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Points for Discussion. Anti-Infective Drugs Advisory Committee Meeting March 5, 2003. Morning Discussion. Points for Discussion. Listing Pathogens of Public Health Importance :

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Points for discussion

Points for Discussion

Anti-Infective Drugs Advisory Committee Meeting

March 5, 2003



Points for discussion1
Points for Discussion

  • Listing Pathogens of Public Health Importance:

    • The criteria proposed are intended to identify resistant pathogens of public health importance. Please discuss these criteria and provide comments on the factors that comprise the criteria.

    • Data were presented for 27 taxa that the Agency plans to evaluate according to these criteria. Are there other pathogens which should be added for evaluation?

    • Are there other analyses the committee believes would be useful in evaluating multi-drug resistant organisms?


Criteria for developing list
Criteria for Developing List

1. Organism of sufficient prevalence in population with disease under study

2. Organism causes serious and severe disease

3. Drug to which organism is resistant is commonly used in disease under study

4. Limited available therapies due to multi-drug resistance

5. Drug used to control spread of disease in population

6. Clinical correlation of in vitro resistance with poor clinical outcomes


Prevalence of clinically relevant species from all specimen sources
Prevalence of Clinically Relevant Species from All Specimen Sources

Top 10 Enterobacteriaceae

Escherichia coli

Klebsiella pneumoniae

Proteus mirabilis

Enterobacter cloacae

Serratia marcescens

Enterobacter aerogenes

Citrobacter freundii

Klebsiella oxytoca

Citrobacter koseri

Morganella morganii

Staphylococcus aureus

Coagulase-negative staphylococci

Pseudomonas aeruginosa

Enterococcus faecalis

Enterococcus faecium

Acinetobacter baumannii

Stenotrophomonas maltophilia

Burkholderia cepacia

Streptococcus pneumoniae

Viridans streptococci

Beta-hemolytic streptococci

Streptococcus agalactiae

Streptococcus pyogenes

Haemophilus spp.

Haemophilus influenzae

Haemophilus parainfluenzae

Anaerobic bacteria

Percent of Patients

5



Points for discussion 1
Points for Discussion-1 Sources

Data from Studies in One Indication Supporting Studies in a Different Indication:

1. Please discuss the concept of data from studies in one indication supporting studies in a different indication. In your discussions please also discuss the proposed criteria that are intended to identify factors which should be evaluated when considering the evidence from studies in one indication supporting studies in a different indication. Are there factors that should be added, modified, or removed?


Points for discussion 2
Points for Discussion -2 Sources

Data from Studies in One Indication Supporting Studies in a Different Indication:

2. Please discuss which indications may provide supportive evidence for a single clinical study in another indication.

3. Please discuss whether data for a “more serious” indication can support safety and efficacy in a “less serious” indication. Are there situations where the converse could be considered (“less serious” indication supporting “more serious” indication)?


Proposed criteria 1
Proposed Criteria - 1 Sources

1. Natural history of the disease under study - what is the spontaneous resolution rate and what is the morbidity/ mortality without treatment?

2. Factors other than he antimicrobial which may affect outcome in a given indications

  • surgical debridement

  • adjunctive therapies - ABECB

    3. Characteristics of the study drug, e.g., pharmacokinetics of the drug - does it reach site of infection?

  • tissue levels

  • effects of pH


Proposed criteria 2
Proposed Criteria - 2 Sources

4. Monomicrobial vs. polymicrobial nature of infection

  • enterococci in a polymicrobial intraabdominal infection

    5. Similar site of infection

  • Lung for CAP and HAP

    6. Host effects

  • Host differences in CAP vs. HAP

    7. Similarity in spectrum of organisms causing disease

  • differences in organism most commonly associated with CAP vs. HAP


Relating indications

Related by Organ System Sources

CAP  HAP

CAP  ABECB

cSSSI  uSSSI

cUTI  uUTI

cUTI  Prosatitis

Other Relationships.

CIAI  cSSSI

cSSSI  CIAI

cSSSI  HAP

HAP cSSSI

ABS  AOM

AOM  ABS

Relating Indications (?)