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      Procalcitonin to Reduce Long-Term Infection-associated Adverse Events in Sepsis. A Randomized Trial

      1 , 1 , 2 , 1 , 1 , 2 , 2 , 3 , 2 , 4 , 4 , 5 , 6 , 7 , 1 , 1 , 6 , 6 , 7 , 5 , 5 , 4 , 4 , 4 , 3 , 1 , , 1

      American Journal of Respiratory and Critical Care Medicine

      American Thoracic Society

      procalcitonin, sepsis, multidrug-resistant, mortality

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          Abstract

          Rationale: Although early antimicrobial discontinuation guided by procalcitonin (PCT) has shown decreased antibiotic consumption in lower respiratory tract infections, the outcomes in long-term sepsis sequelae remain unclear.

          Objectives: To investigate if PCT guidance may reduce the incidence of long-term infection-associated adverse events in sepsis.

          Methods: In this multicenter trial, 266 patients with sepsis (by Sepsis-3 definitions) with lower respiratory tract infections, acute pyelonephritis, or primary bloodstream infection were randomized (1:1) to receive either PCT-guided discontinuation of antimicrobials or standard of care. The discontinuation criterion was ≥80% reduction in PCT levels or any PCT ≤0.5 μg/L at Day 5 or later. The primary outcome was the rate of infection-associated adverse events at Day 180, a composite of the incidence of any new infection by Clostridioides difficile or multidrug-resistant organisms, or any death attributed to baseline C. difficile or multidrug-resistant organism infection. Secondary outcomes included 28-day mortality, length of antibiotic therapy, and cost of hospitalization.

          Measurements and Main Results: The rate of infection-associated adverse events was 7.2% (95% confidence interval [CI], 3.8–13.1%; 9/125) versus 15.3% (95% CI, 10.1–22.4%; 20/131) (hazard ratio, 0.45; 95% CI, 0.20–0.98; P = 0.045); 28-day mortality 15.2% (95% CI, 10–22.5%; 19/125) versus 28.2% (95% CI, 21.2–36.5%; 37/131) (hazard ratio, 0.51; 95% CI, 0.29–0.89; P = 0.02); and median length of antibiotic therapy 5 (range, 5–7) versus 10 (range, 7–15) days ( P < 0.001) in the PCT and standard-of-care arms, respectively. The cost of hospitalization was also reduced in the PCT arm.

          Conclusions: In sepsis, PCT guidance was effective in reducing infection-associated adverse events, 28-day mortality, and cost of hospitalization.

          Clinical trial registered with www.clinicaltrials.gov (NCT03333304).

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          Most cited references 30

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          The Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3).

          Definitions of sepsis and septic shock were last revised in 2001. Considerable advances have since been made into the pathobiology (changes in organ function, morphology, cell biology, biochemistry, immunology, and circulation), management, and epidemiology of sepsis, suggesting the need for reexamination.
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            Surviving Sepsis Campaign: International Guidelines for Management of Sepsis and Septic Shock: 2016.

            To provide an update to "Surviving Sepsis Campaign Guidelines for Management of Sepsis and Septic Shock: 2012".
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              The relationship between antimicrobial resistance and patient outcomes: mortality, length of hospital stay, and health care costs.

              There is an association between the development of antimicrobial resistance in Staphylococcus aureus, enterococci, and gram-negative bacilli and increases in mortality, morbidity, length of hospitalization, and cost of health care. For many patients, inadequate or delayed therapy and severe underlying disease are primarily responsible for the adverse outcomes of infections caused by antimicrobial-resistant organisms. Patients with infections due to antimicrobial-resistant organisms have higher costs (approximately 6,000-30,000 dollars) than do patients with infections due to antimicrobial-susceptible organisms; the difference in cost is even greater when patients infected with antimicrobial-resistant organisms are compared with patients without infection. Strategies to prevent nosocomial emergence and spread of antimicrobial-resistant organisms are essential.
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                Author and article information

                Journal
                Am J Respir Crit Care Med
                Am J Respir Crit Care Med
                ajrccm
                American Journal of Respiratory and Critical Care Medicine
                American Thoracic Society
                1073-449X
                1535-4970
                15 January 2021
                15 January 2021
                15 January 2021
                15 January 2021
                : 203
                : 2
                : 202-210
                Affiliations
                [ 1 ]Fourth Department of Internal Medicine and
                [ 6 ]Third Department of Internal Medicine, National and Kapodistrian University of Athens, Medical School, Athens, Greece
                [ 2 ]First Department of Internal Medicine, G. Gennimatas General Hospital of Athens, Athens, Greece
                [ 3 ]Second Department of Internal Medicine, Tzaneio General Hospital of Piraeus, Athens, Greece
                [ 4 ]First Department of Internal Medicine and
                [ 5 ]Second Department of Internal Medicine, Thriasio General Hospital of Eleusis, Athens, Greece; and
                [ 7 ]Second Department of Internal Medicine, Sismanogleio General Hospital of Athens, Athens, Greece
                Author notes
                Correspondence and requests for reprints should be addressed to Evangelos J. Giamarellos-Bourboulis, M.D., Ph.D., Fourth Department of Internal Medicine, ATTIKON University Hospital, 1 Rimini Street, 124 62 Athens, Greece. E-mail: egiamarel@ 123456med.uoa.gr .
                Article
                202004-1201OC
                10.1164/rccm.202004-1201OC
                7874409
                32757963
                Copyright © 2021 by the American Thoracic Society

                This article is open access and distributed under the terms of the Creative Commons Attribution Non-Commercial No Derivatives License 4.0 ( http://creativecommons.org/licenses/by-nc-nd/4.0/). For commercial usage and reprints, please contact Diane Gern ( dgern@ 123456thoracic.org ).

                Page count
                Figures: 3, Tables: 4, Pages: 9
                Product
                Categories
                Original Articles
                Critical Care/Pulmonary Infections

                procalcitonin, sepsis, multidrug-resistant, mortality

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