Efficacy and Safety of Finafloxacin versus Ciprofloxacin in the Treatment of Complicated Urinary Tract Infections: An Explorative Randomized Phase II Clinical Study. [PublishAheadOfPrint]

Introduction

The broad spectrum C-8-cyano-fluoroquinolone finafloxacin displays enhanced activity at acidic conditions. This phase II clinical study compared efficacy and safety of finafloxacin and ciprofloxacin in patients with complicated urinary tract infection and/or pyelonephritis.

Results

A 5-day regimen with finafloxacin 800 mg q.d. (FINA05) had similar results as a 10-day regimen with finafloxacin 800 mg q.d. (FINA10). Combined microbiological and clinical responses at test of cure visit (TOC) were 70% for FINA05, 68% for FINA10, and 57% for a 10-day ciprofloxacin regimen (CIPRO10) in 193 (64 for FINA05, 68 for FINA10 and 61 for CIPRO10) patients of the microbiological intent-to-treat (mITT) population. Additionally, the clinical effects of ciprofloxacin in patients with an acidic urine pH (80% of patients) were reduced whereas the effects of finafloxacin were unchanged. Finafloxacin was safe and well tolerated. Overall 43.4% of the patients in FINA05, 42.7% in FINA10 and 54.2% in the CIPRO10 group experienced mostly mild and treatment emergent, but unrelated adverse events.

Conclusion

A short course regimen of five days with finafloxacin resulted in higher eradication and improved clinical outcome rates than treatment with ciprofloxacin for 10 days. In contrast to ciprofloxacin, the clinical effects of finafloxacin were not reduced by acidic urine pH.

Methods

Hospitalized adults were randomized 1:1:1 to finafloxacin (800 mg q.d.) either for 5 or 10 days or ciprofloxacin (400 mg/500 mg b.i.d.) for 10 days with an optional switch from i.v. to oral administration at day 3. The primary endpoint was the combined microbiological and clinical response at TOC in the microbiological intent-to-treat population.

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