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. - FLUT

• Conditions: ower uncomplicated Urinary Tract Infection; MedDRA version: 9.1Level: LLTClassification code 10046571Term: Urinary tract infection

• Registration Number: EUCTR2007-007742-35-DE
• Lead Sponsor: MerLion Pharmaceuticals GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-03-25
• Last Update Posted: 3 July 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 48

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.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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 immunosuppresion.
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 behaviour 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, aluminum or calcium intake during the course of the study..
13.Clinically abnormal vital signs and ECG findings at Baseline; clinically relevant abnormal findings from the safety laboratory collected 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To compare the bacteriological eradication rates of Finafloxacin and Ciprofloxacin in female patients with uUTI.;Secondary Objective: ;Primary end point(s): Bacteriological eradication of the initial pathogen (=10exp.3) at Day 4-6 (Visit 3).