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Procalcitonin-Guided Antibiotic Therapy

Procalcitonin-Guided Antibiotic Therapy. Prepared for: Agency for Healthcare Research and Quality (AHRQ) www.ahrq.gov. Outline of Material. Introduction to procalcitonin and its role in guiding antibiotic therapy in adult and pediatric patients with suspected infections

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Procalcitonin-Guided Antibiotic Therapy

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  1. Procalcitonin-Guided Antibiotic Therapy Prepared for: Agency for Healthcare Research and Quality (AHRQ) www.ahrq.gov

  2. Outline of Material • Introduction to procalcitonin and its role in guiding antibiotic therapy in adult and pediatric patients with suspected infections • Systematic review methods • The clinical questions addressed by the comparative effectiveness review • Results of studies and evidence-based conclusions about the effects of using procalcitonin versus clinical criteria to guide antibiotic therapy in adult and pediatric patients with suspected local or systemic infections • Gaps in knowledge and future research needs • What to discuss with patients and their caregivers Soni NJ, Samson DJ, Galaydick JL, et al. AHRQ Comparative Effectiveness Review No. 78. Available at www.effectivehealthcare.ahrq.gov/procalcitonin.cfm.

  3. Background: The Need for Biomarkers To Guide Antibiotic Therapy for Bacterial Infections • The early initiation and appropriate use of antibiotics are important factors in managing: • Critically ill patients with suspected bacterial infections such as sepsis • Patients with bacterial upper and lower respiratory tract infections in the ambulatory care or hospital setting • Pediatric patients with suspected bacterial infections, including neonates with suspected sepsis • Patients in the postoperative setting with suspected infections • A key challenge associated with antibiotic therapy is the overuse and misuse of antibiotics, which can result in adverse effects and add to the increasing problem of antibiotic resistance. • However, the duration of antibiotic therapy that is appropriate for these patients is often undefined, and clinical features offer limited guidance. Soni NJ, Samson DJ, Galaydick JL, et al. AHRQ Comparative Effectiveness Review No. 78. Available at www.effectivehealthcare.ahrq.gov/procalcitonin.cfm. Pierrakos C, Vincent JL. Crit Care 2010;14(1):R15. PMID: 20144219.

  4. Background: Procalcitonin and Its Role as a Biomarker of Bacterial Infections • Several serum biomarkers have been identified with the potential to help diagnose local and systemic infections and guide their clinical management, particularly antibiotic therapy. • Procalcitonin is the most extensively studied biomarker among these. • Procalcitonin is the precursor of the hormone calcitonin; its levels have been found to increase during infections and different degrees of inflammation. • The primary utility of procalcitonin is suggested to be in establishing the presence of local or systemic bacterial infections and in guiding their management. • Procalcitonin is often used with algorithms to guide care in association with clinical impressions. Soni NJ, Samson DJ, Galaydick JL, et al. AHRQ Comparative Effectiveness Review No. 78. Available at www.effectivehealthcare.ahrq.gov/procalcitonin.cfm. Jones AE, Fiechtl JF, Brown MD, et al. Ann Emerg Med 2007 Jul;50(1):34- 41. PMID: 17161501. Pierrakos C, Vincent JL. Crit Care 2010;14(1):R15. PMID: 20144219. Tang H, Huang T, Jing J, et al. Infection 2009 Dec;37(6):497-507. PMID:19826761.

