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Evaluation of New Anti-Infective Drugs for the Treatment of Urinary Tract Infection

Robert H. RubinDepartment of Medicine, Massachusetts General Hospital, Harvard Medical School, Boston 02114Eugene D. ShapiroFrom the Department of Medicine, Massachusetts General Hospital, and Harvard Medical School, Boston, Massachusetts; the Primary Care Center, Yale-New Haven Hospital, and the Department of Medicine, Yale University School of Medicine, New Haven, Connecticut; Pharmaco Dynamics Research, Inc., Austin, Texas; and the Department of Medicine, Harborview Medical Center, Seattle, WashingtonVincent T. AndrioleFrom the Department of Medicine, Massachusetts General Hospital, and Harvard Medical School, Boston, Massachusetts; the Primary Care Center, Yale-New Haven Hospital, and the Department of Medicine, Yale University School of Medicine, New Haven, Connecticut; Pharmaco Dynamics Research, Inc., Austin, Texas; and the Department of Medicine, Harborview Medical Center, Seattle, WashingtonRobert J. DavisFrom the Department of Medicine, Massachusetts General Hospital, and Harvard Medical School, Boston, Massachusetts; the Primary Care Center, Yale-New Haven Hospital, and the Department of Medicine, Yale University School of Medicine, New Haven, Connecticut; Pharmaco Dynamics Research, Inc., Austin, Texas; and the Department of Medicine, Harborview Medical Center, Seattle, WashingtonWalter E. StammFrom the Department of Medicine, Massachusetts General Hospital, and Harvard Medical School, Boston, Massachusetts; the Primary Care Center, Yale-New Haven Hospital, and the Department of Medicine, Yale University School of Medicine, New Haven, Connecticut; Pharmaco Dynamics Research, Inc., Austin, Texas; and the Department of Medicine, Harborview Medical Center, Seattle, Washington

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The term urinary tract infection (UTI) encompasses a broad range of clinical entities that share one characteristic: a positive urine culture. Clinical manifestations and responses to therapy are diverse even when comparable numbers of a particular bacterial species are identified on urine culture. These guidelines include discussion of acute uncomplicated cystitis, acute uncomplicated pyelonephritis, and complicated infections of the urinary tract. It is proposed that the finding of > or = 10(3) cfu/mL of urine defines significant bacteriuria in acute uncomplicated cystitis, > or = 10(4) cfu/mL in acute uncomplicated pyelonephritis and UTI in men, and > or = 10(5) cfu/mL in complicated UTI. The preferred clinical study design is prospective, randomized, and controlled with an active agent. Ideally, treatment with antimicrobial agents should eradicate the infecting organism, bring about the resolution of clinical signs and symptoms, have few adverse effects, and prevent reinfection.

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DOI: 10.1093/clind/15.supplement_1.s216

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