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    Clinical Trial Results:
    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

    Summary
    EudraCT number
    		 2011-006041-14
    Trial protocol
    		 PL  
    Global end of trial date
    15 Jun 2014

    Results information
    Results version number
    		 v1(current)
    This version publication date
    05 Jan 2017
    First version publication date
    05 Jan 2017
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    FINA-007
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01928433
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    MerLion Pharmaceuticals GmbH
    Sponsor organisation address
    Robert-Roessle-Str. 10, Berlin, Germany, 13125
    Public contact
    Head of Regulatory Affairs, MerLion Pharmaceuticals GmbH, lueckermann@merlionpharma.de
    Scientific contact
    Head of Regulatory Affairs, MerLion Pharmaceuticals GmbH, lueckermann@merlionpharma.de
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    30 Oct 2015
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    15 Jun 2014
    Global end of trial reached?
    Yes
    Global end of trial date
    15 Jun 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main 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
    Protection of trial subjects
    Stringent ECG monitoring, patients will be excluded in case of any significant ECG abnormalities.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    08 Dec 2012
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Poland: 192
    Country: Number of subjects enrolled
    Germany: 33
    Worldwide total number of subjects
    225
    EEA total number of subjects
    225
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    144
    From 65 to 84 years
    75
    85 years and over
    6

    Subject disposition

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    Recruitment
    Recruitment details
    		 First patient enrolled: 08 December 2012 Last patient completed: 15 June 2014 Countries: Germany and Poland

    Pre-assignment
    Screening details
    		 After signing the informed consent patient received screening no. If these patients are eligible to continue the study, based on the inclusion and exclusion criteria they will be assigned to one of the three treatment groups (Finafloxacin for 5 days, Finafloxacin for 10 days or Ciprofloxacin for 10 days) in a ratio of 1:1:1.

    Period 1
    Period 1 title
    Overall Trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst, Carer, Assessor
    Blinding implementation details
    Blinding was conducted using the double-blind, double-dummy technique.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Group I -Finafloxacin 5 days
    Arm description
    		 Finafloxacin 800 mg intravenous (i.v.) once daily (o.d.) (infused over 60 mins [i.v. pump]) for at least 3 days (in-patient) followed by finafloxacin 800 mg tablets (as four 200 mg tablets) o.d. (outpatient): total treatment period of 5 days. For blinding the patients received additional 5 days oral placebo treatment.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Finafloxacin hydrochloride
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Finafloxacin 800 mg intravenous (i.v.) once daily (o.d.) infused over 60 mins [i.v. pump] for at least 3 days.

    Investigational medicinal product name
    Finafloxacin hydrochloride
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Finafloxacin 800 mg oral (as four 200 mg film-coated tablets) o.d. (outpatient).

    Arm title
    		 Group II -Finafloxacin 10 days
    Arm description
    		 Finafloxacin 800 mg intravenous (i.v.) once daily (o.d.) (infused over 60 mins [i.v. pump]) for at least 3 days (in-patient) followed by finafloxacin 800 mg tablets (as four 200 mg tablets) o.d. (outpatient): total treatment period of 10 days.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Finafloxacin hydrochloride
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Finafloxacin 800 mg intravenous (i.v.) once daily (o.d.) infused over 60 mins [i.v. pump] for at least 3 days.

    Investigational medicinal product name
    Finafloxacin hydrochloride
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Finafloxacin 800 mg oral (as four 200 mg film-coated tablets) o.d. (outpatient).

    Arm title
    		 Group III - Ciprofloxacin 10 days
    Arm description
    		 Ciprofloxacin 400 mg i.v. two times daily (b.i.d.) for at least 3 days (in-patient) followed by ciprofloxacin 500 mg oral (as two 250 mg capsules each) (b.i.d.) two times daily (outpatient); total treatment period of 10 days.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Ciprofloxacin hydrogen sulphate
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    Ciprofloxacin 400 mg i.v. two times daily (b.i.d.) infused over approximately 60 mins (i.v. pump).

    Investigational medicinal product name
    Ciprofloxacin hydrochloride
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Ciprofloxacin 500 mg oral (as two 250 mg capsules each) (b.i.d.) two times daily (outpatient).

    Number of subjects in period 1
    		Group I -Finafloxacin 5 days Group II -Finafloxacin 10 days Group III - Ciprofloxacin 10 days
    Started
    76
    75
    74
    Completed
    56
    54
    46
    Not completed
    20
    21
    28
         Consent withdrawn by subject
    -
    4
    -
         Adverse event, non-fatal
    5
    2
    5
         Other
    3
    3
    4
         Lost to follow-up
    -
    2
    3
         Negative screeening urine culture
    7
    6
    10
         Lack of efficacy
    5
    4
    4
         Protocol deviation
    -
    -
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Group I -Finafloxacin 5 days
    Reporting group description
    		 Finafloxacin 800 mg intravenous (i.v.) once daily (o.d.) (infused over 60 mins [i.v. pump]) for at least 3 days (in-patient) followed by finafloxacin 800 mg tablets (as four 200 mg tablets) o.d. (outpatient): total treatment period of 5 days. For blinding the patients received additional 5 days oral placebo treatment.

