This document discusses antibiotic resistance and the need for improved antibiotic stewardship programs. It notes that up to 50% of antibiotic use is inappropriate and leads to adverse outcomes for patients like C. difficile infections and increased resistance. The document promotes optimizing antibiotic use through improved prescribing practices and developing antibiotic stewardship programs in healthcare facilities. The goals are to improve patient outcomes, reduce resistance, and lower costs by ensuring the right antibiotic is used for the right duration.

1. CDC; Antibiotic resistance threats
in the United States, 2013
“ANTIBIOTIC STEWARDSHIP”
2

2. National Center for Emerging and Zoonotic Infectious Diseases
Division of Healthcare Quality Promotion
Used with permission from:
Centers for Disease Control and Prevention; CDC
24/7: Savings Lives, Protecting People TM

3. Mission- Get Smart for Healthcare
To optimize the use of antimicrobial agents in in-
patient healthcare settings.

4. Antibiotics are misused
in hospitals
“It has been recognized for several decades
that up to 50% of antimicrobial use
is inappropriate.”
• IDSA/SHEA Guidelines for Antimicrobial Stewardship Programs
• http://www.journals.uchicago.edu/doi/pdf/10.1086/510393

5. Why we need to improve
in-patient antibiotic use
• Antibiotics are misused in hospitals
• Antibiotic misuse adversely impacts patients and
society
• Improving antibiotic use improves patient outcomes
and saves money
• Improving antibiotic use is a public health imperative

6. Antibiotics are misuse
in a variety of ways
• Given when they are not needed
• Continued when they are no longer necessary
• Given at the wrong dose
• Broad spectrum agents are used to treat very
susceptible bacteria
• The wrong antibiotic is given to treat an infection

7. Antibiotic misuse adversely impacts
patients- C. difficile
• Antibiotic exposure is the single most important risk
factor for the development of Clostridium difficile
associated disease (CDAD).1
• Up to 85% of patients with CDAD have antibiotic
exposure in the 28 days before infection.1
1. Chang HT et al. Infect Control Hosp Epidemiol 2007; 28:926–931.

8. Antibiotic exposure increases the
risks of resistance
Pathogen and Antibiotic Exposure Increased Risk
Carbapenem Resistant Enterobactericeae
and Carbapenems
15 fold 1
ESBL producing organisms and Cephalosoprins 6- 29 fold 3,4
Patel G et al. Infect Control Hosp Epidemiol 2008;29:1099-1106
Zaoutis TE et al. Pediatrics 2005;114:942-9
Talon D et al. Clin Microbiol Infect 2000;6:376-84

9. Antibiotic misuse adversely impacts
patients- resistance
• Increasing use of antibiotics increases the prevalence
of resistant bacteria in hospitals.
• Antibiotic resistance increases mortality.
• Getting an antibiotic increases a patient’s chance of
becoming colonized or infected with a resistant
organism.

10. Antibiotic misuse adversely impacts
patients - adverse events
• In 2008, there were 142,000 visits to emergency
departments for adverse events attributed to
antibiotics.1
• National estimates for in-patient adverse events are
not available, but there are many reports of serious
adverse events (aside from C. difficile infection) from
in-patient antibiotic use.
1 Shehab N et al. Clinical Infectious Diseases 2008; 15:735-43

11. Clinical outcomes better with
antimicrobial management program
0
20
40
60
80
100
Appropriate Cure Failure
AMP
UP
RR 2.8 (2.1-3.8) RR 1.7 (1.3-2.1) RR 0.2 (0.1-0.4)
Percent
AMP = Antibiotic Management Program UP = Usual Practice
Fishman N. Am J Med. 2006;119:S53.

12. Improving antibiotic use
saves money
• “Comprehensive programs have consistently
demonstrated a decrease in antimicrobial use with
annual savings of $200,000 - $900,000”
• IDSA/SHEA Guidelines for Antimicrobial Stewardship Programs
• http://www.journals.uchicago.edu/doi/pdf/10.1086/510393

13. Improving antibiotic use is a public
health imperative
• Antibiotics are the only drug where use in one
patient can impact the effectiveness in another.
• If everyone does not use antibiotics well, we will all
suffer the consequences.
• Antibiotics are a shared resource, (and becoming a
scarce resource).
• Using antibiotics properly is analogous to developing
and maintaining good roads.

