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    Clinical Trial Results:
    A Phase 3 Randomized, Double-Blind, Multi-Center Study to Compare the Safety and Efficacy of Omadacycline IV/PO to Moxifloxacin IV/PO for Treating Adult Subjects with Community-Acquired Bacterial Pneumonia (CABP)

    Summary
    EudraCT number
    		 2013-004071-13
    Trial protocol
    		 SK   HU   CZ   LV   DE   ES   BE   PL   GR   HR  
    Global end of trial date
    17 Feb 2017

    Results information
    Results version number
    		 v1(current)
    This version publication date
    14 Apr 2018
    First version publication date
    14 Apr 2018
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    PTK0796-CABP-1200
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02531438
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Paratek Pharma LLC
    Sponsor organisation address
    75 Park Plaza, Boston, MA, 02116, United States,
    Public contact
    Head of Clinical of Development, Paratek Pharma LLC, +1 6172750040,
    Scientific contact
    Head of Clinical of Development, Paratek Pharma LLC, +1 6172750040,
    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 Jan 2018
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    17 Feb 2017
    Global end of trial reached?
    Yes
    Global end of trial date
    17 Feb 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of this study is to demonstrate that omadacycline 100 mg intravenous (iv) once every 12 hours (q12h) for 2 doses, followed by 100 mg iv/300 mg per oral (po) once every 24 hours (q24h) is non-inferior to moxifloxacin 400 mg iv/po q24h in the treatment of adults with CABP with a Pneumonia Outcomes Research Team (PORT) Risk Class of III/IV.
    Protection of trial subjects
    The switching from iv to po treatment, the first dose of po therapy should begin in the morning, 24 hours after the last iv dose, to ensure the subjects continued to receive uninterrupted daily therapy. To facilitate study enrollment infusion times were adjusted to iv q12h (first 2 doses), followed by iv q24h (starting 24 hours after first dose) and switch to po q24h after at least 3 days (4 doses) of iv treatment infusion interval to achieve desired administration schedule.
    Background therapy
    		 -
    Evidence for comparator
    		 Moxifloxacin was selected as the optimal comparator, given its long history of efficacy and tolerability. Moxifloxacin has a similar spectrum of activity with coverage against the most common typical and atypical causes of CABP. Moxifloxacin can be administered iv and po and has regulatory approval for the treatment of CABP.
    Actual start date of recruitment
    06 Nov 2015
    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: 40
    Country: Number of subjects enrolled
    Romania: 61
    Country: Number of subjects enrolled
    Slovakia: 4
    Country: Number of subjects enrolled
    Spain: 1
    Country: Number of subjects enrolled
    Croatia: 81
    Country: Number of subjects enrolled
    Bulgaria: 105
    Country: Number of subjects enrolled
    Czech Republic: 27
    Country: Number of subjects enrolled
    Greece: 30
    Country: Number of subjects enrolled
    Hungary: 81
    Country: Number of subjects enrolled
    Latvia: 37
    Country: Number of subjects enrolled
    United States: 3
    Country: Number of subjects enrolled
    Georgia: 26
    Country: Number of subjects enrolled
    Russian Federation: 26
    Country: Number of subjects enrolled
    Ukraine: 157
    Country: Number of subjects enrolled
    Brazil: 4
    Country: Number of subjects enrolled
    Israel: 19
    Country: Number of subjects enrolled
    Peru: 8
    Country: Number of subjects enrolled
    Philippines: 31
    Country: Number of subjects enrolled
    Turkey: 2
    Country: Number of subjects enrolled
    Taiwan: 1
    Country: Number of subjects enrolled
    South Africa: 29
    Country: Number of subjects enrolled
    Mexico: 1
    Worldwide total number of subjects
    774
    EEA total number of subjects
    467
    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)
    450
    From 65 to 84 years
    285
    85 years and over
    39

    Subject disposition

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    Recruitment
    Recruitment details
    		 The study is designed to enroll adults with CABP. Subject randomization was stratified by PORT Risk Class (II or III/IV), receipt of an allowed antibacterial therapy in the 72 hours prior to study treatment, and geographic region. All subjects were expected to present with CABP severe enough to require a minimum of at least 3 days of iv treatment.

