Safety of Rifampicin at High Dose for Difficult-to-Treat Tuberculosis: Protocol for RIAlta Phase 2b/c Trial

Rifampicin; Tuberculosis; Vulnerable population

Detalhes bibliográficos
Autores: Espinosa Pereiro, Juan, Ghimire, Samiksha, Sturkenboom, Marieke G.G., Alffenaar, Jan-Willem, Tavares, Margarida, Aguirre García, Sarita Katerinne, Tórtola Fernández, Mª Teresa, Sánchez Montalvá, Adrián
Tipo de documento: artigo
Estado:Versão publicada
Data de publicação:2022
País:España
Recursos:Varias* (Consorci de Biblioteques Universitáries de Catalunya, Centre de Serveis Científics i Acadèmics de Catalunya)
Repositório:Recercat. Dipósit de la Recerca de Catalunya
OAI Identifier:oai:recercat.cat:11351/9078
Acesso em linha:https://hdl.handle.net/11351/9078
Access Level:Acceso aberto
Palavra-chave:Tuberculosi - Tractament
Medicaments antibacterians - Ús terapèutic
DISEASES::Bacterial Infections and Mycoses::Bacterial Infections::Gram-Positive Bacterial Infections::Actinomycetales Infections::Mycobacterium Infections::Tuberculosis
CHEMICALS AND DRUGS::Chemical Actions and Uses::Pharmacologic Actions::Therapeutic Uses::Anti-Infective Agents::Anti-Bacterial Agents
Other subheadings::Other subheadings::/therapeutic use
ENFERMEDADES::infecciones bacterianas y micosis::infecciones bacterianas::infecciones por bacterias grampositivas::infecciones por Actinomycetales::micobacteriosis::tuberculosis
COMPUESTOS QUÍMICOS Y DROGAS::acciones y usos químicos::acciones farmacológicas::usos terapéuticos::antiinfecciosos::antibacterianos
Otros calificadores::Otros calificadores::/uso terapéutico
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oai_identifier_str oai:recercat.cat:11351/9078
network_acronym_str ES
network_name_str España
repository_id_str
dc.title.none.fl_str_mv Safety of Rifampicin at High Dose for Difficult-to-Treat Tuberculosis: Protocol for RIAlta Phase 2b/c Trial
title Safety of Rifampicin at High Dose for Difficult-to-Treat Tuberculosis: Protocol for RIAlta Phase 2b/c Trial
spellingShingle Safety of Rifampicin at High Dose for Difficult-to-Treat Tuberculosis: Protocol for RIAlta Phase 2b/c Trial
Espinosa Pereiro, Juan
Tuberculosi - Tractament
Medicaments antibacterians - Ús terapèutic
DISEASES::Bacterial Infections and Mycoses::Bacterial Infections::Gram-Positive Bacterial Infections::Actinomycetales Infections::Mycobacterium Infections::Tuberculosis
CHEMICALS AND DRUGS::Chemical Actions and Uses::Pharmacologic Actions::Therapeutic Uses::Anti-Infective Agents::Anti-Bacterial Agents
Other subheadings::Other subheadings::/therapeutic use
ENFERMEDADES::infecciones bacterianas y micosis::infecciones bacterianas::infecciones por bacterias grampositivas::infecciones por Actinomycetales::micobacteriosis::tuberculosis
COMPUESTOS QUÍMICOS Y DROGAS::acciones y usos químicos::acciones farmacológicas::usos terapéuticos::antiinfecciosos::antibacterianos
Otros calificadores::Otros calificadores::/uso terapéutico
title_short Safety of Rifampicin at High Dose for Difficult-to-Treat Tuberculosis: Protocol for RIAlta Phase 2b/c Trial
title_full Safety of Rifampicin at High Dose for Difficult-to-Treat Tuberculosis: Protocol for RIAlta Phase 2b/c Trial
title_fullStr Safety of Rifampicin at High Dose for Difficult-to-Treat Tuberculosis: Protocol for RIAlta Phase 2b/c Trial
title_full_unstemmed Safety of Rifampicin at High Dose for Difficult-to-Treat Tuberculosis: Protocol for RIAlta Phase 2b/c Trial
title_sort Safety of Rifampicin at High Dose for Difficult-to-Treat Tuberculosis: Protocol for RIAlta Phase 2b/c Trial
dc.creator.none.fl_str_mv Espinosa Pereiro, Juan
Ghimire, Samiksha
Sturkenboom, Marieke G.G.
