URINARY TRACT INFECTION (UTI)

5/28/97


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Table of Contents

URINARY TRACT INFECTION (UTI)

CATEGORIES OF UTI-IDSA

CATEGORIES OF UTI- FDA

RECENT UTI LABEL

UNCOMPLICATED UTI Definition

INCLUSION CRITERIA

INCLUSION CRITERIA (continued)

IDSA Entry Criteria

Significant Bacteriuria

EXCLUSION CRITERIA

EXCLUSION CRITERIA (continued)

EXCLUSION CRITERIA (continued)

Treatment Duration/ Choice of Comparator

ASSESSMENTS

OUTCOME MEASURES

Microbiologic Outcome

Microbiologic Outcome (continued)

Microbiologic Outcome (continued)

Clinical Outcome

Clinical Outcome (continued)

Rationale for Strict Criteria For Bacteriuria in New Drug Trials

Rationale for Strict Criteria For Bacteriuria in New Drug Trials

Author: Janice Soreth, M.D.

Email: sorethj@cder.fda.gov

Home Page: http://www.fda.gov/cder/adac.htm