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


A total of 427 patients (224 male and 203 female patients) with cUTI met all inclusion criteria and were analyzed in the mITT group. Of those 427 patients, 350 (189 male, 161 female) adhered to the study protocol and were included in the ME group (Figure 2). Baseline demographics of the patients are listed in Table 3; approximately half of the patients in the mITT population were males and the majority of subjects were white, over the age of 60, and infected with E coli. Nearly all were treated in an outpatient setting, rather than in a hospital.

Figure 2.

Patient disposition. cUTI, complicated urinary tract infection; mITT, modified intent-to-treat; ME, microbiologically evaluable.

Overall, the clinical success rates for males and females with cUTI were similar in both the mITT and ME populations at EOT and PT (Table 4). In the mITT population, males who received levofloxacin had a success rate of 83% at EOT and 76% PT, compared with their female counterparts, who experienced success rates of 81% both EOT and PT (P = .73 and .411, respectively). In the ME population, the clinical success rate for males who received levofloxacin at EOT and PT were 87% and 81% compared with 94% and 86% in females, respectively (P = .141 and .428, respectively). Similarly, there were no statistical differences between males and females who received ciprofloxacin in the mITT and ME populations at both EOT and PT. Furthermore, when comparing the clinical success rates of either a 5-day course of levofloxacin or a 10-day course of ciprofloxacin in the male population alone, no significant differences were found in the mITT or ME population at EOT or PT (Table 5).

Further analyses were performed within the male population to determine clinical success rates for subjects with additional complicating factors (Table 6). Patients who received levofloxacin had a statistically similar rate of clinical success as those who received ciprofloxacin for all additional complicating factors, with the exception of those with a catheter. In this cohort of patients, the clinical success rate with levofloxacin (91.3%) was significantly higher than those who received ciprofloxacin (56.3%; P = .019).

Comparison of the clinical success rates among male patients within the antimicrobial group (ciprofloxacin or levofloxacin), based on additional complicating factors, yielded significantly different results (Table 7). In this analysis, males who received ciprofloxacin were less likely to have clinical success if they had a catheter, neurogenic bladder or urinary retention, and ≥2 complicating factors, compared with patients who received ciprofloxacin without the associated complicating factor (56.3% vs 91.5%, P = .002; 69.2% vs 91.7%, P = .009; and 70.4% vs 92.3%, P = .04, respectively). By contrast, there was no significant difference in clinical success rates among males with these complicating factors who received levofloxacin.