Is once-daily high-dose ceftriaxone plus ampicillin an alternative for enterococcus faecalis infective endocarditis in outpatient parenteral antibiotic therapy programs?

Ceftriaxone administered as once-daily high-dose short infusion combined with ampicillin has been proposed for the treatment of Enterococcus faecalis infective endocarditis in outpatient parenteral antibiotic therapy programs (OPAT). This combination requires synergistic activity, but the attainment...

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Autores: Herrera-Hidalgo, Laura, de Alarcón, Arístides, López-Cortés, Luis E., Luque-Márquez, Rafael, López-Cortes, Luis Fernando, Gutiérrez-Valencia, Alicia, Gil Navarro, María Victoria
Tipo de recurso: artículo
Estado:Versión publicada
Fecha de publicación:2021
País:España
Institución:Universidad de Sevilla (US)
Repositorio:idUS. Depósito de Investigación de la Universidad de Sevilla
OAI Identifier:oai:idus.us.es:11441/137492
Acceso en línea:https://hdl.handle.net/11441/137492
https://doi.org/10.1128/AAC.02099-20
Access Level:acceso abierto
Palabra clave:Ceftriaxone
Ampicillin
Enterococcus faecalis
Infective Endocarditis
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spelling Is once-daily high-dose ceftriaxone plus ampicillin an alternative for enterococcus faecalis infective endocarditis in outpatient parenteral antibiotic therapy programs?Herrera-Hidalgo, Laurade Alarcón, ArístidesLópez-Cortés, Luis E.Luque-Márquez, RafaelLópez-Cortes, Luis FernandoGutiérrez-Valencia, AliciaGil Navarro, María VictoriaCeftriaxoneAmpicillinEnterococcus faecalisInfective EndocarditisCeftriaxone administered as once-daily high-dose short infusion combined with ampicillin has been proposed for the treatment of Enterococcus faecalis infective endocarditis in outpatient parenteral antibiotic therapy programs (OPAT). This combination requires synergistic activity, but the attainment of ceftriaxone synergic concentration (Cs) with the regimen proposed for OPAT has not been studied. This phase II pharmacokinetic study enrolled healthy adult volunteers who underwent two sequential treatment phases. During phase A, volunteers received 2 g of ceftriaxone each 12 h during 24 h followed by a 7-day wash-out. Then the participants received phase B, which consisted of a single dose of 4 g of ceftriaxone. Throughout both phases, each volunteer underwent intensive pharmacokinetic (PK) sampling over 24 h. Ceftriaxone total and unbound concentrations were measured. Twelve participants were enrolled and completed both phases. Mean ceftriaxone total and free concentrations 24 h after the administration of 2 g each 12 h were 86.44 ± 25.90 mg/liter and 3.59 ± 1.35 mg/liter, respectively, and after the 4-g single dose were 34.60 ± 11.16 mg/liter and 1.40 ± 0.62 mg/liter, respectively. Only 3 (25%) patients in phase A maintained unbound plasma concentrations superior to the suggested Cs = 5 mg/liter during 24 h, and none (0%) in phase B. No grade 3 to 4 adverse events or laboratory abnormalities were observed. Ceftriaxone optimal exposure combined with ampicillin to achieve maximal synergistic activity against E. faecalis required for the treatment of infective endocarditis remains unknown. However, the administration of a single daily dose of 4 g of ceftriaxone implies a reduction in the time of exposure to the proposed Cs. (This study has been registered in the European Union Drug Regulating Authorities Clinical Trials [EudraCT] database under identifier 2017-003127-29.)American Society for MicrobiologyMedicina2021info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionapplication/pdfapplication/pdfhttps://hdl.handle.net/11441/137492https://doi.org/10.1128/AAC.02099-20reponame:idUS. Depósito de Investigación de la Universidad de Sevillainstname:Universidad de Sevilla (US)InglésAntimicrobial Agents and Chemotherapy, 65 (1), 1-8.http://doi.org/10.1128/AAC.02099-20info:eu-repo/semantics/openAccessoai:idus.us.es:11441/1374922026-06-17T12:51:07Z
dc.title.none.fl_str_mv Is once-daily high-dose ceftriaxone plus ampicillin an alternative for enterococcus faecalis infective endocarditis in outpatient parenteral antibiotic therapy programs?
title Is once-daily high-dose ceftriaxone plus ampicillin an alternative for enterococcus faecalis infective endocarditis in outpatient parenteral antibiotic therapy programs?
spellingShingle Is once-daily high-dose ceftriaxone plus ampicillin an alternative for enterococcus faecalis infective endocarditis in outpatient parenteral antibiotic therapy programs?
Herrera-Hidalgo, Laura
Ceftriaxone
Ampicillin
Enterococcus faecalis
Infective Endocarditis
title_short Is once-daily high-dose ceftriaxone plus ampicillin an alternative for enterococcus faecalis infective endocarditis in outpatient parenteral antibiotic therapy programs?
