دورية أكاديمية
Evaluation of an Opt-Out Protocol for Antibiotic De-Escalation in Patients With Suspected Sepsis: A Multicenter, Randomized, Controlled Trial.
| العنوان: | Evaluation of an Opt-Out Protocol for Antibiotic De-Escalation in Patients With Suspected Sepsis: A Multicenter, Randomized, Controlled Trial. |
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| المؤلفون: | Moehring RW; Department of Medicine, Infectious Diseases, Duke University, Durham, North Carolina, USA.; Duke Center for Antimicrobial Stewardship and Infection Prevention, Durham, North Carolina, USA., Yarrington ME; Department of Medicine, Infectious Diseases, Duke University, Durham, North Carolina, USA.; Duke Center for Antimicrobial Stewardship and Infection Prevention, Durham, North Carolina, USA., Warren BG; Duke Center for Antimicrobial Stewardship and Infection Prevention, Durham, North Carolina, USA., Lokhnygina Y; Department of Biostatistics and Bioinformatics, Duke University, Durham, North Carolina, USA., Atkinson E; Department of Pharmacy, Southeastern Regional Medical Center, Lumberton, North Carolina, USA., Bankston A; Department of Pharmacy, Piedmont Newnan Hospital, Newnan, Georgia, USA., Collucio J; Department of Pharmacy, Piedmont Atlanta Hospital, Atlanta, Georgia, USA., David MZ; Department of Medicine, Infectious Diseases, University of Pennsylvania, Philadelphia, Pennsylvania, USA., Davis AE; Duke Center for Antimicrobial Stewardship and Infection Prevention, Durham, North Carolina, USA., Davis J; Department of Pharmacy, Piedmont Fayette Hospital, Fayette, Georgia, USA., Dionne B; Department of Pharmacy, Brigham and Women's Hospital, Boston, Massachusetts, USA.; Department of Pharmacy and Health Systems Sciences, Northeastern University School of Pharmacy and Pharmaceutical Sciences, Boston, Massachusetts, USA., Dyer AP; Department of Medicine, Infectious Diseases, Duke Center for Antimicrobial Stewardship and Infection Prevention, Durham, North Carolina, USA., Jones TM; Duke Center for Antimicrobial Stewardship and Infection Prevention, Durham, North Carolina, USA., Klompas M; Department of Medicine, Infectious Diseases, Brigham and Women's Hospital, Boston, Massachusetts, USA.; Department of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston, Massachusetts, USA., Kubiak DW; Department of Pharmacy, Brigham and Women's Hospital, Boston, Massachusetts, USA., Marsalis J; Department of Pharmacy, Piedmont Newnan Hospital, Newnan, Georgia, USA., Omorogbe J; University of Pennsylvania, Philadelphia, Pennsylvania, USA., Orajaka P; Department of Pharmacy, Iredell Health, Statesville, North Carolina, USA., Parish A; Department of Biostatistics and Bioinformatics, Duke University, Durham, North Carolina, USA., Parker T; Department of Pharmacy, Piedmont Atlanta Hospital, Atlanta, Georgia, USA., Pearson JC; Department of Pharmacy, Brigham and Women's Hospital, Boston, Massachusetts, USA., Pearson T; Department of Pharmacy, Piedmont Fayette Hospital, Fayette, Georgia, USA., Sarubbi C; Department of Pharmacy, UNC REX Healthcare, Raleigh, North Carolina, USA., Shaw C; Department of Pharmacy, Wilson Medical Center, Wilson, North Carolina, USA., Spivey J; Duke Center for Antimicrobial Stewardship and Infection Prevention, Durham, North Carolina, USA.; Department of Pharmacy, Duke University Medical Center, Durham, North Carolina, USA., Wolf R; Brigham and Women's Hospital, Boston, Massachusetts, USA., Wrenn RH; Duke Center for Antimicrobial Stewardship and Infection Prevention, Durham, North Carolina, USA.; Department of Pharmacy, Duke University Medical Center, Durham, North Carolina, USA., Dodds Ashley ES; Department of Medicine, Infectious Diseases, Duke Center for Antimicrobial Stewardship and Infection Prevention, Durham, North Carolina, USA., Anderson DJ; Department of Medicine, Infectious Diseases, Duke University, Durham, North Carolina, USA.; Duke Center for Antimicrobial Stewardship and Infection Prevention, Durham, North Carolina, USA. |
| مؤلفون مشاركون: | Centers for Disease Control and Prevention’s Prevention Epicenters Program |
| المصدر: | Clinical infectious diseases : an official publication of the Infectious Diseases Society of America [Clin Infect Dis] 2023 Feb 08; Vol. 76 (3), pp. 433-442. |
| نوع المنشور: | Clinical Trial Protocol; Journal Article; Research Support, U.S. Gov't, P.H.S. |
| اللغة: | English |
| بيانات الدورية: | Publisher: Oxford University Press Country of Publication: United States NLM ID: 9203213 Publication Model: Print Cited Medium: Internet ISSN: 1537-6591 (Electronic) Linking ISSN: 10584838 NLM ISO Abbreviation: Clin Infect Dis Subsets: MEDLINE |
| أسماء مطبوعة: | Publication: Jan. 2011- : Oxford : Oxford University Press Original Publication: Chicago, IL : The University of Chicago Press, c1992- |
| مواضيع طبية MeSH: | Anti-Bacterial Agents*/adverse effects , Sepsis*/drug therapy , Sepsis*/microbiology, Adult ; Humans ; Randomized Controlled Trials as Topic ; Multicenter Studies as Topic |
