A phase 2 randomized trial of a rifapentine plus moxifloxacin-based regimen for treatment of pulmonary tuberculosis

Detalhes bibliográficos
Autor(a) principal: Conde, Marcus B.
Data de Publicação: 2016
Outros Autores: Mello, Fernanda C. Q., Duarte, Rafael Silva, Cavalcante, Solange C., Rolla, Valeria, Dalcolmo, Margareth, Loredo, Carla, Durovni, Betina, Armstrong, Derek T., Efron, Anne, Barnes, Grace L., Marzinke, Mark A., Savic, Radojka M., Dooley, Kelly E., Cohn, Silvia, Moulton, Lawrence H., Chaisson, Richard E., Dorman, Susan E.
Tipo de documento: Artigo
Idioma: eng
Título da fonte: Repositório Institucional da FIOCRUZ (ARCA)
Texto Completo: https://www.arca.fiocruz.br/handle/icict/31845
Resumo: Universidade Federal do Rio de Janeiro. Instituto de Doenças do Tórax. Rio de Janeiro, RJ, Brasil.
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spelling Conde, Marcus B.Mello, Fernanda C. Q.Duarte, Rafael SilvaCavalcante, Solange C.Rolla, ValeriaDalcolmo, MargarethLoredo, CarlaDurovni, BetinaArmstrong, Derek T.Efron, AnneBarnes, Grace L.Marzinke, Mark A.Savic, Radojka M.Dooley, Kelly E.Cohn, SilviaMoulton, Lawrence H.Chaisson, Richard E.Dorman, Susan E.2019-02-22T14:57:39Z2019-02-22T14:57:39Z2016CONDE, Marcus B. et al. A phase 2 randomized trial of a Rifapentine plus Moxifloxacin-based regimen for treatment of pulmonary tuberculosis. Plos One, p.1-13, May 9, 2016.1932-6203https://www.arca.fiocruz.br/handle/icict/3184510.1371/journal.pone.01547781932-6203engPublic Library of ScienceA phase 2 randomized trial of a rifapentine plus moxifloxacin-based regimen for treatment of pulmonary tuberculosisinfo:eu-repo/semantics/publishedVersioninfo:eu-repo/semantics/articleUniversidade Federal do Rio de Janeiro. Instituto de Doenças do Tórax. Rio de Janeiro, RJ, Brasil.Universidade Federal do Rio de Janeiro. Instituto de Doenças do Tórax. Rio de Janeiro, RJ, Brasil.Universidade Federal do Rio de Janeiro. Instituto de Microbiologia Paulo de Góes. Rio de Janeiro, RJ, Brasil.Municipal Health Secretariat. Rio de Janeiro, RJ, Brazil / Fundação Oswaldo Cruz. Instituto Nacional de Infectologia Evandro Chagas. Rio de Janeiro, RJ, Brasil.Fundação Oswaldo Cruz. Instituto Nacional de Infectologia Evandro Chagas. Rio de Janeiro, RJ, Brasil.Fundação Oswaldo Cruz. Escola Nacional de Saúde Pública Sergio Arouca. Centro de Referência Hélio Fraga. Rio de Janeiro, RJ, Brasil.Universidade Federal do Rio de Janeiro. Instituto de Doenças do Tórax. Rio de Janeiro, RJ, Brasil.Municipal Health Secretariat. Rio de Janeiro, RJ, Brazil.Johns Hopkins University School of Medicine. Department of Medicine. Baltimore, MD, USA.Johns Hopkins University School of Medicine. Department of Medicine. Baltimore, MD, USA.Johns Hopkins University School of Medicine. Department of Medicine. Baltimore, MD, USA.Johns Hopkins University School of Medicine. Department of Medicine. Baltimore, MD, USA.University of California San Francisco. San Francisco, CA, USA.Johns Hopkins University. Johns Hopkins School of Medicine. Department of Medicine. Baltimore, MD, USA.Johns Hopkins University. Johns Hopkins School of Medicine. Department of Medicine. Baltimore, MD, USA.Johns Hopkins University. Johns Hopkins Bloomberg School of Public Health. Department of International Health. Baltimore, MD, USA.Johns Hopkins University. Johns Hopkins School of Medicine. Department of Medicine. Baltimore, MD, USA.Johns Hopkins University. Johns Hopkins School of Medicine. Department of Medicine. Baltimore, MD, USA.Background: The combination of rifapentine and moxifloxacin administered daily with other anti-tuberculosis drugs is highly active in mouse models of tuberculosis chemotherapy. The objective of this phase 2 clinical trial was to determine the bactericidal activity, safety, and tolerability of a regimen comprised of rifapentine, moxifloxacin, isoniazid, and pyrazinamide administered