Procalcitonin-guided use of antibiotics for lower respiratory tract infection

New England Journal of Medicine

Volumn 379, Issue 3, 2018, Pages 236-249

  Huang, D T ^a,b,c,e   Yealy, D M ^c,e   Filbin, M R ^h   Brown, A M ^c   Chang, C C H ^a,f   Doi, Y ^a   Donnino, M W ⁱ   Fine, J ^k   Fine, M J ^f,g   Fischer, M A ^l   Holst, J M ^m   Hou, P C ^j   Kellum, J A ^a,b   Khan, F ⁿ   Kurz, M C ^o   Lotfipour, S ^p   Lovecchio, F ^q   Peck Palmer, O M ^a,b,d   Pike, F ^r   Prunty, H ^c   Sherwin, R L ^s   Southerland, L ^t   Terndrup, T ^l,t   Weissfeld, L A ^u   Yabes, J ^f   Angus, D C ^a,b,e   more..

^a UNIVERSITY OF PITTSBURGH SCHOOL OF MEDICINE   (United States)

^b Departments of Critical Care Medicine   (United States)

^c Departments of Psychiatry and Medicine   (United States)

^d UPMC Shadyside   (United States)

^e The MACRO (Multidisciplinary Acute Care Research Organization) Center   (United States)

^f Division of General Internal Medicine   (United States)

^g VETERANS AFFAIRS MEDICAL CENTER   (United States)

^h MASSACHUSETTS GENERAL HOSPITAL   (United States)

ⁱ BETH ISRAEL DEACONESS MEDICAL CENTER   (United States)

^j BRIGHAM AND WOMEN S HOSPITAL   (United States)

^k NORWALK HOSPITAL   (United States)

^l PENN STATE MILTON S HERSHEY MEDICAL CENTER   (United States)

^m Department of Emergency Medicine ^*  (United States)

ⁿ UNIVERSITY OF MARYLAND MEDICAL CENTER   (United States)

^o UNIVERSITY OF ALABAMA AT BIRMINGHAM   (United States)

^p UNIVERSITY OF CALIFORNIA   (United States)

^q MARICOPA MEDICAL CENTER   (United States)

^r ELI LILLY   (United States)

^s DETROIT RECEIVING HOSPITAL   (United States)

^t OHIO STATE UNIVERSITY   (United States)

^u University of Iowa   (United States)

more..

Author keywords

[No Author keywords available]

Indexed keywords

ANTIBIOTIC AGENT; PROCALCITONIN; ANTIINFECTIVE AGENT; BIOLOGICAL MARKER; CALCITONIN;

ADULT; ADVERSE OUTCOME; ANTIBIOTIC THERAPY; ARTICLE; ASTHMA; BRONCHITIS; CHRONIC OBSTRUCTIVE LUNG DISEASE; CLINICAL DECISION MAKING; CLINICAL PRACTICE; COHORT ANALYSIS; COMMUNITY ACQUIRED PNEUMONIA; CONTROLLED STUDY; DRUG USE; EMERGENCY WARD; FEMALE; HOSPITAL PATIENT; HUMAN; LOWER RESPIRATORY TRACT INFECTION; MAJOR CLINICAL STUDY; MALE; MIDDLE AGED; MULTICENTER STUDY; OUTCOME ASSESSMENT; PATIENT COMPLIANCE; PHYSICIAN; PNEUMONIA; PRACTICE GUIDELINE; PRESCRIPTION; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; TREATMENT DURATION; UNITED STATES; AGED; BACTERIAL INFECTION; BLOOD; CLINICAL TRIAL; HOSPITAL EMERGENCY SERVICE; INAPPROPRIATE PRESCRIBING; MEDICAL STAFF; PREVENTION AND CONTROL; PROTOCOL COMPLIANCE; RESPIRATORY TRACT INFECTION; STATISTICS AND NUMERICAL DATA;

