Oral vs. Outpatient Parenteral Antimicrobial Treatment for Infective Endocarditis: Study Protocol for the Spanish OraPAT-IE GAMES Trial.
The POET trial demonstrated that moving from intravenous to oral antibiotics in stable patients with left-sided infective endocarditis (IE) was noninferior to fully parenteral treatment. However, it did not compare outpatient strategies. The OraPAT-IE GAMES trial is a noninferiority, multicenter, ra...
| Autores: | , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , |
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| Formato: | artículo |
| Estado: | Versión publicada |
| Fecha de publicación: | 2025 |
| País: | España |
| Recursos: | Varias* (Consorci de Biblioteques Universitáries de Catalunya, Centre de Serveis Científics i Acadèmics de Catalunya) |
| Repositorio: | Recercat. Dipósit de la Recerca de Catalunya |
| OAI Identifier: | oai:recercat.cat:2445/219730 |
| Acesso em linha: | https://hdl.handle.net/2445/219730 |
| Access Level: | acceso abierto |
| Palavra-chave: | Assaigs clínics Endocarditis Terapèutica Clinical trials Therapeutics |
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Oral vs. Outpatient Parenteral Antimicrobial Treatment for Infective Endocarditis: Study Protocol for the Spanish OraPAT-IE GAMES Trial.Cuervo Requena, GuillermoHernández Meneses, MartaAlarcón, A. DeLuque Márquez, R.Alonso Socas, M. M.López Lirola, A.González Ramallo, VíctorGoikoetxea Agirre, A. J.Nicolás, DavidGoenaga, M. Á.Merino Cabrera, EsperanzaEscrihuela-Vidal, FrancescMartín Dávila, P.Loeches, B.Boix Palop, LuciaGasch, O.Camprecios, M.Hernández Torres, A.García Álvarez, L.Pajarón, M.Ribas, M. A.Blanes Hernández, R.López Montesinos, I.López Cortés, L. E.Vidal, B.Fernández Pittol, M.Navarro, D.Moreno, A.Sala, C.Ambrosioni Czyrko, Juan Carlos EnriqueMiró Meda, José M. (José María), 1956-OraPAT-IE GAMES InvestigatorsAssaigs clínicsEndocarditisTerapèuticaClinical trialsEndocarditisTherapeuticsThe POET trial demonstrated that moving from intravenous to oral antibiotics in stable patients with left-sided infective endocarditis (IE) was noninferior to fully parenteral treatment. However, it did not compare outpatient strategies. The OraPAT-IE GAMES trial is a noninferiority, multicenter, randomized, open-label study aimed to compare partial oral versus outpatient parenteral antibiotic therapy (OPAT) for consolidation of antibiotic treatment in left-sided IE. A total of 342 stable patients with IE caused by selected micro-organisms will eventually be included. After a minimum of 10 days of parenteral treatment, stable patients are randomized to oral therapy or OPAT. The primary end-point is a composite of all-cause mortality, unplanned cardiac surgery, relapse of positive blood cultures and/or unplanned hospital admission. Patients are followed-up for 6 months after completing antibiotic therapy. This trial seeks to demonstrate the equivalent efficacy of the two outpatient strategies currently available for stable patients with IE in the consolidation phase of antibiotic treatment. In a global context of limited healthcare resources and a sustained increase in elderly and frail patients, it is of great importance to demonstrate the effectiveness and safety of outpatient management strategies that could reduce the duration of conventional hospitalizations with their potential complications and inherent costs. EudraCT: 2020-001024-34. gov identifier: NCT05398679.Spinger Nature2025202520252025info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersion13 p.application/pdfhttps://hdl.handle.net/2445/219730Articles publicats en revistes (IDIBAPS: Institut d'investigacions Biomèdiques August Pi i Sunyer)reponame:Recercat. Dipósit de la Recerca de Catalunyainstname:Varias* (Consorci de Biblioteques Universitáries de Catalunya, Centre de Serveis Científics i Acadèmics de Catalunya)InglésReproducció del document publicat a: https://doi.org/10.1007/s40121-025-01110-9Infectious diseases and therapy, 2025https://doi.org/10.1007/s40121-025-01110-9cc-by-nc (c) Cuervo Requena, Guillermo et al., 2025http://creativecommons.org/licenses/by-nc/3.0/es/info:eu-repo/semantics/openAccessoai:recercat.cat:2445/2197302026-05-29T05:05:01Z |