Alffenaar, Jan-Willem
Tavares, Margarida
Aguirre García, Sarita Katerinne
Tórtola Fernández, Mª Teresa
Sánchez Montalvá, Adrián
author Espinosa Pereiro, Juan
author_facet Espinosa Pereiro, Juan
Ghimire, Samiksha
Sturkenboom, Marieke G.G.
Alffenaar, Jan-Willem
Tavares, Margarida
Aguirre García, Sarita Katerinne
Tórtola Fernández, Mª Teresa
Sánchez Montalvá, Adrián
author_role author
author2 Ghimire, Samiksha
Sturkenboom, Marieke G.G.
Alffenaar, Jan-Willem
Tavares, Margarida
Aguirre García, Sarita Katerinne
Tórtola Fernández, Mª Teresa
Sánchez Montalvá, Adrián
author2_role author
author
author
author
author
author
author
dc.contributor.none.fl_str_mv Institut Català de la Salut
[Espinosa-Pereiro J] Unitat de Medicina Tropical i Salut Internacional Drassanes-Vall d'Hebron Hospital Universitari, Barcelona, Spain. Servei de Malalties Infeccioses, Vall d'Hebron Hospital Universitari, Barcelona, Spain. PROSICS Barcelona, Barcelona, Spain. Centro de Investigación Biomédica en Red de Enfermedades Infecciosas (CIBERINFEC), Instituto de Salud Carlos III, Madrid, Spain. [Ghimire S, Sturkenboom MGG] Department Clinical Pharmacy and Pharmacology, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands. [Alffenaar JC] Department Clinical Pharmacy and Pharmacology, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands. School of Pharmacy, Faculty of Medicine and Health, The University of Sydney, Sydney, Australia. Westmead Hospital, Sydney, Australia. Sydney Institute for Infectious Diseases, The University of Sydney, Sydney, Australia. [Tavares M] Infectious Diseases Service, Centro Hospitalar de São João, Porto, Portugal. [Aguirre S] National Program for Tuberculosis, Ministry of Health, Asunción, Paraguay. [Tórtola T] Servei de Microbiologia, Vall d’Hebron Hospital Universitari, Barcelona, Spain. [Sanchez-Montalva A] Unitat de Medicina Tropical i Salut Internacional Drassanes-Vall d'Hebron Hospital Universitari, Barcelona, Spain. Servei de Malalties Infeccioses, Vall d'Hebron Hospital Universitari, Barcelona, Spain. PROSICS Barcelona, Barcelona, Spain. Centro de Investigación Biomédica en Red de Enfermedades Infecciosas (CIBERINFEC), Instituto de Salud Carlos III, Madrid, Spain. Grupo de Estudio de Infecciones por Micobacterias, Sociedad Española de Enfermedades Infecciosas y Microbiología Clínica (GEIM-SEIMC), Madrid, Spain
Vall d'Hebron Barcelona Hospital Campus
dc.subject.none.fl_str_mv Tuberculosi - Tractament
Medicaments antibacterians - Ús terapèutic
DISEASES::Bacterial Infections and Mycoses::Bacterial Infections::Gram-Positive Bacterial Infections::Actinomycetales Infections::Mycobacterium Infections::Tuberculosis
CHEMICALS AND DRUGS::Chemical Actions and Uses::Pharmacologic Actions::Therapeutic Uses::Anti-Infective Agents::Anti-Bacterial Agents
Other subheadings::Other subheadings::/therapeutic use
ENFERMEDADES::infecciones bacterianas y micosis::infecciones bacterianas::infecciones por bacterias grampositivas::infecciones por Actinomycetales::micobacteriosis::tuberculosis
COMPUESTOS QUÍMICOS Y DROGAS::acciones y usos químicos::acciones farmacológicas::usos terapéuticos::antiinfecciosos::antibacterianos
Otros calificadores::Otros calificadores::/uso terapéutico
topic Tuberculosi - Tractament
Medicaments antibacterians - Ús terapèutic
DISEASES::Bacterial Infections and Mycoses::Bacterial Infections::Gram-Positive Bacterial Infections::Actinomycetales Infections::Mycobacterium Infections::Tuberculosis
CHEMICALS AND DRUGS::Chemical Actions and Uses::Pharmacologic Actions::Therapeutic Uses::Anti-Infective Agents::Anti-Bacterial Agents
Other subheadings::Other subheadings::/therapeutic use
ENFERMEDADES::infecciones bacterianas y micosis::infecciones bacterianas::infecciones por bacterias grampositivas::infecciones por Actinomycetales::micobacteriosis::tuberculosis
