Administración Nacional de Laboratorio e Instituto de Salud “Dr. C. G. Malbrán”. Instituto Nacional de Parasitología "Dr. Mario Fatala Chaben”; Argentina Fil: Bosch Nicolau, P.. Universidad Autónoma de Barcelona. Hospital Vall D' Hebron; España Fil: Sulleiro, E.. Universidad Autónoma de Barcelona. Hospital Vall D' Hebron; España Fil: Bangher, M.. Instituto de Cardiologia de Corrientes Juana Francisca Cabral.; Argentina Fil: Salvador, F.. Universidad Autónoma de Barcelona. Hospital Vall D' Hebron; España Fil: Sanchez Montalva, A.. Universidad Autónoma de Barcelona. Hospital Vall D' Hebron; España Fil: Ribeiro, A.L.P.. Universidade Federal de Minas Gerais; Brasil Fil: De Paula, A.M.B.. Universidad Federal de Montes Claros; Brasil Fil: Eloi, S.. Universidade Federal de Minas Gerais; Brasil Fil: Oliveira Correa, Ronaldo. Fundación Oswaldo Cruz; Brasil Fil: Villar, J. C.. Instituto de Cardiología; Colombia Fil: Sosa-Estani, Sergio Alejandro. Consejo Nacional de Investigaciones Científicas y Técnicas. Oficina de Coordinación Administrativa Parque Centenario. Centro de Investigaciones en Epidemiología y Salud Pública. Instituto de Efectividad Clínica y Sanitaria. Centro de Investigaciones en Epidemiología y Salud Pública; Argentina Fil: Molina, I.. Universidad Autónoma de Barcelona. Hospital Vall D' Hebron; España
description	Background: Chagas disease (CD) continues to be a neglected infectious disease with one of the largest burdens globally. Despite the modest cure rates in adult chronic patients and its safety profile, benznidazole (BNZ) is still the drug of choice. Its current recommended dose is based on nonrandomized studies, and efficacy and safety of the optimal dose of BNZ have been scarcely analyzed in clinical trials.Methods/design: MULTIBENZ is a phase II, randomized, noninferiority, double-blind, multicenter international clinical trial. A total of 240 patients with Trypanosoma CD in the chronic phase will be recruited in four different countries (Argentina, Brazil, Colombia, and Spain). Patients will be randomized to receive BNZ 150 mg/day for 60 days, 400 mg/day for 15 days, or 300 mg/day for 60 days (comparator arm). The primary outcome is the efficacy of three different BNZ therapeutic schemes in terms of dose and duration. Efficacy will be assessed according to the proportion of patients with sustained parasitic load suppression in peripheral blood measured by polymerase chain reaction. The secondary outcomes are related to pharmacokinetics and drug tolerability. The follow-up will be 12 months from randomization to end of study participation. Recruitment was started in April 2018.Conclusion: This is a clinical trial conducted for the assessment of different dose schemes of BNZ compared with the standard treatment regimen for the treatment of CD in the chronic phase. MULTIBENZ may help to clarify which is the most adequate BNZ regimen in terms of efficacy and safety, predicated on sustained parasitic load suppression in peripheral blood.
publishDate	2020
dc.date.none.fl_str_mv	2020-04
dc.type.none.fl_str_mv	info:eu-repo/semantics/article info:eu-repo/semantics/publishedVersion http://purl.org/coar/resource_type/c_6501 info:ar-repo/semantics/articulo
format	article
status_str	publishedVersion
dc.identifier.none.fl_str_mv	http://hdl.handle.net/11336/142510 Molina Morant, D.; Fernández, M. L.; Bosch Nicolau, P.; Sulleiro, E.; Bangher, M.; et al.; 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; BioMed Central; Trials; 21; 1; 4-2020; 1-10 1745-6215 CONICET Digital CONICET
url	http://hdl.handle.net/11336/142510
identifier_str_mv	Molina Morant, D.; Fernández, M. L.; Bosch Nicolau, P.; Sulleiro, E.; Bangher, M.; et al.; 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; BioMed Central; Trials; 21; 1; 4-2020; 1-10 1745-6215 CONICET Digital CONICET
dc.language.none.fl_str_mv	eng
language	eng
dc.relation.none.fl_str_mv	info:eu-repo/semantics/altIdentifier/url/https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-020-4226-2 info:eu-repo/semantics/altIdentifier/doi/10.1186/s13063-020-4226-2
dc.rights.none.fl_str_mv	info:eu-repo/semantics/openAccess https://creativecommons.org/licenses/by/2.5/ar/
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dc.publisher.none.fl_str_mv	BioMed Central
publisher.none.fl_str_mv	BioMed Central
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repository.mail.fl_str_mv	dasensio@conicet.gov.ar; lcarlino@conicet.gov.ar
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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...

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