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

TLDR

UTI refers to any infection with a positive urine culture, yet clinical presentations and treatment responses vary widely, and effective therapy should eradicate the pathogen, resolve symptoms, minimize side effects, and prevent recurrence. The study proposes urine bacterial count thresholds (≥10³ cfu/mL for uncomplicated cystitis, ≥10⁴ for uncomplicated pyelonephritis/UTI in men, and ≥10⁵ for complicated UTI) to define significant bacteriuria. The guidelines cover acute uncomplicated cystitis, acute uncomplicated pyelonephritis, and complicated UTI, recommending prospective randomized controlled trials with active agents and defining bacteriuria thresholds.

Abstract

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 ⩾103 cfu/mL of urine defines significant bacteriuria in acute uncomplicated cystitis, ⩾104 cfu/mL in acute uncomplicated pyelonephritis and UTI in men, and ⩾105 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.