Purpose Evaluate the efficacy of extended-release ciprofloxacin (CIP XR) for treatment of women with acute uncomplicated urinary tract infections (uUTIs) caused by Staphylococcus saprophyticus. Methods: Two studies (a Phase III controlled, double-blind trial and a Phase IV uncontrolled, open-label trial) enrolled women with symptomatic lower uUTI and a positive pre-treatment clean-catch midstream urine culture at enrollment, defined as ≥ 104 CFU/mL for S. saprophyticus and ≥ 105 CFU/mL for all other uropathogens. CIP XR 500 mg once-daily tablets were administered for 3 days in both trials. Clinical and bacteriologic outcomes were assessed at test-of-cure visit (4-11 days post-therapy).
Results Among 294 efficacy-valid, CIP XR-treated patients, most had a uUTI due to Escherichia coli (n = 231 [79%]), while other major uropathogens were Klebsiella pneumoniae (n = 16 [5%]), Proteus mirabilis (n = 15 [5%]), S. saprophyticus (n = 14 [5%]), and Enterococcus faecalis (n = 11 [4%]). For the 294 patients, mean age was 33 years, 77% were Caucasian, and 65% had no UTIs in the previous year. For the 14 S. saprophyticus patients, mean age was 29 years, 71% were Caucasian, and 79% had no UTIs in the previous year. At test-of-cure, 14/14 (100%) S. saprophyticus were clinical cures and 12/14 (86%) achieved bacteriologic eradication. Clinical cure/bacteriologic eradication rates for other uropathogens were: E. coli: 94%/97%; K. pneumoniae: 88%/88%; P. mirabilis: 93%/93%; and E. faecalis: 91%/91%.
Conclusions A three-day once-daily CIP XR 500 mg regimen is an effective treatment option for women with acute uncomplicated UTIs who are at risk for infection with S. saprophyticus and other common uUTI pathogens.