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    Clinical Trial Results:
    A Phase II, Randomized, Double-Blind, Multicenter, Comparative Study to Determine the Safety, Tolerability, Pharmacokinetics and Efficacy of Oral Nafithromycin Versus Oral Moxifloxacin in the Treatment of Community-Acquired Bacterial Pneumonia (CABP) in Adults

    Summary
    EudraCT number
    		 2016-001246-26
    Trial protocol
    		 LV   BG  
    Global end of trial date
    08 Jul 2017

    Results information
    Results version number
    		 v1(current)
    This version publication date
    18 Apr 2019
    First version publication date
    18 Apr 2019
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    W-4873-201
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02903836
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Wockhardt Bio AG
    Sponsor organisation address
    Grafenauweg 6, Zug, Switzerland, 6300
    Public contact
    Associate Vice President Clinical Research Europe, Wockhardt , +48 221105473, piwanowski@wockhardt.com
    Scientific contact
    Senior Vice President, Global Clinical Development Study Director, Wockhardt , +91 2271596830, abhatia@wockhardt.com
    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
    13 Apr 2018
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    08 Jul 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    · To assess the overall safety and tolerability of oral nafithromycin; · To assess the clinical response in the Intention-to-Treat (ITT) population at Day 4;
    Protection of trial subjects
    An internal, blinded Data Monitoring Committee reviewed the accumulated safety data on an ongoing basis.
    Background therapy
    		 None
    Evidence for comparator
    		 Moxifloxacin was selected as the optimal comparator for this Phase II CABP study, given its long history of efficacy and tolerability in this infection. The proposed dose regimen and treatment scheme (400 mg once daily for 7 days) was selected for consistency purposes worldwide as this study was planned to be conducted in different regions, such as Europe, US and South Africa.
    Actual start date of recruitment
    18 Nov 2016
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United States: 16
    Country: Number of subjects enrolled
    Georgia: 25
    Country: Number of subjects enrolled
    Romania: 15
    Country: Number of subjects enrolled
    Serbia: 58
    Country: Number of subjects enrolled
    South Africa: 60
    Country: Number of subjects enrolled
    Bulgaria: 41
    Country: Number of subjects enrolled
    Latvia: 9
    Worldwide total number of subjects
    224
    EEA total number of subjects
    65
    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)
    150
    From 65 to 84 years
    73
    85 years and over
    1

    Subject disposition

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    Recruitment
    Recruitment details
    		 Subjects were screened and enrolled at 36 study sites in Bulgaria, Georgia, Latvia, Romania, Serbia, South Africa, and the United States. Subjects were recruited from November 2016 to June 2017.

    Pre-assignment
    Screening details
    		 Adult subjects (≥18 years) with CABP were screened. Enrollment of PORT Risk Class II (PORT score 51 to 70) was capped at 50% and enrollment of subjects with allowed prior systemic antibiotic use (receipt of 1 or more dose(s) of a potentially effective systemic antibacterial treatment for treatment of the index CABP) was capped initially at 25%.

    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, Carer, Assessor
    Blinding implementation details
    Double dummy technique used to maintain the blind. Subjects in the nafithromycin arms also received placebo capsules matching moxifloxacin. Subjects in the moxifloxacin arm also received placebo tablets matching nafithromycin. Subjects in the nafithromycin 3-day treatment arm received matching placebo tablets on Days 4 through Day 7. Subjects in the nafithromycin 5-day treatment arm received matching placebo tablets on Days 6 and 7.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Nafithromycin 3 Days
    Arm description
    		 Nafithromycin 800 mg PO q24h for 3 days
    Arm type
    		 Experimental

    Investigational medicinal product name
    nafithromycin
    Investigational medicinal product code
    WCK 4873
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Nafithromycin 800 mg (two 400 mg tablets) PO q24h for 3 days

    Arm title
    		 Nafithromycin 5 Days
    Arm description
    		 Nafithromycin 800 mg PO q24h for 5 days
    Arm type
    		 Experimental

    Investigational medicinal product name
    nafithromycin
    Investigational medicinal product code
    WCK 4873
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Nafithromycin 800 mg (two 400 mg tablets) PO q24h for 5 days

    Arm title
    		 Moxifloxacin
    Arm description
    		 Moxifloxacin 400 mg PO q24h for 7 days
    Arm type
    		 Active comparator

    Investigational medicinal product name
    moxifloxacin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Moxifloxacin 400 mg (one 400 mg capsule) PO q24h for 7 days

    Number of subjects in period 1
    		Nafithromycin 3 Days Nafithromycin 5 Days Moxifloxacin
    Started
    74
    73
    77
    Completed
    71
    69
    73
    Not completed
    3
    4
    4
         Adverse event, serious fatal
    -
    -
    1
         Consent withdrawn by subject
    2
    4
    1
         Lost to follow-up
    1
    -
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Nafithromycin 3 Days
    Reporting group description
    		 Nafithromycin 800 mg PO q24h for 3 days

    Reporting group title
    Nafithromycin 5 Days
    Reporting group description
    		 Nafithromycin 800 mg PO q24h for 5 days

