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

Geoffrey A. Mospan, PharmD, BCPS; Kurt A. Wargo, PharmD, FCCP, BCPS (AQ-ID)


J Am Board Fam Med. 2016;29(6):654-662. 

In This Article

Abstract and Introduction


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.


Infections of the urinary tract caused by bacteria are a common occurrence in clinical practice. In men, however, the length of the urethra, a drier environment surrounding the meatus, and the antibacterial properties of prostatic fluid all contribute to lower rates of urinary tract infections (UTIs).[1] Therefore, when UTIs occur in men, they are deemed complicated and subject to longer treatment durations compared with infections in women.[1,2] Clinical trials demonstrating the efficacy of antimicrobials in UTIs have typically enrolled a majority of female patients. In general, clinical trials of patients with UTIs enroll small numbers of male patients, and their data are grouped with those of female patients in analyses.[3] Drekonja and colleagues[4] conducted a retrospective study of >30,000 males with a UTI in the Veterans Affairs system. The objective of their study was to evaluate the recurrence of infection in patients who received a short (<7 days) or long (>7 days) duration of treatment. The investigators found that treatment for >7 days in males with a UTI was not associated with a reduction in early or late recurrence of UTI, but it did increase the risk of Clostridium difficile infection compared with a treatment duration <7 days. The optimal duration of therapy for the treatment of UTIs in males is still unclear, and as a result, recommendations are predominantly based on data extrapolated from clinical trials of essentially all females and from expert opinion.[1]

The most common pathogen associated with UTIs is Escherichia coli.[1–3] Given their broad spectrum of activity and their historic efficacy in treating UTIs caused by E coli, fluoroquinolones are among the first-line antimicrobials to treat these infections.[1,2] Unfortunately, widespread use of these agents has led to increased resistance of E coli, and their empiric use is falling out of favor among many clinicians.[5–8] A study of patients treated in an emergency department demonstrated that while resistance of E coli to levofloxacin was high (17%), it was significantly greater in those with hospital-acquired UTIs (38% vs 10% of patients with community-acquired UTIs), long-term medical conditions, and fluoroquinolone use within the previous 1 to 4 weeks.[7]

While resistance to levofloxacin is on the rise, so too is resistance to other antimicrobial agents. The North American Urinary Tract Infection Collaborative Alliance (NAUTICA) trial evaluated 1990 outpatient urinary tract isolates to determine changes in the epidemiology of urinary tract pathogens.[9] In that study, 20.5% of isolates came from male patients. Levofloxacin resistance was highest among males aged ≥65 years, at 19.9%. Interestingly, among males in this same age group, resistance to nitrofurantoin and trimethoprim-sulfamethoxazole were higher: 27.8% and 32.6%, respectively.

Peterson and colleagues[10] conducted a multicenter, double-blind, randomized, noninferiority study of primarily outpatient subjects comparing levofloxacin 750 mg intravenously (IV) by mouth (PO) daily for 5 days with ciprofloxacin 400 mg IV/500 mg PO twice daily for 10 days in both male and female patients with complicated UTIs (cUTIs) and acute pyelonephritis. In that study, susceptibility of E coli to levofloxacin was very high (94%). Furthermore, the clinical success rates for the short course of levofloxacin were shown to be noninferior to ciprofloxacin. Unfortunately, the published results of that study combined data from both male and female subjects in the analysis. Through reanalysis using the original, unpublished data, the objective of the present study is to evaluate clinical success rates in males with cUTI who received 5 days of levofloxacin or 10 days of ciprofloxacin compared with their female counterparts.