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    Clinical Trial Results:
    A Phase 3 Randomized Double-blind Study Comparing TR-701 FA and Linezolid in Ventilated Gram-positive Nosocomial Pneumonia

    Summary
    EudraCT number
    		 2013-004154-22
    Trial protocol
    		 LV   HU   AT   DE   BE   ES   GR   SK   CZ   EE   GB   HR   PT   IT  
    Global end of trial date
    22 Jun 2018

    Results information
    Results version number
    		 v1(current)
    This version publication date
    26 Jun 2019
    First version publication date
    26 Jun 2019
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    1986-002
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02019420
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 Merck Protocol Number: MK-1986-002, Cubist Protocol Number: TR701-132
    Sponsors
    Sponsor organisation name
    Merck Sharp & Dohme Corp.
    Sponsor organisation address
    2000 Galloping Hill Road, Kenilworth, NJ, United States,
    Public contact
    Senior Vice President, Global Clinical Development, Merck Sharp & Dohme Corp., ClinicalTrialsDisclosure@merck.com
    Scientific contact
    Senior Vice President, Global Clinical Development, Merck Sharp & Dohme Corp., ClinicalTrialsDisclosure@merck.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
    22 Jun 2018
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    22 Jun 2018
    Global end of trial reached?
    Yes
    Global end of trial date
    22 Jun 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    This is a 1:1 ratio, randomized, double-blind, double-dummy, multicenter, global Phase 3 study of tedizolid phosphate (TR-701 FA) 200 mg intravenous (IV) once daily for 7 days versus linezolid (Zyvox®, Zyvoxid®, etc.) 600 mg IV every 12 hours for 10 days for the treatment of ventilated participants with presumed gram-positive hospital-acquired bacterial pneumonia (HABP) or ventilator-associated bacterial pneumonia (VABP), collectively referred to as ventilated nosocomial pneumonia (VNP). Participants with concurrent gram-positive bacteremia are to receive 14 days of active therapy in either treatment arm. The primary objective is to determine the noninferiority (NI) in clinical response at Test of Cure (TOC) following treatment with IV tedizolid phosphate compared with IV linezolid in the Intent to Treat (ITT) Analysis Set (NI is declared when the lower bound of the 95% CI > -12.5).
    Protection of trial subjects
    This study was conducted in conformance with Good Clinical Practice standards and applicable country and/or local statutes and regulations regarding ethical committee review, informed consent, and the protection of human subjects participating in biomedical research.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    06 Jan 2014
    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
    Australia: 2
    Country: Number of subjects enrolled
    Belarus: 11
    Country: Number of subjects enrolled
    Belgium: 3
    Country: Number of subjects enrolled
    Brazil: 53
    Country: Number of subjects enrolled
    Canada: 3
    Country: Number of subjects enrolled
    China: 18
    Country: Number of subjects enrolled
    Czech Republic: 15
    Country: Number of subjects enrolled
    Estonia: 7
    Country: Number of subjects enrolled
    France: 27
    Country: Number of subjects enrolled
    Georgia: 123
    Country: Number of subjects enrolled
    Germany: 5
    Country: Number of subjects enrolled
    Greece: 1
    Country: Number of subjects enrolled
    Guatemala: 27
    Country: Number of subjects enrolled
    Israel: 26
    Country: Number of subjects enrolled
    Japan: 53
    Country: Number of subjects enrolled
    Kazakhstan: 6
    Country: Number of subjects enrolled
    Korea, Republic of: 7
    Country: Number of subjects enrolled
    Latvia: 7
    Country: Number of subjects enrolled
    Mexico: 43
    Country: Number of subjects enrolled
    Peru: 4
    Country: Number of subjects enrolled
    Philippines: 37
    Country: Number of subjects enrolled
    Russian Federation: 111
    Country: Number of subjects enrolled
    Serbia: 19
    Country: Number of subjects enrolled
    South Africa: 10
    Country: Number of subjects enrolled
    Spain: 7
    Country: Number of subjects enrolled
    Taiwan: 6
    Country: Number of subjects enrolled
    Thailand: 5
    Country: Number of subjects enrolled
    Turkey: 6
    Country: Number of subjects enrolled
    Ukraine: 48
    Country: Number of subjects enrolled
    United States: 34
    Country: Number of subjects enrolled
    Lebanon: 1
    Country: Number of subjects enrolled
    Sri Lanka: 1
    Worldwide total number of subjects
    726
    EEA total number of subjects
    72
    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)
    435
    From 65 to 84 years
    251
    85 years and over
    40

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Ventilated participants with presumed gram-positive hospital-acquired bacterial pneumonia (HABP) or ventilator-associated bacterial pneumonia (VABP) were enrolled at study sites located in 34 countries.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Investigator, Carer, Assessor, Subject

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Tedizolid
    Arm description
    		 Ventilated HABP/VABP participants received tedizolid phosphate 200 mg IV once daily for 7 days, or for 14 days for concurrent bacteremia.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Tedizolid phosphate
    Investigational medicinal product code
    Other name
    SIVEXTRO® TR-701 FA MK-1986
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Tedizolid phosphate IV 200 mg once daily