14. Goals- Get Smart for Healthcare
• Improve patient safety through better treatment of
infections.
• Reduce the emergence of anti-microbial resistant
pathogens and Clostridium difficile.
• Heighten awareness of the challenges posed by
antimicrobial resistance in healthcare and encourage
better use of antimicrobials as one solution.

15. Development of the National Action Plan
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16. Development of the National Action Plan
The National Action Plan was developed
in response to Executive Order 13676:
Combating Antibiotic - Resistant
Bacteria which was issued by President
Barack Obama on September 18, 2014
in conjunction with the National
Strategy for Combating Antibiotic-
Resistant Bacteria.
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17. The goals of the National Action Plan
Significant Outcomes of Goal 1
Reduction of inappropriate antibiotic
use by 50% in outpatient settings and
by 20% in inpatient settings.
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18. The goals of the National Action Plan
1. Slow the emergence of resistant
bacteria and prevent the spread of
resistant infections.
2. Strengthen national One-Health
Surveillance efforts to combat
resistance.
19

19. The goals of the National Action Plan
3. Advance development and use of
rapid and innovative diagnostic tests for
identification and characterization of
resistant bacteria.
20

20. The goals of the National Action Plan
4. Accelerate basic and applied
research and development for new
antibiotics, other therapeutics and
vaccines.
5. Improve international collaboration
and capacities for antibiotic-resistance
prevention, surveillance, control, and
antibiotic research and development.
21

21. The goals of the National Action Plan
Sub-Objective 1.1.1B:
• Get Smart: Know When Antibiotics
Work.
Many antibiotics prescribed in doctors’
offices, clinics, and other outpatient
settings are not needed. This program
focuses on appropriate antibiotic
prescribing and use for common
illnesses in children and adults.
22

22. The goals of the National Action Plan
Sub-Objective 1.1.1B:
• Get Smart for Healthcare.
Many patients in hospitals, nursing
homes, and other healthcare facilities
receive antibiotics to fight infections,
but these drugs are often prescribed
incorrectly.
23

23. The goals of the National Action Plan
Sub-Objective 1.1.1B:
• Get Smart for Healthcare.
This program helps clinicians prescribe
the right drugs for the right patients at
the right doses and times.
24

24. Antibiotic Stewardship
Antibiotics
25

25. Antibiotics
Myth 1. They can cure colds and the
flu.
• Not so. Antibiotics work against only
bacterial infections, not viral ones
such as colds, the flu, most sore
throats, and many sinus and ear
infections.
26
STOP SUPERBUGS NOW; Myths about antibiotics; No, they won't
help with the cold or flu, and other common misconceptions.
Teresa Carr; Consumer Reports; Published: June 25, 2015

26. Antibiotics
Myth 2. They have few side effects.
• Almost 1 in 5 emergency-room visits
for drug side effects stems from
antibiotics. In children, the drugs are
the leading cause of such visits.
27
STOP SUPERBUGS NOW; Myths about antibiotics; No, they won't
help with the cold or flu, and other common misconceptions.
Teresa Carr; Consumer Reports; Published: June 25, 2015

27. Antibiotics
• Those side effects include diarrhea,
yeast infections, and in rare cases,
nerve damage, torn tendons.
• Allergic reactions that include rashes,
swelling of the face or throat, and
breathing problems.
28
STOP SUPERBUGS NOW; Myths about antibiotics; No, they won't
help with the cold or flu, and other common misconceptions.
Teresa Carr; Consumer Reports; Published: June 25, 2015

28. Antibiotics
• The drugs can kill off good bacteria,
increasing the risk of some
infections, including C. difficile.
• At least 250,000 people a year now
develop C. diff. infections linked to
antibiotic use, and 14,000 die as a
result. 4
29
STOP SUPERBUGS NOW; Myths about antibiotics; No, they won't
help with the cold or flu, and other common misconceptions.
Teresa Carr; Consumer Reports; Published: June 25, 2015

29. Antibiotics
Myth 3. A ‘full course’ lasts at least a
week.
• Not always. A shorter course can work for
some infections, such as certain urinary
tract, ear, and sinus infections.
• So ask your doctor for the shortest course
and lowest dose of antibiotics necessary
to treat your infection.
30
STOP SUPERBUGS NOW; Myths about antibiotics; No, they won't
help with the cold or flu, and other common misconceptions.
Teresa Carr; Consumer Reports; Published: June 25, 2015

