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					Evidence-Based Decisions
  and FA (Clinical) Q’s:
  Community Acquired
       Pneumonia
        John H. Burton, MD
     Dept. Emergency Medicine
      Albany Medical Center
Lecturing on
    CAP
Research Grants:
Binax, Medtronic, Scios
EMF, NIH
Lecture Sponsorship:
20+ Hospitals, Roche,
Bristol-Myers Squibb,
Pfizer, Bayer, Scios,
Aventis
Lecturing on
    CAP
How much money do you
     Receive to do
 a lecture via pharma?

 Initially: 500.00/lecture

       5 years in:
      Local: 750.00
     Travel: 1000.00

Most: 2000.00/ 45 min
Bronchitis vs CAP?
Bronchitis:
1. URI symptoms: cough, fever, congestion, +/-
sputum production (color change…)
2. Vast majority are viral..
3. Don’t treat with antibiotics
4. Consider beta-agonists (2 studies, weak data)

CAP: Class I:
1. URI symptoms: cough, fever, congestion, +/-
sputum production, +CXR (Class I exception)
2. Treat with antibiotics
     How should the
disposition be determined
     in patients with
   community acquired
       pneumonia?
A Prediction Rule to Identify
Low-Risk Patients with CAP
        NEJM 1997; 336:243-250.
 Develop a prediction rule for prognosis
  to identify pts at low risk of dying
  within 30 days.
 Analysis of data on 14,199 adults in a
  with CAP treated as inpatients.
 Prediction rule then validated on
  database of 38,000 CAP pts.
           Pred Rule for Low
           Mortality…Step 1
> 50
yoa  NO Comorbid?   NO EXAM:         NO     Assign
        Neoplasm       Alt LOC              Class I
        CHF            HR > 125
        Cerebral       RR > 30
        Renal          SBP < 90
        Hepatic        T < 35 > 40



YES         YES             YES       Assign Class II-V
                                      by Lab and CXR
Pred Rule for Low Mortality
   Class I /II< 1% mortality
       Class III - 2.8
       Class IV - 9%
       Class V - 27%
             Pred Rule for Low
            Mortality…Next Step...
Neoplasm   +30                          PH < 7.35      + 30
Hepatic    +20      Class:              BUN > 30       +20
CHF        +10      I                   Na < 130       +20
Cerebral   +10      II < 70 pts         Glu >250       +10
Renal      +10      III 71-90           Hct < 30       +10
                    IV 91-130           PO2 < 60       +10
                    V    > 130
Alt LOC    +20
RR > 30    +20                           Pleural Eff   +10
SBP < 90   +20
T<35 >40   +15
HR > 125   +10                            Male      Age
                 Nursing Home     +10     Female    Age -10
What Should I Prescribe
   for Outpatients
      with CAP?
 Community-Acquired Pneumonia
          10%   5%
                                Bacterial Causes
                     7%
     7%                           S Pneumo
                                  Hflu and MCat
                                  S Aur
8%                                Aerobic GNR
                                  Asp/Aner
                                  Legionella
8%                        34%     Mycoplasma
                                  Chlamydia
     6%                           other

                                    Hosp Form 1994; 29: 122-136
          15%
         Outpatients with CAP?
Drug     IDSA    ATS      Sanfrd   CIDS/     IDSA        IDSA
         2000    2001     2000     CTS 00    2003        2003
                                             Healthy     Comrbd
Doxy     Yes     Yes      2nd    2nd         Yes         No
                          Choice Choice
Macro    Yes     Azith    Azith    Azith     Yes         Azith
                 Clarth   Clarth   Clarth                Clarth
Fluorq   Select Select Select 2nd            No          Yes
         Risk Pts Risk Pts Rsk/age Choice

                              *Comrbd = copd, ca, chf, dm, renal
Outpatients with CAP?
   Drug      IDSA/
             ATS
             2007
   Doxy      Yes
             Levl 3

   Macro     Yes
             Levl 1

   Fluorq    Select               Beta-L
             Risk Pts             + Macr
             Levl 1               Levl 1
*Comrbd = abx 3 mos, copd, ca, chf, dm, renal, etoh, asplenia
 Should I Cover Atypical
Pathogens in Hospitalized
        Patients?
      Assoc. Between Initial
Antimicrobial Tx & Med Outcomes
 for Hospitalized Elderly Pts with
           Pneumonia
        Arch Intern Med 99;159:2562-2572

 12,945 eligible pts:
           9751 from community
           3194 from long-term facility
 Mean age 79 years
         Total 30d Mort by Abx

