d7dc81b7d2a6599cc891d948162f5135 pmc_10215141.pdf 74c641d4cd5e79f07b4bab958e999c8ea8de86b9 pmc_10215141.pdf bbee6907e10ec961f113e73b13dd2f4f1f87ef7c9c4fba4586d3cf2c66da8495 pmc_10215141.pdf Title: Randomized Clinical Trial of the Need for Antibiotic Treatment for Low-Risk Catheter-Related Bloodstream Infection Caused by Coagulase-Negative Staphylococci Subject: 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. Keywords: antibiotic stewardship; catheter-related bloodstream infection; coagulase-negative staphylococci; healthcare related infection Author: 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 and Oriol Gasch Creator: LaTeX with hyperref Producer: pdfTeX-1.40.21 CreationDate: Fri May 12 05:42:20 2023 CEST ModDate: Fri May 12 05:46:57 2023 CEST Tagged: no UserProperties: no Suspects: no Form: none JavaScript: no Pages: 11 Encrypted: no Page size: 595.276 x 841.89 pts (A4) Page rot: 0 File size: 593310 bytes Optimized: no PDF version: 1.7 name type encoding emb sub uni object ID ------------------------------------ ----------------- ---------------- --- --- --- --------- IYDCBB+VnURWPalladioL Type 1 Custom yes yes no 10 0 KBDUBP+URWPalladioL-Bold Type 1 Custom yes yes no 15 0 OVMKMU+URWPalladioL-Roma Type 1 Custom yes yes no 20 0 ANUUPL+URWPalladioL-Ital Type 1 Custom yes yes no 24 0 OJYKSJ+VnURWPalladioL-Bold Type 1 Custom yes yes no 28 0 YYFPCJ+TimesNewRomanPS-BoldItalicMT Type 1C WinAnsi yes yes no 47 0 HPGKAD+PalatinoLinotype,Bold TrueType WinAnsi yes yes no 79 0 HPGKAF+PalatinoLinotype TrueType WinAnsi yes yes no 82 0 HPGKAH+PalatinoLinotype,Italic TrueType WinAnsi yes yes no 85 0 MOSBKF+URWPalladioL-BoldItal Type 1 Custom yes yes no 92 0 IKKWKP+CMSY10 Type 1 Builtin yes yes no 96 0 Jhove (Rel. 1.22.1, 2019-04-17) Date: 2023-09-13 02:28:54 CEST RepresentationInformation: pmc_10215141.pdf ReportingModule: PDF-hul, Rel. 1.12.1 (2019-04-17) LastModified: 2023-09-08 02:19:11 CEST Size: 593310 Format: PDF Version: 1.7 Status: Well-Formed and valid SignatureMatches: PDF-hul MIMEtype: application/pdf PDFMetadata: Objects: 231 FreeObjects: 1 IncrementalUpdates: 0 DocumentCatalog: PageLayout: SinglePage PageMode: UseNone Outlines: Item: Title: Introduction Destination: edu.harvard.hul.ois.jhove.module.pdf.PdfSimpleObject@44c8afef Item: Title: Results Destination: edu.harvard.hul.ois.jhove.module.pdf.PdfSimpleObject@7b69c6ba Children: Item: Title: Study Population Destination: edu.harvard.hul.ois.jhove.module.pdf.PdfSimpleObject@46daef40 Item: Title: Primary Outcome Destination: edu.harvard.hul.ois.jhove.module.pdf.PdfSimpleObject@12f41634 Item: Title: Secondary Outcomes Destination: edu.harvard.hul.ois.jhove.module.pdf.PdfSimpleObject@13c27452 Item: Title: Screening Failure Destination: edu.harvard.hul.ois.jhove.module.pdf.PdfSimpleObject@262b2c86 Item: Title: Discussion Destination: edu.harvard.hul.ois.jhove.module.pdf.PdfSimpleObject@371a67ec Item: Title: Materials and Methods Destination: edu.harvard.hul.ois.jhove.module.pdf.PdfSimpleObject@5ed828d Children: Item: Title: Setting Destination: edu.harvard.hul.ois.jhove.module.pdf.PdfSimpleObject@50d0686 Item: Title: Study Design Destination: edu.harvard.hul.ois.jhove.module.pdf.PdfSimpleObject@7a3d45bd Item: Title: Study Population Destination: edu.harvard.hul.ois.jhove.module.pdf.PdfSimpleObject@1e7c7811 Item: Title: Safety Data Destination: edu.harvard.hul.ois.jhove.module.pdf.PdfSimpleObject@77ec78b9 Item: Title: Definitions B23-antibiotics-2360852 Destination: edu.harvard.hul.ois.jhove.module.pdf.PdfSimpleObject@1a3869f4 Item: Title: Endpoints Destination: edu.harvard.hul.ois.jhove.module.pdf.PdfSimpleObject@a38d7a3 Item: Title: Sample Size Destination: edu.harvard.hul.ois.jhove.module.pdf.PdfSimpleObject@77f99a05 Item: Title: Microbiology Studies Destination: edu.harvard.hul.ois.jhove.module.pdf.PdfSimpleObject@63440df3 Item: Title: Statistical Analysis Destination: edu.harvard.hul.ois.jhove.module.pdf.PdfSimpleObject@3aeaafa6 Item: Title: References Destination: edu.harvard.hul.ois.jhove.module.pdf.PdfSimpleObject@76a3e297 Info: Title: Randomized Clinical Trial of the Need for Antibiotic Treatment for Low-Risk Catheter-Related Bloodstream Infection Caused by Coagulase-Negative Staphylococci Author: 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 and Oriol Gasch Subject: 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. 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