30. Antibiotics
Myth 4. It’s OK to take leftover
medication.
• Nope. First, you may not need an
antibiotic at all. And if you do, the
leftovers may not be the right type
or dose for your infection.
31
STOP SUPERBUGS NOW; Myths about antibiotics; No, they won't
help with the cold or flu, and other common misconceptions.
Teresa Carr; Consumer Reports; Published: June 25, 2015

31. Antibiotics
• Taking them could allow the growth
of harmful and resistant bacteria.
• Return unused antibiotics to the
pharmacy or mix them with coffee
grounds or cat litter and toss in the
trash.
32
STOP SUPERBUGS NOW; Myths about antibiotics; No, they won't
help with the cold or flu, and other common misconceptions.
Teresa Carr; Consumer Reports; Published: June 25, 2015

32. Antibiotics
Myth 5. All bacterial infections require
drugs.
• Mild ones sometimes clear up on
their own. So ask your doctor
whether you could try waiting it
out.
33
STOP SUPERBUGS NOW; Myths about antibiotics; No, they won't
help with the cold or flu, and other common misconceptions.
Teresa Carr; Consumer Reports; Published: June 25, 2015

33. Antibiotics
Myth 6. The more bacteria a drug kills,
the better.
• Wrong. So-called broad-spectrum
drugs, such as ceftriaxone, cipro-
floxacin and levofloxacin, should be
reserved for hard-to-treat infections.
34
STOP SUPERBUGS NOW; Myths about antibiotics; No, they won't
help with the cold or flu, and other common misconceptions.
Teresa Carr; Consumer Reports; Published: June 25, 2015

34. Pathogen Cases
Streptococcus pneumoniae 20-60%
Haemophilus influenza 3-10%
Staphylococcus aureus 3-5%
Gram-negative bacilli 3-10%
Legionella species 2-8%
Mycoplasma pneumoniae 1-6%
Chlamydia pneumoniae 4-6%
Viruses 2-15%
Aspiration 6-10%
Others 3-5%
Adapted from Mandell LA, Bartlett JG, Dowell SF, et al: Update of practice guidelines for the management of community-acquired
pneumonia in immunocompetent adults. Clin Infect Dis 2003;37:1405-1433.
Many pathogens: Which to treat?
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35. Methods Used Today
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36. • Medical history
• Physical exam
• Chest x-rays
• Blood tests
• Blood culture
• Sputum collection
• CT – chest computed tomography
Current methods to determine
if patients have pneumonia
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Current methods to determine
if patients have pneumonia

37. • Thoracentesis –
Pleural fluid culture
• Pulse oximetry
• Nasal swab
• Throat swab
• Urine antigen
• Bronchoscopy - BAL
Current methods to determine
if patients have pneumonia
38
Current methods to determine
if patients have pneumonia

38. • Specimens are very often
contaminated from the upper
respiratory resulting in many false
positives.
• This leads to broad antibiotic
treatment because the actual
pathogen causing the pneumonia is
usually never identified.
39
Current sampling data
is not reliable or accurate

