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    Summary
    EudraCT Number:2011-006041-14
    Sponsor's Protocol Code Number:FINA-007
    National Competent Authority:Poland - Office for Medicinal Products
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2012-07-17
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedPoland - Office for Medicinal Products
    A.2EudraCT number2011-006041-14
    A.3Full title of the trial
    A Multi-Dose, Double-Blind, Double-Dummy, Active Control, Randomized Clinical (Phase II) Study of Two Dosing Regimens of Finafloxacin for the Treatment of cUTI and/or Acute Pyelonephritis Requiring Hospitalisation
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A randomized, comparative clinical trial between the investigational drug, finafloxacin, and ciprofloxacin in the treatment of complicated (hospitalised) urinary tract infection
    A.4.1Sponsor's protocol code numberFINA-007
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorMerLion Pharmaceuticals GmbH
    B.1.3.4CountryGermany
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportMerLion Pharmaceuticals GmbH
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameFinafloxacin
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNFinafloxacin
    D.3.9.1CAS number 209342-41-6
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number3,2
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameFinafloxacin
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNFinafloxacin
    D.3.9.1CAS number 209342-41-6
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 3
    D.1.2 and D.1.3IMP RoleComparator
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Ciprofloxacin real 250/500/750 mg
    D.2.1.1.2Name of the Marketing Authorisation holderDolorgiet GmbH & CoKG
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameCiprofloxacin
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCIPROFLOXACIN
    D.3.9.1CAS number 86483-48-9
    D.3.9.4EV Substance CodeSUB01316MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number250
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 4
    D.1.2 and D.1.3IMP RoleComparator
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Ciprofloxacin Kabi 400 mg/200ml Infusionsloesung
    D.2.1.1.2Name of the Marketing Authorisation holderFresenius Kabi Deutschland GmbH
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameCiprofloxacin Kabi 400mg/200ml Infusionloesung
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 85721-33-1
    D.3.9.3Other descriptive nameCIPROFLOXACIN
    D.3.9.4EV Substance CodeSUB07470MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboInfusion
    D.8.4Route of administration of the placeboIntravenous use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule, hard
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 3
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboFilm-coated tablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Complicated Urinary Tract Infection and/or Acute Polyonephritis
    E.1.1.1Medical condition in easily understood language
    Urinary Tract Infection requiring hospitalisation
    E.1.1.2Therapeutic area Diseases [C] - Bacterial Infections and Mycoses [C01]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Evaluate the microbiological and clinical outcome of treatment with finafloxacin for 5 days versus finafloxacin for 10 days versus ciprofloxacin for 10 days
    E.2.2Secondary objectives of the trial
    •The clinical and microbiological response at the On Therapy (OT) visit (Day 3) •The clinical and microbiological response at the End of Therapy (EoT) visit (Day 10) •The clinical and microbiological response at the End of Study (EoS) visit (Day 24) •Separate analyses will be performed for all time points with the outcome variable clinical responder and also microbiological responder •The safety and tolerability of multiple doses of finafloxacin of both 5 days and 10 days of treatment with finafloxacin (i.v. and oral) in subjects with cUTI, compared to 10 days of ciprofloxacin (i.v. and oral) as a reference comparator •The predictive capacity of PK/PD data of both 5 days and 10 days of treatment with finafloxacin (i.v. and oral) in subjects with cUTI, using 10 days of ciprofloxacin (i.v. and oral) as a reference comparator on clinical outcomes (EMA guidance) •Other exploratory parameters as defined by the data (post hoc analyses).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    All subjects MUST:
    1.be male or female subjects ≥ 18 years of age.
    2.if a female
    a.and subject is of childbearing potential, must have documented use of using an effective contraceptive method (such as IUD, hormonal birth control, condom and spermicidal jelly, etc.) during the study, a documented negative serum pregnancy test and must be non-lactating.
    b.subject is of non-childbearing potential, must be post-menopausal for at least 1 year or surgically sterile due to bilateral tubal ligation, bilateral oophorectomy, or hysterectomy
    3.If a male, should agree to use reliable birth control methods (contraception or other barrier device) during study participation.