    Pre-assignment
    Screening details
    		 Subjects who met inclusion criteria and did not meet exclusion criteria will be randomly assigned to a treatment group, and should receive their first dose of test article within 4 hours after randomization. All subjects were expected to present with CABP PORT Risk Class II, III, or IV to require a minimum of at least 3 days of iv treatment

    Period 1
    Period 1 title
    Treatment period 1 (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator
    Blinding implementation details
    Treatment phase (both iv and po) of the study was double-blind and double-dummy. In an effort to maintain blinding, each site employed shrouding of the iv bag and iv lines used for infusion of test article. To maintain double-blinding, subjects in each study arm will receive the same infusion volumes with the same blinded administration instructions and when switch to PO subjects will receive 2 tablets and 1 over-encapsulated tablet in the morning

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Omadacycline
    Arm description
    		 Omadacycline, 100 mg iv q12h (first 2 doses), followed by 100 mg iv q24h (starting 24 hours after first dose), with the option to switch to 300 mg (two 150 mg omadacycline tablets and 1 over-encapsulated placebo tablet matching moxifloxacin) po q24h after at least 3 days (4 doses) of iv treatment. The total duration of test article therapy (iv plus po) for all subjects was at least 7 days and no more than 14 days.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Omadacycline
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for infusion, Tablet
    Routes of administration
    Intravenous use, Oral use
    Dosage and administration details
    2 doses of Omadacycline (100 mg) iv every 12 hours, followed by 100 mg iv every 24 hours, with the option to switch 300 mg po every 24 hours.

    Arm title
    		 Moxifloxacin
    Arm description
    		 Moxifloxacin, 400 mg iv q24h (with a single placebo infusion to match the omadacycline dosing regimen 12 hours after the first dose on Day 1) with the option to switch to 400 mg (one 400 mg moxifloxacin over-encapsulated tablet and 2 placebo tablets matching omadacycline tablets) po q24h after at least 3 days (4 doses) of iv treatment. The total duration of test article therapy (iv plus po) for all subjects was at least 7 days and no more than 14 days.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Moxifloxacin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion, Tablet
    Routes of administration
    Intravenous use, Oral use
    Dosage and administration details
    Moxifloxacin 400 mg iv q24h with the option to switch to to 400 mg po q24h.

    Number of subjects in period 1
    		Omadacycline Moxifloxacin
    Started
    386
    388
    Completed
    352
    346
    Not completed
    34
    42
         Consent withdrawn by subject
    4
    3
         Physician decision
    3
    9
         Death
    4
    1
         Other
    6
    -
         Adverse event
    17
    28
         Lost to follow-up
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Treatment period 1
    Reporting group description
    		 -

    Reporting group values
    		 Treatment period 1 Total
    Number of subjects
    		 774 774
    Age categorical
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 450 450
        From 65-84 years
    		 324 324
        85 years and over
    		 0 0
    Gender categorical
    Units: Subjects
        Female
    		 347 347
        Male
    		 427 427
    Subject analysis sets

    Subject analysis set title
    ITT population
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    The ITT population consisted of all randomized subjects regardless of whether or not the subject received test article. A subject was considered randomized when the Interactive Response System provided the test article assignment (ie, completed a randomization transaction).

    Subject analysis set title
    Safety population
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    The Safety population consisted of all randomized subjects who received test article (either active or placebo). All safety analyses were conducted in this population.

    Subject analysis set title
    CE - EOT population
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Two CE analysis sets were defined, the CE-EOT and CE-PTE. The CE population consisted of all ITT subjects who received test article, have a qualifying CABP, an assessment of outcome, and met all other evaluability criteria. CE-EOT: The number and percentage of subjects in each treatment group with a clinical success, clinical failure, at EOT visit occurred on the day of, or within 2 days following the last dose of test article based on the investigator’s assessment.

    Subject analysis set title
    microITT population
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    The microITT population consisted of all subjects in the ITT population who had at least 1 causative bacterial pathogen identified from a culture of a respiratory specimen (eg, respiratory fluid obtained by BAL or bronchoscopy, pleural fluid obtained by thoracentesis, or expectorated or induced sputum meeting adequacy criteria as defined by the Gram stain results), culture of blood, or from a culture-independent method (eg, positive urinary antigen test [UAT] for Streptococcus pneumoniae or Legionella pneumophila, or positive serology for Legionella pneumophila, Mycoplasma pneumoniae, or Chlamydophila pneumoniae) at Baseline.