    Reporting group title
    Group II -Finafloxacin 10 days
    Reporting group description
    		 Finafloxacin 800 mg intravenous (i.v.) once daily (o.d.) (infused over 60 mins [i.v. pump]) for at least 3 days (in-patient) followed by finafloxacin 800 mg tablets (as four 200 mg tablets) o.d. (outpatient): total treatment period of 10 days.

    Reporting group title
    Group III - Ciprofloxacin 10 days
    Reporting group description
    		 Ciprofloxacin 400 mg i.v. two times daily (b.i.d.) for at least 3 days (in-patient) followed by ciprofloxacin 500 mg oral (as two 250 mg capsules each) (b.i.d.) two times daily (outpatient); total treatment period of 10 days.

    Reporting group values
    		 Group I -Finafloxacin 5 days Group II -Finafloxacin 10 days Group III - Ciprofloxacin 10 days Total
    Number of subjects
    		 76 75 74 225
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0 0
        Newborns (0-27 days)
    		 0 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0 0
        Children (2-11 years)
    		 0 0 0 0
        Adolescents (12-17 years)
    		 0 0 0 0
        Adults (18-64 years)
    		 52 43 49 144
        From 65-84 years
    		 20 31 24 75
        85 years and over
    		 4 1 1 6
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 54.6 ± 19.63 58 ± 19.28 51.1 ± 20.82 -
    Gender categorical
    Units: Subjects
        Female
    		 64 62 59 185
        Male
    		 12 13 15 40
    Subject analysis sets

    Subject analysis set title
    ITT
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Patients who provided written consent to participate and were randomized into the study.

    Subject analysis set title
    Safety Set
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    All patients who met the definition of ITT population and who received at least one dose of study medication during the trial.

    Subject analysis set title
    micro-ITT
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    All subjects who met the definition for the ITT population and who had a positive baseline bacterial pathogen on culture of urine that causes UTI against which the investigational drug had antibacterial activity.

    Subject analysis sets values
    		 ITT Safety Set micro-ITT
    Number of subjects
    225
    223
    193
    Age categorical
    Units: Subjects
        In utero
    0
    0
    0
        Preterm newborn infants (gestational age < 37 wks)
    0
    0
    0
        Newborns (0-27 days)
    0
    0
    0
        Infants and toddlers (28 days-23 months)
    0
    0
    0
        Children (2-11 years)
    0
    0
    0
        Adolescents (12-17 years)
    0
    0
    0
        Adults (18-64 years)
    144
    143
    123
        From 65-84 years
    75
    74
    65
        85 years and over
    6
    6
    5
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    54.6 ± 20.03
    54.6 ± 20.08
    54.9 ± 19.99
    Gender categorical
    Units: Subjects
        Female
    185
    183
    157
        Male
    40
    40
    36

    End points

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    End points reporting groups
    Reporting group title
    Group I -Finafloxacin 5 days
    Reporting group description
    		 Finafloxacin 800 mg intravenous (i.v.) once daily (o.d.) (infused over 60 mins [i.v. pump]) for at least 3 days (in-patient) followed by finafloxacin 800 mg tablets (as four 200 mg tablets) o.d. (outpatient): total treatment period of 5 days. For blinding the patients received additional 5 days oral placebo treatment.

    Reporting group title
    Group II -Finafloxacin 10 days
    Reporting group description
    		 Finafloxacin 800 mg intravenous (i.v.) once daily (o.d.) (infused over 60 mins [i.v. pump]) for at least 3 days (in-patient) followed by finafloxacin 800 mg tablets (as four 200 mg tablets) o.d. (outpatient): total treatment period of 10 days.

    Reporting group title
    Group III - Ciprofloxacin 10 days
    Reporting group description
    		 Ciprofloxacin 400 mg i.v. two times daily (b.i.d.) for at least 3 days (in-patient) followed by ciprofloxacin 500 mg oral (as two 250 mg capsules each) (b.i.d.) two times daily (outpatient); total treatment period of 10 days.

    Subject analysis set title
    ITT
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Patients who provided written consent to participate and were randomized into the study.

    Subject analysis set title
    Safety Set
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    All patients who met the definition of ITT population and who received at least one dose of study medication during the trial.

    Subject analysis set title
    micro-ITT
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    All subjects who met the definition for the ITT population and who had a positive baseline bacterial pathogen on culture of urine that causes UTI against which the investigational drug had antibacterial activity.

