Daptomycin Plus Fosfomycin Versus Daptomycin Alone for Methicillin-resistant Staphylococcus aureus Bacteremia and Endocarditis: A Randomized Clinical Trial
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| Název: | Daptomycin Plus Fosfomycin Versus Daptomycin Alone for Methicillin-resistant Staphylococcus aureus Bacteremia and Endocarditis: A Randomized Clinical Trial |
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| Autoři: | Miquel Pujol, José-María Miró, Evelyn Shaw, Jose-María Aguado, Rafael San-Juan, Mireia Puig-Asensio, Carles Pigrau, Esther Calbo, Miguel Montejo, Regino Rodriguez-Álvarez, María-Jose Garcia-Pais, Vicente Pintado, Rosa Escudero-Sánchez, Joaquín Lopez-Contreras, Laura Morata, Milagros Montero, Marta Andrés, Juan Pasquau, María-del-Mar Arenas, Belén Padilla, Javier Murillas, Alfredo Jover-Sáenz, Luis-Eduardo López-Cortes, Graciano García-Pardo, Oriol Gasch, Sebastian Videla, Pilar Hereu, Cristian Tebé, Natalia Pallarès, Mireia Sanllorente, María-Ángeles Domínguez, Jordi Càmara, Anna Ferrer, Ariadna Padullés, Guillermo Cuervo, Jordi Carratalà, Alex Soriano, Manel Almela, Frederic Gómez, Fernando Chávez, Beatriz Mirelis, Emma Padilla, Maria Dolores Pérez-Ramírez, Mateu Espasa, Ana Maria Sánchez-Díaz, Emilia Cercenado, Enrique Ruiz de Gopegui, Ana Siverio, Marina de Cueto, Fernando García-Garrote, Mercè Garcia, Mariona Xercavins, Maria Nieves Larrosa |
| Přispěvatelé: | MRSA Bacteremia (BACSARM) Trial Investigators, Spanish Ministry of Science, Innovation and Universities, Spanish Network for Research in Infectious Diseases, Instituto de Salud Carlos III (ISCIII), 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, Consejo Superior de Investigaciones Científicas [https://ror.org/02gfc7t72], 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 |
| Zdroj: | Clin Infect Dis Repisalud Instituto de Salud Carlos III (ISCIII) CLINICAL INFECTIOUS DISEASES r-IIB SANT PAU. Repositorio Institucional de Producción Científica del Instituto de Investigación Biomédica Sant Pau Institut dInvestigació Biomèdica Sant Pau (IIB Sant Pau) RISalud-ANDALUCIA. Repositorio Institucional de Salud de Andalucía instname Articles publicats en revistes (Patologia i Terapèutica Experimental) Dipòsit Digital de la UB Digital.CSIC. Repositorio Institucional del CSIC Consejo Superior de Investigaciones Científicas (CSIC) Docusalut Conselleria de Salut i Consum del Govern de les Illes Balears Repositorio Abierto de la UdL Universitad de Lleida r-I3PT. Repositorio Institucional Producción Científica del Institut d'Investigació i Innovació Parc Taulí Universidad Europea (UEM) Scientia Scientia. Dipòsit d'Informació Digital del Departament de Salut Repositori Obert UdL Repositorio Institucional de la Consejería de Sanidad de la Comunidad de Madrid Consejería de Sanidad de la Comunidad de Madrid Universidad de Barcelona |
| Informace o vydavateli: | Oxford University Press (OUP), 2020. |
| Rok vydání: | 2020 |
| Témata: | Otros calificadores::Otros calificadores::Otros calificadores::/farmacoterapia, daptomycin, Terapéutica, Bacteremia, MRSA, Communicable diseases, Infeccions per estafilococs - Tractament, Bacteris, Bacterièmia, Clinical trials, 0302 clinical medicine, Antibiotics, Medicaments antibacterians - Ús terapèutic, fosfomycin, ANALYTICAL, DIAGNOSTIC AND THERAPEUTIC TECHNIQUES, AND EQUIPMENT::Therapeutics::Combined Modality Therapy, Other subheadings::Other subheadings::Other subheadings::/drug therapy, Endocarditis, Adulto, Staphylococcus aureus Resistente a Meticilina, Bacterèmia, Fosfomicina, ENFERMEDADES::infecciones bacterianas y micosis::infecciones bacterianas::infecciones por bacterias grampositivas::infecciones