Daptomycin plus fosfomycin versus Daptomycin lone 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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Autores: Pujol, Miquel, Montero, Maria Milagro, Carratalà, Jordi, MRSA Bacteremia (BACSARM) Trial Investigators
Tipo de documento: artigo
Estado:Versión aceptada para publicación
Data de publicação:2021
País:España
Recursos:Universitat Pompeu Fabra
Repositório:Repositorio Digital de la UPF
OAI Identifier:oai:repositori.upf.edu:10230/47874
Acesso em linha:http://hdl.handle.net/10230/47874
http://dx.doi.org/10.1093/cid/ciaa1081
Access Level:Acceso aberto
Palavra-chave:MRSA
Bacteremia
Clinical trial
Daptomycin
Fosfomycin
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spelling Daptomycin plus fosfomycin versus Daptomycin lone for methicillin-resistant staphylococcus aureus bacteremia and endocarditis: a randomized clinical trialPujol, MiquelMontero, Maria MilagroCarratalà, JordiMRSA Bacteremia (BACSARM) Trial InvestigatorsMRSABacteremiaClinical trialDaptomycinFosfomycinBackground: 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.Oxford University Press202120212021info:eu-repo/semantics/articleinfo:eu-repo/semantics/acceptedVersionapplication/pdfapplication/pdfhttp://hdl.handle.net/10230/47874http://dx.doi.org/10.1093/cid/ciaa1081reponame:Repositorio Digital de la UPFinstname:Universitat Pompeu FabraInglésClinical Infectious Diseases. 2021 May 4;72(9):1517-25Copyright © The Author(s) 2020. Published by Oxford University Press for the Infectious Diseases Society of America. 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/), 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.comhttp://creativecommons.org/licenses/by-nc-nd/4.0/info:eu-repo/semantics/openAccessoai:repositori.upf.edu:10230/478742026-06-12T07:21:37Z
dc.title.none.fl_str_mv Daptomycin plus fosfomycin versus Daptomycin lone for methicillin-resistant staphylococcus aureus bacteremia and endocarditis: a randomized clinical trial
title Daptomycin plus fosfomycin versus Daptomycin lone for methicillin-resistant staphylococcus aureus bacteremia and endocarditis: a randomized clinical trial
spellingShingle Daptomycin plus fosfomycin versus Daptomycin lone for methicillin-resistant staphylococcus aureus bacteremia and endocarditis: a randomized clinical trial
Pujol, Miquel
MRSA
Bacteremia
Clinical trial
Daptomycin
Fosfomycin
title_short Daptomycin plus fosfomycin versus Daptomycin lone for methicillin-resistant staphylococcus aureus bacteremia and endocarditis: a randomized clinical trial
title_full Daptomycin plus fosfomycin versus Daptomycin lone for methicillin-resistant staphylococcus aureus bacteremia and endocarditis: a randomized clinical trial
title_fullStr Daptomycin plus fosfomycin versus Daptomycin lone for methicillin-resistant staphylococcus aureus bacteremia and endocarditis: a randomized clinical trial
title_full_unstemmed Daptomycin plus fosfomycin versus Daptomycin lone for methicillin-resistant staphylococcus aureus bacteremia and endocarditis: a randomized clinical trial
title_sort Daptomycin plus fosfomycin versus Daptomycin lone for methicillin-resistant staphylococcus aureus bacteremia and endocarditis: a randomized clinical trial
dc.creator.none.fl_str_mv Pujol, Miquel
Montero, Maria Milagro
Carratalà, Jordi
MRSA Bacteremia (BACSARM) Trial Investigators
author Pujol, Miquel
author_facet Pujol, Miquel
Montero, Maria Milagro
Carratalà, Jordi
MRSA Bacteremia (BACSARM) Trial Investigators
author_role author
author2 Montero, Maria Milagro
Carratalà, Jordi
MRSA Bacteremia (BACSARM) Trial Investigators
author2_role author
author
author
dc.subject.none.fl_str_mv MRSA
Bacteremia
Clinical trial
Daptomycin
Fosfomycin
topic MRSA
Bacteremia
Clinical trial
Daptomycin
Fosfomycin
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 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.
publishDate 2021
dc.date.none.fl_str_mv 2021
2021
2021
dc.type.none.fl_str_mv info:eu-repo/semantics/article
info:eu-repo/semantics/acceptedVersion
format article
status_str acceptedVersion
dc.identifier.none.fl_str_mv http://hdl.handle.net/10230/47874
http://dx.doi.org/10.1093/cid/ciaa1081
url http://hdl.handle.net/10230/47874
http://dx.doi.org/10.1093/cid/ciaa1081
dc.language.none.fl_str_mv Inglés
language_invalid_str_mv Inglés
dc.relation.none.fl_str_mv Clinical Infectious Diseases. 2021 May 4;72(9):1517-25
dc.rights.none.fl_str_mv http://creativecommons.org/licenses/by-nc-nd/4.0/
info:eu-repo/semantics/openAccess
rights_invalid_str_mv http://creativecommons.org/licenses/by-nc-nd/4.0/
eu_rights_str_mv openAccess
dc.format.none.fl_str_mv application/pdf
application/pdf
dc.publisher.none.fl_str_mv Oxford University Press
publisher.none.fl_str_mv Oxford University Press
dc.source.none.fl_str_mv reponame:Repositorio Digital de la UPF
instname:Universitat Pompeu Fabra
instname_str Universitat Pompeu Fabra
reponame_str Repositorio Digital de la UPF
collection Repositorio Digital de la UPF
repository.name.fl_str_mv
repository.mail.fl_str_mv
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