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...

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Detalles Bibliográficos
Autores: 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
Tipo de recurso: artículo
Estado:Versión publicada
Fecha de publicación:2025
País:España
Institución: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
Acceso en línea:https://hdl.handle.net/2445/219730
Access Level:acceso abierto
Palabra clave:Assaigs clínics
Endocarditis
Terapèutica
Clinical trials
Therapeutics
Descripción
Sumario: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.

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