title_full Is once-daily high-dose ceftriaxone plus ampicillin an alternative for enterococcus faecalis infective endocarditis in outpatient parenteral antibiotic therapy programs?
title_fullStr Is once-daily high-dose ceftriaxone plus ampicillin an alternative for enterococcus faecalis infective endocarditis in outpatient parenteral antibiotic therapy programs?
title_full_unstemmed Is once-daily high-dose ceftriaxone plus ampicillin an alternative for enterococcus faecalis infective endocarditis in outpatient parenteral antibiotic therapy programs?
title_sort Is once-daily high-dose ceftriaxone plus ampicillin an alternative for enterococcus faecalis infective endocarditis in outpatient parenteral antibiotic therapy programs?
dc.creator.none.fl_str_mv Herrera-Hidalgo, Laura
de Alarcón, Arístides
López-Cortés, Luis E.
Luque-Márquez, Rafael
López-Cortes, Luis Fernando
Gutiérrez-Valencia, Alicia
Gil Navarro, María Victoria
author Herrera-Hidalgo, Laura
author_facet Herrera-Hidalgo, Laura
de Alarcón, Arístides
López-Cortés, Luis E.
Luque-Márquez, Rafael
López-Cortes, Luis Fernando
Gutiérrez-Valencia, Alicia
Gil Navarro, María Victoria
author_role author
author2 de Alarcón, Arístides
López-Cortés, Luis E.
Luque-Márquez, Rafael
López-Cortes, Luis Fernando
Gutiérrez-Valencia, Alicia
Gil Navarro, María Victoria
author2_role author
author
author
author
author
author
dc.contributor.none.fl_str_mv Medicina
dc.subject.none.fl_str_mv Ceftriaxone
Ampicillin
Enterococcus faecalis
Infective Endocarditis
topic Ceftriaxone
Ampicillin
Enterococcus faecalis
Infective Endocarditis
description Ceftriaxone administered as once-daily high-dose short infusion combined with ampicillin has been proposed for the treatment of Enterococcus faecalis infective endocarditis in outpatient parenteral antibiotic therapy programs (OPAT). This combination requires synergistic activity, but the attainment of ceftriaxone synergic concentration (Cs) with the regimen proposed for OPAT has not been studied. This phase II pharmacokinetic study enrolled healthy adult volunteers who underwent two sequential treatment phases. During phase A, volunteers received 2 g of ceftriaxone each 12 h during 24 h followed by a 7-day wash-out. Then the participants received phase B, which consisted of a single dose of 4 g of ceftriaxone. Throughout both phases, each volunteer underwent intensive pharmacokinetic (PK) sampling over 24 h. Ceftriaxone total and unbound concentrations were measured. Twelve participants were enrolled and completed both phases. Mean ceftriaxone total and free concentrations 24 h after the administration of 2 g each 12 h were 86.44 ± 25.90 mg/liter and 3.59 ± 1.35 mg/liter, respectively, and after the 4-g single dose were 34.60 ± 11.16 mg/liter and 1.40 ± 0.62 mg/liter, respectively. Only 3 (25%) patients in phase A maintained unbound plasma concentrations superior to the suggested Cs = 5 mg/liter during 24 h, and none (0%) in phase B. No grade 3 to 4 adverse events or laboratory abnormalities were observed. Ceftriaxone optimal exposure combined with ampicillin to achieve maximal synergistic activity against E. faecalis required for the treatment of infective endocarditis remains unknown. However, the administration of a single daily dose of 4 g of ceftriaxone implies a reduction in the time of exposure to the proposed Cs. (This study has been registered in the European Union Drug Regulating Authorities Clinical Trials [EudraCT] database under identifier 2017-003127-29.)
publishDate 2021
dc.date.none.fl_str_mv 2021
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/11441/137492
https://doi.org/10.1128/AAC.02099-20
url https://hdl.handle.net/11441/137492
https://doi.org/10.1128/AAC.02099-20
dc.language.none.fl_str_mv Inglés
language_invalid_str_mv Inglés
dc.relation.none.fl_str_mv Antimicrobial Agents and Chemotherapy, 65 (1), 1-8.
http://doi.org/10.1128/AAC.02099-20
dc.rights.none.fl_str_mv info:eu-repo/semantics/openAccess
eu_rights_str_mv openAccess
dc.format.none.fl_str_mv application/pdf
application/pdf
dc.publisher.none.fl_str_mv American Society for Microbiology
publisher.none.fl_str_mv American Society for Microbiology
dc.source.none.fl_str_mv reponame:idUS. Depósito de Investigación de la Universidad de Sevilla
instname:Universidad de Sevilla (US)
instname_str Universidad de Sevilla (US)
reponame_str idUS. Depósito de Investigación de la Universidad de Sevilla
collection idUS. Depósito de Investigación de la Universidad de Sevilla
repository.name.fl_str_mv
repository.mail.fl_str_mv
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score 15,300719

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