ADULT; AGED; ANTI-BACTERIAL AGENTS; BACTERIAL INFECTIONS; BIOMARKERS; CALCITONIN; EMERGENCY SERVICE, HOSPITAL; FEMALE; GUIDELINE ADHERENCE; HOSPITALISTS; HUMANS; INAPPROPRIATE PRESCRIBING; MALE; MIDDLE AGED; PNEUMONIA; PRACTICE GUIDELINES AS TOPIC; PRACTICE PATTERNS, PHYSICIANS'; RESPIRATORY TRACT INFECTIONS;

EID: 85050366822     PISSN: 00284793     EISSN: 15334406     Source Type: Journal    
DOI: 10.1056/NEJMoa1802670     Document Type: Article

References (50)

1. Fleming-Dutra KE, Hersh AL, Shapiro DJ, et al. Prevalence of inappropriate antibiotic prescriptions among US ambulatory care visits, 2010-2011. JAMA 2016; 315: 1864-1873.
2. Nathan C, Cars O. Antibiotic resistance - problems, progress, and prospects. N Engl J Med 2014; 371: 1761-1763.
3. Linder JA. Antibiotic prescribing for acute respiratory infections - success that's way off the mark: comment on "A cluster randomized trial of decision support strategies for reducing antibiotic use in acute bronchitis." JAMA Intern Med 2013; 173: 273-275.
4. Antibiotic use in the United States, 2017: progress and opportunities. Atlanta: Centers for Disease Control and Prevention, 2017 (https://www.cdc.gov/antibiotic-use/stewardship-report/hospital.html).
5. Tonkin-Crine SK, Tan PS, van Hecke O, et al. Clinician-targeted interventions to influence antibiotic prescribing behaviour for acute respiratory infections in primary care: An overview of systematic reviews. Cochrane Database Syst Rev 2017; 9: CD012252.
6. Muller B, White JC, Nylen ES, Snider RH, Becker KL, Habener JF. Ubiquitous expression of the calcitonin-I gene in multiple tissues in response to sepsis. J Clin Endocrinol Metab 2001; 86: 396-404.
7. Assicot M, Gendrel D, Carsin H, Raymond J, Guilbaud J, Bohuon C. High serum procalcitonin concentrations in patients with sepsis and infection. Lancet 1993; 341: 515-518.
8. Huang DT, Weissfeld LA, Kellum JA, et al. Risk prediction with procalcitonin and clinical rules in community-acquired pneumonia. Ann Emerg Med 2008; 52(1): 48-58.e2.
9. Muller B, Harbarth S, Stolz D, et al. Diagnostic and prognostic accuracy of clinical and laboratory parameters in com munity-acquired pneumonia. BMC Infect Dis 2007; 7: 10.
10. Luyt CE, Guerin V, Combes A, et al. Procalcitonin kinetics as a prognostic marker of ventilator-associated pneumonia. Am J Respir Crit Care Med 2005; 171: 48-53.
11. Schuetz P, Christ-Crain M, Thomann R, et al. Effect of procalcitonin-based guidelines vs standard guidelines on antibiotic use in lower respiratory tract infections: The ProHOSP randomized controlled trial. JAMA 2009; 302: 1059-1066.
12. Christ-Crain M, Stolz D, Bingisser R, et al. Procalcitonin guidance of antibiotic therapy in community-acquired pneumonia: A randomized trial. Am J Respir Crit Care Med 2006; 174: 84-93.
13. Christ-Crain M, Jaccard-Stolz D, Bingisser R, et al. Effect of procalcitoninguided treatment on antibiotic use and outcome in lower respiratory tract infections: cluster-randomised, single-blinded intervention trial. Lancet 2004; 363: 600-607.
14. Stolz D, Christ-Crain M, Bingisser R, et al. Antibiotic treatment of exacerbations of COPD: A randomized, controlled trial comparing procalcitonin-guidance with standard therapy. Chest 2007; 131: 9-19.
15. FDA clears test to help manage antibiotic treatment for lower respiratory tract infections and sepsis. News release of the Food and Drug Administration, Silver Spring, MD, February 23, 2017 (https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm543160.htm).
