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Presented by Carl Norden, M.D. at the Anti-Infective Drugs Advisory Committee

Presented by Carl Norden, M.D. at the Anti-Infective Drugs Advisory Committee meeting on October 28, 2003. Study Exclusion Criteria - 1. General conditions Pregnant/breast-feeding women Hypersensitivity to any of the main study antibiotics Absolute neutrophil count <500/mm 3

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Presented by Carl Norden, M.D. at the Anti-Infective Drugs Advisory Committee

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  1. Presented by Carl Norden, M.D. at the Anti-Infective Drugs Advisory Committee meeting on October 28, 2003

  2. Study Exclusion Criteria - 1 • General conditions • Pregnant/breast-feeding women • Hypersensitivity to any of the main study antibiotics • Absolute neutrophil count <500/mm3 • Enrollment in additional concurrent investigational protocol

  3. Measuring Lesion Ulcer Length Ulcer depth must also be measured Erythema Width Ulcer Width Lesion or Ulcer Erythema Length

  4. Wound Measurements

  5. General Wound Parameters - 1

  6. General Wound Parameters - 2

  7. General Wound Parameters - 3

  8. General Wound Parameters - 4

  9. Total Wound Score

  10. Wound Infection Score Circle the single most appropriate choice indicating your evaluation of the study diabetic ulcer regarding the above parameters. Patient should be in a sitting position for 3-5 minutes before these assessments are conducted.

  11. Osteomyelitis Evaluation yes Visible bone, or [+ Probe to bone] no yes X-ray characteristic for osteomyelitis no X-ray compatible with osteomyelitis, or high clinical suspicion Osteomyelitis yes no Consider additional testing, eg, imaging MRI, or bone biopsy + Treat as soft tissue infection – + Repeat X-ray in 7-14 days

  12. Vasculopathy • Present in < ¾ of diabetic foot infections • Highly associated with ability to cure infection & to heal wound • Patients with non-critical ischemia may be enrolled in this study • Patients with potentially critical ischemia may be enrolled- if approved by vascular consultant

  13. Vascular Evaluation yes History of claudication at < 1 block walking no yes Neither DP nor PT pulse palpable no yes Doppler evaluation (wave form analysis) Ankle/Brachial BP <0.5 Consider vascular evaluation no Toe BP <30 Ankle BP <50 yes no yes TcpO2 <30 no No vascular evaluation required

  14. Assessing Efficacy • Primary assessment is clinical outcome • assessed at days 7, 14, 21, iv  po switch • determined at EOT and FU visits • Criteria for assessment • Cured: resolution of all pre-therapy signs & symptoms of infection; wound healing • Improved: resolution of >2 but not all infection signs & symptoms; only at EOT • Failed: persistence/progression baseline signs/sx infection or new clinical findings • Indeterminate: extenuating circumstances preclude classification

  15. Microbiology • S. aureus (MSSA and MRSA) • ß-hemolytic streptococci • Coagulase-negative staphylococci

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