    Subject analysis set title
    CE-PTE population
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Two CE analysis sets were defined, the CE-EOT and CE-PTE. The CE population consisted of all ITT subjects who received test article, have a qualifying CABP, an assessment of outcome, and met all other evaluability criteria. CE-PTE: The number and percentage of subjects in each treatment group with a clinical success, clinical failure, and indeterminate for the overall assessment of clinical response at PTE visit. PTE visit occurred 5 to 10 days after the last dose of test article (based on the investigator’s assessment) unless the subject was considered to be a clinical failure based on the investigator’s assessment at the EOT visit or the subject died after EOT and before PTE.

    Subject analysis sets values
    		 ITT population Safety population CE - EOT population microITT population CE-PTE population
    Number of subjects
    774
    770
    714
    386
    685
    Age categorical
    Units: Subjects
        In utero
    0
        Preterm newborn infants (gestational age < 37 wks)
    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)
    450
        From 65-84 years
    324
        85 years and over
    0
    Age continuous
    Units:
        
    ±
    ±
    ±
    ±
    ±
    Gender categorical
    Units: Subjects
        Female
    347
        Male
    427

    End points

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    End points reporting groups
    Reporting group title
    Omadacycline
    Reporting group description
    		 Omadacycline, 100 mg iv q12h (first 2 doses), followed by 100 mg iv q24h (starting 24 hours after first dose), with the option to switch to 300 mg (two 150 mg omadacycline tablets and 1 over-encapsulated placebo tablet matching moxifloxacin) po q24h after at least 3 days (4 doses) of iv treatment. The total duration of test article therapy (iv plus po) for all subjects was at least 7 days and no more than 14 days.

    Reporting group title
    Moxifloxacin
    Reporting group description
    		 Moxifloxacin, 400 mg iv q24h (with a single placebo infusion to match the omadacycline dosing regimen 12 hours after the first dose on Day 1) with the option to switch to 400 mg (one 400 mg moxifloxacin over-encapsulated tablet and 2 placebo tablets matching omadacycline tablets) po q24h after at least 3 days (4 doses) of iv treatment. The total duration of test article therapy (iv plus po) for all subjects was at least 7 days and no more than 14 days.

    Subject analysis set title
    ITT population
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    The ITT population consisted of all randomized subjects regardless of whether or not the subject received test article. A subject was considered randomized when the Interactive Response System provided the test article assignment (ie, completed a randomization transaction).

    Subject analysis set title
    Safety population
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    The Safety population consisted of all randomized subjects who received test article (either active or placebo). All safety analyses were conducted in this population.

    Subject analysis set title
    CE - EOT population
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Two CE analysis sets were defined, the CE-EOT and CE-PTE. The CE population consisted of all ITT subjects who received test article, have a qualifying CABP, an assessment of outcome, and met all other evaluability criteria. CE-EOT: The number and percentage of subjects in each treatment group with a clinical success, clinical failure, at EOT visit occurred on the day of, or within 2 days following the last dose of test article based on the investigator’s assessment.

    Subject analysis set title
    microITT population
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    The microITT population consisted of all subjects in the ITT population who had at least 1 causative bacterial pathogen identified from a culture of a respiratory specimen (eg, respiratory fluid obtained by BAL or bronchoscopy, pleural fluid obtained by thoracentesis, or expectorated or induced sputum meeting adequacy criteria as defined by the Gram stain results), culture of blood, or from a culture-independent method (eg, positive urinary antigen test [UAT] for Streptococcus pneumoniae or Legionella pneumophila, or positive serology for Legionella pneumophila, Mycoplasma pneumoniae, or Chlamydophila pneumoniae) at Baseline.

    Subject analysis set title
    CE-PTE population
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Two CE analysis sets were defined, the CE-EOT and CE-PTE. The CE population consisted of all ITT subjects who received test article, have a qualifying CABP, an assessment of outcome, and met all other evaluability criteria. CE-PTE: The number and percentage of subjects in each treatment group with a clinical success, clinical failure, and indeterminate for the overall assessment of clinical response at PTE visit. PTE visit occurred 5 to 10 days after the last dose of test article (based on the investigator’s assessment) unless the subject was considered to be a clinical failure based on the investigator’s assessment at the EOT visit or the subject died after EOT and before PTE.