16. Food and Drug Administration. Discussion and recommendations for the application of procalcitonin to the evaluation and management of suspected lower respiratory tract infections and sepsis. FDA Executive Summary. 2016 (https://www.fda.gov/downloads/advisorycommittees/committeesmeetingmaterials/medicaldevices/medicaldevicesadvisorycommittee/microbiologydevicespanel/ucm528156.pdf).
17. Schuetz P, Christ-Crain M, Wolbers M, et al. Procalcitonin guided antibiotic therapy and hospitalization in patients with lower respiratory tract infections: A prospective, multicenter, randomized controlled trial. BMC Health Serv Res 2007; 7: 102.
18. McDonagh M, Peterson K, Winthrop K, et al. Improving antibiotic prescribing for uncomplicated acute respiratory tract infections. Comparative effectiveness review no. 163. Rockville, MD: Agency for Healthcare Research and Quality, 2016 (https://effectivehealthcare.ahrq.gov/sites/default/files/pdf/antibiotics-respiratory-infection-research.pdf).
19. National Institute for Health and Care Excellence. Assessment of communityacquired pneumonia. London: NICE, March 2018 (https://pathways.nice.org.uk/pathways/pneumonia).
20. Kalil AC, Metersky ML, Klompas M, et al. Management of adults with hospital- Acquired and ventilator-associated pneumonia: 2016 clinical practice guidelines by the Infectious Diseases Society of America and the American Thoracic Society. Clin Infect Dis 2016; 63(5): e61-e111.
21. Branche AR, Walsh EE, Vargas R, et al. Serum procalcitonin measurement and viral testing to guide antibiotic use for respiratory infections in hospitalized adults: A randomized controlled trial. J Infect Dis 2015; 212: 1692-1700.
22. Stolz D, Smyrnios N, Eggimann P, et al. Procalcitonin for reduced antibiotic exposure in ventilator-associated pneumonia: A randomised study. Eur Respir J 2009; 34: 1364-1375.
23. Huang DT, Angus DC, Chang CH, et al. Design and rationale of the Procalcitonin Antibiotic Consensus Trial (ProACT), a multicenter randomized trial of procalcitonin antibiotic guidance in lower respiratory tract infection. BMC Emerg Med 2017; 17: 25.
24. Seymann GB. Community-acquired pneumonia: defining quality care. J Hosp Med 2006; 1: 344-353.
25. Fine MJ, Auble TE, Yealy DM, et al. A prediction rule to identify low-risk patients with community-acquired pneumonia. N Engl J Med 1997; 336: 243-250.
26. Bone RC. Toward an epidemiology and natural history of SIRS (systemic inflammatory response syndrome). JAMA 1992; 268: 3452-3455.
27. Vogelmeier CF, Criner GJ, Martinez FJ, et al. Global Strategy for the Diagnosis, Management, and Prevention of Chronic Obstructive Lung Disease 2017 report: GOLD executive summary. Am J Respir Crit Care Med 2017; 195: 557-582.
28. National Asthma Education and Prevention Program. Expert Panel Report 3 (EPR-3): guidelines for the diagnosis and management of asthma-summary report 2007. J Allergy Clin Immunol 2007; 120: Suppl: S94-S138.
29. Reddel HK, Taylor DR, Bateman ED, et al. An official American Thoracic Society/European Respiratory Society statement: Asthma control and exacerbations: standardizing endpoints for clinical asthma trials and clinical practice. Am J Respir Crit Care Med 2009; 180: 59-99.
30. Loymans RJ, Ter Riet G, Sterk PJ. Definitions of asthma exacerbations. Curr Opin Allergy Clin Immunol 2011; 11: 181-186.
31. Gonzales R, Sande MA. Uncomplicated acute bronchitis. Ann Intern Med 2000; 133: 981-991.
