Randomized Clinical Trial of the Need for Antibiotic Treatment for Low-Risk Catheter-Related Bloodstream Infection Caused by Coagulase-Negative Staphylococci
Laia Badia-Cebada,
João Carmezim,
María-Teresa Pérez-Rodríguez,
Elena Bereciartua,
Luis-Eduardo López,
Marta Represa Montenegro,
Virginia Pomar,
Marta Andrés,
Elizabet Petkova,
Nieves Sopena,
Jaime Lora-Tamayo,
Víctor Monsálvez,
Maria Fernanda Ramirez-Hidalgo,
Silvia Gómez-Zorrilla,
Lucía Boix,
Yolanda Meije,
Emili Jiménez,
Oriol Gasch
Affiliations
Laia Badia-Cebada
Internal Medicine Department, Hospital Universitari Parc Taulí, Institut d’investigació i innovació Parc Taulí, Universitat Autònoma de Barcelona, 08208 Sabadell, Spain
João Carmezim
Unit of Statistics, Hospital Universitari de Bellvitge/Institut d’Investigació Biomèdica de Bellvitge-IDIBELL, 08908 L’Hospitalet de Llobregat, Spain
María-Teresa Pérez-Rodríguez
Infectious Diseases Unit, Department of Internal Medicine. Hospital Álvaro Cunqueiro, Galicia Sur Health Research Institute, 36312 Vigo, Spain
Elena Bereciartua
Infectious Diseases Unit, Hospital Universitario de Cruces, 48903 Barakaldo, Spain
Luis-Eduardo López
Infectious Diseases and Microbiology Clinical Unit, University Hospital Virgen Macarena, 41009 Seville, Spain
Marta Represa Montenegro
Infectious Diseases Unit, Department of Internal Medicine. Hospital Álvaro Cunqueiro, Galicia Sur Health Research Institute, 36312 Vigo, Spain
Virginia Pomar
Infectious Diseases Unit, Department of Internal Medicine, Hospital de la Santa Creu I Sant Pau, 08025 Barcelona, Spain
Marta Andrés
Infectious Diseases Unit, Department of Internal Medicine, Hospital Consorci de Terrassa, 08227 Terrassa, Spain
Elizabet Petkova
Infectious Diseases Unit, Department of Internal Medicine, Hospital Universitario Fundación Jiménez Díaz, 28040 Madrid, Spain
Nieves Sopena
Infectious Diseases Department Hospital Germans Trias i Pujol, 08916 Badalona, Spain
Jaime Lora-Tamayo
Center for Biomedical Research in Infectious Diseases Network (CIBERINFEC), Instituto de Salud Carlos III, 28029 Madrid, Spain
Víctor Monsálvez
Internal Medicine Department, Hospital Universitari Parc Taulí, Institut d’investigació i innovació Parc Taulí, Universitat Autònoma de Barcelona, 08208 Sabadell, Spain
Maria Fernanda Ramirez-Hidalgo
Nosocomial Infections Departmen, Arnau de Vilanova University Hospital, 08202 Lleida, Spain
Silvia Gómez-Zorrilla
Center for Biomedical Research in Infectious Diseases Network (CIBERINFEC), Instituto de Salud Carlos III, 28029 Madrid, Spain
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.