  5. Background: Cutoffs for Procalcitonin Used in Clinical Practice • In healthy people, the levels of procalcitonin are very low. • In systemic bacterial infections, including sepsis, the level of procalcitonin is generally ≥0.5 ng/mL, with higher levels being associated with severe disease. • In patients with suspected respiratory tract infection, a cutoff >0.25 ng/mL is predictive of a bacterial infection. • A level <0.25 ng/mL signals resolution of the infection. • In neonates, a nomogram accounting for the time from birth in hours is recommended for assessing procalcitonin cutoffs. • The cutoff level of procalcitonin to identify postoperative patients with infection may be higher than that used for other patient groups due to cytokine release during surgery. Soni NJ, Samson DJ, Galaydick JL, et al. AHRQ Comparative Effectiveness Review No. 78. Available at www.effectivehealthcare.ahrq.gov/procalcitonin.cfm. Chiesa C, Panero A, Rossi N, et al. Clin Infect Dis 1998 Mar;26(3):664-72. PMID: 9524841. Christ-Crain M, Muller B. Eur Respir J 2007 Sep;30(3):556-73. PMID: 17766633. Luyt CE, Guerin V, Combes A, et al. Am J Respir Crit Care Med 2005 Jan 1;171(1):48-53. PMID: 15447947. Simon L, Gauvin F, Amre DK, et al. Clin Infect Dis 2004 Jul 15;39(2):206-17. PMID: 15307030.

  6. Uncertainties Related to the Use of Procalcitonin To Guide Antibiotic Therapy • Earlier studies have investigated the potential roles of procalcitonin in diagnosing and managing local and systemic infections. • Some evidence indicates that procalcitonin, when compared with other markers, is more specific for bacterial infections. • However, its clinical utility in diagnosing and managing patients with suspected infections remains unclear. • This review focused on the clinical utility of procalcitonin in managing patients with suspected infections. • Although questions about the clinical utility of procalcitonin in the diagnosis of patients with suspected infections persist, they were not addressed in this review. Soni NJ, Samson DJ, Galaydick JL, et al. AHRQ Comparative Effectiveness Review No. 78. Available at www.effectivehealthcare.ahrq.gov/procalcitonin.cfm.

  7. Agency for Healthcare Research and Quality (AHRQ) Comparative Effectiveness Review (CER) Development • Topics are nominated through a public process, which includes submissions from health care professionals, professional organizations, the private sector, policymakers, members of the public, and others. • A systematic review of all relevant clinical studies is conducted by independent researchers, funded by AHRQ, to synthesize the evidence in a report summarizing what is known and not known about the select clinical issue. The research questions and the results of the report are subject to expert input, peer review, and public comment. • The results of these reviews are summarized into Clinician Research Summaries and Consumer Research Summaries for use in decisionmaking and in discussions with patients. The Research Summaries and the full report, with references for included and excluded studies, are available at www.effectivehealthcare.ahrq.gov/procalcitonin.cfm. Soni NJ, Samson DJ, Galaydick JL, et al. AHRQ Comparative Effectiveness Review No. 78. Available at www.effectivehealthcare.ahrq.gov/procalcitonin.cfm.

  8. Rating the Strength of Evidence From the Comparative Effectiveness Review • The strength of evidence was classified into four broad categories: Soni NJ, Samson DJ, Galaydick JL, et al. AHRQ Comparative Effectiveness Review No. 78. Available at www.effectivehealthcare.ahrq.gov/procalcitonin.cfm.

  9. The Clinical Question Addressed by This Comparative Effectiveness Review • Key Question: In selected populations of patients with suspected local or systemic infection, what are the effects of using procalcitonin measurement plus clinical criteria for infection to guide initiation, discontinuation, or a change of antibiotic therapy when compared with clinical criteria for infection alone on: • Intermediate outcomes, such as initiation, discontinuation or change of antibiotic therapy, antibiotic usage, and length of stay? • Health outcomes, such as morbidity, mortality, function, quality of life, and adverse events of antibiotic therapy (persistent or recurrent infection and antibiotic resistance)? Soni NJ, Samson DJ, Galaydick JL, et al. AHRQ Comparative Effectiveness Review No. 78. Available at www.effectivehealthcare.ahrq.gov/procalcitonin.cfm.