COMPUESTOS QUÍMICOS Y DROGAS::acciones y usos químicos::acciones farmacológicas::usos terapéuticos::antiinfecciosos::antibacterianos
Otros calificadores::Otros calificadores::/uso terapéutico
description Rifampicin; Tuberculosis; Vulnerable population
publishDate 2022
dc.date.none.fl_str_mv 2022
2023
2023
dc.type.none.fl_str_mv info:eu-repo/semantics/article
info:eu-repo/semantics/publishedVersion
format article
status_str publishedVersion
dc.identifier.none.fl_str_mv https://hdl.handle.net/11351/9078
url https://hdl.handle.net/11351/9078
dc.language.none.fl_str_mv Inglés
language_invalid_str_mv Inglés
dc.relation.none.fl_str_mv Pharmaceutics;15(1)
https://doi.org/10.3390/pharmaceutics15010009
info:eu-repo/grantAgreement/EC/H2020/823890
dc.rights.none.fl_str_mv Attribution 4.0 International
http://creativecommons.org/licenses/by/4.0/
info:eu-repo/semantics/openAccess
rights_invalid_str_mv Attribution 4.0 International
http://creativecommons.org/licenses/by/4.0/
eu_rights_str_mv openAccess
dc.format.none.fl_str_mv application/pdf
dc.publisher.none.fl_str_mv MDPI
publisher.none.fl_str_mv MDPI
dc.source.none.fl_str_mv Scientia
reponame:Recercat. Dipósit de la Recerca de Catalunya
instname:Varias* (Consorci de Biblioteques Universitáries de Catalunya, Centre de Serveis Científics i Acadèmics de Catalunya)
instname_str Varias* (Consorci de Biblioteques Universitáries de Catalunya, Centre de Serveis Científics i Acadèmics de Catalunya)
reponame_str Recercat. Dipósit de la Recerca de Catalunya
collection Recercat. Dipósit de la Recerca de Catalunya
repository.name.fl_str_mv
repository.mail.fl_str_mv
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spelling Safety of Rifampicin at High Dose for Difficult-to-Treat Tuberculosis: Protocol for RIAlta Phase 2b/c TrialEspinosa Pereiro, JuanGhimire, SamikshaSturkenboom, Marieke G.G.Alffenaar, Jan-WillemTavares, MargaridaAguirre García, Sarita KaterinneTórtola Fernández, Mª TeresaSánchez Montalvá, AdriánTuberculosi - TractamentMedicaments antibacterians - Ús terapèuticDISEASES::Bacterial Infections and Mycoses::Bacterial Infections::Gram-Positive Bacterial Infections::Actinomycetales Infections::Mycobacterium Infections::TuberculosisCHEMICALS AND DRUGS::Chemical Actions and Uses::Pharmacologic Actions::Therapeutic Uses::Anti-Infective Agents::Anti-Bacterial AgentsOther subheadings::Other subheadings::/therapeutic useENFERMEDADES::infecciones bacterianas y micosis::infecciones bacterianas::infecciones por bacterias grampositivas::infecciones por Actinomycetales::micobacteriosis::tuberculosisCOMPUESTOS QUÍMICOS Y DROGAS::acciones y usos químicos::acciones farmacológicas::usos terapéuticos::antiinfecciosos::antibacterianosOtros calificadores::Otros calificadores::/uso terapéuticoRifampicin; Tuberculosis; Vulnerable populationRifampicina; Tuberculosis; Población vulnerableRifampicina; Tuberculosi; Població vulnerablePrevious clinical trials for drug-susceptible tuberculosis (DS-TB) have shown that first-line treatment with doses of rifampicin up to 40 mg/kg are safe and increase the early treatment response for young adults with pulmonary tuberculosis. This may lead to a shorter treatment duration for those persons with TB and a good baseline prognosis, or increased treatment success for vulnerable subgroups (age > 60, diabetes, malnutrition, HIV, hepatitis B or hepatitis C coinfection, TB meningitis, stable chronic liver diseases). Here, we describe the design of a phase 2b/c clinical study under the hypothesis that rifampicin at 35 mg/kg is as safe for these vulnerable groups as for the participants included in previous clinical trials. RIAlta is an interventional, open-label, multicenter, prospective