    4.have at least two of the following (acute?) signs and symptoms
    a.Chills or rigors or warmth associated with fever (e.g., oral temperature greater than 38 degrees Celsius)
    b.Flank pain (pyelonephritis) or pelvic pain (cUTI)
    c.Nausea or vomiting
    d.Dysuria, urinary frequency, or urinary urgency
    e.Costo-vertebral angle tenderness on physical examination
    of complicated lower urinary tract infection including acute complicated and uncomplicated pyelonephritis (cPN or uPN) (see 5.3).
    5.provide one pre-treatment adequate urine culture (the urine culture must return a positive culture in order for the subject to remain eligible for the study) (for males: midstream clean catch, for females: in-out catheterisation or midstream clean catch) which must be provided within 24 hours before the start of administration of the first dose of study drug, defined as ≥ 105 CFU/mL (in case of pyelonephritis ≥ 104 CFU/mL). Patients may be admitted to the study pending baseline urine culture results.
    NOTE: Because biofilms on indwelling catheters (e.g., Foley catheters) are more likely to be present after the catheter has been in place for a period of time, samples should be collected following the placement of a new catheter. If the placement of a new catheter is contraindicated or is not feasible, specimens should be collected using aseptic techniques with the urine obtained through a properly disinfected collection port. Urine samples should never be obtained from the collection bag.
    If the subject’s pre-treatment culture shows the presence of a ciprofloxacin resistant pathogen or negative urine culture (defined as < 104 cfu/mL of causative pathogens), the Investigator’s medical judgement will determine whether or not the subject should continue in the study:
    •in case of resistant pathogen, the Investigator has to decide according to clinical signs and symptoms whether the subject can stay in the study.
    •in the case of a NEGATIVE culture (see above) the subject must be switched to standard care, because the inclusion criterion was not fulfilled.
    6.have pyuria (i.e. a dipstick analysis positive for leukocyte esterase or at least 10 white blood cells per cubic millimetre [1 µl])
    7.be considered ill enough to be hospitalized and require initial parenteral therapy to manage cUTI and/or acute pyelonephritis by the standard of care.
    8.provide written informed consent to participate in the study.
    9.be willing and able to comply with all study procedures and activities.
    E.4Principal exclusion criteria
    1. Uncomplicated cystitis in females.
    2. Failed previous antibiotic treatment within the last 4 weeks due to culture confirmed fluoroquinolone resistant pathogens.
    3. Having Ileal loops, urinary diversion with bowel segments or suspected or confirmed vesico-ureteral reflux, suspected or confirmed perinephric or intrarenal abscess (if an abscess is suspected an ultrasound should be performed to confirm and exclude).
    4. History of renal transplant any permanent complicating factors of the urinary tract (including complete obstruction, suspected or confirmed
    prostatitis or epididymitis) which cannot be effectively treated during the therapy of the infection.
    5. Indwelling urinary catheters expected to remain in place after therapy has been completed.
    6. The urinary tract infection or any other concomitant bacterial infection that requires systemic antibiotic therapy (in addition to the study treatment) at the time of randomisation. Antibiotics with only grampositive
    activity are permitted.
    7. Any infection that, in the opinion of the Investigator, would be considered intractable and likely to require more than 10 days of study drug therapy.
    8. Any recent use (e.g., within 48 hours before the first dose of study medication) of an antimicrobial therapy with a drug that has activity in the treatment of urinary tract infection.
    9. Having been exposed to any fluoroquinolone in the 30 days before Day 1 (study enrolment), previous participation in a finafloxacin clinical trial or participation within the last 30 days in any other clinical study in
    general.
    10. Known uncontrolled condition of hypertension or symptomatic hypotension, known ischaemic heart disease or history of myocardial infarction (within 12 months before study enrolment), coronary
    arterybypass surgery or percutaneous transluminal coronary angioplasty.
    11. Significantly immunocompromised (defined as a WBC < 1000) and/or having a known infection with human immunodeficiency virus (HIV/AIDS), any haematological malignancy, bone marrow transplantation, or current immunosuppressive therapy (including but not limited to cancer chemotherapy, or medications for prevention of organ transplantation rejection).
