50% of antibiotics prescribed for acute respiratory conditions are unnecessary1

34.3 Million Antibiotic prescriptions unnecessary1

34.6 Million Antibiotic prescriptions appropriate1

BIOMÉRIEUX

*Lower Respiratory Tract Infections

PCT GUIDED ANTIBIOTIC THERAPY FOR LRTI*

Enhancing patient careImproving antibiotic stewardship

LRTI can present in many different ways

Acute bronchitis

Community-acquired pneumonia

Acute exacerbation of COPD

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 stimulation2,3

• PCT rises in 3-6 hours• Half-life of 20-24 hours• Early identification &

risk assessment

Procalcitonin is a host response to bacterial insult4-6

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

PCT is different from other markers7-10

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.7-10

Clinical characteristics are non-specific

Cough • Sputum • Fever

Shortness of breath

?

PLAS

MA

CON

CEN

TRAT

ION

TIME (HOURS)

Day 36 12 24 Day 2310

PCT

CRP

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 IN HEALTHY TISSUE

PCT PRESENCEWHEN BACTERIAL

INFECTION OCCURS

Golgi apparatusAdipocyte PCT

viralinfection

IFN-γ

IL-1βTNF-α

LPS

INFL

AM

MAT

OR

Y H

OST

RES

PO

NS

E

constitutive secretionwithout processing

Pro CT

CT-mRNA“hormokine”

Adapted from Meisner10

VIDAS® B.R.A.H.M.S PCT TM

START OR NOTKnow with confidence.

WHEN TO STOPGain valuable information.

1 2

VIDAS B•R•A•H•M•S PCT has been cleared by the FDA to aid in decision-making 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).

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%

< 0.10 ng/mLPCT Value

Initiation of antibiotic use

recommendation

Strongly discourage

0.10–0.25 ng/mL

Discourage

0.26–0.50 ng/mL

Encourage

> 0.50 ng/mL

Strongly encourage

This new indication is important because antibiotic overuse is a serious problem.

For each patientInappropriate 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 systemThere 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

VIDAS® B.R.A.H.M.S PCT TM

A new way to think about antibiotic use — based on extensive study.

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

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 showed16:• 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.

PRESCRIBE — OR NOT — WITH CONFIDENCE For enhanced patient care

PCT-GUIDED ANTIBIOTIC THERAPY FOR LRTIFor better antibiotic stewardship

114090 Patients

Randomized Control Trials

Every year, 70M antibiotic prescriptions are written in the U.S. for acute respiratory conditions, of which half are unnecessary.1

$1.6BA N N U A L S A V I N G S

For the US insured population, PCT-guided therapy

would result in $1.6 billion in

annual savings.

15

VIDAS® B.R.A.H.M.S PCT TM

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.

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.

Reference number 30450-01

Tests / kit 60

VIDAS® B·R·A·H·M·S PCT™

For more information, please visit our website: www.biomerieux-usa.com/vidas-pct

To place an order, visit

www.bioMerieuxDIRECT.com

REFERENCES1. Fleming-Dutra KE, Hersh AL, Shapiro DJ, et al. Prevalence of

inappropriate antibiotic prescriptions among US ambulatory care visits, 2010-2011. JAMA. 2016;315(17):1864-1873.

2. 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):1589-1596.

3. 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):396-404.

4. Linscheid P, Seboek D, Schaer DJ, Zulewski H, Keller U, Müller B. Expression and secretion of procalcitonin and calcitonin gene-related peptide by adherent monocytes and by macrophage-activated adipocytes. Crit Care Med. 2004;32(8):1715-1721.

5. 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):5578-5584.

6. Linscheid P, Seboek D , Zulewski H, Keller U, Müller B. Autocrine/Paracrine role of inflammation-mediated calcitonin gene-related peptide and adrenomedullin expression in human adipose tissue. Endocrinology. 2005;146(6):2699-2708.

7. 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):394-402.

8. 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):977-983.

9. Brunkhorst FM, Heinz U, Forycki ZF. Kinetics of Procalcitonin in iatrogenic sepsis. Intensive Care Med. 1998;24(8):888-889.

10. Meisner M, Procalcitonin: Experience with a new diagnostic tool for bacterial infection and systemic inflammation. J Lab Med. 1999;23:263-272.

11. Antibiotics – side effects. NHS Choices. http://www.nhs.uk/Conditions/Antibiotics-penicillins/Pages/Side-effects.aspx. Accessed December 20, 2017.

12. Lessa FC, Mu Y, Bamberg WM, et al. Burden of Clostridium difficile infection in the United States. N Engl J Med. 2015;372:825-834.

13. Antibiotic/Antimicrobial Resistance. Centers for Disease Control and Prevention Website. https://www.cdc.gov/drugresistance/ Page last updated: August 18, 2017. Accessed December 20, 2017.

14. Goldberg B. Clinical Considerations for Procalcitonin-Guided Evaluation and Management of Lower Respiratory Tract Infections and Sepsis. http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/MicrobiologyDevicesPanel/UCM529262.pdf. November 10, 2016. Accessed December 20, 2017.

15. 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):583-592.

15. Reference data on file at bioMérieux.

©20

17-2

018

bioM

érie

ux, I

nc. •

BIO

MER

IEUX

, the

BIO

MER

IEUX

logo

, VID

AS a

nd V

IDAS

B•R

•A•H

•M•S

PCT

are

use

d pe

ndin

g an

d/or

regi

ster

ed tr

adem

arks

bel

ongi

ng to

bio

Mér

ieux

, or o

ne o

f its

sub

sidi

arie

s, o

r one

of i

ts c

ompa

nies

• w

ww.

biom

erie

ux-u

sa.c

om/p

aten

ts •

B•R

•A•H

•M•S

PCT

™ is

the

prop

erty

of

Ther

mo

Fish

er S

cien

tific

Inc.

and

its

subs

idia

ries.

• P

RN 17

-005

2-00

VIDAS® B.R.A.H.M.S PCT TM

VIDAS B.R.A.H.M.S PCT

• Determine whether to start antibiotics• Determine when to stop antibiotics• Get rapid results in 20 minutes

BIOMÉRIEUX

bioMérieux, Inc. • 100 Rodolphe Street • Durham, NC 27712 • U.S.A. Tel: (800) 682 2666 • Fax: (800) 968 9494www.biomerieux-usa.com