    20
    18
    16
    14
                                    Fluoroq
    12                              3rd+M
%   10                              2nd+M
                                    Blact
    8
                                    2nd
    6                               Cef3ax
    4
    2
    0
             30-d Mort
                                 95% Conf I
  Atypical Pathogens in
  Hospitalized Patients?
   Yes             No
IDSA 2000
Sanford 2000
ATS 2001
CIDS/CTS 2000
IDSA 2003
  Atypical Pathogens in
  Hospitalized Patients?
    Yes            No
IDSA/ATS
    2007
1. Resp Fqln
2. Beta+Macrld
  (both Levl 1)
What’s the Deal with
Macrolide Resistance?
                                       Macrolide-Resistant
                     40
                                         S. pneumoniae:
                                                                                                      36     35
                     35
                                                                                               29
                     30
 Percent Resistant




                     25
                                                                          20     19
                     20                                                                 17
                                                                   13.8
                     15
                     10                                        7
                                                        6
                     5
                            0      0      0      1
                     0
                       70

                              72

                                     74

                                            76

                                                   78

                                                          80

                                                                 82

                                                                        84

                                                                               86

                                                                                      88

                                                                                                90


                                                                                                  *

                                                                                                 **
                                                                                               99

                                                                                              03
                     19

                            19

                                   19

                                          19

                                                 19

                                                        19

                                                               19

                                                                      19

                                                                             19

                                                                                    19

                                                                                             19

                                                                                            19

                                                                                           20
Clin Infect Dis. 1992;15:95-98
JAMA 94; 271, 1831-1835.                                                       ** Current estimates: 20-30%
                                                                                  depending on region or country.
   Pneumococcal macrolide resistance
          - myth or reality
             Jour Antimicrob Chem 1999; 44:1-6
 “Despite the in-vitro resistance trends ….there is a
   paucity of data indicating resistance trends are
   translating into in vivo clinical failures..it appears the
   opposite is true.”
   Significance of Serum vs Tissue Levels
    of Abx in Treatment of PRSP & CAP
                    Chest 1999; 116:535-538
“Clinical results in pneumonia may depend more on
  tissue penetration and accumulation in the infected
  lung than on serum levels.”
No correlation of increasing in vitro resistance has been
  made with mortality outcomes.
    Practice Guidelines for the
  Management of CAP: IDSA 2000
        Clin Inf Dis 2000; 31:347-82
“Cases of macrolide failure have been described
  anecdotally but have been infrequent so far.”


 Canadian Guidelines: CIDS/CTS
      Clin Inf Dis 2000; 31:383-421
“Very few cases have been reported in which
  ..macrolide resistance has led to clinical
  failure or breakthrough bacteremia.”
     Update of Practice Guidelines for
         Management of CAP in
        Immunocompetent Adults
     Clin Inf Disease 2003;37:1405-33
“S Pneumo resistance in vitro may be deceptive,
  because the M phenotype may not be
  clinically relevant, and alveolar lining fluid or
  intracellular levels may be more important
  than serum levels used to determine in vitro
  activity.”
       Does the
fluoroquinolone choice
   make a difference?
    Generations of Fluoroquinolones

 1st: Nalidixic Acid
 2nd: Cipro/Ofloxacin
 3rd: Levofloxacin
 4th: Gatifloxacin, Moxiflox
      (improved Gram Pos and Anaerobe)
            Adverse Events: Quinolones
                 CNS                                                Prolonged QTc
                 seizures & dizziness                               interval
                 (sparfloxacin, trovafloxacin                       (grepafloxacin, gatifloxacin,
                 ofloxacin)                                         levofloxacin, sparfloxacin,
                                                                    moxifloxacin)
                 Taste perversion
                 (grepafloxacin)                                    Phototoxicity
                                                                    (sparfloxacin, lomefloxacin,
                 GI                                                 clinafloxacin)
                 nausea/vomiting
                 (all quinolones)                                   Arthritis/
                                                                    Tendonitis
                                                                    (all quinolones)
                 Liver toxicity
                 (trovafloxacin)


Adapted from Fish. Clin Pharmacokinet. 1997;32:101-119. Haria. Drugs. 1997;54:435-446.
Goa. Drugs. 1997;53:700-725. Wagstaff. Drugs. 1997;53:817-824.
Avelox (moxifloxacin) package insert.
         Current Indications and Uses
          for the Fluoroquinolones
                  Gatifloxacin   Levofloxacin   Moxifloxacin
AECB                   +              +              +
 5 day                 +              -              +
CAP                    +              +              +
Acute Sinusitis        +              +              +
UTI                    +              +              -
Comp. UTI/Pyelo        +              +              -
Uncomp. Gonorr.        +              -              -
What’s the Deal with
 Fluoroquinolone
    Resistance?
 Fluoroquinolone Resistance
      THE BAD NEWS
 Resistances to Levoflox have been
  reported recently.
 Increasing number of centers are
  reserving fluoroquinolones for the
  sickest patients and oldest: Umass,
  Brigham, etc...
What’s the Deal with
 Fluoroquinolone
    Resistance?
(CDC:Drug-Resistant Strep Pneumo Working Group)

