Urinary Tract InfectionsPhase 2FLUTNCT00722735
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)
A Phase 2 study testing Finafloxacin and Ciprofloxacin in people with Urinary Tract Infections, run by MerLion Pharmaceuticals GmbH at 2 sites in 2 countries.
Trial summary
To compare the bacteriological eradication rates of Finafloxacin and Ciprofloxacin in female patients with uUTI. Read more about this study
- Who is it for?
- Ages 18 to 55 years, women only
- Conditions the study is for
- Urinary Tract Infections
- What is being tested?
- Finafloxacin and Ciprofloxacin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Oct 2008to Apr 2009
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
- Failed UTI therapy within 2 months before study inclusion.
- 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.
- Current diagnosis or history of substance abuse.
- Exposure to any of the investigational drugs 30 days prior to Baseline.
- 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.
- The patient, planned to be enrolled is an employee of any involved study investigator or any involved institution including the study sponsor.
- Inability or lacking motivation to participate in the study.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Germany1 site
Medical practice, Dr. J. Hein (Principal Study Investigator)
Marburg, 35037
About this 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
To compare the bacteriological eradication rates of Finafloxacin and Ciprofloxacin in female patients with uUTI.
Read the 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.
- Conditions
- Urinary Tract Infections
- Being tested
- Finafloxacin, Ciprofloxacin
- Keywords
- uncomplicated Urinary Tract Infection in Women, Antibacterial Chemotherapy, Proof-of-Concept
- Medical subject headings
- Urinary Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FinafloxacinDrug
Finafloxacin tablets, 300 mg b.i.d., oral administration; Ciprofloxacin placebo capsule, 1 capsule b.i.d.,oral administration; duration: 3 days
CiprofloxacinDrug
Finafloxacin placebo, 6 tablets b.i.d., oral administration; Ciprofloxacin capsule, 250 mg b.i.d., oral administration; duration: 3 days
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Group I: Finafloxacin tablets + Ciprofloxacin placebo capsule Receives: Drug: Finafloxacin |
| 2 | Active comparator | Group II: Ciprofloxacin capsule + Finafloxacin placebo tablets Receives: Drug: Ciprofloxacin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bacteriological eradication of the initial pathogen.
Measured: 4-6 days
Secondary outcomes (1)
Clinical cure: Absence of signs or symptoms of uUTI.
Measured: 10-14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2008 (estimated)
- Study startOct 2008
- Primary completionApr 2009
- Study completionApr 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Urinary Tract InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- MerLion Pharmaceuticals GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Jasper Hein, MD, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00722735
- Sponsor's protocol ID
- FINA-003
- Acronym
- FLUT
- Status last verified
- Oct 2008
- First submitted
- 25 Jul 2008
- Last updated
- 11 Jun 2009
- Results posted
- No
- Data monitoring committee
- Yes
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.
PubMed 29339393
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00722735
- Acronym / sponsor ID
- FLUT / FINA-003
- Conditions
- Urinary Tract Infections
- Keywords
- uncomplicated Urinary Tract Infection in Women, Antibacterial Chemotherapy, Proof-of-Concept
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- MerLion Pharmaceuticals GmbHIndustry (pharma, biotech, devices)
- Study start
- Oct 2008
- Primary completion
- Apr 2009 (actual)
- Study completion
- Apr 2009 (actual)
- First posted
- 28 Jul 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: FinafloxacinGroup I: Finafloxacin tablets + Ciprofloxacin placebo capsule |
| 2 | Active comparator | Drug: CiprofloxacinGroup II: Ciprofloxacin capsule + Finafloxacin placebo tablets |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (21 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FinafloxacinFinafloxacin tablets, 300 mg b.i.d., oral administration; Ciprofloxacin placebo capsule, 1 capsule b.i.d.,oral administration; duration: 3 days | Drug | 1 |
| CiprofloxacinFinafloxacin placebo, 6 tablets b.i.d., oral administration; Ciprofloxacin capsule, 250 mg b.i.d., oral administration; duration: 3 days | Drug | 2 |
Primary outcome
Bacteriological eradication of the initial pathogen.
Time frame: 4-6 days
1 secondary outcome
Clinical cure: Absence of signs or symptoms of uUTI.
Time frame: 10-14 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2009.
- Derived from this study: PubMed 29339393Vente 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jasper Hein, MD principal investigator
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Finafloxacin and Ciprofloxacin in people with Urinary Tract Infections, run by MerLion Pharmaceuticals GmbH at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jun 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany, Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bacteriological eradication of the initial pathogen. (time frame: 4-6 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00722735, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2009.