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 tri...
| Autores: | , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , |
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| Tipo de recurso: | artículo |
| Estado: | Versión publicada |
| Fecha de publicación: | 2021 |
| País: | España |
| Institución: | Universitat de Lleida (UdL) |
| Repositorio: | Repositori Obert UdL |
| OAI Identifier: | oai:repositori.udl.cat:10459.1/73000 |
| Acceso en línea: | https://doi.org/10.1093/cid/ciaa1081 http://hdl.handle.net/10459.1/73000 |
| Access Level: | acceso abierto |
| Palabra clave: | MRSA Bacteremia Daptomycin Fosfomycin Clinical trial |
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Daptomycin plus fosfomycin versus daptomycin alone for methicillin-resistant staphylococcus aureus bacteremia and endocarditis: a randomized clinical trialPujol, MiquelMiró, José MaríaShaw, EvelynAguado, Jose MaríaSan Juan, RafaelPuig Asensio, MireiaPigrau, CarlesCalbo Sebastian, EstherMontejo, MiguelRodríguez Álvarez, ReginoGarcía Pais, María JosePintado, VicenteEscudero Sánchez, RosaLópez Contreras, JoaquínMorata, LauraMontero, MilagrosAndrés, MartaPasquau, JuanArenas, María del MarPadilla, BelénMurillas, JavierJover-Saenz, AlfredoLópez Cortes, Luis EduardoGarcía Pardo, GracianoGasch, OriolVidela, SebastianHereu, PilarTebé, CristianPallarès, NataliaSanllorente, MireiaDomínguez, María ÁngelesCàmara, JordiFerrer, AnnaPadullés, AriadnaCuervo, GuillermoCarratalà, JordiMRSABacteremiaDaptomycinFosfomycinClinical trialBackground. 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 intra-venously 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 bac-teremia (16.2% vs 32.1%; P = .022). Adverse events leading to treatment discontinuation occurred in 13 of 74 patients (17.6%) re-ceiving 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 dif-ference did not reach statistical significance. This antibiotic combination prevented microbiological failure and complicated bacte-remia, but it was more often associated with adverse eventsThis 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.Oxford University PressInfectious Diseases Society of America2021info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionhttps://doi.org/10.1093/cid/ciaa1081http://hdl.handle.net/10459.1/73000reponame:Repositori Obert UdL instname:Universitat de Lleida (UdL)InglésReproducció del document publicat a: https://doi.org/10.1093/cid/ciaa1081Clinical Infectious Diseases, 2021, vol. 72, núm. 9, p. 1517-1525cc-by-nc-nd (c) authors, 2020info:eu-repo/semantics/openAccesshttp://creativecommons.org/licenses/by-nc-nd/4.0/oai:repositori.udl.cat:10459.1/730002026-06-24T12:42:17Z |
| dc.title.none.fl_str_mv |
Daptomycin plus fosfomycin versus daptomycin alone for methicillin-resistant staphylococcus aureus bacteremia and endocarditis: a randomized clinical trial |
| title |
Daptomycin plus fosfomycin versus daptomycin alone for methicillin-resistant staphylococcus aureus bacteremia and endocarditis: a randomized clinical trial |
| spellingShingle |
Daptomycin plus fosfomycin versus daptomycin alone for methicillin-resistant staphylococcus aureus bacteremia and endocarditis: a randomized clinical trial Pujol, Miquel MRSA Bacteremia Daptomycin Fosfomycin Clinical trial |
| title_short |
Daptomycin plus fosfomycin versus daptomycin alone for methicillin-resistant staphylococcus aureus bacteremia and endocarditis: a randomized clinical trial |
| title_full |
Daptomycin plus fosfomycin versus daptomycin alone for methicillin-resistant staphylococcus aureus bacteremia and endocarditis: a randomized clinical trial |
| title_fullStr |
Daptomycin plus fosfomycin versus daptomycin alone for methicillin-resistant staphylococcus aureus bacteremia and endocarditis: a randomized clinical trial |
| title_full_unstemmed |
Daptomycin plus fosfomycin versus daptomycin alone for methicillin-resistant staphylococcus aureus bacteremia and endocarditis: a randomized clinical trial |
| title_sort |
Daptomycin plus fosfomycin versus daptomycin alone for methicillin-resistant staphylococcus aureus bacteremia and endocarditis: a randomized clinical trial |