    Arm title
    		 Linezolid
    Arm description
    		 Ventilated HABP/VABP participants received linezolid 600 mg IV every 12 hours for 10 days, or for 14 days for concurrent bacteremia.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Linezolid
    Investigational medicinal product code
    Other name
    ZYVOX®
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Linezolid IV 600 mg once daily

    Number of subjects in period 1
    		Tedizolid Linezolid
    Started
    366
    360
    Treated
    361
    357
    Completed
    258
    254
    Not completed
    108
    106
         Adverse event, serious fatal
    104
    99
         Consent withdrawn by subject
    1
    3
         At request of sponsor or investigator
    -
    1
         Did not receive study drug
    2
    2
         Transferred to other care facility
    1
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Tedizolid
    Reporting group description
    		 Ventilated HABP/VABP participants received tedizolid phosphate 200 mg IV once daily for 7 days, or for 14 days for concurrent bacteremia.

    Reporting group title
    Linezolid
    Reporting group description
    		 Ventilated HABP/VABP participants received linezolid 600 mg IV every 12 hours for 10 days, or for 14 days for concurrent bacteremia.

    Reporting group values
    		 Tedizolid Linezolid Total
    Number of subjects
    		 366 360 726
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 221 214 435
        65 years and over
    		 145 146 291
    Age Continuous
    Units: Years
        arithmetic mean (standard deviation)
    		 58.1 ( 18.41 ) 58.7 ( 17.44 ) -
    Sex: Female, Male
    Units: Subjects
        Female
    		 117 106 223
        Male
    		 249 254 503
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    		 65 61 126
        Not Hispanic or Latino
    		 290 289 579
        Unknown or Not Reported
    		 11 10 21
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    		 1 1 2
        Asian
    		 68 70 138
        Native Hawaiian or Other Pacific Islander
    		 0 0 0
        Black or African American
    		 3 11 14
        White
    		 269 258 527
        More than one race
    		 2 1 3
        Unknown or Not Reported
    		 23 19 42
    Subject analysis sets

    Subject analysis set title
    Tedizolid Safety Set
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    The Safety analysis set is based on actual treatment received. Four participants randomized to tedizolid received linezolid.

    Subject analysis set title
    Linezolid Safety Set
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    The Safety analysis set is based on actual treatment received. Four participants randomized to tedizolid received linezolid.

    Subject analysis sets values
    		 Tedizolid Safety Set Linezolid Safety Set
    Number of subjects
    357
    361
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    216
    215
        65 years and over
    141
    146
    Age Continuous
    Units: Years
        arithmetic mean (standard deviation)
    57.9 ( 18.43 )
    58.7 ( 17.49 )
    Sex: Female, Male
    Units: Subjects
        Female
    114
    105
        Male
    243
    256
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    63
    63
        Not Hispanic or Latino
    283
    288
        Unknown or Not Reported
    11
    10
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    1
    1
        Asian
    66
    70
        Native Hawaiian or Other Pacific Islander
    0
    0
        Black or African American
    3
    10
        White
    263
    259
        More than one race
    2
    1
        Unknown or Not Reported
    22
    20

    End points

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    End points reporting groups
    Reporting group title
    Tedizolid
    Reporting group description
    		 Ventilated HABP/VABP participants received tedizolid phosphate 200 mg IV once daily for 7 days, or for 14 days for concurrent bacteremia.

    Reporting group title
    Linezolid
    Reporting group description
    		 Ventilated HABP/VABP participants received linezolid 600 mg IV every 12 hours for 10 days, or for 14 days for concurrent bacteremia.

    Subject analysis set title
    Tedizolid Safety Set
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    The Safety analysis set is based on actual treatment received. Four participants randomized to tedizolid received linezolid.

    Subject analysis set title
    Linezolid Safety Set
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    The Safety analysis set is based on actual treatment received. Four participants randomized to tedizolid received linezolid.

    Primary: Clinical Response at Test of Cure (TOC) Visit in the Intent-to-Treat (ITT) Population

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    End point title
    		 Clinical Response at Test of Cure (TOC) Visit in the Intent-to-Treat (ITT) Population
    End point description
    The clinical response in the ITT population at the TOC visit (derived from the Investigator's assessment at the EOT and TOC visits) was determined by the investigator to be either: clinical success, clinical failure, or indeterminate. Clinical success was declared when most or all clinical signs were completely resolved, with no new signs of infection, no additional antibiotic therapy was required, and the participant was alive. Indeterminate was declared when the investigator could not determine success or failure. Clinical failure was declared with progression, relapse, or recurrence of new symptoms of infection, or a persistence or insufficient improvement in signs and symptoms of VNP. The ITT set includes all randomized participants.
    End point type
    Primary
    End point timeframe
    7-14 days after end of therapy - TOC
    End point values
    		 Tedizolid Linezolid
    Number of subjects analysed
    366
    360
    Units: Participants
        Clinical Success
    206
    230
        Clinical Failure
    144
    110
        Indeterminate
    16
    20
    Statistical analysis title
    		 Difference in success (tedizolid - linezolid)
    Statistical analysis description
    Difference and 95% CI were calculated with the Miettinen and Nurminen method without stratification.
    Comparison groups
    Tedizolid v Linezolid
    Number of subjects included in analysis
    726
    Analysis specification
    Pre-specified
    Analysis type
    		 [1]
    Method
    Parameter type
    		 Difference in clinical success
    Point estimate
    -7.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -14.7
         upper limit
    		 -0.5
    Notes
    [1] - Noninferiority is declared when the lower bound of the 95% CI > -12.5

