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) (FLUT)

This study has been completed.
Sponsor:
Information provided by:
MerLion Pharmaceuticals GmbH
ClinicalTrials.gov Identifier:
NCT00722735
First received: July 25, 2008
Last updated: June 10, 2009
Last verified: October 2008
  Purpose

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


Condition Intervention Phase
Urinary Tract Infections
Drug: Finafloxacin
Drug: Ciprofloxacin
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by MerLion Pharmaceuticals GmbH:

Primary Outcome Measures:
  • Bacteriological eradication of the initial pathogen. [ Time Frame: 4-6 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Clinical cure: Absence of signs or symptoms of uUTI. [ Time Frame: 10-14 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 36
Study Start Date: October 2008
Study Completion Date: April 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Group I: Finafloxacin tablets + Ciprofloxacin placebo capsule
Drug: Finafloxacin
Finafloxacin tablets, 300 mg b.i.d., oral administration; Ciprofloxacin placebo capsule, 1 capsule b.i.d.,oral administration; duration: 3 days
Active Comparator: 2
Group II: Ciprofloxacin capsule + Finafloxacin placebo tablets
Drug: Ciprofloxacin
Finafloxacin placebo, 6 tablets b.i.d., oral administration; Ciprofloxacin capsule, 250 mg b.i.d., oral administration; duration: 3 days

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.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00722735

Locations
Germany
Medical practice, Dr. J. Hein (Principal Study Investigator)
Marburg, Germany, 35037
Singapore
National University Hospital
Singapore, Singapore, 119074
Sponsors and Collaborators
MerLion Pharmaceuticals GmbH
Investigators
Principal Investigator: Jasper Hein, MD
  More Information

No publications provided

Responsible Party: Jasper Hein, MD, Prinzipal Investigator, Practicing Physician
ClinicalTrials.gov Identifier: NCT00722735     History of Changes
Other Study ID Numbers: FINA-003
Study First Received: July 25, 2008
Last Updated: June 10, 2009
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by MerLion Pharmaceuticals GmbH:
uncomplicated Urinary Tract Infection in Women
Antibacterial Chemotherapy
Proof-of-Concept

Additional relevant MeSH terms:
Infection
Urinary Tract Infections
Urologic Diseases
Ciprofloxacin
Fluoroquinolones
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on September 18, 2014