    Primary: Overall Clinical Response at the EOT and PTE Visit Based on Investigator Assessments

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    End point title
    		 Overall Clinical Response at the EOT and PTE Visit Based on Investigator Assessments
    End point description
    At the EOT visit the investigator indicated the clinical status of the infection under study as follows: Clinical Success, Clinical Failure or Indeterminate (the clinical response to test article could not be adequately inferred). At the PTE visit the investigator indicated 1 of the following outcomes relating to the primary infection under study: Clinical Success, Clinical Failure or Indeterminate (the clinical response to test article could not be adequately inferred). If the lower limit of the 97.5% CI for the difference in both the ITT and CE-PTE populations exceeded -10%, then the null hypothesis was rejected and the non-inferiority of omadacycline to moxifloxacin was declared.
    End point type
    Primary
    End point timeframe
    End of Trial (EOT visit) was on the calendar day of, or within 2 days following the last dose of test article. Post Treatment Evaluation (PTE) visit was 5 to 10 days after the subject’s last day of study therapy.
    End point values
    		 Omadacycline Moxifloxacin ITT population CE - EOT population CE-PTE population
    Number of subjects analysed
    329
    331
    660
    616
    591
    Units: Number of subjects analysed
        Clinical success
    291
    282
    573
    574
    541
        Indeterminate
    11
    14
    25
    0
    0
        Clinical failure
    27
    35
    62
    42
    50
    Statistical analysis title
    		 SAP dated 24 March 2017/ ITT Population
    Statistical analysis description
    To test the null hypothesis, a 2-sided 97.5% CI for the observed difference in primary outcome rates (omadacycline treatment group minus moxifloxacin treatment group) was calculated for the ITT and CE-PTE populations. The 2-sided 97.5% CI for non-inferiority testing based on the difference of clinical success rates, was computed using the method proposed with stratification.
    Comparison groups
    Moxifloxacin v Omadacycline
    Number of subjects included in analysis
    660
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [1]
    Method
    Parameter type
    		 Median difference (net)
    Point estimate
    3.3
    Confidence interval
         level
    		 97.5%
         sides
    2-sided
         lower limit
    		 -2.7
         upper limit
    		 9.3
    Variability estimate
    Standard deviation
    Notes
    [1] - The primary efficacy analyses were based on subjects with an eCRF PORT Risk Class of III/IV in the ITT and CE-PTE populations.
    Statistical analysis title
    		 SAP dated 24 March 2017/ CE-PTE Population
    Statistical analysis description
    To test the null hypothesis, a 2-sided 97.5% CI for the observed difference in primary outcome rates was calculated for the ITT and CE-PTE populations. If the lower limit of the 97.5% CI for the difference in both the ITT and CE-PTE populations exceeded -10%, then the null hypothesis was rejected and the non-inferiority of omadacycline to moxifloxacin was declared. Subjects in this analysis: Omadacycline arm - 295; Moxifloxacin arm - 296; all subjects - 591
    Comparison groups
    Omadacycline v Moxifloxacin
    Number of subjects included in analysis
    660
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [2]
    Method
    Parameter type
    		 Median difference (net)
    Point estimate
    2
    Confidence interval
         level
    		 97.5%
         sides
    2-sided
         lower limit
    		 -3.2
         upper limit
    		 7.4
    Variability estimate
    Standard deviation
    Notes
    [2] - Given that the lower limit of the 97.5% CI for the treatment difference (omadacycline – moxifloxacin) was greater than -10% in both the ITT and CE-PTE populations, omadacycline was considered non-inferior to moxifloxacin.

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse events were assessed from the signing of ICF to the time of the Final Follow-up assessment.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    17.1
    Reporting groups
    Reporting group title
    Omadacycline
    Reporting group description
    		 Investigational therapy: omadacycline, 100 mg iv q12h (first 2 doses), followed by 100 mg iv q24h (starting 24 hours after first dose), with the option to switch to 300 mg (two 150 mg omadacycline tablets and 1 over-encapsulated placebo tablet matching moxifloxacin) po q24h after at least 3 days (4 doses) of iv treatment.

