Randomized Clinical Trial of the Need for Antibiotic Treatment for Low-Risk Catheter-Related Bloodstream Infection Caused by Coagulase-Negative Staphylococci
Badia Cebada, Laia (Parc Taulí Hospital Universitari. Institut d'Investigació i Innovació Parc Taulí (I3PT))
Carmezim, João (Institut d'Investigació Biomèdica de Bellvitge)
Pérez Rodriguez, María Teresa (Hospital Álvaro Cunqueiro (Vigo))
Bereciartua, Elena (Hospital Universitario de Cruces (Barakaldo, País Basc))
López, Luis-Eduardo (Instituto de Salud Carlos III)
Montenegro, Marta Represa (Hospital Álvaro Cunqueiro (Vigo))
Pomar, Virginia (Hospital de la Santa Creu i Sant Pau (Barcelona, Catalunya))
Andrés, Marta (Consorci Sanitari de Terrassa. Hospital de Terrassa (Terrassa, Catalunya))
Petkova, Elizabet (Hospital Universitario Fundación Jiménez Díaz)
Sopena, Nieves (Institut Germans Trias i Pujol. Fundació Lluita Contra les Infeccions)
Lora-Tamayo, Jaime (Hospital 12 de Octubre (Madrid))
Monsálvez, Víctor (Parc Taulí Hospital Universitari. Institut d'Investigació i Innovació Parc Taulí (I3PT))
Ramirez-Hidalgo, Maria Fernanda (Hospital Universitari Arnau de Vilanova)
Gómez-Zorrilla, Silvia (Hospital del Mar (Barcelona, Catalunya))
Boix-Palop, Lucía (Universitat Internacional de Catalunya)
Meije, Yolanda (Hospital de Barcelona)
Jiménez, Emili (Institut d'Investigació Biomèdica de Bellvitge)
Gasch Blasi, Oriol (Parc Taulí Hospital Universitari. Institut d'Investigació i Innovació Parc Taulí (I3PT))
Universitat Autònoma de Barcelona

Date:	2023
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.
Rights:	Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, la comunicació pública de l'obra i la creació d'obres derivades, fins i tot amb finalitats comercials, sempre i quan es reconegui l'autoria de l'obra original.
Language:	Anglès
Document:	Article ; recerca ; Versió publicada
Subject:	Antibiotic stewardship ; Catheter-related bloodstream infection ; Coagulase-negative staphylococci ; Healthcare related infection
Published in:	Antibiotics, Vol. 12 (may 2023) , ISSN 2079-6382

DOI: 10.3390/antibiotics12050839
PMID: 37237744

11 p, 579.4 KB

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Research literature > UAB research groups literature > Research Centres and Groups (research output) > Health sciences and biosciences > Parc Taulí Research and Innovation Institute (I3PT
Articles > Research articles
Articles > Published articles