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)

NCT00722735 | Completed Phase 2 DMC

• 1 other identifier: FINA-003
• Study Type: interventional
• Target: 36
• Locations: 2 countries
• Sites: 2

Brief Summary

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

Conditions

Urinary Tract Infections

Keywords

uncomplicated Urinary Tract Infection in Women; Antibacterial Chemotherapy; Proof-of-Concept

Outcome Measures

Primary Outcomes (1)

• Bacteriological eradication of the initial pathogen.

  4-6 days

Secondary Outcomes (1)

• Clinical cure: Absence of signs or symptoms of uUTI.

  10-14 days

Study Arms (2)

1

EXPERIMENTAL

Group I: Finafloxacin tablets + Ciprofloxacin placebo capsule

Drug: Finafloxacin

2

ACTIVE COMPARATOR

Group II: Ciprofloxacin capsule + Finafloxacin placebo tablets

Drug: Ciprofloxacin

Interventions

Finafloxacin DRUG

Finafloxacin tablets, 300 mg b.i.d., oral administration; Ciprofloxacin placebo capsule, 1 capsule b.i.d.,oral administration; duration: 3 days

1

Ciprofloxacin DRUG

Finafloxacin placebo, 6 tablets b.i.d., oral administration; Ciprofloxacin capsule, 250 mg b.i.d., oral administration; duration: 3 days

2

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Female patients between 18 and 55 years with uUTI.
• Two of the following sign and symptoms of uUTI: dysuria, frequency, urgency, miction pain, suprapubic pain, gross hematuria, turbid urine or malodorous urine.
• Able to supply a mid-stream, clean catch urine sample for microbiological analysis.
• The result of the dipstick should indicate a high probability of the required number of bacteria.
• Be able to communicate with the study personnel.
• Has given written consent to participate in the study.

You may not qualify if:

• Female patients having signs and symptoms of upper urinary tract infection (e.g. fever, flank pain) indicating complicated UTI.
• Male patients
• History or evidence of other functional or anatomical abnormalities of the urinary tract (e.g. acute pyelonephritis), diabetes mellitus and immunosuppression.
• Recurrent cystitis with more than 3 episodes in the past 12 months.
• Clinical symptoms for more than 7 days before Baseline.
• Psychiatric, neurological or behavior disorders.
• Clinically significant serious unstable physical illness.
• 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.
• 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.
• Antibiotic intake 2 weeks before study enrolment.
• 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.
• Clinically abnormal vital signs, ECG findings and safety laboratory results at Baseline.
• Known hypersensitivity or contraindication to the use of fluoroquinolones.
• History of tendon lesions or ruptures during quinolone treatment.
• 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.

Sponsors & Collaborators

• MerLion Pharmaceuticals GmbH: lead

Study Sites (2)

Medical practice, Dr. J. Hein (Principal Study Investigator)

Marburg, 35037, Germany

Location

National University Hospital

Singapore, 119074, Singapore

Location

Related Publications (1)

• 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.

  PMID: 29339393 DERIVED

MeSH Terms

Conditions

Urinary Tract Infections

Interventions

finafloxacin; Ciprofloxacin

Condition Hierarchy (Ancestors)

Infections; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Jasper Hein, MD

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: July 25, 2008
• First Posted: July 28, 2008
• Study Start: October 1, 2008
• Primary Completion: April 1, 2009
• Study Completion: April 1, 2009
• Last Updated: June 11, 2009

Record last verified: 2008-10

Locations

DE (1); SG (1)