    Reporting group title
    Moxifloxacin
    Reporting group description
    		 Reference therapy: moxifloxacin, 400 mg iv q24h (with a single placebo infusion to match the omadacycline dosing regimen 12 hours after the first dose on Day 1) with the option to switch to 400 mg (one 400 mg moxifloxacin over-encapsulated tablet and 2 placebo tablets matching omadacycline tablets) po q24h after at least 3 days (4 doses) of iv treatment.

    Serious adverse events
    		 Omadacycline Moxifloxacin
    Total subjects affected by serious adverse events
         subjects affected / exposed
    23 / 386 (5.96%)
    26 / 388 (6.70%)
         number of deaths (all causes)
    8
    4
         number of deaths resulting from adverse events
    8
    4
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Lung neoplasm
         subjects affected / exposed
    2 / 386 (0.52%)
    2 / 388 (0.52%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Chronic lymphocytic leukaemia
         subjects affected / exposed
    0 / 386 (0.00%)
    1 / 388 (0.26%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Adenocarcinoma
         subjects affected / exposed
    0 / 386 (0.00%)
    1 / 388 (0.26%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancreatic carcinoma
         subjects affected / exposed
    0 / 386 (0.00%)
    1 / 388 (0.26%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Colon cancer metastatic
         subjects affected / exposed
    0 / 386 (0.00%)
    1 / 388 (0.26%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular disorders
    Aortic aneurysm rupture
         subjects affected / exposed
    1 / 386 (0.26%)
    0 / 388 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Peripheral ischaemia
         subjects affected / exposed
    0 / 386 (0.00%)
    1 / 388 (0.26%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Multi-organ failure
         subjects affected / exposed
    1 / 386 (0.26%)
    0 / 388 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Pleural effusion
         subjects affected / exposed
    3 / 386 (0.78%)
    0 / 388 (0.00%)
         occurrences causally related to treatment / all
    1 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acute respiratory distress syndrome
         subjects affected / exposed
    2 / 386 (0.52%)
    0 / 388 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Acute respiratory failure
         subjects affected / exposed
    2 / 386 (0.52%)
    3 / 388 (0.77%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Acute pulmonary oedema
         subjects affected / exposed
    1 / 386 (0.26%)
    0 / 388 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    1 / 386 (0.26%)
    0 / 388 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Bladder injury
    Additional description: Urinary bladder damage
         subjects affected / exposed
    0 / 386 (0.00%)
    1 / 388 (0.26%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Cardiac failure
         subjects affected / exposed
    1 / 386 (0.26%)
    1 / 388 (0.26%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Cardiac arrest
         subjects affected / exposed
    1 / 386 (0.26%)
    0 / 388 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tachycardia
         subjects affected / exposed
    1 / 386 (0.26%)
    0 / 388 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acute myocardial infarction
    Additional description: Non ST elevation myocardial infarction
         subjects affected / exposed
    2 / 386 (0.52%)
    0 / 388 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Cardiogenic shock
         subjects affected / exposed
    2 / 386 (0.52%)
    1 / 388 (0.26%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Cardio-respiratory arrest
         subjects affected / exposed
    1 / 386 (0.26%)
    0 / 388 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Pericardial effusion
         subjects affected / exposed
    0 / 386 (0.00%)
    1 / 388 (0.26%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Right ventricular failure
         subjects affected / exposed
    0 / 386 (0.00%)
    1 / 388 (0.26%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Cerebrovascular accident
    Additional description: Ischemic cerebrovascular accident
         subjects affected / exposed
    2 / 386 (0.52%)
    0 / 388 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Gastrointestinal disorders
    Colitis
         subjects affected / exposed
    0 / 386 (0.00%)
    1 / 388 (0.26%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholecystitis acute
         subjects affected / exposed
    1 / 386 (0.26%)
    0 / 388 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatic failure
         subjects affected / exposed
    1 / 386 (0.26%)
    0 / 388 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatic congestion
         subjects affected / exposed
    0 / 386 (0.00%)
    1 / 388 (0.26%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Renal failure acute
         subjects affected / exposed
    0 / 386 (0.00%)
    2 / 388 (0.52%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Lumbago
         subjects affected / exposed
    1 / 386 (0.26%)
    0 / 388 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Septic shock
         subjects affected / exposed
    1 / 386 (0.26%)
    2 / 388 (0.52%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 2
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    Influenza
         subjects affected / exposed
    3 / 386 (0.78%)
    0 / 388 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    2 / 386 (0.52%)
    6 / 388 (1.55%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 6
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Cellulitis
         subjects affected / exposed
    1 / 386 (0.26%)
    0 / 388 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atypical mycobacterial pneumonia
         subjects affected / exposed
    0 / 386 (0.00%)
    1 / 388 (0.26%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lung abscess
         subjects affected / exposed
    0 / 386 (0.00%)
    1 / 388 (0.26%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Clostridium difficile infection
         subjects affected / exposed
    0 / 386 (0.00%)
    2 / 388 (0.52%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Clostridium difficile colitis
         subjects affected / exposed
    0 / 386 (0.00%)
    1 / 388 (0.26%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    HIV infection
         subjects affected / exposed
    0 / 386 (0.00%)
    1 / 388 (0.26%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infectious pleural effusion
         subjects affected / exposed
    1 / 386 (0.26%)
    1 / 388 (0.26%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infective exacerbation of bronchiectasis
         subjects affected / exposed
    0 / 386 (0.00%)
    1 / 388 (0.26%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia viral
         subjects affected / exposed
    0 / 386 (0.00%)
    1 / 388 (0.26%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Decreased appetite
    Additional description: Worsening of anorexia
         subjects affected / exposed
    1 / 386 (0.26%)
    0 / 388 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Omadacycline Moxifloxacin
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    157 / 386 (40.67%)
    188 / 388 (48.45%)
    Cardiac disorders
    Cardiac disorders
         subjects affected / exposed
    15 / 386 (3.89%)
    20 / 388 (5.15%)
         occurrences all number
    15
    20
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    9 / 386 (2.33%)
    21 / 388 (5.41%)
         occurrences all number
    9
    21
    Diarrheaa
         subjects affected / exposed
    4 / 386 (1.04%)
    31 / 388 (7.99%)
         occurrences all number
    4
    31
    Respiratory, thoracic and mediastinal disorders
    Respiratory, thoracic, and mediastinal disorders
         subjects affected / exposed
    22 / 386 (5.70%)
    29 / 388 (7.47%)
         occurrences all number
    22
    29
    Infections and infestations
    Infections and infestations
         subjects affected / exposed
    35 / 386 (9.07%)
    41 / 388 (10.57%)
         occurrences all number
    35
    41
    Metabolism and nutrition disorders
    Metabolism and nutrition disorders
         subjects affected / exposed
    15 / 386 (3.89%)
    20 / 388 (5.15%)
         occurrences all number
    15
    20

