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Introduction <p>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.</p> Methods <p>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&#xa0;months after completing antibiotic therapy.</p> Planned Outcome <p>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.</p> Conclusion <p>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.</p> Trial Registration <p>EudraCT: 2020-001024-34. ClinicalTrials.gov identifier: NCT05398679.</p>

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Oral vs. Outpatient Parenteral Antimicrobial Treatment for Infective Endocarditis: Study Protocol for the Spanish OraPAT-IE GAMES Trial

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  • 发表日期：

    2025年3月1日

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  • Guillermo Cuervo,
  • Marta Hernández-Meneses,
  • Arístides de Alarcón,
  • Rafael Luque-Marquez,
  • María M. Alonso-Socas,
  • Ana López-Lirola,
  • Víctor González-Ramallo,
  • Ane J. Goikoetxea-Agirre,
  • David Nicolás,
  • Miguel A. Goenaga,
  • Esperanza Merino,
  • Francesc Escrihuela-Vidal,
  • Pilar Martín-Dávila,
  • Belén Loeches,
  • Lucía Boix-Palop,
  • Oriol Gasch,
  • Marta Camprecios,
  • Alicia Hernández-Torres,
  • Lara García-Álvarez,
  • Marcos Pajarón,
  • María Angels Ribas,
  • Rosa Blanes-Hernández,
  • Inmaculada López-Montesinos,
  • Luis E. López-Cortés,
  • Bárbara Vidal,
  • Mariana Fernández-Pittol,
  • Dolores Navarro,
  • Asunción Moreno,
  • Coral Sala,
  • Juan Ambrosioni,
  • José M. Miró,
  • Rut Andrea,
  • Manuel Almela,
  • Jorge Alcocer,
  • María Ascaso,
  • Manuel Azqueta,
  • Mercè Brunet,
  • Ramón Cartañá,
  • Manuel Castellá,
  • María Alexandra Cañas,
  • Guillermo Cuervo,
  • Oriol de Diego,
  • Carlos Falces,
  • Mateu Espasa,
  • Mariana Fernández-Pittol,
  • Guillermina Fita,
  • David Fuster,
  • Cristina García de la María,
  • Delia García-Pares,
  • Marta Hernández-Meneses,
  • Jaume Llopis-Pérez,
  • Teresa López,
  • Francesc Marco,
  • José M. Miró,
  • Asunción Moreno,
  • David Nicolás,
  • Salvador Ninot,
  • José Ortiz,
  • Carlos Paré,
  • Daniel Pereda,
  • Juan M. Pericás,
  • Andrés Perissinotti,
  • José L. Pomar,
  • Eduard Quintana,
  • José Ramírez,
  • Ander Regueiro,
  • Carlos Roca,
  • Mercè Roque,
  • Irene Rovira,
  • Elena Sandoval,
  • Laura Sanchis,
  • Marta Sitges,
  • Dolors Soy,
  • Adrián Téllez,
  • José M. Tolosana,
  • Xabier Urra,
  • Bárbara Vidal,
  • Montse Tuset,
  • Jordi Vila,
  • Arístides de Alarcón,
  • Dolores Navarro-Amuedo,
  • Encarnación Gutiérrez-Carretero,
  • José Antonio Lepe,
  • José López-Haldón,
  • Rafael Luque-Márquez,
  • Guillermo Marín,
  • Antonio Ortiz-Carrellán,
  • Eladio Sánchez-Domínguez,
  • Manuel Poyato-Borrego,
  • María del Mar Alonso,
  • Beatriz Castro,
  • Teresa Delgado-Melian,
  • Javier Fernández-Sarabia,
  • Dácil García-Rosado,
