Randomized clinical trial of the need for antibiotic treatment for low-risk catheter-related bloodstream infection caused by coagulase-negative staphylococci

According to clinical guidelines, the management of catheter-related bloodstream infections (CRBSI) due to coagulase-negative staphylococci (CoNS) includes catheter removal and antibiotic treatment for 5 to 7 days. However, in low-risk episodes, it remains uncertain whether antibiotic therapy is nec...

Full description

Bibliographic Details
Authors: Badia-Cebada, Laia, Carmezim, João, Pérez-Rodríguez, María-Teresa, Bereciartua, Elena, López, Luis-Eduardo, Represa Montenegro, Marta, Pomar, Virginia, Andrés, Marta, Petkova, Elizabet, Sopena, Nieves, Lora-Tamayo, Jaime, Monsálvez, Víctor, Ramirez-Hidalgo, Maria Fernanda, Gómez-Zorrilla, Silvia, Boix Palop, Lucía, Meije, Yolanda, Jiménez, Emili, Gasch, Oriol
Format: article
Status:Published version
Publication Date:2023
Country:España
Institution:Universitat Pompeu Fabra
Repository:Repositorio Digital de la UPF
OAI Identifier:oai:repositori.upf.edu:10230/57818
Online Access:http://hdl.handle.net/10230/57818
http://dx.doi.org/10.3390/antibiotics12050839
Access Level:Open access
Keyword:Antibiotic stewardship
Catheter-related bloodstream infection
Coagulase-negative staphylococci
Healthcare related infection
id ES_f348e2ea6807a24da3ce136b4f05ec7d
oai_identifier_str oai:repositori.upf.edu:10230/57818
network_acronym_str ES
network_name_str España
repository_id_str
spelling Randomized clinical trial of the need for antibiotic treatment for low-risk catheter-related bloodstream infection caused by coagulase-negative staphylococciBadia-Cebada, LaiaCarmezim, JoãoPérez-Rodríguez, María-TeresaBereciartua, ElenaLópez, Luis-EduardoRepresa Montenegro, MartaPomar, VirginiaAndrés, MartaPetkova, ElizabetSopena, NievesLora-Tamayo, JaimeMonsálvez, VíctorRamirez-Hidalgo, Maria FernandaGómez-Zorrilla, SilviaBoix Palop, LucíaMeije, YolandaJiménez, EmiliGasch, OriolAntibiotic stewardshipCatheter-related bloodstream infectionCoagulase-negative staphylococciHealthcare related infectionAccording to clinical guidelines, the management of catheter-related bloodstream infections (CRBSI) due to coagulase-negative staphylococci (CoNS) includes catheter removal and antibiotic treatment for 5 to 7 days. However, in low-risk episodes, it remains uncertain whether antibiotic therapy is necessary. This randomized clinical trial aims to determine whether the non-administration of antibiotic therapy is as safe and effective as the recommended strategy in low-risk episodes of CRBSI caused by CoNS. With this purpose, a randomized, open-label, multicenter, non-inferiority clinical trial was conducted in 14 Spanish hospitals from 1 July 2019 to 31 January 2022. Patients with low-risk CRBSI caused by CoNS were randomized 1:1 after catheter withdrawal to receive/not receive parenteral antibiotics with activity against the isolated strain. The primary endpoint was the presence of any complication related to bacteremia or to antibiotic therapy within 90 days of follow-up. The secondary endpoints were persistent bacteremia, septic embolism, time until microbiological cure, and time until the disappearance of a fever. EudraCT: 2017-003612-39 INF-BACT-2017. A total of 741 patients were assessed for eligibility. Of these, 27 were included in the study; 15 (55.6%) were randomized to the intervention arm (non-antibiotic administration) and 12 (44.4%) to the control arm (antibiotic therapy as per standard practice). The primary endpoint occurred in one of the 15 patients in the intervention group (septic thrombophlebitis) and in no patients in the control group. The median time until microbiological cure was 3 days (IQR 1-3) in the intervention arm and 1.25 days (IQR 0.5-2.62) in the control arm, while the median time until fever resolution was zero days in both arms. The study was stopped due to the insufficient number of recruited patients. These results seem to indicate that low-risk CRBSI caused by CoNS can be managed without antibiotic therapy after catheter removal; efficacy and safety are not affected.MDPI202320232023info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionapplication/pdfapplication/pdfhttp://hdl.handle.net/10230/57818http://dx.doi.org/10.3390/antibiotics12050839reponame:Repositorio Digital de la UPFinstname:Universitat Pompeu FabraInglésAntibiotics. 2023;12(5):839© 2023 by the authors. Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (http://creativecommons.org/licenses/by/4.0/).http://creativecommons.org/licenses/by/4.0/info:eu-repo/semantics/openAccessoai:repositori.upf.edu:10230/578182026-06-12T07:21:37Z
dc.title.none.fl_str_mv Randomized clinical trial of the need for antibiotic treatment for low-risk catheter-related bloodstream infection caused by coagulase-negative staphylococci
title Randomized clinical trial of the need for antibiotic treatment for low-risk catheter-related bloodstream infection caused by coagulase-negative staphylococci
spellingShingle Randomized clinical trial of the need for antibiotic treatment for low-risk catheter-related bloodstream infection caused by coagulase-negative staphylococci
Badia-Cebada, Laia
Antibiotic stewardship
Catheter-related bloodstream infection
Coagulase-negative staphylococci
