URINARY TRACT INFECTION (UTI)
CATEGORIES OF UTI-IDSA
CATEGORIES OF UTI- FDA
RECENT UTI LABEL
UNCOMPLICATED UTIDefinition
INCLUSION CRITERIA
INCLUSION CRITERIA (continued)
IDSA Entry Criteria
Significant Bacteriuria
EXCLUSION CRITERIA
EXCLUSION CRITERIA (continued)
Treatment Duration/ Choice of Comparator
ASSESSMENTS
OUTCOME MEASURES
Microbiologic Outcome
Microbiologic Outcome (continued)
Clinical Outcome
Clinical Outcome (continued)
Rationale for Strict Criteria For Bacteriuria in New Drug Trials
Email: sorethj@cder.fda.gov
Home Page: http://www.fda.gov/cder/adac.htm