NCT00722735

Finafloxacin 300 mg Twice a Day (b.i.d.) Versus Ciprofloxacin 250 mg Twice a Day (b.i.d) in Patients With Lower Uncomplicated UTI (uUTI)

A Double-Blind, Double-Dummy, Prospective, Randomized Multiple-Site Study of Oral Finafloxacin 300 mg b.i.d. Versus Oral Ciprofloxacin 250 mg b.i.d. in Patients With Lower Uncomplicated UTI (uUTI) With a Treatment Duration of 3 Days

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 36 (estimated)
• Sponsor: MerLion Pharmaceuticals GmbH · Industry
• Sex: Female
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

Summary

To compare the bacteriological eradication rates of Finafloxacin and Ciprofloxacin in female patients with uUTI.

Detailed description

Patients with clinical signs and symptoms of uUTI who have a high probability of the required number of bacteria in their urine, measured by positive test for nitrite and /or leucocyte esterase by means of a dipstick will be enrolled in this study. Only these patients with bacterial count equal or more than 10e5 cfu/mL will be included in the efficacy analysis. At Baseline, patients will be randomly assigned (2:1) to receive Finafloxacin 300 mg or Ciprofloxacin 250 mg, following a double-dummy design, ie Group 1 will receive Finafloxacin tablets + Ciprofloxacin placebo capsule while Group II will receive Ciprofloxacin capsule + Finafloxacin placebo tablets. The treatment will last in total 3 days. The microbiological results will be compared with the baseline microbiology. If the concentration of initial pathogen in the urine is equal or more than 10e3 cfu/mL in the post-therapy culture compared with the baseline , this will define a bacteriological eradication. Microbiological assessment will be performed as well. Evaluation of the bacteria reinfection or relapse will be performed, based on the microbiology results. The status of clinical improvement and cure will be considered additionally.

Conditions

• Urinary Tract Infections

Interventions

Type	Name	Description
DRUG	Finafloxacin	Finafloxacin tablets, 300 mg b.i.d., oral administration; Ciprofloxacin placebo capsule, 1 capsule b.i.d.,oral administration; duration: 3 days
DRUG	Ciprofloxacin	Finafloxacin placebo, 6 tablets b.i.d., oral administration; Ciprofloxacin capsule, 250 mg b.i.d., oral administration; duration: 3 days

Timeline

• Start date: 2008-10-01
• Primary completion: 2009-04-01
• Completion: 2009-04-01
• First posted: 2008-07-28
• Last updated: 2009-06-11

Locations

2 sites across 2 countries: Germany, Singapore