| dc.creator.none.fl_str_mv |
Pujol, Miquel Miró, José María Shaw, Evelyn Aguado, Jose María San Juan, Rafael Puig Asensio, Mireia Pigrau, Carles Calbo Sebastian, Esther Montejo, Miguel Rodríguez Álvarez, Regino García Pais, María Jose Pintado, Vicente Escudero Sánchez, Rosa López Contreras, Joaquín Morata, Laura Montero, Milagros Andrés, Marta Pasquau, Juan Arenas, María del Mar Padilla, Belén Murillas, Javier Jover-Saenz, 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 |
| author |
Pujol, Miquel |
| author_facet |
Pujol, Miquel Miró, José María Shaw, Evelyn Aguado, Jose María San Juan, Rafael Puig Asensio, Mireia Pigrau, Carles Calbo Sebastian, Esther Montejo, Miguel Rodríguez Álvarez, Regino García Pais, María Jose Pintado, Vicente Escudero Sánchez, Rosa López Contreras, Joaquín Morata, Laura Montero, Milagros Andrés, Marta Pasquau, Juan Arenas, María del Mar Padilla, Belén Murillas, Javier Jover-Saenz, 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 |
| author_role |
author |
| author2 |
Miró, José María Shaw, Evelyn Aguado, Jose María San Juan, Rafael Puig Asensio, Mireia Pigrau, Carles Calbo Sebastian, Esther Montejo, Miguel Rodríguez Álvarez, Regino García Pais, María Jose Pintado, Vicente Escudero Sánchez, Rosa López Contreras, Joaquín Morata, Laura Montero, Milagros Andrés, Marta Pasquau, Juan Arenas, María del Mar Padilla, Belén Murillas, Javier Jover-Saenz, 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 |
| author2_role |
author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author |
| dc.subject.none.fl_str_mv |
MRSA Bacteremia Daptomycin Fosfomycin Clinical trial |
| topic |
MRSA Bacteremia Daptomycin Fosfomycin Clinical trial |
| description |
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 intra-venously 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 bac-teremia (16.2% vs 32.1%; P = .022). Adverse events leading to treatment discontinuation occurred in 13 of 74 patients (17.6%) re-ceiving 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 dif-ference did not reach statistical significance. This antibiotic combination prevented microbiological failure and complicated bacte-remia, but it was more often associated with adverse events |
| publishDate |
2021 |
| dc.date.none.fl_str_mv |
2021 |
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info:eu-repo/semantics/article info:eu-repo/semantics/publishedVersion |
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article |
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publishedVersion |
| dc.identifier.none.fl_str_mv |
https://doi.org/10.1093/cid/ciaa1081 http://hdl.handle.net/10459.1/73000 |
| url |
https://doi.org/10.1093/cid/ciaa1081 http://hdl.handle.net/10459.1/73000 |
| dc.language.none.fl_str_mv |
Inglés |
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Inglés |
| dc.relation.none.fl_str_mv |
Reproducció del document publicat a: https://doi.org/10.1093/cid/ciaa1081 Clinical Infectious Diseases, 2021, vol. 72, núm. 9, p. 1517-1525 |
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cc-by-nc-nd (c) authors, 2020 info:eu-repo/semantics/openAccess http://creativecommons.org/licenses/by-nc-nd/4.0/ |
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cc-by-nc-nd (c) authors, 2020 http://creativecommons.org/licenses/by-nc-nd/4.0/ |
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openAccess |
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Oxford University Press Infectious Diseases Society of America |
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Oxford University Press Infectious Diseases Society of America |
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reponame:Repositori Obert UdL instname:Universitat de Lleida (UdL) |
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Universitat de Lleida (UdL) |
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Repositori Obert UdL |
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Repositori Obert UdL |
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