Ignite Creation Date:
2024-05-05 @ 7:43 PM
Last Modification Date:
2024-10-26 @ 9:52 AM
Study NCT ID:
NCT00722735
Status:
COMPLETED
Last Update Posted:
2009-06-11
First Post:
2008-07-25
Brief Title:
Finafloxacin 300 mg Twice a Day bid Versus Ciprofloxacin 250 mg Twice a Day bid in Patients With Lower Uncomplicated UTI uUTI
Sponsor:
MerLion Pharmaceuticals GmbH
Organization:
MerLion Pharmaceuticals GmbH
Study Overview
Official Title:
A Double-Blind Double-Dummy Prospective Randomized Multiple-Site Study of Oral Finafloxacin 300 mg bid Versus Oral Ciprofloxacin 250 mg bid in Patients With Lower Uncomplicated UTI uUTI With a Treatment Duration of 3 Days
Status:
COMPLETED
Status Verified Date:
2008-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
FLUT
Brief 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 cfumL will be included in the efficacy analysis At Baseline patients will be randomly assigned 21 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 cfumL 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None