   Fluoroquinolones Limited to:
-Adults who have failed Macrolide,
BLactam-Macrolide combo, or Doxy
   -Allergy to alternative agents
   -Documented PRSP infection
                              Arch Int Med 2000;160:1399-1408.
    What’s the Deal with
     Fluoroquinolone
        Resistance?
              (JB’s Rules)
You may choose to reserve Fluoroquinolone use:
             -Increased Age (>70)
               -Highest Severity
    -Risk of PRSP (Nursing home patients)
  -Increased Risk: Cardiopulmonary Disease
    Give the Best Drugs to the Oldest (and
               Sickest) Folks...



     IDSA 2003
For Nursing Home Pts

  1. Resp Flouroquinln
2. Amx/Clv + Az/Clrth
What are cost-effective
treatment strategies?
Prestigious Burton Survey
           2004
               10d               14d
Zmax           47 (5d)
Biaxin         82                114
Doxy           11                13
Lvquin         92                128
Gatiflox       85                118
Moxiflox       91                126
Augmtn         113               155
                                       Ver Imp Med Jour, 2004
Walmart Pharmacy: Falmouth, ME
    Why Can’t I use
Doxycycline on everyone?

          IDSA 2003:
 “Very limited recent published
  clinical data on CAP, and few
         clinicians use it.”
Why not use Erythromycin
     on Everyone?

          IDSA 2003:
     “Erythromycin is poorly
  tolerated and is less effective
      against H Influenzae.”
   How long a course of
        therapy?

1. Until Afebrile for 72 hours.
2. Numerous trials: 7-14 days.
3. No controlled, outcome trials.
4. It’s a wash - 10 days.
        Are there any new drugs in the
            pipeline or pharmacy?
     12-Membered Ring                                                         16-Membered Ring
     • Methymycin                                                             • Spiramycin


                    14-Membered Ring                                    15-Membered Ring
                                                                        • Azithromycin

Natural Erythromycin                  Semisynthetic
• A, B, C, etc                        • Clarithromycin
                                      • Dirithromycin
                                      • Flurithromycin                            Ketolides (telithromycin)
                                      • Roxithromycin

      Bryskier A. Macrolides: Chemistry, Pharmacology and Clinical Uses. Oxford, England: Blackwell
      Scientific Publications; 1993.
What’s the deal with all
this 4 hour business for
  time to antibiotics?
    Quality of Care, Process, Outcomes
       in Elderly with Pneumonia
             JAMA 1997; 278:2080-2084


            JCAHO CAP Indicators

   Smoking cessation program
   Pneumovax program and documentation
   Time to Antibiotics (less than 8h) - less than 4h
   Blood Cultures for admitted patients
Odds of Survival at 30days vs Time to Antibiotic
1.6


1.4


1.2


 1                                                              OR


0.8


0.6


0.4
      0   1   2   3   4   5   6   7   8   9    10
                                              JAMA 1997; 278:2080-2084
What’s the deal with cultures?
  Don’t Get Em:
  1. Positive approx 8%
  2. When Positive, no change in RX
  3. Cost: Patient discomfort, false positive,
  contaminants, etc..

  Get Em:
  1. JCAHO interest
  2. Association with decreased mortality.
  3. Microbiologic/Resistance monitoring
  Clinical Utility of Blood Cultures in
 Adult Pts with Comm-Acqd Pneumonia
              Chest 1995; 108:932-936



                                Culture Result
                    7%
                     5%           Positive
                                  Contaminant
                                  Negative
  88%




517 Community Acquired Pnemonia Pts
    Clinical Utility of Blood Cultures

   Blood Culture (+) 34 patients:
       Strep Pneumo - 29
       H Flu          - 3
       Strep Pyogenes- 1
       E Coli         - 1
Utility of Blood Cultures in Pediatric
       ED Pts with Pneumonia
           Ann Emer Med 1996; 27:721-725



                         3%
                                 11 patients (+) cultures
              409 pts     8%     10 - S Pneumo
              with               1 - H Parainfluenzae
              cultures
     89%



                               Positive
                               Contaminant
                               Negative
What’s the deal with cultures?
  Don’t Get Em:
  1. Positive approx 8%
  2. When Positive, no change in RX
  3. Cost: Patient discomfort, false positive,
  contaminants, etc..

  Get Em:
  1. JCAHO interest
  2. Association with decreased mortality.
  3. Microbiologic/Resistance monitoring

				
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