| dc.title.none.fl_str_mv |
Oral vs. Outpatient Parenteral Antimicrobial Treatment for Infective Endocarditis: Study Protocol for the Spanish OraPAT-IE GAMES Trial. |
| title |
Oral vs. Outpatient Parenteral Antimicrobial Treatment for Infective Endocarditis: Study Protocol for the Spanish OraPAT-IE GAMES Trial. |
| spellingShingle |
Oral vs. Outpatient Parenteral Antimicrobial Treatment for Infective Endocarditis: Study Protocol for the Spanish OraPAT-IE GAMES Trial. Cuervo Requena, Guillermo Assaigs clínics Endocarditis Terapèutica Clinical trials Endocarditis Therapeutics |
| title_short |
Oral vs. Outpatient Parenteral Antimicrobial Treatment for Infective Endocarditis: Study Protocol for the Spanish OraPAT-IE GAMES Trial. |
| title_full |
Oral vs. Outpatient Parenteral Antimicrobial Treatment for Infective Endocarditis: Study Protocol for the Spanish OraPAT-IE GAMES Trial. |
| title_fullStr |
Oral vs. Outpatient Parenteral Antimicrobial Treatment for Infective Endocarditis: Study Protocol for the Spanish OraPAT-IE GAMES Trial. |
| title_full_unstemmed |
Oral vs. Outpatient Parenteral Antimicrobial Treatment for Infective Endocarditis: Study Protocol for the Spanish OraPAT-IE GAMES Trial. |
| title_sort |
Oral vs. Outpatient Parenteral Antimicrobial Treatment for Infective Endocarditis: Study Protocol for the Spanish OraPAT-IE GAMES Trial. |
| dc.creator.none.fl_str_mv |
Cuervo Requena, Guillermo Hernández Meneses, Marta Alarcón, A. De Luque Márquez, R. Alonso Socas, M. M. López Lirola, A. González Ramallo, Víctor Goikoetxea Agirre, A. J. Nicolás, David Goenaga, M. Á. Merino Cabrera, Esperanza Escrihuela-Vidal, Francesc Martín Dávila, P. Loeches, B. Boix Palop, Lucia Gasch, O. Camprecios, M. Hernández Torres, A. García Álvarez, L. Pajarón, M. Ribas, M. A. Blanes Hernández, R. López Montesinos, I. López Cortés, L. E. Vidal, B. Fernández Pittol, M. Navarro, D. Moreno, A. Sala, C. Ambrosioni Czyrko, Juan Carlos Enrique Miró Meda, José M. (José María), 1956- OraPAT-IE GAMES Investigators |
| author |
Cuervo Requena, Guillermo |
| author_facet |
Cuervo Requena, Guillermo Hernández Meneses, Marta Alarcón, A. De Luque Márquez, R. Alonso Socas, M. M. López Lirola, A. González Ramallo, Víctor Goikoetxea Agirre, A. J. Nicolás, David Goenaga, M. Á. Merino Cabrera, Esperanza Escrihuela-Vidal, Francesc Martín Dávila, P. Loeches, B. Boix Palop, Lucia Gasch, O. Camprecios, M. Hernández Torres, A. García Álvarez, L. Pajarón, M. Ribas, M. A. Blanes Hernández, R. López Montesinos, I. López Cortés, L. E. Vidal, B. Fernández Pittol, M. Navarro, D. Moreno, A. Sala, C. Ambrosioni Czyrko, Juan Carlos Enrique Miró Meda, José M. (José María), 1956- OraPAT-IE GAMES Investigators |
| author_role |
author |
| author2 |
Hernández Meneses, Marta Alarcón, A. De Luque Márquez, R. Alonso Socas, M. M. López Lirola, A. González Ramallo, Víctor Goikoetxea Agirre, A. J. Nicolás, David Goenaga, M. Á. Merino Cabrera, Esperanza Escrihuela-Vidal, Francesc Martín Dávila, P. Loeches, B. Boix Palop, Lucia Gasch, O. Camprecios, M. Hernández Torres, A. García Álvarez, L. Pajarón, M. Ribas, M. A. Blanes Hernández, R. López Montesinos, I. López Cortés, L. E. Vidal, B. Fernández Pittol, M. Navarro, D. Moreno, A. Sala, C. Ambrosioni Czyrko, Juan Carlos Enrique Miró Meda, José M. (José María), 1956- OraPAT-IE GAMES Investigators |