32. Barley EA, Quirk FH, Jones PW. Asthma health status measurement in clinical practice: validity of a new short and simple instrument. Respir Med 1998; 92: 1207-1214.
33. Department of Health and Human Services. Common Terminology Criteria for Adverse Events (CTCAE), version 4.03. 2010 (https://ctep.cancer.gov/protocolDevelopment/codes-values.htm#ctc).
34. Rubin DB. Multiple imputation for nonresponse in surveys. New York: John Wiley, 1987.
35. Lindenauer PK, Pekow PS, Lahti MC, Lee Y, Benjamin EM, Rothberg MB. Association of corticosteroid dose and route of administration with risk of treatment failure in acute exacerbation of chronic obstructive pulmonary disease. JAMA 2010; 303: 2359-2367.
36. Piaggio G, Elbourne DR, Pocock SJ, Evans SJ, Altman DG. Reporting of noninferiority and equivalence randomized trials: extension of the CONSORT 2010 statement. JAMA 2012; 308: 2594-2604.
37. Bang H, Davis CE. On estimating treatment effects under non-compliance in randomized clinical trials: Are intent-totreat or instrumental variables analyses perfect solutions? Stat Med 2007; 26: 954- 964.
38. Kim MY. Using the instrumental variables estimator to analyze noninferiority trials with noncompliance. J Biopharm Stat 2010; 20: 745-758.
39. Ten Have TR, Normand SL, Marcus SM, Brown CH, Lavori P, Duan N. Intentto- treat vs. non-intent-to-treat analyses under treatment non-adherence in mental health randomized trials. Psychiatr Ann 2008; 38: 772-783.
40. O'Kelly M, Ratitch B. Clinical trials with missing data: A guide for practitioners. Chichester, England: John Wiley, 2014.
41. Charlson ME, Pompei P, Ales KL, MacKenzie CR. A new method of classifying prognostic comorbidity in longitudinal studies: development and validation. J Chronic Dis 1987; 40: 373-383.
42. Schuetz P, Wirz Y, Sager R, et al. Procalcitonin to initiate or discontinue antibiotics in acute respiratory tract infections. Cochrane Database Syst Rev 2017; 10: CD007498.
43. Barlam TF, Cosgrove SE, Abbo LM, et al. Implementing an antibiotic stewardship program: guidelines by the Infectious Diseases Society of America and the Society for Healthcare Epidemiology of America. Clin Infect Dis 2016; 62(10): e51- e77.
44. Spellberg B. The new antibiotic mantra - "shorter is better." JAMA Intern Med 2016; 176: 1254-1255.
45. Mandell LA, Wunderink RG, Anzueto A, et al. Infectious Diseases Society of America/American Thoracic Society consensus guidelines on the management of community-acquired pneumonia in adults. Clin Infect Dis 2007; 44: Suppl 2: S27-S72.
46. Jacobs DM, Noyes K, Zhao J, et al. Early hospital readmissions following an acute exacerbation of COPD in the Nationwide Readmissions Database. Ann Am Thorac Soc 2018 April 3 (Epub ahead of print).
47. Shorr AF, Zilberberg MD, Reichley R, et al. Readmission following hospitalization for pneumonia: The impact of pneumonia type and its implication for hospitals. Clin Infect Dis 2013; 57: 362-367.
48. Hasegawa K, Gibo K, Tsugawa Y, Shimada YJ, Camargo CA Jr. Age-related differences in the rate, timing, and diagnosis of 30-day readmissions in hospitalized adults with asthma exacerbation. Chest 2016; 149: 1021-1029.
49. Cunha BA. Empiric antimicrobial therapy of community-acquired pneumonia: clinical diagnosis versus procalcitonin levels. Scand J Infect Dis 2009; 41: 782-784.
50. Riedel S. Procalcitonin and antibiotic therapy: can we improve antimicrobial stewardship in the intensive care setting? Crit Care Med 2012; 40: 2499-2500.