  10. Effects of Using Procalcitonin To Guide AntibioticTherapy in Critically Ill Adult Patients in the ICU (1 of 2) • In the studies that used procalcitonin-based algorithms , physicians could consider other clinical information and over-ride algorithms based on their judgment. • Procalcitonin guidance reduced antibiotic usage.Strength of Evidence: High • Using procalcitonin guidance to discontinue antibiotic therapy did not increase morbidity, as indicated by length of stay in the ICU.Strength of Evidence: Moderate • Using procalcitonin guidance to discontinue antibiotic therapy did not increase mortality (in-hospital, 28-day, or overall mortality). • Evidence for this finding was rated low due to disagreement on the appropriate noninferiority margin.Strength of Evidence: Low Soni NJ, Samson DJ, Galaydick JL, et al. AHRQ Comparative Effectiveness Review No. 78. Available at www.effectivehealthcare.ahrq.gov/procalcitonin.cfm.

  11. Effects of Using Procalcitonin To Guide AntibioticTherapy in Critically Ill Adult Patients in the ICU (2 of 2) • In this review, antibiotic intensification included a change in the antibiotic regimen or broadening the spectrum of antibiotic therapy. • Procalcitonin-guided intensification of antibiotic therapy was associated with greater duration of use and increased total exposure to antibiotics.Strength of Evidence: Moderate • Procalcitonin-guided intensification of antibiotic therapy was associated with increased morbidity, including increase in intensive care unit (ICU) length of stay, days on mechanical ventilation, and days with abnormal renal function.Strength of Evidence: Moderate Soni NJ, Samson DJ, Galaydick JL, et al. AHRQ Comparative Effectiveness Review No. 78. Available at www.effectivehealthcare.ahrq.gov/procalcitonin.cfm.

  12. Effects of Using Procalcitonin To Guide Antibiotic Therapy in Patients With RTIs in the Ambulatory Care or Hospital Setting (1 of 2) • Patient populations with respiratory tract infections (RTIs) included those with acute exacerbations of chronic obstructive pulmonary disease, community-acquired pneumonia, bronchitis, sinusitis, tonsillitis, or pharyngitis. • In the studies that used procalcitonin-based algorithms , physicians could consider other clinical information and over-ride algorithms based on their judgment. • Procalcitonin guidance reduced duration of use of and prescription rates of antibiotics.Strength of Evidence: High • Procalcitonin guidance reduced total antibiotic exposure.Strength of Evidence: Moderate Soni NJ, Samson DJ, Galaydick JL, et al. AHRQ Comparative Effectiveness Review No. 78. Available at www.effectivehealthcare.ahrq.gov/procalcitonin.cfm.

  13. Effects of Using Procalcitonin To Guide Antibiotic Therapy in Patients With RTIs in the Ambulatory Care or Hospital Setting (2 of 2) • Procalcitonin guidance did not increase mortality, hospital length of stay, or intensive care unit admission rates.Strength of Evidence: Moderate • Evidence was insufficient to determine the effect of procalcitonin guidance on antibiotic-associated adverse events.Strength of Evidence: Insufficient Soni NJ, Samson DJ, Galaydick JL, et al. AHRQ Comparative Effectiveness Review No. 78. Available at www.effectivehealthcare.ahrq.gov/procalcitonin.cfm.

  14. Effects of Using Procalcitonin To Guide Antibiotic Therapy in Pediatric Patients • Procalcitonin guidance reduced the use of antibiotic therapy for suspected early neonatal sepsis.Strength of Evidence: Moderate • The evidence was insufficient to determine if procalcitonin guidance reduced antibiotic usage in children aged 1–36 months with fever.Strength of Evidence: Insufficient Soni NJ, Samson DJ, Galaydick JL, et al. AHRQ Comparative Effectiveness Review No. 78. Available at www.effectivehealthcare.ahrq.gov/procalcitonin.cfm.

  15. Effects of Using Procalcitonin To Guide Antibiotic Therapy in Postoperative Patients • Evidence was insufficient to determine if procalcitonin guidance can identify postoperative patients at risk of developing infections who might benefit from pre-emptive antibiotic therapy.Strength of Evidence: Insufficient Soni NJ, Samson DJ, Galaydick JL, et al. AHRQ Comparative Effectiveness Review No. 78. Available at www.effectivehealthcare.ahrq.gov/procalcitonin.cfm.

