Daptomycin Plus Fosfomycin Versus Daptomycin Alone for Methicillin-resistant Staphylococcus aureus Bacteremia and Endocarditis: A Randomized Clinical Trial

Background. We aimed to determine whether daptomycin plus fosfomycin provides higher treatment success than daptomycin alone for methicillin-resistant Staphylococcus aureus (MRSA) bacteremia and endocarditis. Methods. A randomized (1:1) phase 3 superiority, open-label, and parallel group clinical tr...

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Detalhes bibliográficos
Autores: Pujol, Miquel, Miró, José María, Shaw, Evelyn, Aguado, José María, San-Juan, Rafael, Puig-Asensio, Mireia, Pigrau, Carles, Calbo, Esther, Montejo, Miguel, Rodriguez-Alvarez, Regino, Garcia-Pais, Maria-Jose, Pintado, Vicente, Escudero-Sanchez, Rosa, Lopez-Contreras, Joaquin, Morata, Laura, Montero, Milagros, Andres, Marta, Pasquau, Juan, Arenas, Maria-del-Mar, Padilla, Belen, Murillas, Javier, Jover-Saenz, Alfredo, Lopez-Cortes, Luis Eduardo, Garcia-Pardo, Graciano, Gasch, Oriol, Videla, Sebastian, Hereu, Pilar, Tebe, Cristian, Pallares, Natalia, Sanllorente, Mireia, Dominguez, Maria-Angeles, Camara, Jordi, Ferrer, Ana, Padulles, Ariadna, Cuervo, Guillermo, Carratalà, Jordi, MRSA Bacteremia (BACSARM) Trial Investigators
Formato: artículo
Fecha de publicación:2021
País:España
Recursos:Instituto de Salud Carlos III (ISCIII)
Repositorio:Repisalud
Idioma:inglés
OAI Identifier:oai:repisalud.isciii.es:20.500.12105/23328
Acesso em linha:https://hdl.handle.net/20.500.12105/23328
Access Level:acceso abierto
Palavra-chave:MRSA
Bacteremia
Daptomycin
Fosfomycin
Clinical trial
Endocarditis
Staphylococcus aureus Resistente a Meticilina
Resultado del Tratamiento
Daptomicina
Humanos
Infecciones Estafilocócicas
Fosfomicina
Bacteriemia
Adulto
Antibacterianos
Adult
Anti-Bacterial Agents
Methicillin-Resistant Staphylococcus aureus
Treatment Outcome
Humans
Staphylococcal Infections
Descrição
Resumo:Background. We aimed to determine whether daptomycin plus fosfomycin provides higher treatment success than daptomycin alone for methicillin-resistant Staphylococcus aureus (MRSA) bacteremia and endocarditis. Methods. A randomized (1:1) phase 3 superiority, open-label, and parallel group clinical trial of adult inpatients with MRSA bacteremia was conducted at 18 Spanish hospitals. Patients were randomly assigned to receive either 10 mg/kg of daptomycin intravenously daily plus 2 g of fosfomycin intravenously every 6 hours, or 10 mg/kg of daptomycin intravenously daily. Primary endpoint was treatment success 6 weeks after the end of therapy. Results. of 167 patients randomized, 155 completed the trial and were assessed for the primary endpoint. Treatment success at 6 weeks after the end of therapy was achieved in 40 of 74 patients who received daptomycin plus fosfomycin and in 34 of 81 patients who were given daptomycin alone (54.1% vs 42.0%; relative risk, 1.29 [95% confidence interval, .93-1.8]; P = .135). At 6 weeks, daptomycin plus fosfomycin was associated with lower microbiologic failure (0 vs 9 patients; P = .003) and lower complicated bacteremia (16.2% vs 32.1%; P = .022). Adverse events leading to treatment discontinuation occurred in 13 of 74 patients (17.6%) receiving daptomycin plus fosfomycin, and in 4 of 81 patients (4.9%) receiving daptomycin alone (P = .018). Conclusions. Daptomycin plus fosfomycin provided 12% higher rate of treatment success than daptomycin alone, but this difference did not reach statistical significance. This antibiotic combination prevented microbiological failure and complicated bacteremia, but it was more often associated with adverse events.

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