estafilocócicas, clinical trial, Staphylococcal Infections, Humanos, Anti-Bacterial Agents, 3. Good health, Clinical trial, Treatment Outcome, Antibacterianos, Estafilococ aureus resistent a la meticil·lina, Hospitales, TÉCNICAS Y EQUIPOS ANALÍTICOS, DIAGNÓSTICOS Y TERAPÉUTICOS::terapéutica::tratamiento combinado, Adult, Methicillin-Resistant Staphylococcus aureus, Infecciones Estafilocócicas, Resultado del Tratamiento, Antibiòtics, Estafilococo aureus resistente a la meticilina, 03 medical and health sciences, Daptomycin, Fosfomycin, Ensayo clínico, Humans, bacteremia, Bacteria, Malalties infeccioses, DISEASES::Bacterial Infections and Mycoses::Bacterial Infections::Gram-Positive Bacterial Infections::Staphylococcal Infections, Staphylococcus aureus resistente a Meticilina, Major Articles and Commentaries, CHEMICALS AND DRUGS::Chemical Actions and Uses::Pharmacologic Actions::Therapeutic Uses::Anti-Infective Agents::Anti-Bacterial Agents, Daptomicina, Bacteriemia, Methicillin-resistant staphylococcus aureus, COMPUESTOS QUÍMICOS Y DROGAS::acciones y usos químicos::acciones farmacológicas::usos terapéuticos::antiinfecciosos::antibacterianos, Assaigs clínics |
| Popis: | 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. |
| Druh dokumentu: | Article Other literature type |
| Popis souboru: | application/pdf; application/vnd.openxmlformats-officedocument.wordprocessingml.document |
| Jazyk: | English |
| ISSN: | 1537-6591 1058-4838 |
| DOI: | 10.1093/cid/ciaa1081 |
| DOI: | 10.13039/501100000780 |
| DOI: | 10.13039/501100010198 |
| DOI: | 10.13039/501100004587 |
| Přístupová URL adresa: | https://academic.oup.com/cid/advance-article-pdf/doi/10.1093/cid/ciaa1081/33881479/ciaa1081.pdf https://pubmed.ncbi.nlm.nih.gov/32725216 https://hdl.handle.net/20.500.12105/23328 http://hdl.handle.net/2445/183825 https://iibsantpau.fundanetsuite.com/Publicaciones/ProdCientif/PublicacionFrw.aspx?id=5744 https://hdl.handle.net/10668/26334 https://hdl.handle.net/2445/183825 http://hdl.handle.net/10261/265131 https://hdl.handle.net/20.500.13003/19522 https://i3pt.portalinvestigacion.com/publicaciones/2333 https://www.scopus.com/inward/record.uri?eid=2-s2.0-85099091169&doi=10.1093/cid/ciaa1081&partnerID=40&md5=6c7f8d079bee069fc5e00f37c9f71183 https://iibsantpau.fundanetsuite.com/Publicaciones/ProdCientif/PublicacionFrw.aspx?id=5744 https://hdl.handle.net/11351/7632 https://hdl.handle.net/20.500.12530/58607 http://hdl.handle.net/2445/183825 https://pubmed.ncbi.nlm.nih.gov/32725216/ https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8096235 https://repositori.upf.edu/handle/10230/47874 http://repositori.uic.es/handle/20.500.12328/2666 http://www.ncbi.nlm.nih.gov/pubmed/32725216 https://academic.oup.com/cid/article/72/9/1517/5877897 https://ddd.uab.cat/record/283282 |
| Rights: | CC BY NC ND URL: http://creativecommons.org/licenses/by-nc-nd/4.0/This is an Open Access article distributed under the terms of the Creative Commons Attribution-NonCommercial-NoDerivs licence (http://creativecommons.org/licenses/by-nc-nd/4.0/ (http://creativecommons.org/licenses/by-nc-nd/4.0/) ), which permits non-commercial reproduction and distribution of the work, in any medium, provided the original work is not altered or transformed in any way, and that the work is properly cited. For commercial re-use, please contact journals.permissions@oup.com |
| Přístupové číslo: | edsair.doi.dedup.....66401b9c2a5f062323c54d908e2533ad |
| Databáze: | OpenAIRE |
Nájsť tento článok vo Web of Science | Abstrakt: | 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. |
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| ISSN: | 15376591 10584838 |
| DOI: | 10.1093/cid/ciaa1081 |