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)

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

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

Study Overview

• Status: Completed
• Conditions: Urinary Tract Infections
• Intervention / Treatment: Drug: Finafloxacin; Drug: Ciprofloxacin

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.

• Study Type: Interventional
• Enrollment (Anticipated): 36
• Phase: Phase 2

Contacts and Locations

Study Locations

• Germany
  • Marburg, Germany, 35037
    • Medical practice, Dr. J. Hein (Principal Study Investigator)
• Singapore
  • Singapore, Singapore, 119074
    • National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Bacteriological eradication of the initial pathogen.	4-6 days

Secondary Outcome Measures

Outcome Measure	Time Frame
Clinical cure: Absence of signs or symptoms of uUTI.	10-14 days

Collaborators and Investigators

• Sponsor: MerLion Pharmaceuticals GmbH
• Investigators: Principal Investigator: Jasper Hein, MD

Publications and helpful links

General Publications

• Vente A, Bentley C, Luckermann M, Tambyah P, Dalhoff A. Early Clinical Assessment of the Antimicrobial Activity of Finafloxacin Compared to Ciprofloxacin in Subsets of Microbiologically Characterized Isolates. Antimicrob Agents Chemother. 2018 Mar 27;62(4):e02325-17. doi: 10.1128/AAC.02325-17. Print 2018 Apr.

Study record dates

Study Major Dates

• Study Start: October 1, 2008
• Primary Completion (ACTUAL): April 1, 2009
• Study Completion (ACTUAL): April 1, 2009

Study Registration Dates

• First Submitted: July 25, 2008
• First Submitted That Met QC Criteria: July 25, 2008
• First Posted (ESTIMATE): July 28, 2008

Study Record Updates

• Last Update Posted (ESTIMATE): June 11, 2009
• Last Update Submitted That Met QC Criteria: June 10, 2009
• Last Verified: October 1, 2008

More Information

Terms related to this study

• Keywords: Proof-of-Concept; uncomplicated Urinary Tract Infection in Women; Antibacterial Chemotherapy
• Additional Relevant MeSH Terms: Infections; Urologic Diseases; Urinary Tract Infections; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Antineoplastic Agents; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Anti-Bacterial Agents; Cytochrome P-450 Enzyme Inhibitors; Cytochrome P-450 CYP1A2 Inhibitors; Anti-Infective Agents, Urinary; Renal Agents; Ciprofloxacin; Finafloxacin
• Other Study ID Numbers: FINA-003