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

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dc.contributor.author Badia-Cebada, Laia
dc.contributor.author Carmezim, João
dc.contributor.author Pérez-Rodríguez, María-Teresa
dc.contributor.author Bereciartua, Elena
dc.contributor.author López, Luis-Eduardo
dc.contributor.author Represa Montenegro, Marta
dc.contributor.author Pomar, Virginia
dc.contributor.author Andrés, Marta
dc.contributor.author Petkova, Elizabet
dc.contributor.author Sopena, Nieves
dc.contributor.author Lora-Tamayo, Jaime
dc.contributor.author Monsálvez, Víctor
dc.contributor.author Ramirez-Hidalgo, Maria Fernanda
dc.contributor.author Gómez-Zorrilla, Silvia
dc.contributor.author Boix Palop, Lucía
dc.contributor.author Meije, Yolanda
dc.contributor.author Jiménez, Emili
dc.contributor.author Gasch, Oriol
dc.date.accessioned 2023-09-06T06:35:06Z
dc.date.available 2023-09-06T06:35:06Z
dc.date.issued 2023
dc.identifier.citation Badia-Cebada L, Carmezim J, Pérez-Rodríguez MT, Bereciartua E, López LE, Represa Montenegro M, Pomar V, Andrés M, Petkova E, Sopena N, Lora-Tamayo J, Monsálvez V, Ramirez-Hidalgo MF, Gómez-Zorrilla S, Boix L, Meije Y, Jiménez E, Gasch O. Randomized clinical trial of the need for antibiotic treatment for low-risk catheter-related bloodstream infection caused by coagulase-negative staphylococci. Antibiotics. 2023;12(5):839. DOI: 10.3390/antibiotics12050839
dc.identifier.issn 2079-6382
dc.identifier.uri http://hdl.handle.net/10230/57818
dc.description.abstract 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.
dc.format.mimetype application/pdf
dc.language.iso eng
dc.publisher MDPI
dc.relation.ispartof Antibiotics. 2023;12(5):839
dc.rights © 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/).
dc.rights.uri http://creativecommons.org/licenses/by/4.0/
dc.title Randomized clinical trial of the need for antibiotic treatment for low-risk catheter-related bloodstream infection caused by coagulase-negative staphylococci
dc.type info:eu-repo/semantics/article
dc.identifier.doi http://dx.doi.org/10.3390/antibiotics12050839
dc.subject.keyword Antibiotic stewardship
dc.subject.keyword Catheter-related bloodstream infection
dc.subject.keyword Coagulase-negative staphylococci
dc.subject.keyword Healthcare related infection
dc.rights.accessRights info:eu-repo/semantics/openAccess
dc.type.version info:eu-repo/semantics/publishedVersion

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