Randomized Clinical Trial of the Need for Antibiotic Treatment for Low-Risk Catheter-Related Bloodstream Infection Caused by Coagulase-Negative Staphylococci
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 nec...
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| Format: | Article |
| Language: | English |
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MDPI AG
2023-05-01
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| Series: | Antibiotics |
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| Online Access: | https://www.mdpi.com/2079-6382/12/5/839 |
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| 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 Oriol Gasch |
| author_facet | 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 |
| author_sort | Laia Badia-Cebada |
| collection | DOAJ |
| description | 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. |
| first_indexed | 2024-03-11T04:00:34Z |
| format | Article |
| id | doaj.art-59d95ba457a846da9c47fedb3a1b1042 |
| institution | Directory Open Access Journal |
| issn | 2079-6382 |
| language | English |
| last_indexed | 2024-03-11T04:00:34Z |
| publishDate | 2023-05-01 |
| publisher | MDPI AG |
| record_format | Article |
| series | Antibiotics |
| spelling | doaj.art-59d95ba457a846da9c47fedb3a1b10422023-11-18T00:12:04ZengMDPI AGAntibiotics2079-63822023-05-0112583910.3390/antibiotics12050839Randomized Clinical Trial of the Need for Antibiotic Treatment for Low-Risk Catheter-Related Bloodstream Infection Caused by Coagulase-Negative StaphylococciLaia Badia-Cebada0João Carmezim1María-Teresa Pérez-Rodríguez2Elena Bereciartua3Luis-Eduardo López4Marta Represa Montenegro5Virginia Pomar6Marta Andrés7Elizabet Petkova8Nieves Sopena9Jaime Lora-Tamayo10Víctor Monsálvez11Maria Fernanda Ramirez-Hidalgo12Silvia Gómez-Zorrilla13Lucía Boix14Yolanda Meije15Emili Jiménez16Oriol Gasch17Internal Medicine Department, Hospital Universitari Parc Taulí, Institut d’investigació i innovació Parc Taulí, Universitat Autònoma de Barcelona, 08208 Sabadell, SpainUnit of Statistics, Hospital Universitari de Bellvitge/Institut d’Investigació Biomèdica de Bellvitge-IDIBELL, 08908 L’Hospitalet de Llobregat, SpainInfectious Diseases Unit, Department of Internal Medicine. Hospital Álvaro Cunqueiro, Galicia Sur Health Research Institute, 36312 Vigo, SpainInfectious Diseases Unit, Hospital Universitario de Cruces, 48903 Barakaldo, SpainInfectious Diseases and Microbiology Clinical Unit, University Hospital Virgen Macarena, 41009 Seville, SpainInfectious Diseases Unit, Department of Internal Medicine. Hospital Álvaro Cunqueiro, Galicia Sur Health Research Institute, 36312 Vigo, SpainInfectious Diseases Unit, Department of Internal Medicine, Hospital de la Santa Creu I Sant Pau, 08025 Barcelona, SpainInfectious Diseases Unit, Department of Internal Medicine, Hospital Consorci de Terrassa, 08227 Terrassa, SpainInfectious Diseases Unit, Department of Internal Medicine, Hospital Universitario Fundación Jiménez Díaz, 28040 Madrid, SpainInfectious Diseases Department Hospital Germans Trias i Pujol, 08916 Badalona, SpainCenter for Biomedical Research in Infectious Diseases Network (CIBERINFEC), Instituto de Salud Carlos III, 28029 Madrid, SpainInternal Medicine Department, Hospital Universitari Parc Taulí, Institut d’investigació i innovació Parc Taulí, Universitat Autònoma de Barcelona, 08208 Sabadell, SpainNosocomial Infections Departmen, Arnau de Vilanova University Hospital, 08202 Lleida, SpainCenter for Biomedical Research in Infectious Diseases Network (CIBERINFEC), Instituto de Salud Carlos III, 28029 Madrid, SpainInfectious Diseases Department, Hospital Universitari Mútua Terrassa, 08221 Terrassa, SpainInfectious Diseases Unit, Department of Internal Medicine. Hospital de Barcelona, 08034 Barcelona, SpainInfectious Diseases Department, Hospital Universitari de Bellvitge, Institut d’Investigació Biomèdica de Bellvitge-IDIBELL, 08907 L’Hospitalet de Llobregat, SpainInfectious Diseases Department, Hospital Universitari Parc Taulí. Institut d’investigació i Innovació Parc Taulí, Universitat Autònoma de Barcelona, 08193 Sabadell, SpainAccording 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.https://www.mdpi.com/2079-6382/12/5/839antibiotic stewardshipcatheter-related bloodstream infectioncoagulase-negative staphylococcihealthcare related infection |
| spellingShingle | 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 Randomized Clinical Trial of the Need for Antibiotic Treatment for Low-Risk Catheter-Related Bloodstream Infection Caused by Coagulase-Negative Staphylococci Antibiotics antibiotic stewardship catheter-related bloodstream infection coagulase-negative staphylococci healthcare related infection |
| title | Randomized Clinical Trial of the Need for Antibiotic Treatment for Low-Risk Catheter-Related Bloodstream Infection Caused by Coagulase-Negative Staphylococci |
| title_full | Randomized Clinical Trial of the Need for Antibiotic Treatment for Low-Risk Catheter-Related Bloodstream Infection Caused by Coagulase-Negative Staphylococci |
| title_fullStr | Randomized Clinical Trial of the Need for Antibiotic Treatment for Low-Risk Catheter-Related Bloodstream Infection Caused by Coagulase-Negative Staphylococci |
| title_full_unstemmed | Randomized Clinical Trial of the Need for Antibiotic Treatment for Low-Risk Catheter-Related Bloodstream Infection Caused by Coagulase-Negative Staphylococci |
| title_short | Randomized Clinical Trial of the Need for Antibiotic Treatment for Low-Risk Catheter-Related Bloodstream Infection Caused by Coagulase-Negative Staphylococci |
| title_sort | randomized clinical trial of the need for antibiotic treatment for low risk catheter related bloodstream infection caused by coagulase negative staphylococci |
| topic | antibiotic stewardship catheter-related bloodstream infection coagulase-negative staphylococci healthcare related infection |
| url | https://www.mdpi.com/2079-6382/12/5/839 |
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