Daptomycin Plus Fosfomycin Versus Daptomycin Alone for Methicillin-resistant Staphylococcus aureus Bacteremia and Endocarditis: A Randomized Clinical Trial.
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Pujol Miquel, Miró José-María, Shaw Evelyn, Aguado Jose-María, San-Juan Rafael, Puig-Asensio Mireia, Pigrau Carles, Calbo Esther, Montejo Miguel, Rodriguez-Álvarez Regino, Garcia-Pais María-Jose, Pintado Vicente, Escudero-Sánchez Rosa, Lopez-Contreras Joaquín, Morata Laura, Montero Milagros, Andrés Marta, Pasquau Juan, Arenas María-Del-Mar, Padilla Belén, Murillas Javier, Jover-Sáenz Alfredo, López-Cortes Luis-Eduardo, García-Pardo Graciano, Gasch Oriol, Videla Sebastian, Hereu Pilar, Tebé Cristian, Pallarès Natalia, Sanllorente Mireia, Domínguez María-Ángeles, Càmara Jordi, Ferrer Anna, Padullés Ariadna, Cuervo Guillermo, Carratalà Jordi, MRSA Bacteremia (BACSARM) Trial Investigators
Аннотация
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.
CLINICAL TRIALS REGISTRATION: NCT01898338.