  16. Conclusions (1 of 2) • Procalcitonin guidance for antibiotic discontinuation reduced antibiotic usage in adult patients in intensive care units (ICUs) without increasing mortality. • However, there was uncertainty related to the evidence on mortality. • The use of procalcitonin to guide antibiotic intensification rather than discontinuation in adult patients in ICUs resulted in increased antibiotic usage, which was associated with increased morbidity. Soni NJ, Samson DJ, Galaydick JL, et al. AHRQ Comparative Effectiveness Review No. 78. Available at www.effectivehealthcare.ahrq.gov/procalcitonin.cfm.

  17. Conclusions (2 of 2) • Procalcitonin guidance for initiating and discontinuing antibiotic therapy significantly reduced antibiotic prescription rates and duration of use in patients with acute respiratory tract infections (including acute exacerbations of chronic obstructive pulmonary disease, community-acquired pneumonia, and acute bronchitis) in the ambulatory care or hospital setting. • Data to support a role for procalcitonin guidance in the pediatric population were lacking in the literature. • However, there was moderate-strength evidence showing that procalcitonin guidance resulted in reduced antibiotic usage in neonates with suspected early sepsis. Soni NJ, Samson DJ, Galaydick JL, et al. AHRQ Comparative Effectiveness Review No. 78. Available at www.effectivehealthcare.ahrq.gov/procalcitonin.cfm. 

  18. Applicability of the Findings of This Review • This systematic review found that procalcitonin guidance for antibiotic discontinuation reduces antibiotic usage for adult patients in both medical and surgical intensive care units (ICUs) and, therefore, is applicable to clinical practice related to antibiotic discontinuation in the ICU settings. • This systematic review found that procalcitonin guidance for initiating and discontinuing antibiotic therapy for patients with respiratory tract infections in the ambulatory care or hospital setting significantly reduced antibiotic prescription rates and duration of use and, hence, is applicable to these patient populations. • Certain populations of interest were excluded from one or more studies of procalcitonin guidance reviewed in this report. Thus, findings from this review should not be extrapolated to these high-risk groups. Soni NJ, Samson DJ, Galaydick JL, et al. AHRQ Comparative Effectiveness Review No. 78. Available at www.effectivehealthcare.ahrq.gov/procalcitonin.cfm.

  19. Gaps in Knowledge and Future Research Needs (1 of 2) • Assessing the effect of using procalcitonin guidance in patients who are immunocompromised is an important research need, as this patient population may gain significant clinical benefit from potentially reduced antibiotic usage. • Future studies are needed to assess procalcitonin-guided initiation and discontinuation of antibiotics in pediatric populations in both inpatient and outpatient settings. • Future studies are needed to assess the effects of procalcitonin-guided antibiotic usage and total exposure on antibiotic-associated adverse reactions, superinfections, or the development of antibiotic resistance. Soni NJ, Samson DJ, Galaydick JL, et al. AHRQ Comparative Effectiveness Review No. 78. Available at www.effectivehealthcare.ahrq.gov/procalcitonin.cfm.

  20. Gaps in Knowledge and Future Research Needs (2 of 2) • More research is needed regarding the effect on mortality of reduced antibiotic usage resulting from procalcitonin-guided antibiotic therapy. • For a more pertinent comparative effectiveness approach, different comparators should have been selected, such as antibiotic stewardship programs and structured implementation of practice guidelines. • Additional future research needs include the determination of the appropriate procalcitonin cutoff level in different populations, and assessment of the cost-effectiveness of using procalcitonin to guide antibiotic therapy. Soni NJ, Samson DJ, Galaydick JL, et al. AHRQ Comparative Effectiveness Review No. 78. Available at www.effectivehealthcare.ahrq.gov/procalcitonin.cfm.

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