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

 1. Female patients between 18 and 55 years with uUTI.

 2. Two of the following sign and symptoms of uUTI: dysuria, frequency, urgency, miction
 pain, suprapubic pain, gross hematuria, turbid urine or malodorous urine.

 3. Able to supply a mid-stream, clean catch urine sample for microbiological analysis.

 4. The result of the dipstick should indicate a high probability of the required number
 of bacteria.

 5. Be able to communicate with the study personnel.

 6. Has given written consent to participate in the study.

 Exclusion Criteria:

 1. Female patients having signs and symptoms of upper urinary tract infection (e.g.
 fever, flank pain) indicating complicated UTI.

 2. Male patients

 3. History or evidence of other functional or anatomical abnormalities of the urinary
 tract (e.g. acute pyelonephritis), diabetes mellitus and immunosuppression.

 4. Recurrent cystitis with more than 3 episodes in the past 12 months.

 5. Clinical symptoms for more than 7 days before Baseline.

 6. Psychiatric, neurological or behavior disorders.

 7. Clinically significant serious unstable physical illness.

 8. Known uncontrolled condition of hypertension or symptomatic hypotension, known
 ischemic heart disease or history of myocardial infarction (within 12 months prior
 study enrolment), coronary artery bypass surgery or percutaneous transluminal coronary
 angioplasty.

 9. Existence of any surgical or medical condition which might interfere with the
 distribution, metabolism or excretion of the drug, i.e. impaired renal or hepatic
 function, diabetes mellitus, chronic symptoms of pronounced constipation or diarrhea
 or conditions associated with total or partial obstruction of the urinary tract.

 10. Antibiotic intake 2 weeks before study enrolment.

 11. Failed UTI therapy within 2 months before study inclusion.

 12. Expectancy of concomitant administration of antibiotics, sucralfate or divalent and
 trivalent cations such as iron or antacids containing magnesium, aluminium or calcium
 intake during the course of the study.

 13. Clinically abnormal vital signs, ECG findings and safety laboratory results at
 Baseline.

 14. Known hypersensitivity or contraindication to the use of fluoroquinolones.

 15. History of tendon lesions or ruptures during quinolone treatment.

 16. Any malignant disease or a history of malignant neoplasm other than carcinoma in situ
 of the cervix or basal cell carcinoma of the skin, within the last 5 years before
 Baseline.

 17. Current diagnosis or history of substance abuse.

 18. Exposure to any of the investigational drugs 30 days prior to Baseline.

 19. Pregnant or nursing woman, or woman of childbearing potential who is not using an
 effective contraceptive method during the study, e.g. oral (stable doses for at least
 3 months prior to Baseline) or injectable (stable doses for at least 2 months prior to
 Baseline) contraceptives, intrauterine devices (for at least 2 months prior Baseline),
 double-barrier method, contraceptive patch, female sterilization or condoms.

 20. The patient, planned to be enrolled is an employee of any involved study investigator
 or any involved institution including the study sponsor.

 21. Inability or lacking motivation to participate in the study.