    Secondary: Number of Participants with All-Cause Mortality in the Intent-to-Treat (ITT) Population

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    End point title
    		 Number of Participants with All-Cause Mortality in the Intent-to-Treat (ITT) Population
    End point description
    The numbers of participants with all-cause mortality within 28 days after randomization was determined in the ITT population. Any participants who were lost to follow-up and not known to be alive or deceased by Day 28 were imputed as deceased. The ITT set is all randomized participants.
    End point type
    Secondary
    End point timeframe
    Up to 28 days
    End point values
    		 Tedizolid Linezolid
    Number of subjects analysed
    366
    360
    Units: Participants
    103
    95
    Statistical analysis title
    		 Difference in mortality (linezolid - tedizolid)
    Comparison groups
    Tedizolid v Linezolid
    Number of subjects included in analysis
    726
    Analysis specification
    Pre-specified
    Analysis type
    		 [2]
    Method
    Parameter type
    		 Difference in all-cause mortality
    Point estimate
    -1.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -8.2
         upper limit
    		 4.7
    Notes
    [2] - Difference and 95% CI were calculated with the Miettinen and Nurminen method without stratification.

    Secondary: Number of Participants with All-Cause Mortality in the Microbiological Intent-to-Treat (mITT) Population

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    End point title
    		 Number of Participants with All-Cause Mortality in the Microbiological Intent-to-Treat (mITT) Population
    End point description
    The numbers of participants with all-cause mortality within 28 days after randomization was determined in the mITT population. Any participants who were lost to follow-up and not known to be alive or deceased by Day 28 were imputed as deceased. The mITT set is all randomized, treated participants who have gram-positive pathogen(s) confirmed by respiratory tract/pleural fluid culture results obtained within 36 hours (or 72 hours if methicillin-resistant S. aureus [MRSA]) before first study drug dose, and bacterial pathogen against which the investigational drug has antibacterial activity.
    End point type
    Secondary
    End point timeframe
    Up to 28 days
    End point values
    		 Tedizolid Linezolid
    Number of subjects analysed
    178
    202
    Units: Participants
    46
    49
    Statistical analysis title
    		 Difference in mortality (linezolid - tedizolid)
    Comparison groups
    Tedizolid v Linezolid
    Number of subjects included in analysis
    380
    Analysis specification
    Pre-specified
    Analysis type
    		 [3]
    Method
    Parameter type
    		 Difference in all-cause mortality
    Point estimate
    -1.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -10.3
         upper limit
    		 7.1
    Notes
    [3] - Difference and 95% CI were calculated with the Miettinen and Nurminen method without stratification.

    Secondary: Clinical Response at Test of Cure (TOC) Visit in the Clinically-Evaluable (CE) Population

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    End point title
    		 Clinical Response at Test of Cure (TOC) Visit in the Clinically-Evaluable (CE) Population
    End point description
    The clinical response in the CE population at the TOC visit (derived from the Investigator's assessment at the EOT and TOC visits) was determined by the investigator to be either: clinical success, clinical failure, or indeterminate. Clinical success was declared when most or all clinical signs were completely resolved, with no new signs of infection, no additional antibiotic therapy was required, and the participant was alive. Indeterminate was declared when the investigator could not determine success or failure. Clinical failure was declared with progression, relapse, or recurrence of new symptoms of infection, or a persistence or insufficient improvement in signs and symptoms of VNP. The CE set is all randomized and treated participants who had assessment data available and did not have confounding events.
    End point type
    Secondary
    End point timeframe
    7-14 days after end of therapy - TOC
    End point values
    		 Tedizolid Linezolid
    Number of subjects analysed
    267
    243
    Units: Participants
        Clinical Success
    143
    146
        Clinical Failure
    124
    97
        Indeterminate
    0
    0
    Statistical analysis title
    		 Difference in success (tedizolid - linezolid)
    Comparison groups
    Tedizolid v Linezolid
    Number of subjects included in analysis
    510
    Analysis specification
    Pre-specified
    Analysis type
    		 [4]
    Method
    Parameter type
    		 Difference in clinical success
    Point estimate
    -6.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -15.1
         upper limit
    		 2.1
    Notes
    [4] - Difference and 95% CI were calculated with the Miettinen and Nurminen method without stratification.