  • Julia González González,
  • Juan Lacalzada,
  • Lissete Lorenzo de la Peña,
  • Alina Pérez-Ramírez,
  • Pablo Prada-Arrondo,
  • Fermín Rodríguez-Moreno,
  • Iván Adán,
  • Juan Carlos Alonso,
  • Ana Álvarez-Uría,
  • Javier Bermejo,
  • Emilio Bouza,
  • Javier Calatayud,
  • Gregorio Cuerpo-Caballero,
  • Antonia Delgado-Montero,
  • Agustín Estévez,
  • Ramón Fortuny-Ribas,
  • Esther Gargallo,
  • María Eugenia García-Leoni,
  • Ana González Mansilla,
  • Francisco Javier González-Moraga,
  • Víctor González-Ramallo,
  • Martha Kestler-Hernández,
  • Amaia Mari Hualde,
  • Marina Machado,
  • Mercedes Marín,
  • Manuel Martínez-Sellés,
  • Rosa Melero,
  • Patricia Muñoz,
  • Diego Monzón,
  • María Olmedo,
  • Álvaro Pedraz,
  • Blanca Pinilla,
  • Ángel Pinto,
  • Cristina Rincón,
  • Hugo Rodríguez-Abella,
  • Eduardo Sánchez-Pérez,
  • Antonio Segado,
  • Maricela Valerio,
  • Pilar Vázquez,
  • Eduardo Verde-Moreno,
  • Sofía de la Villa,
  • Elena Bereciartua,
  • María José Blanco-Vidal,
  • Roberto Blanco,
  • María Victoria Boado,
  • Marta Campaña-Lázaro,
  • Alejandro Crespo,
  • Laura Guio-Carrión,
  • Mikel Del Álamo Martínez de Lagos,
  • Gorane Euba-Ugarte,
  • Ane Josune Goikoetxea,
  • Marta Ibarrola-Hierro,
  • José Ramón Iruretagoyena,
  • Josu Irurzun-Zuazabal,
  • Leire López-Soria,
  • Miguel Montejo,
  • Javier Nieto,
  • David Rodrigo,
  • Regino Rodríguez,
  • Yolanda Vitoria,
  • Roberto Voces,
  • Ignacio Álvarez-Rodríguez,
  • Xabier Camino,
  • Harkaitz Azkune-Galparsoro,
  • Elisa Berritu-Boronat,
  • María Jesús Bustinduy-Odriozola,
  • Cristina del Bosque-Martín,
  • Tomás Echeverría,
  • Alberto Eizaguirre-Yarza,
  • Ana Fuentes,
  • Miguel Ángel Goenaga,
  • Muskilda Goyeneche del Río,
  • Ángela Granda-Bauza,
  • José Antonio Iribarren,
  • Xabier Kortajarena-Urkola,
  • José Ignacio Pérez-Moreiras-López,
  • Ainhoa Rengel-Jiménez,
  • Karlos Reviejo,
  • Alberto Sáez-Berbejillo,
  • Elou Sánchez-Haza,
  • Rosa Sebastián-Alda,
  • Itziar Solla-Ruiz,
  • Irati Unamuno-Ugartemendia,
  • Diego Vicente-Anza,
  • Iñaki Villanueva-Benito,
  • Mar Zabalo-Arrieta,
  • Sara Sánchez,
  • Mikel Bidegain,
  • Muskilda Goyeneche,
  • Rafael Carrasco,
  • Vicente Climent,
  • Patricio Llamas,
  • Esperanza Merino,
  • Joaquín Plazas,
  • Sergio Reus,
  • Héctor Pinargote-Celorio,
  • Pilar González-de-la-Aleja,
  • Francesc Escrihuela-Vidal,
  • Jordi Carratalà,
  • Inmaculada Grau,
  • Carmen Ardanuy,
  • Dámaris Berbel,
  • José Carlos Sánchez-Salado,
  • Oriol Alegre,
  • Alejandro Ruiz-Majoral,
  • Fabrizio Sbraga,
  • Arnau Blasco,
  • Laura Gracia-Sánchez,
  • Iván Sánchez-Rodríguez,
  • Tomasa Centella,
  • Jos Manuel Hermida,
  • José Luis Moya,
  • Pilar Martín-Dávila,
  • Enrique Navas,
  • Enrique Oliva,
  • Alejandro del Río,
  • Jorge Rodríguez-Roda-Stuart,
  • Soledad Ruiz,
  • Isabel Antorrena,
  • Belén Loeches,
  • Mar Moreno,
