PCT GUIDED ANTIBIOTIC THERAPY FOR LRTI *

Transcription

1 BIOMÉRIEUX PCT GUIDED ANTIBIOTIC THERAPY FOR LRTI * Enhancing patient care Improving antibiotic stewardship * Lower Respiratory Tract Infections 34.3 Million Antibiotic prescriptions unnecessary 1 50% of antibiotics prescribed for acute respiratory conditions are unnecessary Million Antibiotic prescriptions appropriate 1

2 ? LRTI can present in many different ways Acute bronchitis Community-acquired pneumonia Acute exacerbation of COPD Clinical characteristics are non-specific Cough Sputum Fever Shortness of breath In the past, this ambiguity was met with almost-automatic antibiotic therapy. Today, we have better information and better ways to decide if antibiotics are warranted. Procalcitonin (PCT) provides critical biomarker information PCT is produced by numerous organs at a cellular level after bacterial pro-inflammatory stimulation 2,3 PCT rises in 3-6 hours Half-life of hours Early identification & risk assessment PCT PRESENCE IN HEALTHY TISSUE Thyroid White Blood Cells Perit. Macrophage Spleen Lung Liver Kidney Adrenal Brain Spine Pancreas Stomach Small Intestine Colon Heart Muscle Skin Visceral Fat Testes PCT PRESENCE WHEN BACTERIAL INFECTION OCCURS

3 Procalcitonin is a host response to bacterial insult 4-6 Viral infections inhibit PCT expression, enhancing the ability to distinguish bacterial infections from non-bacterial infections. * Bacterial infection stimulates PCT Viral infection blocks PCT *PCT is not specifically indicated as a viral marker VIDAS B. R. A. H. M. S PCT TM Adipocyte Golgi apparatus PCT INFLAMMATORY HOST RESPONSE LPS IL-1β TNF-α IFN-γ viral infection Pro CT hormokine CT-mRNA constitutive secretion without processing PCT is different from other markers 7-10 PCT concentration substantially rises 4-6 hours after bacterial induction, peaks at around 6-24 hours, and decreases by 50% daily as an infection is eliminated. These kinetics make PCT unique from other markers in providing timely information specific to bacterial infections PCT PLASMA CONCENTRATION CRP Day 2 Day 3 TIME (HOURS) Adapted from Meisner 10

4 1 START OR NOT Know with confidence. PCT Value < 0.10 ng/ml ng/ml ng/ml > 0.50 ng/ml Initiation of antibiotic use recommendation Strongly discourage Discourage Encourage Strongly encourage VIDAS B R A H M S PCT has been cleared by the FDA to aid in decisionmaking on antibiotic therapy specifically for inpatients or emergency department patients with suspected or confirmed lower respiratory tract infections (LRTI), defined as community-acquired pneumonia (CAP), acute bronchitis, and acute exacerbation of chronic obstructive pulmonary disease (AECOPD).

5 2 WHEN TO STOP Gain valuable information. VIDAS B. R. A. H. M. S PCT TM PCT kinetics over time in conjunction with clinical assessments provides valuable information regarding response to treatment and can support decision-making on antibiotic discontinuation for patients with LRTI. Discontinuation using PCT kinetics PCT 0.25 ng/ml or ΔPCT > 80 % This new indication is important because antibiotic overuse is a serious problem. For each patient Inappropriate use of antibiotics exposes patients to the risk of antibiotic-associated infections such as Clostridium difficile, and other adverse effects. 11,12 For the healthcare system There is an overall safety risk due to the rise of antibiotic resistance, with 2 million illnesses and roughly 23,000 deaths per year in the U.S. 13

6 PRESCRIBE OR NOT WITH CONFIDENCE For enhanced patient care A new way to think about antibiotic use based on extensive study. 11 Randomized Control Trials 4090 Patients To evaluate the safety and effectiveness of PCT-guided therapy, 11 randomized, control trials were evaluated in a meta-analysis in accordance with the recognized standards for conduct and reporting, as outlined by the Cochrane Collaboration. 14 The highest form of clinical evidence Greater statistical power More robust findings than an individual study PCT-guided antibiotic therapy is safe and effective for patients. Significant reduction in antibiotic initiation 19% reduction in relative antibiotic initiation in all patients 39% reduction in initiation of antibiotics in ED patients Significant reduction in exposure to antibiotics 38% reduction in overall antibiotic exposure for inpatients 51% reduction in overall antibiotic exposure for patients in ED No adverse safety signals associated with PCT guidance for LRTI No signal for increase in 30-day mortality, complications or length of stay

7 VIDAS B. R. A. H. M. S PCT TM PCT-GUIDED ANTIBIOTIC THERAPY FOR LRTI For better antibiotic stewardship Every year, 70M antibiotic prescriptions are written in the U.S. for acute respiratory conditions, of which half are unnecessary. 1 $1.6B ANNUAL SAVINGS 15 For the US insured population, PCT-guided therapy would result in $1.6 billion in annual savings. PCT plays a key role in antibiotic stewardship efforts. Use of PCT can promote antibiotic stewardship and support CMS guidelines for antibiotic stewardship and infection prevention. Outcomes for patients receiving PCT-guided therapy versus those receiving standard care showed 16 : Reduced antibiotic exposure Lower incidence of complications Achieve the goal of giving antibiotics to the right patients, at the right time, for the right duration.