    Secondary: Number of Methicillin-Susceptible Staphylococcus Aureus (MSSA)-Infected Participants with All-Cause Mortality in the Microbiological Intent-to-Treat (mITT) Population

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    End point title
    		 Number of Methicillin-Susceptible Staphylococcus Aureus (MSSA)-Infected Participants with All-Cause Mortality in the Microbiological Intent-to-Treat (mITT) Population
    End point description
    The number of MSSA-infected participants with all-cause mortality within 28 days after randomization was determined in the mITT population. Participants who had confirmed MSSA culture results from respiratory tract or pleural fluid specimens obtained within 36 hours of study Day 1 were included. Any participants who were lost to follow-up and not known to be alive or deceased by Day 28 were imputed as deceased. The MSSA-infected mITT set is all randomized, treated participants who have MSSA confirmed by respiratory tract/pleural fluid culture results obtained within 36 hours before first study drug dose, and documented bacterial pathogen against which the investigational drug has antibacterial activity.
    End point type
    Secondary
    End point timeframe
    Up to 28 days
    End point values
    		 Tedizolid Linezolid
    Number of subjects analysed
    117
    128
    Units: Participants
    31
    32
    Statistical analysis title
    		 Difference in mortality (linezolid - tedizolid)
    Comparison groups
    Tedizolid v Linezolid
    Number of subjects included in analysis
    245
    Analysis specification
    Pre-specified
    Analysis type
    		 [5]
    Method
    Parameter type
    		 Difference in all-cause mortality
    Point estimate
    -1.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -12.5
         upper limit
    		 9.5
    Notes
    [5] - Difference and 95% CI were calculated with the Miettinen and Nurminen method without stratification.

    Secondary: Number of Methicillin-Resistant Staphylococcus Aureus (MRSA)-Infected Participants with All-Cause Mortality in the Microbiological Intent-to-Treat (mITT) Population

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    End point title
    		 Number of Methicillin-Resistant Staphylococcus Aureus (MRSA)-Infected Participants with All-Cause Mortality in the Microbiological Intent-to-Treat (mITT) Population
    End point description
    The number of MRSA-infected participants with all-cause mortality within 28 days after randomization was determined in the mITT population. Participants who had confirmed MRSA culture results from respiratory tract or pleural fluid specimens obtained within 72 hours of study Day 1 were included. Any participants who were lost to follow-up and not known to be alive or deceased by Day 28 were imputed as deceased. The MRSA-infected mITT set is all randomized, treated participants who have MRSA confirmed by respiratory tract/pleural fluid culture results obtained within 72 hours before first study drug dose, and documented bacterial pathogen against which the investigational drug has antibacterial activity.
    End point type
    Secondary
    End point timeframe
    Up to 28 days
    End point values
    		 Tedizolid Linezolid
    Number of subjects analysed
    54
    69
    Units: Participants
    14
    20
    Statistical analysis title
    		 Difference in mortality (linezolid - tedizolid)
    Comparison groups
    Tedizolid v Linezolid
    Number of subjects included in analysis
    123
    Analysis specification
    Pre-specified
    Analysis type
    		 [6]
    Method
    Parameter type
    		 Difference in all-cause mortality
    Point estimate
    3.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -12.8
         upper limit
    		 18.9
    Notes
    [6] - Difference and 95% CI were calculated with the Miettinen and Nurminen method without stratification.

    Secondary: Number of Participants with a Favorable Response at End-of-Therapy (EOT) Visit in the Microbiological Intent-to-Treat (mITT) Population

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    End point title
    		 Number of Participants with a Favorable Response at End-of-Therapy (EOT) Visit in the Microbiological Intent-to-Treat (mITT) Population
    End point description
    The number of patients in the mITT population with a favorable response at EOT was determined. Favorable response included eradication (absence of the baseline pathogen) and presumed eradication (no source specimen to culture in a participant assessed as a clinical cure by the investigator). The mITT set is all randomized, treated participants who have gram-positive pathogen(s) confirmed by respiratory tract/pleural fluid culture results obtained within 36 hours (or 72 hours if MRSA) before first study drug dose, and documented bacterial pathogen against which the investigational drug has antibacterial activity.
    End point type
    Secondary
    End point timeframe
    1-3 days after completing study therapy (Days 8-10 or Days 15-17)
    End point values
    		 Tedizolid Linezolid
    Number of subjects analysed
    178
    202
    Units: Participants
    123
    166
    Statistical analysis title
    		 Difference in response (tedizolid - linezolid)
    Comparison groups
    Tedizolid v Linezolid
    Number of subjects included in analysis
    380
    Analysis specification
    Pre-specified
    Analysis type
    		 [7]
    Method
    Parameter type
    		 Difference in clinical success
    Point estimate
    -13.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -21.7
         upper limit
    		 -4.5
    Notes
    [7] - Difference and 95% CI were calculated with the Miettinen and Nurminen method without stratification.

    Secondary: Number of Participants with a Favorable Response at End-of-Therapy (EOT) Visit in the Microbiologically-Evaluable 1 (ME-1) Population

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    End point title
    		 Number of Participants with a Favorable Response at End-of-Therapy (EOT) Visit in the Microbiologically-Evaluable 1 (ME-1) Population
    End point description
    The number of patients in the ME-1 population with a favorable response at EOT was determined. Favorable response included eradication (absence of the baseline pathogen) and presumed eradication (no source specimen to culture in a participant assessed as a clinical cure by the investigator). The ME-1 set is all mITT participants who did not receive an antibiotic (other than study drug) with activity against the baseline pathogen up to 28 days after randomization.
    End point type
    Secondary
    End point timeframe
    1-3 days after completing study therapy (Days 8-10 or Days 15-17)
    End point values
    		 Tedizolid Linezolid
    Number of subjects analysed
    178
    202
    Units: Participants
    123
    166
    Statistical analysis title
    		 Difference in response (tedizolid - linezolid)
    Comparison groups
    Tedizolid v Linezolid
    Number of subjects included in analysis
    380
    Analysis specification
    Pre-specified
    Analysis type
    		 [8]
    Method
    Parameter type
    		 Difference in clinical success
    Point estimate
    -13.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -21.7
         upper limit
    		 -4.5
    Notes
    [8] - Difference and 95% CI were calculated with the Miettinen and Nurminen method without stratification.