daily during the first 8 weeks of pulmonary tuberculosis treatment. Methods: Adults with sputum smear-positive pulmonary tuberculosis were randomized to receive either rifapentine (approximately 7.5 mg/kg) plus moxifloxacin (investigational arm), or rifampin (approximately 10 mg/kg) plus ethambutol (control) daily for 8 weeks, along with isoniazid and pyrazinamide. The primary endpoint was sputum culture status at completion of 8 weeks of treatment. Results: 121 participants (56% of accrual target) were enrolled. At completion of 8 weeks of treatment, negative cultures using Löwenstein-Jensen (LJ) medium occurred in 47/60 (78%) participants in the investigational arm vs. 43/51 (84%, p = 0.47) in the control arm; negative cultures using liquid medium occurred in 37/47 (79%) in the investigational arm vs. 27/41 (66%, p = 0.23) in the control arm. Time to stable culture conversion was shorter for the investigational arm vs. the control arm using liquid culture medium (p = 0.03), but there was no difference using LJ medium. Median rifapentine area under the concentration-time curve (AUC0-24) was 313 mcg*h/mL, similar to recent studies of rifapentine dosed at 450–600 mg daily. Median moxifloxacin AUC0-24 was 28.0 mcg*h/mL, much lower than in trials where rifapentine was given only intermittently with moxifloxacin. The proportion of participants discontinuing assigned treatment for reasons other than microbiological ineligibility was higher in the investigational arm vs. the control arm (11/62 [18%] vs. 3/59 [5%], p = 0.04) although the proportions of grade 3 or higher adverse events were similar (5/62 [8%] in the investigational arm vs. 6/59 [10%, p = 0.76] in the control arm). Conclusion: For intensive phase daily tuberculosis treatment in combination with isoniazid and pyrazinamide, a regimen containing moxifloxacin plus low dose rifapentine was at least as bactericidal as the control regimen containing ethambutol plus standard dose rifampin.TuberculosisTreatment of pulmonary tuberculosisRifapentineMoxifloxacininfo:eu-repo/semantics/openAccessreponame:Repositório Institucional da FIOCRUZ (ARCA)instname:Fundação Oswaldo Cruz (FIOCRUZ)instacron:FIOCRUZLICENSElicense.txtlicense.txttext/plain; charset=utf-82991https://www.arca.fiocruz.br/bitstream/icict/31845/1/license.txt5a560609d32a3863062d77ff32785d58MD51ORIGINALve_Conde_Marcus_etal_INI_2016.pdfve_Conde_Marcus_etal_INI_2016.pdfapplication/pdf584191https://www.arca.fiocruz.br/bitstream/icict/31845/2/ve_Conde_Marcus_etal_INI_2016.pdfbeda6d6cc8463869ace05d988dc47cc8MD52TEXTve_Conde_Marcus_etal_INI_2016.pdf.txtve_Conde_Marcus_etal_INI_2016.pdf.txtExtracted 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dc.title.pt_BR.fl_str_mv A phase 2 randomized trial of a rifapentine plus moxifloxacin-based regimen for treatment of pulmonary tuberculosis
title A phase 2 randomized trial of a rifapentine plus moxifloxacin-based regimen for treatment of pulmonary tuberculosis
spellingShingle A phase 2 randomized trial of a rifapentine plus moxifloxacin-based regimen for treatment of pulmonary tuberculosis
Conde, Marcus B.
Tuberculosis
Treatment of pulmonary tuberculosis
Rifapentine
Moxifloxacin
title_short A phase 2 randomized trial of a rifapentine plus moxifloxacin-based regimen for treatment of pulmonary tuberculosis
title_full A phase 2 randomized trial of a rifapentine plus moxifloxacin-based regimen for treatment of pulmonary tuberculosis
title_fullStr A phase 2 randomized trial of a rifapentine plus moxifloxacin-based regimen for treatment of pulmonary tuberculosis
title_full_unstemmed A phase 2 randomized trial of a rifapentine plus moxifloxacin-based regimen for treatment of pulmonary tuberculosis
title_sort A phase 2 randomized trial of a rifapentine plus moxifloxacin-based regimen for treatment of pulmonary tuberculosis
author Conde, Marcus B.
author_facet Conde, Marcus B.
