Seven-versus 14-day course of antibiotics for the treatment of bloodstream infections by Enterobacterales: a randomized, controlled trial

Objective: To prove that 7-day courses of antibiotics for bloodstream infections caused by members of the Enterobacterales (eBSIs) allow a reduction in patients' exposure to antibiotics while achieving clinical outcomes similar to those of 14-day schemes. Methods: A randomized trial was perform...

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Detalles Bibliográficos
Autores: Molina, Jose, Montero-Mateos, Enrique, Praena-Segovia, Julia, Leon-Jimenez, Eva, Natera, Clara, Lopez-Cortes, Luis E, Valiente, Lucía, Rosso-Fernandez, Clara M, Herrero, Marta, Aller-García, Ana I., Cano, Angela, Gutierrez-Gutierrez, Belen, Marquez-Gomez, Ignacio, Alvarez-Marín, Rocío, Infante, Carmen, Roca, Cristina, Valiente-Mendez, Adoracion, Pachon, Jeronimo, Reguera, Jose María, Corzo-Delgado, Juan Enrique, Torre-Cisneros, Julian, Rodríguez-Baño, Jesús, Cisneros, Jose Miguel
Tipo de recurso: artículo
Fecha de publicación:2021
País:España
Institución:Universidad Loyola Andalucía
Repositorio:Brújula
OAI Identifier:oai:repositorio.uloyola.es:20.500.12412/7129
Acceso en línea:https://hdl.handle.net/20.500.12412/7129
Access Level:acceso abierto
Palabra clave:Antimicrobial stewardship
Bacteraemia
Bloodstream infections
DOOR/RADAR
Treatment duration
Descripción
Sumario:Objective: To prove that 7-day courses of antibiotics for bloodstream infections caused by members of the Enterobacterales (eBSIs) allow a reduction in patients' exposure to antibiotics while achieving clinical outcomes similar to those of 14-day schemes. Methods: A randomized trial was performed. Adult patients developing eBSI with appropriate source control were assigned to 7 or 14 days of treatment, and followed 28 days after treatment cessation; treatments could be resumed whenever necessary. The primary endpoint was days of treatment at the end of follow-up. Clinical outcomes included clinical cure, relapse of eBSI and relapse of fever. A superiority margin of 3 days was set for the primary endpoint, and a non-inferiority margin of 10% was set for clinical outcomes. Efficacy and safety were assessed together with a DOOR/RADAR (desirability of outcome ranking and response adjusted for duration of antibiotic risk) analysis. Results: 248 patients were assigned to 7 (n ¼ 119) or 14 (n ¼ 129) days of treatment. In the intention-totreat analysis, median days of treatment at the end of follow-up were 7 and 14 days (difference 7, 95%CI 7 e7). The non-inferiority margin was also met for clinical outcomes, except for relapse of fever (e0.2%, 95%CI e10.4 to 10.1). The DOOR/RADAR showed that 7-day schemes had a 77.7% probability of achieving better results than 14-day treatments. Conclusions: 7-day schemes allowed a reduction in antibiotic exposure of patients with eBSI while achieving outcomes similar to those of 14-day schemes. The possibility of relapsing fever in a limited