    Secondary: Number of Participants with a Favorable Response at Test-of-Cure (TOC) Visit in the Microbiological Intent-to-Treat (mITT) Population

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    End point title
    		 Number of Participants with a Favorable Response at Test-of-Cure (TOC) Visit in the Microbiological Intent-to-Treat (mITT) Population
    End point description
    The number of patients in the mITT population with a favorable response at TOC was determined. Favorable response included eradication (absence of the baseline pathogen) and presumed eradication (no source specimen to culture in a participant assessed as a clinical cure by the investigator). The mITT set is all randomized, treated participants who have gram-positive pathogen(s) confirmed by respiratory tract/pleural fluid culture results obtained within 36 hours (or 72 hours if MRSA) before first study drug dose, and documented bacterial pathogen against which the investigational drug has antibacterial activity.
    End point type
    Secondary
    End point timeframe
    7-14 days after end of therapy - TOC
    End point values
    		 Tedizolid Linezolid
    Number of subjects analysed
    178
    202
    Units: Participants
    117
    158
    Statistical analysis title
    		 Difference in response (tedizolid - linezolid)
    Comparison groups
    Tedizolid v Linezolid
    Number of subjects included in analysis
    380
    Analysis specification
    Pre-specified
    Analysis type
    		 [9]
    Method
    Parameter type
    		 Difference in clinical success
    Point estimate
    -12.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -21.5
         upper limit
    		 -3.5
    Notes
    [9] - Difference and 95% CI were calculated with the Miettinen and Nurminen method without stratification.

    Secondary: Number of Participants with a Favorable Response at Test-of-Cure (TOC) Visit in the Microbiologically-Evaluable 2 (ME-2) Population

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    End point title
    		 Number of Participants with a Favorable Response at Test-of-Cure (TOC) Visit in the Microbiologically-Evaluable 2 (ME-2) Population
    End point description
    The number of patients in the ME-2 population with a favorable response at TOC was determined. Favorable response included eradication (absence of the baseline pathogen) and presumed eradication (no source specimen to culture in a participant assessed as a clinical cure by the investigator). The ME-2 set is all mITT participants who did not receive an antibiotic (other than study drug) with activity against the baseline pathogen up to the TOC visit and is also in the clinically-evaluable (CE) set.
    End point type
    Secondary
    End point timeframe
    7-14 days after end of therapy - TOC
    End point values
    		 Tedizolid Linezolid
    Number of subjects analysed
    120
    109
    Units: Participants
    65
    74
    Statistical analysis title
    		 Difference in response (tedizolid - linezolid)
    Comparison groups
    Tedizolid v Linezolid
    Number of subjects included in analysis
    229
    Analysis specification
    Pre-specified
    Analysis type
    		 [10]
    Method
    Parameter type
    		 Difference in clinical success
    Point estimate
    -13.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -26.2
         upper limit
    		 -1.2
    Notes
    [10] - Difference and 95% CI were calculated with the Miettinen and Nurminen method without stratification.

    Secondary: Number of Participants with ≥1 Adverse Events (AEs)

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    End point title
    		 Number of Participants with ≥1 Adverse Events (AEs)
    End point description
    An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Safety analysis is based on actual treatment received instead of randomization. The safety set is all randomized participants who received any amount of study drug. A total of 4 participants were randomized to tedizolid but received linezolid.
    End point type
    Secondary
    End point timeframe
    Up to 32 days
    End point values
    		 Tedizolid Safety Set Linezolid Safety Set
    Number of subjects analysed
    357
    361
    Units: Participants
    327
    325
    No statistical analyses for this end point

    Secondary: Number of Participants Discontinuing Study Therapy Due to an Adverse Event (AE)

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    End point title
    		 Number of Participants Discontinuing Study Therapy Due to an Adverse Event (AE)
    End point description
    An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Safety analysis is based on actual treatment received instead of randomization. The safety set is all randomized participants who received any amount of study drug. A total of 4 participants were randomized to tedizolid but received linezolid.
    End point type
    Secondary
    End point timeframe
    Up to 14 days
    End point values
    		 Tedizolid Safety Set Linezolid Safety Set
    Number of subjects analysed
    357
    361
    Units: Participants
    4
    3
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Up to 32 days
    Adverse event reporting additional description
    All participants who received any amount of study drug are included. The safety assessment is based on actual treatment received, and thus the linezolid arm includes 4 participants randomized to tedizolid who received the wrong treatment.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    21.0
    Reporting groups
    Reporting group title
    Tedizolid
    Reporting group description
    		 The Safety analysis set is based on actual treatment received. Four participants randomized to tedizolid received linezolid.

