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)
Information source: MerLion Pharmaceuticals GmbH
Information obtained from ClinicalTrials.gov on February 12, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Urinary Tract Infections
Intervention: Finafloxacin (Drug); Ciprofloxacin (Drug)
Phase: Phase 2
Status: Recruiting
Sponsored by: MerLion Pharmaceuticals GmbH Official(s) and/or principal investigator(s):
Jasper Hein, MD, Principal Investigator, Affiliation: Unaffiliated
Overall contact:
Andreas Vente, Ph.D., Phone: +49 30 9489 4050, Email: vente@merlionpharma.de
Summary
To compare the bacteriological eradication rates of Finafloxacin and Ciprofloxacin in female
patients with uUTI.
Clinical Details
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
Study design: Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Bacteriological eradication of the initial pathogen.
Secondary outcome: Clinical cure: Absence of signs or symptoms of 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 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
Minimum age: 18 Years.
Maximum age: 55 Years.
Gender(s): Female.
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.
Locations and Contacts
Andreas Vente, Ph.D., Phone: +49 30 9489 4050, Email: vente@merlionpharma.de
Medical practice, Dr. J. Hein (Principal Study Investigator), Marburg 35037, Germany; Recruiting
Jasper Hein, MD, Phone: +49 6421 13290, Email: dr.jasper-hein@t-online.de
Jasper Hein, MD, Principal Investigator
National University Hospital, Singapore 119074, Singapore; Not yet recruiting
Paul Tambyah, MD, Phone: -64 67724375, Email: mdcpat@nus.edu.sg
Paul Tambyah, MD, Principal Investigator
Additional Information
Starting date: October 2008
Ending date: December 2008
Last updated: October 14, 2008
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