8 biomérieux, Inc. BIOMERIEUX, the BIOMERIEUX logo, VIDAS and VIDAS B R A H M S PCT are used pending and/or registered trademarks belonging to biomérieux, or one of its subsidiaries, or one of its companies B R A H M S PCT is the property of Thermo Fisher Scientific Inc. and its subsidiaries. PRN VIDAS B. R. A. H. M. S PCT TM Reference number Tests / kit 60 REFERENCES VIDAS B R A H M S PCT 1. Fleming-Dutra KE, Hersh AL, Shapiro DJ, et al. Prevalence of inappropriate antibiotic prescriptions among US ambulatory care visits, JAMA. 2016;315(17): Kumar A, Roberts D, Wood KE, et al. Duration of hypotension before initiation of effective antimicrobial therapy is the critical determinant of survival in human septic shock. Crit Care Med. 2006;34(6): Müller B, White JC, Nylén 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(1): Linscheid P, Seboek D, Schaer DJ, Zulewski H, Keller U, Müller B. Expression and secretion of procalcitonin and calcitonin generelated peptide by adherent monocytes and by macrophageactivated adipocytes. Crit Care Med. 2004;32(8): Linscheid P, Seboek D, Nylen ES, et al. In vitro and in vivo calcitonin-i gene expression in parenchymal cells: a novel product of human adipose tissue. Endocrinology. 2003;144(12): Linscheid P, Seboek D, Zulewski H, Keller U, Müller B. Autocrine/ Paracrine role of inflammation-mediated calcitonin generelated peptide and adrenomedullin expression in human adipose tissue. Endocrinology. 2005;146(6): Harbarth S, Holeckova K, Froidevaux C, et al, Diagnostic value of procalcitonin, interleukin-6, and interleukin-8 in critically ill patients admitted with suspected sepsis. Am J Respir Crit Care Med 2001;164(3): Müller B, Becker KL, Schächinger H, et al. Calcitonin precursors are reliable markers of sepsis in a medical intensive care unit. Crit Care Med. 2000;28(4): Brunkhorst FM, Heinz U, Forycki ZF. Kinetics of Procalcitonin in iatrogenic sepsis. Intensive Care Med. 1998;24(8): Meisner M, Procalcitonin: Experience with a new diagnostic tool for bacterial infection and systemic inflammation. J Lab Med. 1999;23: Antibiotics side effects. NHS Choices. Conditions/Antibiotics-penicillins/Pages/Side-effects.aspx. Accessed December 20, Lessa FC, Mu Y, Bamberg WM, et al. Burden of Clostridium difficile infection in the United States. N Engl J Med. 2015;372: Antibiotic/Antimicrobial Resistance. Centers for Disease Control and Prevention Website. Page last updated: August 18, Accessed December 20, Goldberg B. Clinical Considerations for Procalcitonin- Guided Evaluation and Management of Lower Respiratory Tract Infections and Sepsis. AdvisoryCommittees/CommitteesMeetingMaterials/ MedicalDevices/MedicalDevicesAdvisoryCommittee/ MicrobiologyDevicesPanel/UCM pdf. November 10, Accessed December 20, Schuetz P, Balk R, Briel M, et al. Economic evaluation of procalcitonin-guided antibiotic therapy in acute respiratory infections: a US health system perspective. Clin Chem Lab Med. 2015;53(4): Reference data on file at biomérieux. Learn more about VIDAS B R A H M S PCT a proven, sensitive, specific STAT biomarker that can produce results in just 20 minutes. And find out how you can put it to the test. For more information, please visit our website: To place an order, visit biomérieux, Inc. 100 Rodolphe Street Durham, NC U.S.A. Tel: (800) Fax: (800) BIOMÉRIEUX Important Information The evaluation of VIDAS B R A H M S PCT assay results must always be performed taking into consideration the patient s history and the results of any other tests performed. In certain situations (newborns, polytrauma, burns, major surgery, prolonged or severe cardiogenic shock, etc.), PCT elevation may occur in the absence of infection. The return to normal values is usually rapid. Viral infections, allergies, autoimmune diseases and graft rejection do not lead to a significant increase in PCT. A localized bacterial infection can lead to a moderate increase in PCT levels. Some patient characteristics, such as severity of renal failure or insufficiency, may influence PCT values and should be considered when interpreting test results. PCT levels tend to be lower in patients infected with certain atypical pathogens, such as Chlamydophila pneumoniae and Mycoplasma pneumoniae, compared to those with typical bacterial infections. PCT levels are elevated in both severe and uncomplicated Plasmodium falciparum malaria. The safety of PCT-guided therapy for individuals younger than 17 years-of-age, pregnant women, immunocompromised individuals or those on immunomodulatory agents, including anti-inflammatories (e.g., NSAIDs), was not analyzed separately in the supportive clinical trials. Discrepancies between the laboratory and clinical findings should prompt additional evaluations, including repeat PCT testing. Please see full package insert for VIDAS B R A H M S PCT (13975) for additional important information. VIDAS B. R. A. H. M. S PCT Determine whether to start antibiotics Determine when to stop antibiotics Get rapid results in 20 minutes