    Reporting group title
    Moxifloxacin
    Reporting group description
    		 Moxifloxacin 400 mg PO q24h for 7 days

    Reporting group values
    		 Nafithromycin 3 Days Nafithromycin 5 Days Moxifloxacin Total
    Number of subjects
    		 74 73 77 224
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 49 48 53 150
        From 65-74 years
    		 17 13 15 45
        75 years and over
    		 8 12 9 29
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 57.0 ( 15.73 ) 54.9 ( 16.90 ) 56.1 ( 15.18 ) -
    Gender categorical
    Units: Subjects
        Female
    		 37 32 35 104
        Male
    		 37 41 42 120

    End points

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    End points reporting groups
    Reporting group title
    Nafithromycin 3 Days
    Reporting group description
    		 Nafithromycin 800 mg PO q24h for 3 days

    Reporting group title
    Nafithromycin 5 Days
    Reporting group description
    		 Nafithromycin 800 mg PO q24h for 5 days

    Reporting group title
    Moxifloxacin
    Reporting group description
    		 Moxifloxacin 400 mg PO q24h for 7 days

    Primary: Clinical Response in the ITT Population

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    End point title
    		 Clinical Response in the ITT Population [1]
    End point description
    End point type
    Primary
    End point timeframe
    Day 4
    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 was an exploratory study and, therefore, was not powered for inferential statistical analyses. No comparative statistical analyses for any endpoint were performed. The 95% confidence interval for the response was obtained using the Clopper- Pearson method.
    End point values
    		 Nafithromycin 3 Days Nafithromycin 5 Days Moxifloxacin
    Number of subjects analysed
    74
    73
    77
    Units: Clinical Responders (%)
        arithmetic mean (confidence interval 95%)
    91.9 (83.2 to 97.0)
    89.0 (79.5 to 95.1)
    87.0 (77.4 to 93.6)
    No statistical analyses for this end point

    Secondary: Clinical Response in the Micro-ITT Population

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    End point title
    		 Clinical Response in the Micro-ITT Population
    End point description
    End point type
    Secondary
    End point timeframe
    Day 4
    End point values
    		 Nafithromycin 3 Days Nafithromycin 5 Days Moxifloxacin
    Number of subjects analysed
    22
    27
    20
    Units: Clinical Responders (%)
        arithmetic mean (confidence interval 95%)
    95.5 (77.2 to 99.9)
    96.3 (81.0 to 99.9)
    90.0 (68.3 to 98.8)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From signing of Informed Consent Form to Follow up Visit
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    19
    Reporting groups
    Reporting group title
    Nafithromycin 3 Days
    Reporting group description
    		 Nafithromycin 800 mg PO q24h for 3 days

    Reporting group title
    Nafithromycin 5 Days
    Reporting group description
    		 Nafithromycin 800 mg PO q24h for 5 days

    Reporting group title
    Moxifloxacin
    Reporting group description
    		 Moxifloxacin 400 mg PO q24h for 7 days

    Serious adverse events
    		 Nafithromycin 3 Days Nafithromycin 5 Days Moxifloxacin
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 74 (1.35%)
    1 / 72 (1.39%)
    2 / 76 (2.63%)
         number of deaths (all causes)
    0
    0
    1
         number of deaths resulting from adverse events
    0
    0
    1
    Congenital, familial and genetic disorders
    Cor pulmonale
         subjects affected / exposed
    1 / 74 (1.35%)
    0 / 72 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hypertrophic cardiomyopathy
         subjects affected / exposed
    1 / 74 (1.35%)
    0 / 72 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Cerebral ischaemia
         subjects affected / exposed
    0 / 74 (0.00%)
    1 / 72 (1.39%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Epilepsy
         subjects affected / exposed
    0 / 74 (0.00%)
    0 / 72 (0.00%)
    1 / 76 (1.32%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ischaemic stroke
         subjects affected / exposed
    0 / 74 (0.00%)
    0 / 72 (0.00%)
    1 / 76 (1.32%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    Infections and infestations
    Urinary tract infection
         subjects affected / exposed
    0 / 74 (0.00%)
    0 / 72 (0.00%)
    1 / 76 (1.32%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 3%
    Non-serious adverse events
    		 Nafithromycin 3 Days Nafithromycin 5 Days Moxifloxacin
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    9 / 74 (12.16%)
    8 / 72 (11.11%)
    7 / 76 (9.21%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    3 / 74 (4.05%)
    1 / 72 (1.39%)
    2 / 76 (2.63%)
         occurrences all number
    3
    1
    2
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    2 / 74 (2.70%)
    2 / 72 (2.78%)
    3 / 76 (3.95%)
         occurrences all number
    2
    3
    3
    Nausea
         subjects affected / exposed
    3 / 74 (4.05%)
    5 / 72 (6.94%)
    2 / 76 (2.63%)
         occurrences all number
    3
    5
    2
    Vomiting
         subjects affected / exposed
    3 / 74 (4.05%)
    1 / 72 (1.39%)
    0 / 76 (0.00%)
         occurrences all number
    4
    1
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    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
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    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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