clinical study with matched historical controls comparing the standard DS-TB treatment (isoniazid, pyrazinamide, and ethambutol) with rifampicin at 35 mg/kg (HR35ZE group) vs. rifampicin at 10 mg/kg (historical HR10ZE group). The primary outcome is the incidence of grade ≥ 3 Adverse Events or Severe Adverse Events. A total of 134 participants will be prospectively included, and compared with historical matched controls with at least a 1:1 proportion. This will provide a power of 80% to detect non-inferiority with a margin of 8%. This study will provide important information for subgroups of patients that are more vulnerable to TB bad outcomes and/or treatment toxicity. Despite limitations such as non-randomized design and the use of historical controls, the results of this trial may inform the design of future more inclusive clinical trials, and improve the management of tuberculosis in subgroups of patients for whom scientific evidence is still scarce. Trial registration: EudraCT 2020-003146-36, NCT04768231.This study is part of the European South American TB Research Collaborative Network (EUSAT-RCS), a project that has received funding from the European Union’s Horizon 2020 research and innovation programme under the Marie Skłodowska-Curie grant agreement No. 823890. A.S.M. is supported by a Juan Rodés (JR18/00022) postdoctoral fellowship from ISCIII.MDPIInstitut Català de la Salut[Espinosa-Pereiro J] Unitat de Medicina Tropical i Salut Internacional Drassanes-Vall d'Hebron Hospital Universitari, Barcelona, Spain. Servei de Malalties Infeccioses, Vall d'Hebron Hospital Universitari, Barcelona, Spain. PROSICS Barcelona, Barcelona, Spain. Centro de Investigación Biomédica en Red de Enfermedades Infecciosas (CIBERINFEC), Instituto de Salud Carlos III, Madrid, Spain. [Ghimire S, Sturkenboom MGG] Department Clinical Pharmacy and Pharmacology, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands. [Alffenaar JC] Department Clinical Pharmacy and Pharmacology, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands. School of Pharmacy, Faculty of Medicine and Health, The University of Sydney, Sydney, Australia. Westmead Hospital, Sydney, Australia. Sydney Institute for Infectious Diseases, The University of Sydney, Sydney, Australia. [Tavares M] Infectious Diseases Service, Centro Hospitalar de São João, Porto, Portugal. [Aguirre S] National Program for Tuberculosis, Ministry of Health, Asunción, Paraguay. [Tórtola T] Servei de Microbiologia, Vall d’Hebron Hospital Universitari, Barcelona, Spain. [Sanchez-Montalva A] Unitat de Medicina Tropical i Salut Internacional Drassanes-Vall d'Hebron Hospital Universitari, Barcelona, Spain. Servei de Malalties Infeccioses, Vall d'Hebron Hospital Universitari, Barcelona, Spain. PROSICS Barcelona, Barcelona, Spain. Centro de Investigación Biomédica en Red de Enfermedades Infecciosas (CIBERINFEC), Instituto de Salud Carlos III, Madrid, Spain. Grupo de Estudio de Infecciones por Micobacterias, Sociedad Española de Enfermedades Infecciosas y Microbiología Clínica (GEIM-SEIMC), Madrid, SpainVall d'Hebron Barcelona Hospital Campus202320232022info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionapplication/pdfhttps://hdl.handle.net/11351/9078Scientiareponame:Recercat. Dipósit de la Recerca de Catalunyainstname:Varias* (Consorci de Biblioteques Universitáries de Catalunya, Centre de Serveis Científics i Acadèmics de Catalunya)InglésPharmaceutics;15(1)https://doi.org/10.3390/pharmaceutics15010009info:eu-repo/grantAgreement/EC/H2020/823890Attribution 4.0 Internationalhttp://creativecommons.org/licenses/by/4.0/info:eu-repo/semantics/openAccessoai:recercat.cat:11351/90782026-05-29T05:05:01Z
score 15,812429

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