    Reporting group title
    Linezolid
    Reporting group description
    		 The Safety analysis set is based on actual treatment received. Four participants randomized to tedizolid received linezolid.

    Serious adverse events
    		 Tedizolid Linezolid
    Total subjects affected by serious adverse events
         subjects affected / exposed
    129 / 357 (36.13%)
    149 / 361 (41.27%)
         number of deaths (all causes)
    101
    103
         number of deaths resulting from adverse events
    0
    1
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Cerebellopontine angle tumour
         subjects affected / exposed
    0 / 357 (0.00%)
    1 / 361 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Chronic myelomonocytic leukaemia
         subjects affected / exposed
    0 / 357 (0.00%)
    1 / 361 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular disorders
    Circulatory collapse
         subjects affected / exposed
    0 / 357 (0.00%)
    1 / 361 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Deep vein thrombosis
         subjects affected / exposed
    1 / 357 (0.28%)
    0 / 361 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Extremity necrosis
         subjects affected / exposed
    0 / 357 (0.00%)
    1 / 361 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemodynamic instability
         subjects affected / exposed
    0 / 357 (0.00%)
    2 / 361 (0.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 2
    Hypotension
         subjects affected / exposed
    2 / 357 (0.56%)
    3 / 361 (0.83%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Neurogenic shock
         subjects affected / exposed
    0 / 357 (0.00%)
    1 / 361 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Shock haemorrhagic
         subjects affected / exposed
    2 / 357 (0.56%)
    1 / 361 (0.28%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 2
    0 / 1
    General disorders and administration site conditions
    Brain death
         subjects affected / exposed
    0 / 357 (0.00%)
    1 / 361 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Multiple organ dysfunction syndrome
         subjects affected / exposed
    8 / 357 (2.24%)
    12 / 361 (3.32%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 12
         deaths causally related to treatment / all
    0 / 8
    0 / 12
    Sudden cardiac death
         subjects affected / exposed
    0 / 357 (0.00%)
    1 / 361 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Systemic inflammatory response syndrome
         subjects affected / exposed
    0 / 357 (0.00%)
    1 / 361 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Acute respiratory distress syndrome
         subjects affected / exposed
    2 / 357 (0.56%)
    2 / 361 (0.55%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 2
    Acute respiratory failure
         subjects affected / exposed
    2 / 357 (0.56%)
    6 / 361 (1.66%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 6
         deaths causally related to treatment / all
    0 / 1
    0 / 3
    Apnoea
         subjects affected / exposed
    0 / 357 (0.00%)
    1 / 361 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Aspiration
         subjects affected / exposed
    0 / 357 (0.00%)
    1 / 361 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchospasm
         subjects affected / exposed
    1 / 357 (0.28%)
    0 / 361 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Chronic obstructive pulmonary disease
         subjects affected / exposed
    2 / 357 (0.56%)
    2 / 361 (0.55%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 2
    0 / 2
    Haemothorax
         subjects affected / exposed
    1 / 357 (0.28%)
    0 / 361 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypoxia
         subjects affected / exposed
    2 / 357 (0.56%)
    2 / 361 (0.55%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Laryngospasm
         subjects affected / exposed
    1 / 357 (0.28%)
    1 / 361 (0.28%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Organising pneumonia
         subjects affected / exposed
    0 / 357 (0.00%)
    1 / 361 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Pharyngeal haematoma
         subjects affected / exposed
    0 / 357 (0.00%)
    1 / 361 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pleural effusion
         subjects affected / exposed
    1 / 357 (0.28%)
    2 / 361 (0.55%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pleural thickening
         subjects affected / exposed
    1 / 357 (0.28%)
    0 / 361 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia aspiration
         subjects affected / exposed
    0 / 357 (0.00%)
    2 / 361 (0.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumothorax
         subjects affected / exposed
    2 / 357 (0.56%)
    1 / 361 (0.28%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary alveolar haemorrhage
         subjects affected / exposed
    0 / 357 (0.00%)
    1 / 361 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Pulmonary embolism
         subjects affected / exposed
    2 / 357 (0.56%)
    5 / 361 (1.39%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 2
    Pulmonary oedema
         subjects affected / exposed
    1 / 357 (0.28%)
    0 / 361 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory arrest
         subjects affected / exposed
    0 / 357 (0.00%)
    1 / 361 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory failure
         subjects affected / exposed
    2 / 357 (0.56%)
    3 / 361 (0.83%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 2
    0 / 1
    Respiratory tract haemorrhage
         subjects affected / exposed
    0 / 357 (0.00%)
    1 / 361 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Injury, poisoning and procedural complications
    Accidental overdose
         subjects affected / exposed
    0 / 357 (0.00%)
    1 / 361 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Brain herniation
         subjects affected / exposed
    4 / 357 (1.12%)
    3 / 361 (0.83%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 3
         deaths causally related to treatment / all
    0 / 4
    0 / 2
    Endotracheal intubation complication
         subjects affected / exposed
    1 / 357 (0.28%)
    1 / 361 (0.28%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal stoma complication
         subjects affected / exposed