39. • Chest x-rays can reveal areas of
opacity (seen as white) which
represent consolidation.
• Pneumonia is not always seen on x-
rays, either because the disease is
only in its initial stages, or because it
involves a part of the lung not easily
seen by x-ray.
• X-rays cannot identify pathogens.
Routine chest x-rays
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40. PneumoniaChecktm
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41. Glossary
Disruptive technology:
Introducing new technology to
current technology which will
change the way things are done.
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42. The Need
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43. The Need
• Pneumonia is a leading cause of
death in children worldwide. Over 2
million children die from pneumonia
each year and one child dies every 20
seconds.
• The problem with current diagnosis
methods is one of sampling. Mouth
and nose samples have
contaminating bacteria, which result
in many false positives.
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44. The Need
• Additionally, the samples are unable
to identify the pathogen; hospital
stays are lengthened increasing the
chances that cases will become
complicated.
• Since the pathogen cannot be
identified, patients receive broad-
spectrum antibiotics, which are often
unnecessary and can cause antibiotic
resistance.
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45. The Need
• Other methods, such as a chest x-ray,
can identify fluid in the lungs, but
cannot identify the specific pathogen
causing the pneumonia.
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46. The Need
• Antibiotic resistance is one of the
world's most pressing public health
threats.
• Antibiotics are the most important
tool we have to combat life-
threatening bacterial disease, but
using antibiotics can also result in side
effects.
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47. The Need
• Antibiotic use leads to new drug-
resistant germs and increased risks to
patients.
• Patients, healthcare providers,
hospital administrators and policy
makers must work together to
employ safe and effective strategies
for improving antibiotic use—
ultimately saving lives.
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48. The Need
“Antimicrobial resistance is one of our
most serious health threats.
Infections from resistant bacteria are
now too common, and some pathogens
have even become resistant to multiple
types or classes of antibiotics.”
Dr. Tom Frieden, MD, MPH
Director, U.S. Centers for Disease Control and Prevention
Meeting the Challenges of Drug-Resistant Diseases in Developing Countries
Committee on Foreign Affairs Subcommittee on Africa, Global Health, Human
Rights, and International Organizations
United States House of Representatives
April 23, 2013
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49. The Solution
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50. • Pneumonia kills more children than
any other disease. Unfortunately,
the pathogen cannot be identified in
most patients.
• Thepathogens causing pneumonia
are difficult to identify because a
high quality specimen from the
lower lung is difficult to obtain due
to contamination of the sample.
Development of
PneumoniaCheck
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51. • PneumoniaCheck was developed and
designed to collect aerosolspecimens
selectively from the lower lung
generated during deep cough.
• This technology allows
PneumoniaCheck to effectively
separate the upper respiratory tract
from the aerosols in the lung by
>90%.
Development of
PneumoniaCheck
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52. • PneumoniaCheck utilizes a
separation reservoir and specially
designed mouthpiece to segregate
contents from the upper airway and
the lower lungs.
Development of
PneumoniaCheck
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53. • PneumoniaCheck includes several
specially designed features to exclude
oral contaminants from the sample
and a filter to collect theaerosolized
pathogens from the lower lungs.
• The filter can collect >99.97% of virus
and bacteria sized particles from the
sampled lower lung aerosols.
Development of
PneumoniaCheck
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54. • PC saves time and money
diagnosing pneumonia; however, it
is NOT a diagnostic device.
Development of
PneumoniaCheck
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55. PneumoniaCheck - The Device
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56. The Device
• PneumoniaCheck uses fluid
mechanics to separate the upper
airway particles from the lower
airway particles.
• The separation means that only a
lung specimen is captured on the
filter media at the end of the device.
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57. The Device
• This filter can then be analyzed using
traditional microbiology methods or
more sensitive molecular DNA
analysis to identify the specific
pathogen causing pneumonia, or
other lower respiratory infections.
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58. The Device
• The ability to identify the specific
pathogen will allow for more
targeted antibiotic treatment or none
at all if viral, which should reduce
antibiotic resistance and other
complications.
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59. The Device
• PneumoniaCheck is an easy-to-use,
noninvasive, disposable solution for
collecting respiratory specimens to
help reduce one of the world’s
largest health problems.
• PneumoniaCheck may be used on
patients three feet and taller.
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60. 61

61. • To use PneumoniaCheck, a patient
simply coughs deeply into the
mouthpiece and expels the
remaining air in his or her lungs.
• This action can be repeated as
many times as necessary to collect
a sufficient sample of lower
respiratory aerosolized pathogens.
• Recommend collecting 10 coughs
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62. • The air from the upper respiratory is
collected in a reservoir, and aerosols
from the lower respiratory are
captured on a microbial filter.
• The filter can then be sent to a
laboratory to be tested for the
presence of various pathogens.
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63. • PneumoniaCheck uses fluid
mechanics to isolate lung
pathogens onto the filter.
• Fluid mechanics is the branch of
physics that studies fluids (liquids,
gases, and plasmas) and the forces
on them.
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64. 65

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66. 67

67. • The air from the upper respiratory is
collected in a reservoir, and aerosols
from the lower respiratory are
captured on a microbial filter.
• PneumoniaCheck is then sent to a
laboratory to be tested for the
presence of various pathogens.
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68. The link from diagnosis to treatment
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69. 70

70. Questions?
ARC Medical Inc.
PneumoniaCheck
arcmedical.com
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