| مستخلص: | Background: Sepsis guidelines recommend daily review to de-escalate or stop antibiotics in appropriate patients. This randomized, controlled trial evaluated an opt-out protocol to decrease unnecessary antibiotics in patients with suspected sepsis. Methods: We evaluated non-intensive care adults on broad-spectrum antibiotics despite negative blood cultures at 10 US hospitals from September 2018 through May 2020. A 23-item safety check excluded patients with ongoing signs of systemic infection, concerning or inadequate microbiologic data, or high-risk conditions. Eligible patients were randomized to the opt-out protocol vs usual care. Primary outcome was post-enrollment antibacterial days of therapy (DOT). Clinicians caring for intervention patients were contacted to encourage antibiotic discontinuation using opt-out language. If continued, clinicians discussed the rationale for continuing antibiotics and de-escalation plans. To evaluate those with zero post-enrollment DOT, hurdle models provided 2 measures: odds ratio of antibiotic continuation and ratio of mean DOT among those who continued antibiotics. Results: Among 9606 patients screened, 767 (8%) were enrolled. Intervention patients had 32% lower odds of antibiotic continuation (79% vs 84%; odds ratio, 0.68; 95% confidence interval [CI], .47-.98). DOT among those who continued antibiotics were similar (ratio of means, 1.06; 95% CI, .88-1.26). Fewer intervention patients were exposed to extended-spectrum antibiotics (36% vs 44%). Common reasons for continuing antibiotics were treatment of localized infection (76%) and belief that stopping antibiotics was unsafe (31%). Thirty-day safety events were similar. Conclusions: An antibiotic opt-out protocol that targeted patients with suspected sepsis resulted in more antibiotic discontinuations, similar DOT when antibiotics were continued, and no evidence of harm. Clinical Trials Registration: NCT03517007. Competing Interests: Potential conflicts of interest. E. D. A. reports grants or contracts from the University of Maryland (paid to author), University of Chicago (paid to author), CDC Prevention Epicenter Program (paid to institution), Oxford University Clinical Research Unit (paid to author), CDC (paid to institution), and DASON Member Hospital Contracts (paid to institution); royalties or licenses from UpToDate (paid to author); consulting fees from the American College of Clinical Pharmacy (paid to author), Hospital Association of New York State (paid to author), Sarah Moreland Russel Consulting (paid to author), and HealthTrackRX (paid to author); and support for attending meetings and/or travel from the American Society of Microbiology (paid to author), Pew Charitable Trusts (paid to author), and Oxford University Clinical Research Unit (paid to institution). A. E. D. reports payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing, or educational events from Merck & Co (paid to author). M. Z. D. reports grants or contracts from the National Institutes of Health, GSK, Johnson & Johnson, and Contrafect (paid to institution); support for attending meetings and/or travel from GSK; and participation on a data and safety monitoring board or advisory board for GSK (paid to author). D. J. A. reports grants or contracts from Agency for Healthcare Research and Quality (to institution), royalties or licenses from UpToDate Online (paid to author), and other financial or nonfinancial interests from Infection Control Education for Major Sports, LLC (owner). M. K. reports grants or contracts from Agency for Healthcare Research and Quality (paid to institution) and the Massachusetts Department of Public Health (paid to institution) and royalties or licenses from UpToDate (paid to author). R. W. M. reports grants or contracts from the CDC (paid to institution) and the Agency for Healthcare Research and Quality (paid to institution), royalties or licenses from UpToDate, Inc. (paid to author), speaker honoraria for the North Carolina Statewide Program for Infection Control and Epidemiology (paid to author), support for attending meetings and/or travel from the Society for Healthcare Epidemiology of America, and is on the Society for Healthcare Epidemiology of America Board of Trustees. A. P. reports grants from Clinical and Translational Science Award (to Biostatistics, Epidemiology, and Research Design Core, within the Biostatistics and Bioinformatics Department at Duke University). J. C. P. reports serving on the advisory boards for Shionogi, Inc, and Gilead Sciences, Inc. All other authors report no potential conflicts. All authors have submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Conflicts that the editors consider relevant to the content of the manuscript have been disclosed. (© The Author(s) 2022. Published by Oxford University Press on behalf of Infectious Diseases Society of America. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.) |
| فهرسة مساهمة: | Keywords: SEP-1; antibiotic; antimicrobial stewardship; de-escalation; sepsis |
| سلسلة جزيئية: | ClinicalTrials.gov NCT03517007 |
| المشرفين على المادة: | 0 (Anti-Bacterial Agents) |
| تواريخ الأحداث: | Date Created: 20220927 Date Completed: 20230210 Latest Revision: 20230220 |
| رمز التحديث: | 20231215 |
| DOI: | 10.1093/cid/ciac787 |
| PMID: | 36167851 |
| قاعدة البيانات: | MEDLINE |
Full Text Finder | تدمد: | 1537-6591 |
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| DOI: | 10.1093/cid/ciac787 |