Evaluation of a 5-day course of levofloxacin in males with a urinary tract infection, a subgroup analysis of a previously published trial

Introduction: Based upon the current guideline recommendations, urinary tract infections (UTIs) in males are deemed complicated and are therefore treated for longer than their female counterparts. Given their efficacy and broad spectrum of activity, fluoroquinolones are among the recommended antimicrobials to treat complicated UTIs.

Objectives: This study evaluated a 5-day course of levofloxacin compared with a 10-day course of ciprofloxacin in patients with complicated UTIs to determine overall clinical success rates in males, and differences in clinical success rates between males and females.

Study Design: Data was obtained from a previously conducted clinical trial (NCT00210886), a multicenter, double-blind, randomized, non-inferiority study comparing levofloxacin 750 mg once daily for 5 days and 400/500 mg IV/PO ciprofloxacin twice daily for 10 days in complicated UTI and acute pyelonephritis. This current study was a post-hoc, subgroup, analysis of male and female subjects with complicated UTI.

Methods: Subjects were stratified into groups based on gender and antibiotic received. The subjects were analyzed at end of therapy (EOT) and post therapy (PT) for clinical success rates (defined as no further need for antimicrobial treatment).

Results: A total of 189 male and 161 female subjects were included in the final analysis (microbiologically evaluable). Clinical success rates at EOT for males were 87% and 86% for the levofloxacin and ciprofloxacin groups, respectively (p=0.837).  Clinical success rates at PT among males were 81% and 86% in the levofloxacin and ciprofloxacin groups, respectively (p=0.438). Differences in clinical success rates between males and females were not statistically significant at EOT or PT. Results were similar in the modified intent to treat population.

Conclusions: This study demonstrates that males can be treated with a shorter course of antimicrobial therapy for UTI than previously recommended.