Mello, Fernanda C. Q.
Duarte, Rafael Silva
Cavalcante, Solange C.
Rolla, Valeria
Dalcolmo, Margareth
Loredo, Carla
Durovni, Betina
Armstrong, Derek T.
Efron, Anne
Barnes, Grace L.
Marzinke, Mark A.
Savic, Radojka M.
Dooley, Kelly E.
Cohn, Silvia
Moulton, Lawrence H.
Chaisson, Richard E.
Dorman, Susan E.
author_role author
author2 Mello, Fernanda C. Q.
Duarte, Rafael Silva
Cavalcante, Solange C.
Rolla, Valeria
Dalcolmo, Margareth
Loredo, Carla
Durovni, Betina
Armstrong, Derek T.
Efron, Anne
Barnes, Grace L.
Marzinke, Mark A.
Savic, Radojka M.
Dooley, Kelly E.
Cohn, Silvia
Moulton, Lawrence H.
Chaisson, Richard E.
Dorman, Susan E.
author2_role author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
dc.contributor.author.fl_str_mv Conde, Marcus B.
Mello, Fernanda C. Q.
Duarte, Rafael Silva
Cavalcante, Solange C.
Rolla, Valeria
Dalcolmo, Margareth
Loredo, Carla
Durovni, Betina
Armstrong, Derek T.
Efron, Anne
Barnes, Grace L.
Marzinke, Mark A.
Savic, Radojka M.
Dooley, Kelly E.
Cohn, Silvia
Moulton, Lawrence H.
Chaisson, Richard E.
Dorman, Susan E.
dc.subject.en.pt_BR.fl_str_mv Tuberculosis
Treatment of pulmonary tuberculosis
Rifapentine
Moxifloxacin
topic Tuberculosis
Treatment of pulmonary tuberculosis
Rifapentine
Moxifloxacin
description Universidade Federal do Rio de Janeiro. Instituto de Doenças do Tórax. Rio de Janeiro, RJ, Brasil.
publishDate 2016
dc.date.issued.fl_str_mv 2016
dc.date.accessioned.fl_str_mv 2019-02-22T14:57:39Z
dc.date.available.fl_str_mv 2019-02-22T14:57:39Z
dc.type.status.fl_str_mv info:eu-repo/semantics/publishedVersion
dc.type.driver.fl_str_mv info:eu-repo/semantics/article
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status_str publishedVersion
dc.identifier.citation.fl_str_mv CONDE, Marcus B. et al. A phase 2 randomized trial of a Rifapentine plus Moxifloxacin-based regimen for treatment of pulmonary tuberculosis. Plos One, p.1-13, May 9, 2016.
dc.identifier.uri.fl_str_mv https://www.arca.fiocruz.br/handle/icict/31845
dc.identifier.issn.pt_BR.fl_str_mv 1932-6203
dc.identifier.doi.none.fl_str_mv 10.1371/journal.pone.0154778
dc.identifier.eissn.none.fl_str_mv 1932-6203
identifier_str_mv CONDE, Marcus B. et al. A phase 2 randomized trial of a Rifapentine plus Moxifloxacin-based regimen for treatment of pulmonary tuberculosis. Plos One, p.1-13, May 9, 2016.
1932-6203
10.1371/journal.pone.0154778
url https://www.arca.fiocruz.br/handle/icict/31845
dc.language.iso.fl_str_mv eng
language eng
dc.rights.driver.fl_str_mv info:eu-repo/semantics/openAccess
eu_rights_str_mv openAccess
dc.publisher.none.fl_str_mv Public Library of Science
publisher.none.fl_str_mv Public Library of Science
dc.source.none.fl_str_mv reponame:Repositório Institucional da FIOCRUZ (ARCA)
instname:Fundação Oswaldo Cruz (FIOCRUZ)
instacron:FIOCRUZ
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instacron_str FIOCRUZ
institution FIOCRUZ
reponame_str Repositório Institucional da FIOCRUZ (ARCA)
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