  • Ulises Ramírez,
  • Verónica Rial-Bastón,
  • María Romero,
  • Sandra Rosillo,
  • Cristina Badía,
  • Lucía Boix-Palop,
  • Mariona Xercavins,
  • Sónia Ibars,
  • Beatriz Dietl,
  • Gastón Araujo,
  • Francesca Castaldo,
  • Eva Guillaumet,
  • Laura Guillamon,
  • Silvia Capilla,
  • Lucía Lozano,
  • Emili Díaz,
  • Sonia Calzado,
  • Aina Gomila,
  • Víctor Monsálvez,
  • Oriol Gasch,
  • Marta Camprecios,
  • Antonio Barros-Membrilla,
  • Antonino Ginel-Iglesias,
  • Sara Grillo,
  • Rubén Leta-Petracca,
  • Joaquín López-Contreras,
  • María Alba Rivera-Martínez,
  • Laura Albert,
  • Sergio Cánovas,
  • Elisa García Vázquez,
  • Alicia Hernández-Torres,
  • Ana Blázquez,
  • Gonzalo de la Morena Valenzuela,
  • José H. de Gea,
  • María Carmen Martínez-Toldos,
  • Encarnación Moral-Escudero,
  • María José Oliva,
  • Alejandro Ortín,
  • Joaquín Pérez-Andreu,
  • Avchel Roura-Piloto,
  • Daniel Saura,
  • Luis Javier Alonso,
  • Pedro Azcárate,
  • José Manuel Azcona-Gutiérrez,
  • José Ramón Blanco,
  • Estíbaliz Corral-Armas,
  • Lara García-Álvarez,
  • José Antonio Oteo,
  • Natalia Martín-Blanco,
  • Jesús Agüero-Balbín,
  • Cristina Amado-Fernández,
  • Carlos Armiñanzas-Castillo,
  • Francisco Arnaiz de las Revillas,
  • Manuel Cobo-Belaustegui,
  • María Carmen Fariñas,
  • Concepción Fariñas-Álvarez,
  • Marta Fernández-Sampedro,
  • Iván García,
  • Raquel Garrido,
  • Claudia González-Rico,
  • Laura Gutiérrez-Fernández,
  • Manuel Gutiérrez-Cuadra,
  • José Gutiérrez-Díez,
  • Marcos Pajarón,
  • José Antonio Parra,
  • Noelia Ruiz-Alonso,
  • Ramón Teira,
  • Jesús Zarauza,
  • María Ángels Ribas-Blanco,
  • Enrique Ruiz de Gopegui-Bordes,
  • Laura Vidal-Bonet,
  • Miquel Vives-Borràs,
  • Rosa Blanes-Hernández,
  • Miguel Ángel Arnau-Vives,
  • Diana Domingo-Valero,
  • Mariona Tasias-Pitarch,
  • Marta Montero-Alonso,
  • Eva Calabuig-Muñoz,
  • Juan Antonio Fernández-Navarro,
  • Víctor García-Bustos,
  • Miguel Salavert-Lleti,
  • Inmaculada López-Montesinos,
  • Mireia Ble,
  • Juan Pablo Horcajada-Gallego,
  • Antonio José Ginel,
  • Alexandra Mas,
  • Antoni Mestres,
  • Lluís Molina,
  • Ramón Serrat,
  • Núria Ribas,
  • Francisca Sánchez,
  • Ana Silverio,
  • Marina Suárez,
  • Luisa Sorlí,
  • Lluís Recasens,
  • Manuel Taurón,
  • Alicia Calvo-Fernández,
  • Ariadna Brasé,
  • Manuel Almendro-Delia,
  • Omar Araji,
  • José Miguel Barquero,
  • Román Calvo-Jambrina,
  • Marina de Cueto,
  • Irene Méndez,
  • Isabel Morales,
  • Luis Eduardo López-Cortés,
  • Paula Olivares

摘要

Introduction

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.

Methods

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.

Planned Outcome

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.

Conclusion

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.

Trial Registration

EudraCT: 2020-001024-34. ClinicalTrials.gov identifier: NCT05398679.