    0 / 357 (0.00%)
    1 / 361 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Post procedural haemorrhage
         subjects affected / exposed
    0 / 357 (0.00%)
    1 / 361 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Splenic rupture
         subjects affected / exposed
    1 / 357 (0.28%)
    0 / 361 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Subarachnoid haemorrhage
         subjects affected / exposed
    0 / 357 (0.00%)
    2 / 361 (0.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Tracheostomy malfunction
         subjects affected / exposed
    1 / 357 (0.28%)
    0 / 361 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Wound dehiscence
         subjects affected / exposed
    0 / 357 (0.00%)
    1 / 361 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Congenital, familial and genetic disorders
    Pyloric stenosis
         subjects affected / exposed
    0 / 357 (0.00%)
    1 / 361 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Acute coronary syndrome
         subjects affected / exposed
    1 / 357 (0.28%)
    0 / 361 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Acute myocardial infarction
         subjects affected / exposed
    1 / 357 (0.28%)
    0 / 361 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arrhythmia
         subjects affected / exposed
    0 / 357 (0.00%)
    1 / 361 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Atrial fibrillation
         subjects affected / exposed
    2 / 357 (0.56%)
    0 / 361 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrial flutter
         subjects affected / exposed
    1 / 357 (0.28%)
    0 / 361 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Cardiac arrest
         subjects affected / exposed
    21 / 357 (5.88%)
    16 / 361 (4.43%)
         occurrences causally related to treatment / all
    0 / 24
    0 / 16
         deaths causally related to treatment / all
    0 / 18
    0 / 14
    Cardiac failure
         subjects affected / exposed
    0 / 357 (0.00%)
    2 / 361 (0.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 2
    Cardiac failure acute
         subjects affected / exposed
    3 / 357 (0.84%)
    1 / 361 (0.28%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 2
    0 / 1
    Cardiac failure chronic
         subjects affected / exposed
    0 / 357 (0.00%)
    3 / 361 (0.83%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 3
    Cardiac failure congestive
         subjects affected / exposed
    0 / 357 (0.00%)
    1 / 361 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardio-respiratory arrest
         subjects affected / exposed
    7 / 357 (1.96%)
    6 / 361 (1.66%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 6
         deaths causally related to treatment / all
    0 / 5
    0 / 1
    Cardiogenic shock
         subjects affected / exposed
    0 / 357 (0.00%)
    1 / 361 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiovascular insufficiency
         subjects affected / exposed
    2 / 357 (0.56%)
    3 / 361 (0.83%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 2
    0 / 2
    Pulseless electrical activity
         subjects affected / exposed
    0 / 357 (0.00%)
    1 / 361 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Ventricular fibrillation
         subjects affected / exposed
    1 / 357 (0.28%)
    0 / 361 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Ventricular tachycardia
         subjects affected / exposed
    0 / 357 (0.00%)
    2 / 361 (0.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Nervous system disorders
    Amyotrophic lateral sclerosis
         subjects affected / exposed
    1 / 357 (0.28%)
    0 / 361 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Autonomic nervous system imbalance
         subjects affected / exposed
    0 / 357 (0.00%)
    1 / 361 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Benign enlargement of the subarachnoid spaces
         subjects affected / exposed
    0 / 357 (0.00%)
    1 / 361 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Brain hypoxia
         subjects affected / exposed
    1 / 357 (0.28%)
    0 / 361 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Brain injury
         subjects affected / exposed
    1 / 357 (0.28%)
    0 / 361 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Brain oedema
         subjects affected / exposed
    13 / 357 (3.64%)
    7 / 361 (1.94%)
         occurrences causally related to treatment / all
    0 / 13
    0 / 7
         deaths causally related to treatment / all
    0 / 12
    0 / 7
    Cerebral infarction
         subjects affected / exposed
    0 / 357 (0.00%)
    1 / 361 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cerebral ischaemia
         subjects affected / exposed
    1 / 357 (0.28%)
    2 / 361 (0.55%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 2
    Cerebral vasoconstriction
         subjects affected / exposed
    0 / 357 (0.00%)
    1 / 361 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholinergic syndrome
         subjects affected / exposed
    1 / 357 (0.28%)
    0 / 361 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Coma
         subjects affected / exposed
    1 / 357 (0.28%)
    0 / 361 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Generalised tonic-clonic seizure
         subjects affected / exposed
    0 / 357 (0.00%)
    1 / 361 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemorrhage intracranial
         subjects affected / exposed
    2 / 357 (0.56%)
    0 / 361 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Haemorrhagic stroke
         subjects affected / exposed
    0 / 357 (0.00%)
    1 / 361 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hydrocephalus
         subjects affected / exposed
    1 / 357 (0.28%)
    1 / 361 (0.28%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Hypoxic-ischaemic encephalopathy
         subjects affected / exposed
    2 / 357 (0.56%)
    0 / 361 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    Intracranial pressure increased
         subjects affected / exposed
    1 / 357 (0.28%)
    0 / 361 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intraventricular haemorrhage
         subjects affected / exposed
    1 / 357 (0.28%)
    0 / 361 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ischaemic stroke
         subjects affected / exposed
    0 / 357 (0.00%)
