FOOD
AND DRUG ADMINISTRATION
Center for Drug Evaluation and Research
ANTI-INFECTIVE DRUGS
ADVISORY COMMITTEE (AIDAC) MEETING
Chair,
AIDAC
Introduction of
Committee
Conflict of Interest
Statement Tara
P. Turner, Pharm. D.
Executive
Secretary, AIDAC
for Diabetic Foot Infections Director
Division
of Anti-Infective Drug Products
FDA
Bone
Infection Unit
Nuffield
Orthopaedic Centre,
Medical
Director
Pfizer
Inc.
of Drugs for Diabetic Foot Infections Medical
Officer
Division
of Anti-Infective Drug Products
FDA
Foot Infections Microbiology
Team Leader
Division
of Anti-Infective Drug Products
FDA
Diabetic Foot Infections Medical
Officer
Division of Special Pathogen
and
Immunologic Drug Products,
FDA
for Diabetic Foot Infections Medical
Team Leader
Division of Anti-Infective
Drug Products
FDA
Office
of Drug Evaluation IV, FDA
QUESTIONS TO
THE COMMITTEE
1. How does one define a
“diabetic foot infection”? Please
include in your discussions the considerations of patients with cellulitis
without breaks in the skin versus patients with pre-existing breaks in the
skin.
2. In patients with a
pre-existing skin ulcer, how does one define infected versus non-infected
ulcers?
3. What is the most accurate
way to obtain microbiologic information in patients with diabetic foot
infections?
4. What are the considerations
for clinical trials for ruling out osteomyelitis in patients in trials of
diabetic foot infections? Please discuss
how to determine drug efficacy for the diabetic foot infection in the setting
of osteomyelitis and whether such patients should be considered clinical cures
or failures.
5. How does one define clinical
success or failure patients in a clinical trial of diabetic foot infections?