Daptomycin plus fosfomycin versus daptomycin alone for methicillin-resistant staphylococcus aureus bacteremia and endocarditis: a randomized clinical trial
| العنوان: | Daptomycin plus fosfomycin versus daptomycin alone for methicillin-resistant staphylococcus aureus bacteremia and endocarditis: a randomized clinical trial |
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| المؤلفون: | María-Ángeles Domínguez, Marta Andrés, Laura Morata, Mireia Sanllorente, María-Jose Garcia-Pais, María-Del-Mar Arenas, Rosa Escudero-Sánchez, Miró Jm, Vicente Pintado, Miguel Montejo, Anna Ferrer, Guillermo Cuervo, Mrsa Bacteremia (Bacsarm) Trial Investigators, Joaquín López-Contreras, Javier Murillas, Cristian Tebé, Pilar Hereu, Mireia Puig-Asensio, Belén Padilla, Natalia Pallares, Oriol Gasch, G. García-Pardo, Rafael San-Juan, Alfredo Jover-Sáenz, Ariadna Padullés, Juan Pasquau, Miquel Pujol, Jordi Carratalà, Luis-Eduardo López-Cortes, Esther Calbo, Milagros Montero, Regino Rodriguez-Alvarez, Sebastián Videla, Jordi Càmara, Evelyn Shaw, Carles Pigrau, José María Aguado |
| المساهمون: | Ministerio de Ciencia, Innovación y Universidades (España), Red Española de Investigación en Patología Infecciosa, Instituto de Salud Carlos III, Ministerio de Economía, Industria y Competitividad (España), European Commission, Spanish Clinical Research Network, Institut d'Investigacions Biomèdiques August Pi i Sunyer, Institut Català de la Salut, [Pujol M, Shaw E] Department of Infectious Diseases, Hospital Universitari de Bellvitge, Institut Investigacions Biomèdiques de Bellvitge, University of Barcelona, Barcelona, Spain. [Miró JM] Department of Infectious Diseases, Hospital Clinic, Institut d’Investigacions Biomèdiques Agust Pi i Sunyer, University of Barcelona, Barcelona, Spain. [Aguado JM, San-Juan R] Department of Infectious Diseases, Hospital Universitario 12 Octubre, Instituto de Investigación Hospital 12 de Octubre, Universidad Complutense, Madrid, Spain. [Puig-Asensio M, Pigrau C] Servei de Malalties Infeccioses, Vall d’Hebron Hospital Universitari, Barcelona, Spain. Vall d’Hebron Institut de Recerca (VHIR), Barcelona, Spain, Vall d'Hebron Barcelona Hospital Campus |
| المصدر: | Repositorio Abierto de la UdL Universitad de Lleida Digital.CSIC. Repositorio Institucional del CSIC instname CLINICAL INFECTIOUS DISEASES r-IIB SANT PAU. Repositorio Institucional de Producción Científica del Instituto de Investigación Biomédica Sant Pau Universidad Europea (UEM) Scientia |
| بيانات النشر: | Oxford University Press, 2021. |
| سنة النشر: | 2021 |
| مصطلحات موضوعية: | 0301 basic medicine, Bacteremia, MRSA, medicine.disease_cause, Other subheadings::Other subheadings::/drug therapy [Other subheadings], terapéutica::tratamiento combinado [TÉCNICAS Y EQUIPOS ANALÍTICOS, DIAGNÓSTICOS Y TERAPÉUTICOS], Infeccions per estafilococs - Tractament, law.invention, Bacterièmia, 0302 clinical medicine, Randomized controlled trial, law, Clinical endpoint, polycyclic compounds, Medicaments antibacterians - Ús terapèutic, 030212 general & internal medicine, Endocarditis, Bacterèmia, Fosfomicina, Staphylococcal Infections, infecciones bacterianas y micosis::infecciones bacterianas::infecciones por bacterias grampositivas::infecciones estafilocócicas [ENFERMEDADES], Anti-Bacterial Agents, Clinical trial, Infectious Diseases, Treatment Outcome, Chemical Actions and Uses::Pharmacologic Actions::Therapeutic Uses::Anti-Infective Agents::Anti-Bacterial Agents [CHEMICALS AND DRUGS], lipids (amino acids, peptides, and proteins), Estafilococ aureus resistent a la meticil·lina, medicine.drug, Microbiology (medical), Adult, medicine.medical_specialty, 030106 microbiology, Otros calificadores::Otros calificadores::/farmacoterapia [Otros calificadores], Fosfomycin, acciones y usos químicos::acciones farmacológicas::usos terapéuticos::antiinfecciosos::antibacterianos [COMPUESTOS QUÍMICOS Y DROGAS], Estafilococo aureus resistente a la meticilina, 03 medical and health sciences, Daptomycin, Internal medicine, medicine, Humans, Adverse effect, business.industry, biochemical phenomena, metabolism, and nutrition, medicine.disease, bacterial infections and mycoses, Methicillin-resistant Staphylococcus aureus, Therapeutics::Combined Modality Therapy [ANALYTICAL, DIAGNOSTIC AND THERAPEUTIC TECHNIQUES, AND EQUIPMENT], carbohydrates (lipids), Daptomicina, Bacteriemia, Methicillin-resistant staphylococcus aureus, Bacterial Infections and Mycoses::Bacterial Infections::Gram-Positive Bacterial Infections::Staphylococcal Infections [DISEASES], business |
| الوصف: | [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. [Clinical Trials Registration] NCT01898338. This work was supported by the Spanish Ministry of Science, Innovation and Universities (PI12/01907); Spanish Network for Research in Infectious Diseases (RD16/0016/0005); Instituto de Salud Carlos III (ISCIII); and Spanish Ministry of Economy, Industry and Competitiveness. This work was also supported by the European Development Regional Fund “A way to achieve Europe,” Operational Programme Intelligent Growth 2014–2020; Spanish Clinical Research Network (SCReN), co-financed by the Plan Nacional de I+D and ISCIII, Subdirección General de Evaluación y Fomento de la Investigación (PT13/0002/0007); and the Grupo de Estudio de la Infección Relacionada con la Asistencia Sanitaria. J. M.-M. received a personal 80:20 research grant from the Institut d’Investigacions Biomèdiques Agust Pi i Sunyer, Barcelona, Spain, during 2017–2021. |
| وصف الملف: | application/pdf |
| اللغة: | English |
| تدمد: | 1058-4838 |
| الوصول الحر: | https://explore.openaire.eu/search/publication?articleId=doi_dedup___::66401b9c2a5f062323c54d908e2533adTest http://hdl.handle.net/20.500.12328/2758Test |
| حقوق: | OPEN |
| رقم الانضمام: | edsair.doi.dedup.....66401b9c2a5f062323c54d908e2533ad |
| قاعدة البيانات: | OpenAIRE |
| تدمد: | 10584838 |
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