    12. Any concomitant psychiatric, neurological or behavioural disorder, including epilepsy or other lesions of the central nervous system sufficient in the opinion of the Investigator to prevent or compromise the subject´s particiaption in the sudy.
    13. Any known concomitant bacterial or fungal sexually transmitted disease.
    14. Having, in the opinion of the Investigator, any clinically significant serious or unstable physical illness likely to impact on the subject's wellbeing or the conduct and analysis of the study, including, but not
    limited to, acute hepatic failure, respiratory failure, severe, persistent diarrhoea and septic shock.
    15. Any surgical or medical condition which might interfere with the distribution, metabolism or excretion of the drug, including, but not limited to moderate (including estimated creatinine clearance of 20 - 39
    mL/min) or severe impairment of renal function (including an estimated creatinine clearance of < 20 mL/min), requirement for peritoneal dialysis, haemodialysis or haemofiltration, or oliguria.
    16. Any malignant disease or a history of malignant neoplasm requiring a treatment with immune suppressive properties within the last 6 months before baseline.
    17. Known history of drug abuse.
    18. Clinically abnormal haematology, biochemistry and urinalysis results at baseline including, but not limited to:
    • AST, ALT, or alkaline phosphatase level greater than 3 times the upper limit of normal (ULN).
    • Total bilirubin greater than 2 times ULN.
    • WBC count less than 1000/μL, platelet count less than 50,000/μL.
    • Haematocrit less than 25%.
    • Serum creatinine >265 micromole/l or creatinine clearance < 40mL/minute.
    19. Any clinically significant ECG abnormality on the baseline ECG subjects at risk for torsade de pointes arrhythmia or a history of significant or inadequately treated cardiac disease.
    20. Documented history of hypersensitivity or allergy to or known contraindication to the use of fluoroquinolones.
    21. Any history of tendon lesions or ruptures either during quinolone treatment or for any other reason.
    22. Concomitant tizanidine use.
    23. Any administration of corticosteroids equivalent to or greater than 20 mg of prednisone per day for more than 14 days before randomisation.
    24. the subject, planned to be enrolled is an employee or relative of any involved study Investigator or any involved institution including MerLion or Galenus.
    25. Life expectancy of less than 3 months.
    26. Women who are pregnant or nursing.
    27. Any other condition that, in the opinion of the Investigator, would prevent the subject from effectively participating in the study, place the subject at risk or affect the assessment of efficacy and safety of the
    study medication.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint of this study is the clinical and microbiological response of patients with cUTI or pyelonephritis to treatment with finafloxacin for 5 days versus finafloxacin for 10 days versus ciprofloxacin for 10 days as a reference comparator at the ToC visit (Day 17) in the microbiological intent–to-treat population (micro-ITT
    population).
    E.5.1.1Timepoint(s) of evaluation of this end point
    ToC visit (Day 17) in the micro-ITT population
    E.5.2Secondary end point(s)
    •The clinical and microbiological response at the On Therapy (OT) visit (Day 3)
    •The clinical and microbiological response at the End of Therapy (EoT) visit (Day 10)
    •The clinical and microbiological response at the End of Study (EoS) visit (Day 24)
    •Separate analyses will be performed for all time points with the outcome variable clinical responder and also microbiological responder
    •To assess the safety and tolerability of multiple doses of finafloxacin of both 5 days and 10 days of treatment with finafloxacin (i.v. and oral) in subjects with cUTI, compared to 10 days of ciprofloxacin (i.v. and oral) as a reference comparator
    •To assess the predictive capacity of PK/PD data of both 5 days and 10 days of treatment with finafloxacin (i.v. and oral) in subjects with cUTI, using 10 days of ciprofloxacin (i.v. and oral) as a reference comparator on clinical outcomes (EMA guidance)
    •Other exploratory parameters as defined by the data (post hoc analyses).

    E.5.2.1Timepoint(s) of evaluation of this end point
    On Therapy visit - Day 3;
    End of Therapy visit - Day 10
    End of Study visit - Day 24
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Ciprofloxacin
    E.8.2.4Number of treatment arms in the trial3
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned15
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA27
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months2
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months2
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 232
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 26
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state230
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 258
    F.4.2.2In the whole clinical trial 258
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2012-10-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-06-19
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2014-06-15
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