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Sponsored by: |
MerLion Pharmaceuticals GmbH |
Information provided by: | MerLion Pharmaceuticals GmbH |
ClinicalTrials.gov Identifier: | NCT00722735 |
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 II |
MedlinePlus related topics: | Urinary Tract Infections |
Drug Information available for: | Ciprofloxacin Ciprofloxacin hydrochloride Finafloxacin |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study |
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 |
Estimated Enrollment: | 36 |
Study Start Date: | October 2008 |
Estimated Study Completion Date: | December 2008 |
Estimated Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
1: Experimental
Group I: Finafloxacin tablets + Ciprofloxacin placebo capsule
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Drug: Finafloxacin
Finafloxacin tablets, 300 mg b.i.d., oral administration; Ciprofloxacin placebo capsule, 1 capsule b.i.d.,oral administration; duration: 3 days
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2: Active Comparator
Group II: Ciprofloxacin capsule + Finafloxacin placebo tablets
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Drug: Ciprofloxacin
Finafloxacin placebo, 6 tablets b.i.d., oral administration; Ciprofloxacin capsule, 250 mg b.i.d., oral administration; duration: 3 days
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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.
Ages Eligible for Study: | 18 Years to 55 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Andreas Vente, Ph.D. | +49 30 9489 4050 | vente@merlionpharma.de |
Contact: Harald Labischinski, Ph.D. | +49 30 9489 4050 | labischinski@merlionpharma.de |
Germany | |||||
Medical practice, Dr. J. Hein (Principal Study Investigator) | Recruiting | ||||
Marburg, Germany, 35037 | |||||
Contact: Jasper Hein, MD +49 6421 13290 dr.jasper-hein@t-online.de | |||||
Principal Investigator: Jasper Hein, MD | |||||
Singapore | |||||
National University Hospital | Not yet recruiting | ||||
Singapore, Singapore, 119074 | |||||
Contact: Paul Tambyah, MD -64 67724375 mdcpat@nus.edu.sg | |||||
Principal Investigator: Paul Tambyah, MD |
MerLion Pharmaceuticals GmbH |
Principal Investigator: | Jasper Hein, MD | Unaffiliated |
Responsible Party: | Practicing Physician ( Jasper Hein, MD, Prinzipal Investigator ) |
Study ID Numbers: | FINA-003 |
First Received: | July 25, 2008 |
Last Updated: | October 14, 2008 |
ClinicalTrials.gov Identifier: | NCT00722735 |
Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
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