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    27 Oct 2015
    There was 1 amendment to the protocol (dated 27-OCT-2015 and labeled as Version 2). In addition to minor administrative changes and clarifications, the following key modifications were made: - Inclusion criterion #5 was changed to “hypoxemia (PaO2 < 60 mm Hg by ABG or oxygen saturation < 90% by pulse oximetry)” - Inclusion Criterion #9 was changed from a “highly effective method” to “an acceptable method” because of the different regional definitions of highly effective methods of birth control; postmenopausal was added as a method of birth control - In exclusion criterion #7, specific QT interval thresholds were added for clarification - In exclusion criterion #10, regarding the receipt of corticosteroids equivalent to prednisone, a reference and hyperlink to Appendix 4 was added - In exclusion criterion #10, known or suspected “active tuberculosis” was added - The Safety population definition was updated to subjects who received any amount of test article, including less than 1 complete dose - "Subjects should receive their first dose of test article within 4 hours after randomization” was added to ensure subjects received timely treatment of their infection - Population PK sampling schedule was updated to reflect blood samples for the PK analysis collected on Days 1 to 7 - Language was added to indicate that at the PTE visit, a respiratory specimen culture, and Gram stain should be obtained only for subjects who were clinical failures and required alternative antibacterial treatment for the infection under study - Urine antigen screening for Legionella pneumophila and Streptococcus pneumoniae was removed at the PTE visit - The criteria for an adequate quality sputum specimen were changed to “1) < 10 SECs/lpf (ie, 100 ×), 2) > 25 PMN/lpf (ie, 100 ×)" - The results of Cempra’s solithromycin oral CABP study, the first completed study to use the ECR endpoint, reported following finalization of the original protocol and were added to the discussion

    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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