5-Day versus 10-Day Course of Fluoroquinolones in Outpatient Males with a Urinary Tract Infection (UTI)

J Am Board Fam Med. 2016 Nov 12;29(6):654-662. doi: 10.3122/jabfm.2016.06.160065.


Introduction: Current guidelines classify urinary tract infections (UTIs) in males as complicated and recommend longer treatment than for UTIs in females. The objective of this study is to demonstrate that males with UTIs may be successfully treated with an outpatient 5-day course of levofloxacin.

Methods: Data were obtained from a previously conducted clinical trial (www.clinicaltrials.gov identifier NCT00210886), a multicenter, double-blind, randomized, noninferiority study comparing levofloxacin 750 mg intravenously/by mouth once daily for 5 days and ciprofloxacin 400/500 mg intravenously/by mouth twice daily for 10 days in complicated UTI (cUTI). The current study was a post hoc, subgroup analysis of male and female subjects with cUTI. Subjects were stratified into groups based on sex and antibiotic received. The subjects were analyzed at the end of therapy (EOT) and post therapy (PT) for clinical success rates, defined as no further need for antimicrobial treatment.

Results: Totals of 427 patients (224 male, 203 female) and 350 patients (189 male, 161 female) were included in the modified intent-to-treat (mITT) population and microbiologically evaluable (ME) populations, respectively. Clinical success rates between males and females were not statistically different between antibiotic groups in either the mITT or ME populations at EOT or PT.

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

Keywords: Anti-infective Agents; Antibacterial Agents; Ciprofloxacin; Double-Blind Method; Levofloxacin; Outpatients; Urinary Tract Infections.

Publication types

  • Comparative Study

MeSH terms

  • Administration, Intravenous
  • Administration, Oral
  • Adult
  • Ambulatory Care / methods
  • Ciprofloxacin / administration & dosage
  • Ciprofloxacin / therapeutic use
  • Escherichia coli / drug effects*
  • Escherichia coli / isolation & purification
  • Female
  • Fluoroquinolones / administration & dosage*
  • Fluoroquinolones / therapeutic use*
  • Humans
  • Levofloxacin / administration & dosage
  • Levofloxacin / therapeutic use
  • Male
  • Middle Aged
  • Practice Guidelines as Topic
  • Randomized Controlled Trials as Topic
  • Sex Factors
  • Time Factors
  • Urinary Tract Infections / complications
  • Urinary Tract Infections / drug therapy*
  • Urinary Tract Infections / microbiology


  • Fluoroquinolones
  • Ciprofloxacin
  • Levofloxacin

Associated data

  • ClinicalTrials.gov/NCT00210886