Healthcare related infection
title_short Randomized clinical trial of the need for antibiotic treatment for low-risk catheter-related bloodstream infection caused by coagulase-negative staphylococci
title_full Randomized clinical trial of the need for antibiotic treatment for low-risk catheter-related bloodstream infection caused by coagulase-negative staphylococci
title_fullStr Randomized clinical trial of the need for antibiotic treatment for low-risk catheter-related bloodstream infection caused by coagulase-negative staphylococci
title_full_unstemmed Randomized clinical trial of the need for antibiotic treatment for low-risk catheter-related bloodstream infection caused by coagulase-negative staphylococci
title_sort Randomized clinical trial of the need for antibiotic treatment for low-risk catheter-related bloodstream infection caused by coagulase-negative staphylococci
dc.creator.none.fl_str_mv Badia-Cebada, Laia
Carmezim, João
Pérez-Rodríguez, María-Teresa
Bereciartua, Elena
López, Luis-Eduardo
Represa Montenegro, Marta
Pomar, Virginia
Andrés, Marta
Petkova, Elizabet
Sopena, Nieves
Lora-Tamayo, Jaime
Monsálvez, Víctor
Ramirez-Hidalgo, Maria Fernanda
Gómez-Zorrilla, Silvia
Boix Palop, Lucía
Meije, Yolanda
Jiménez, Emili
Gasch, Oriol
author Badia-Cebada, Laia
author_facet Badia-Cebada, Laia
Carmezim, João
Pérez-Rodríguez, María-Teresa
Bereciartua, Elena
López, Luis-Eduardo
Represa Montenegro, Marta
Pomar, Virginia
Andrés, Marta
Petkova, Elizabet
Sopena, Nieves
Lora-Tamayo, Jaime
Monsálvez, Víctor
Ramirez-Hidalgo, Maria Fernanda
Gómez-Zorrilla, Silvia
Boix Palop, Lucía
Meije, Yolanda
Jiménez, Emili
Gasch, Oriol
author_role author
author2 Carmezim, João
Pérez-Rodríguez, María-Teresa
Bereciartua, Elena
López, Luis-Eduardo
Represa Montenegro, Marta
Pomar, Virginia
Andrés, Marta
Petkova, Elizabet
Sopena, Nieves
Lora-Tamayo, Jaime
Monsálvez, Víctor
Ramirez-Hidalgo, Maria Fernanda
Gómez-Zorrilla, Silvia
Boix Palop, Lucía
Meije, Yolanda
Jiménez, Emili
Gasch, Oriol
author2_role author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
dc.subject.none.fl_str_mv Antibiotic stewardship
Catheter-related bloodstream infection
Coagulase-negative staphylococci
Healthcare related infection
topic Antibiotic stewardship
Catheter-related bloodstream infection
Coagulase-negative staphylococci
Healthcare related infection
description According to clinical guidelines, the management of catheter-related bloodstream infections (CRBSI) due to coagulase-negative staphylococci (CoNS) includes catheter removal and antibiotic treatment for 5 to 7 days. However, in low-risk episodes, it remains uncertain whether antibiotic therapy is necessary. This randomized clinical trial aims to determine whether the non-administration of antibiotic therapy is as safe and effective as the recommended strategy in low-risk episodes of CRBSI caused by CoNS. With this purpose, a randomized, open-label, multicenter, non-inferiority clinical trial was conducted in 14 Spanish hospitals from 1 July 2019 to 31 January 2022. Patients with low-risk CRBSI caused by CoNS were randomized 1:1 after catheter withdrawal to receive/not receive parenteral antibiotics with activity against the isolated strain. The primary endpoint was the presence of any complication related to bacteremia or to antibiotic therapy within 90 days of follow-up. The secondary endpoints were persistent bacteremia, septic embolism, time until microbiological cure, and time until the disappearance of a fever. EudraCT: 2017-003612-39 INF-BACT-2017. A total of 741 patients were assessed for eligibility. Of these, 27 were included in the study; 15 (55.6%) were randomized to the intervention arm (non-antibiotic administration) and 12 (44.4%) to the control arm (antibiotic therapy as per standard practice). The primary endpoint occurred in one of the 15 patients in the intervention group (septic thrombophlebitis) and in no patients in the control group. The median time until microbiological cure was 3 days (IQR 1-3) in the intervention arm and 1.25 days (IQR 0.5-2.62) in the control arm, while the median time until fever resolution was zero days in both arms. The study was stopped due to the insufficient number of recruited patients. These results seem to indicate that low-risk CRBSI caused by CoNS can be managed without antibiotic therapy after catheter removal; efficacy and safety are not affected.
publishDate 2023
dc.date.none.fl_str_mv 2023
2023
2023
dc.type.none.fl_str_mv info:eu-repo/semantics/article
info:eu-repo/semantics/publishedVersion
format article
status_str publishedVersion
dc.identifier.none.fl_str_mv http://hdl.handle.net/10230/57818
http://dx.doi.org/10.3390/antibiotics12050839
url http://hdl.handle.net/10230/57818
http://dx.doi.org/10.3390/antibiotics12050839
dc.language.none.fl_str_mv Inglés
language_invalid_str_mv Inglés
dc.relation.none.fl_str_mv Antibiotics. 2023;12(5):839
dc.rights.none.fl_str_mv http://creativecommons.org/licenses/by/4.0/
info:eu-repo/semantics/openAccess
rights_invalid_str_mv http://creativecommons.org/licenses/by/4.0/
eu_rights_str_mv openAccess
dc.format.none.fl_str_mv application/pdf
application/pdf
dc.publisher.none.fl_str_mv MDPI
publisher.none.fl_str_mv MDPI
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
_version_ 1869424363156013056
score 15,811543

Similar Items