Randomized Clinical Trial of the Need for Antibiotic Treatment for Low-Risk Catheter-Related Bloodstream Infection Caused by Coagulase-Negative Staphylococci
Por:
Badia-Cebada, L, Carmezim, J, Perez-Rodriguez, MT, Bereciartua, E, Lopez, LE, Montenegro, MR, Pomar, V, Andres, M, Petkova, E, Sopena, N, Lora-Tamayo, J, Monsalvez, V, Ramirez-Hidalgo, MF, Gomez-Zorrilla, S, Boix, L, Meije, Y, Jimenez, E, Gasch, O
Publicada:
1 may 2023
Ahead of Print:
1 may 2023
Resumen:
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.
Filiaciones:
Badia-Cebada, L:
Univ Autonoma Barcelona, Hosp Univ Parc Tauli, Inst Invest & Innovacio Parc Tauli, Internal Med Dept, Sabadell 08208, Spain
Carmezim, J:
Hosp Univ Bellvitge, Inst Invest Biomed Bellvitge, Unit Stat, IDIBELL, Lhospitalet De Llobregat 08908, Spain
Perez-Rodriguez, MT:
Hosp Alvaro Cunqueiro, Galicia Hlth Res Inst, Dept Internal Med, Infect Dis Unit, Vigo 36312, Spain
Bereciartua, E:
Hosp Univ Cruces, Infect Dis Unit, Baracaldo 48903, Spain
Lopez, LE:
Univ Hosp Virgen Macarena, Infect Dis & Microbiol Clin Unit, Seville 41009, Spain
Univ Seville, Sch Med, Dept Med, Seville 41009, Spain
CSIC, Biomed Inst Sevilla IBiS, Seville 41009, Spain
Inst Salud Carlos III, Ctr Biomed Res Infect Dis Network CIBERINFEC, Madrid 28029, Spain
Montenegro, MR:
Hosp Alvaro Cunqueiro, Galicia Hlth Res Inst, Dept Internal Med, Infect Dis Unit, Vigo 36312, Spain
Pomar, V:
Hosp Santa Creu & Sant Pau, Dept Internal Med, Infect Dis Unit, Barcelona 08025, Spain
Andres, M:
Hosp Consorci Terrassa, Dept Internal Med, Infect Dis Unit, Terrassa 08227, Spain
Petkova, E:
Hosp Univ Fdn Jimenez Diaz, Dept Internal Med, Infect Dis Unit, Madrid 28040, Spain
Sopena, N:
Infect Dis Dept Hosp Germans Trias & Pujol, Badalona 08916, Spain
Lora-Tamayo, J:
Inst Salud Carlos III, Ctr Biomed Res Infect Dis Network CIBERINFEC, Madrid 28029, Spain
Hosp Univ 12 Octubre, Inst Invest Imas12 Hosp 12 Octubre, Dept Internal Med, Madrid 28041, Spain
Monsalvez, V:
Univ Autonoma Barcelona, Hosp Univ Parc Tauli, Inst Invest & Innovacio Parc Tauli, Internal Med Dept, Sabadell 08208, Spain
Univ Autonoma Barcelona, Hosp Univ Parc Tauli, Inst Invest & Innovacio Parc Tauli, Infect Dis Dept, Sabadell 08193, Spain
Ramirez-Hidalgo, MF:
Arnau de Vilanova Univ Hosp, Nosocomial Infect Departmen, Lleida 08202, Spain
Gomez-Zorrilla, S:
Inst Salud Carlos III, Ctr Biomed Res Infect Dis Network CIBERINFEC, Madrid 28029, Spain
Univ Pompeu Fabra, Hosp Mar, Fundacio Inst Mar Invest Med, Infect Dis Dept, Barcelona 08003, Spain
Boix, L:
Hosp Univ Mutua Terrassa, Infect Dis Dept, Terrassa 08221, Spain
Univ Int Catalunya, Fac Med, Infect Dis, Barcelona 08017, Spain
Meije, Y:
Hosp Barcelona, Dept Internal Med, Infect Dis Unit, Barcelona 08034, Spain
Jimenez, E:
Hosp Univ Bellvitge, Inst Invest Biomed Bellvitge IDIBELL, Infect Dis Dept, Lhospitalet De Llobregat 08907, Spain
Gasch, O:
Univ Autonoma Barcelona, Hosp Univ Parc Tauli, Inst Invest & Innovacio Parc Tauli, Infect Dis Dept, Sabadell 08193, Spain
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