    Primary: Efficacy - Combined Endpoint at Test of Cure

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    End point title
    		 Efficacy - Combined Endpoint at Test of Cure [1]
    End point description
    The primary endpoint of this study was 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 Test of Cure (ToC) visit (Day 17) in the micro-ITT population.
    End point type
    Primary
    End point timeframe
    Day 17 (+/-2) after treatment start.
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: This study was not powered to perform formal inferential statistical analyses.
    End point values
    		 Group I -Finafloxacin 5 days Group II -Finafloxacin 10 days Group III - Ciprofloxacin 10 days
    Number of subjects analysed
    64
    68
    61
    Units: percent
        number (not applicable)
    70.3
    67.6
    57.4
    No statistical analyses for this end point

    Primary: Efficacy - Clinical Success at Test of Cure

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    End point title
    		 Efficacy - Clinical Success at Test of Cure [2]
    End point description
    The clinical 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 Test of Cure (ToC) visit (Day 17) in the micro-ITT population.
    End point type
    Primary
    End point timeframe
    Treatment start to day 17 (+/- 2)
    Notes
    [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: This study was not powered to perform formal inferential statistical analyses.
    End point values
    		 Group I -Finafloxacin 5 days Group II -Finafloxacin 10 days Group III - Ciprofloxacin 10 days
    Number of subjects analysed
    64
    68
    61
    Units: percent
        number (not applicable)
    79.7
    83.8
    72.1
    No statistical analyses for this end point

    Primary: Efficacy - Microbiological Success at Test of Cure

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    End point title
    		 Efficacy - Microbiological Success at Test of Cure [3]
    End point description
    The 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 Test of Cure (ToC) visit (Day 17) in the micro-ITT population.
    End point type
    Primary
    End point timeframe
    Treatment start to day 17 (+/- 2)
    Notes
    [3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: This study was not powered to perform formal inferential statistical analyses.
    End point values
    		 Group I -Finafloxacin 5 days Group II -Finafloxacin 10 days Group III - Ciprofloxacin 10 days
    Number of subjects analysed
    64
    68
    61
    Units: percent
        number (not applicable)
    71.9
    70.6
    59
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Timepoint of written informed consent to End of Study Visit (Day 24).
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    17.0
    Reporting groups
    Reporting group title
    Safety set (2%)
    Reporting group description
    		 -

    Reporting group title
    Finafloxacin
    Reporting group description
    		 -

    Reporting group title
    Ciprofloxacin
    Reporting group description
    		 -

    Serious adverse events
    		 Safety set (2%) Finafloxacin Ciprofloxacin
    Total subjects affected by serious adverse events
         subjects affected / exposed
    8 / 223 (3.59%)
    7 / 151 (4.64%)
    1 / 72 (1.39%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Ovarian adenoma
         subjects affected / exposed
    1 / 223 (0.45%)
    1 / 151 (0.66%)
    0 / 72 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    2 / 223 (0.90%)
    2 / 151 (1.32%)
    0 / 72 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastritis
         subjects affected / exposed
    1 / 223 (0.45%)
    1 / 151 (0.66%)
    0 / 72 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Dermatitis
         subjects affected / exposed
    1 / 223 (0.45%)
    1 / 151 (0.66%)
    0 / 72 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Obstructive uropathy
         subjects affected / exposed
    1 / 223 (0.45%)
    0 / 151 (0.00%)
    1 / 72 (1.39%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Pyonephrosis
         subjects affected / exposed
    1 / 223 (0.45%)
    1 / 151 (0.66%)
    0 / 72 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Clostridium difficile infection
         subjects affected / exposed
    2 / 223 (0.90%)
    2 / 151 (1.32%)
    0 / 72 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 2%
    Non-serious adverse events
    		 Safety set (2%) Finafloxacin Ciprofloxacin
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    58 / 223 (26.01%)
    55 / 151 (36.42%)
    39 / 72 (54.17%)
    Investigations
    Blood pressure increased
         subjects affected / exposed
    6 / 223 (2.69%)
    4 / 151 (2.65%)
    2 / 72 (2.78%)
         occurrences all number
    8
    5
    3
    Nervous system disorders
    Headache
         subjects affected / exposed
    15 / 223 (6.73%)
    9 / 151 (5.96%)
    6 / 72 (8.33%)
         occurrences all number
    19
    10
    9
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    13 / 223 (5.83%)
    8 / 151 (5.30%)
    5 / 72 (6.94%)
         occurrences all number
    16
    11
    5
    Nausea
         subjects affected / exposed
    7 / 223 (3.14%)
    6 / 151 (3.97%)
    1 / 72 (1.39%)
         occurrences all number
    7
    6
    1
    Abdominal pain
         subjects affected / exposed
    6 / 223 (2.69%)
    3 / 151 (1.99%)
    3 / 72 (4.17%)
         occurrences all number
    6
    3
    3
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    6 / 223 (2.69%)
    5 / 151 (3.31%)
    1 / 72 (1.39%)
         occurrences all number
    7
    6
    1
    Metabolism and nutrition disorders
    Hypokalaemia
         subjects affected / exposed
    5 / 223 (2.24%)
    3 / 151 (1.99%)
    2 / 72 (2.78%)
         occurrences all number
    5
    3
    2

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    21 May 2013
    Update of the SmPC for Ciprofloxacin and new Informed Consent was submitted.
    25 Apr 2014
    Implementation of an administrative analysis.

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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