| author2_role |
author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author |
| dc.subject.none.fl_str_mv |
Assaigs clínics Endocarditis Terapèutica Clinical trials Endocarditis Therapeutics |
| topic |
Assaigs clínics Endocarditis Terapèutica Clinical trials Endocarditis Therapeutics |
| description |
The POET trial demonstrated that moving from intravenous to oral antibiotics in stable patients with left-sided infective endocarditis (IE) was noninferior to fully parenteral treatment. However, it did not compare outpatient strategies. The OraPAT-IE GAMES trial is a noninferiority, multicenter, randomized, open-label study aimed to compare partial oral versus outpatient parenteral antibiotic therapy (OPAT) for consolidation of antibiotic treatment in left-sided IE. A total of 342 stable patients with IE caused by selected micro-organisms will eventually be included. After a minimum of 10 days of parenteral treatment, stable patients are randomized to oral therapy or OPAT. The primary end-point is a composite of all-cause mortality, unplanned cardiac surgery, relapse of positive blood cultures and/or unplanned hospital admission. Patients are followed-up for 6 months after completing antibiotic therapy. This trial seeks to demonstrate the equivalent efficacy of the two outpatient strategies currently available for stable patients with IE in the consolidation phase of antibiotic treatment. In a global context of limited healthcare resources and a sustained increase in elderly and frail patients, it is of great importance to demonstrate the effectiveness and safety of outpatient management strategies that could reduce the duration of conventional hospitalizations with their potential complications and inherent costs. EudraCT: 2020-001024-34. gov identifier: NCT05398679. |
| publishDate |
2025 |
| dc.date.none.fl_str_mv |
2025 2025 2025 2025 |
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info:eu-repo/semantics/article info:eu-repo/semantics/publishedVersion |
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article |
| status_str |
publishedVersion |
| dc.identifier.none.fl_str_mv |
https://hdl.handle.net/2445/219730 |
| url |
https://hdl.handle.net/2445/219730 |
| dc.language.none.fl_str_mv |
Inglés |
| language_invalid_str_mv |
Inglés |
| dc.relation.none.fl_str_mv |
Reproducció del document publicat a: https://doi.org/10.1007/s40121-025-01110-9 Infectious diseases and therapy, 2025 https://doi.org/10.1007/s40121-025-01110-9 |
| dc.rights.none.fl_str_mv |
cc-by-nc (c) Cuervo Requena, Guillermo et al., 2025 http://creativecommons.org/licenses/by-nc/3.0/es/ info:eu-repo/semantics/openAccess |
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cc-by-nc (c) Cuervo Requena, Guillermo et al., 2025 http://creativecommons.org/licenses/by-nc/3.0/es/ |
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openAccess |
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13 p. application/pdf |
| dc.publisher.none.fl_str_mv |
Spinger Nature |
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Spinger Nature |
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Articles publicats en revistes (IDIBAPS: Institut d'investigacions Biomèdiques August Pi i Sunyer) reponame:Recercat. Dipósit de la Recerca de Catalunya instname:Varias* (Consorci de Biblioteques Universitáries de Catalunya, Centre de Serveis Científics i Acadèmics de Catalunya) |
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Recercat. Dipósit de la Recerca de Catalunya |
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