    2 / 361 (0.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Loss of consciousness
         subjects affected / exposed
    0 / 357 (0.00%)
    1 / 361 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myasthenia gravis crisis
         subjects affected / exposed
    1 / 357 (0.28%)
    0 / 361 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ruptured cerebral aneurysm
         subjects affected / exposed
    2 / 357 (0.56%)
    0 / 361 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Stroke in evolution
         subjects affected / exposed
    0 / 357 (0.00%)
    1 / 361 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Transient ischaemic attack
         subjects affected / exposed
    0 / 357 (0.00%)
    1 / 361 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    1 / 357 (0.28%)
    0 / 361 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thrombocytopenia
         subjects affected / exposed
    0 / 357 (0.00%)
    5 / 361 (1.39%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Ascites
         subjects affected / exposed
    0 / 357 (0.00%)
    1 / 361 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Duodenal ulcer
         subjects affected / exposed
    2 / 357 (0.56%)
    0 / 361 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Duodenal ulcer haemorrhage
         subjects affected / exposed
    1 / 357 (0.28%)
    0 / 361 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Glossoptosis
         subjects affected / exposed
    0 / 357 (0.00%)
    1 / 361 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intra-abdominal haemorrhage
         subjects affected / exposed
    0 / 357 (0.00%)
    1 / 361 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mallory-Weiss syndrome
         subjects affected / exposed
    0 / 357 (0.00%)
    1 / 361 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oesophageal varices haemorrhage
         subjects affected / exposed
    0 / 357 (0.00%)
    1 / 361 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancreatic necrosis
         subjects affected / exposed
    0 / 357 (0.00%)
    1 / 361 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancreatitis
         subjects affected / exposed
    1 / 357 (0.28%)
    1 / 361 (0.28%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Peritoneal haemorrhage
         subjects affected / exposed
    0 / 357 (0.00%)
    1 / 361 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumatosis intestinalis
         subjects affected / exposed
    1 / 357 (0.28%)
    0 / 361 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Upper gastrointestinal haemorrhage
         subjects affected / exposed
    1 / 357 (0.28%)
    0 / 361 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Acute hepatic failure
         subjects affected / exposed
    1 / 357 (0.28%)
    0 / 361 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Cholecystitis acute
         subjects affected / exposed
    1 / 357 (0.28%)
    0 / 361 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Penile ulceration
         subjects affected / exposed
    0 / 357 (0.00%)
    2 / 361 (0.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    5 / 357 (1.40%)
    7 / 361 (1.94%)
         occurrences causally related to treatment / all
    0 / 5
    2 / 7
         deaths causally related to treatment / all
    0 / 0
    1 / 2
    Chronic kidney disease
         subjects affected / exposed
    1 / 357 (0.28%)
    1 / 361 (0.28%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal impairment
         subjects affected / exposed
    1 / 357 (0.28%)
    0 / 361 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Pain in extremity
         subjects affected / exposed
    0 / 357 (0.00%)
    1 / 361 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Acinetobacter bacteraemia
         subjects affected / exposed
    0 / 357 (0.00%)
    1 / 361 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bacteraemia
         subjects affected / exposed
    2 / 357 (0.56%)
    1 / 361 (0.28%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Bacterial infection
         subjects affected / exposed
    2 / 357 (0.56%)
    0 / 361 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bacterial sepsis
         subjects affected / exposed
    1 / 357 (0.28%)
    0 / 361 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Brain abscess
         subjects affected / exposed
    0 / 357 (0.00%)
    1 / 361 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    CNS ventriculitis
         subjects affected / exposed
    1 / 357 (0.28%)
    1 / 361 (0.28%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Clostridium difficile colitis
         subjects affected / exposed
    0 / 357 (0.00%)
    1 / 361 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Empyema
         subjects affected / exposed
    1 / 357 (0.28%)
    0 / 361 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Endotoxaemia
         subjects affected / exposed
    0 / 357 (0.00%)
    1 / 361 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Endotoxic shock
         subjects affected / exposed
    0 / 357 (0.00%)
    1 / 361 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Enterobacter pneumonia
         subjects affected / exposed
    0 / 357 (0.00%)
    1 / 361 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Enterococcal bacteraemia
         subjects affected / exposed
    1 / 357 (0.28%)
    0 / 361 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Escherichia bacteraemia
         subjects affected / exposed
    1 / 357 (0.28%)
    0 / 361 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fungaemia
         subjects affected / exposed
    0 / 357 (0.00%)
    1 / 361 (0.28%)
         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
    0 / 357 (0.00%)
    1 / 361 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intervertebral discitis
         subjects affected / exposed
    0 / 357 (0.00%)
    1 / 361 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lung infection
         subjects affected / exposed
    0 / 357 (0.00%)
    1 / 361 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Meningitis
         subjects affected / exposed
    1 / 357 (0.28%)
    4 / 361 (1.11%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Meningitis bacterial
         subjects affected / exposed
    1 / 357 (0.28%)
    0 / 361 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peritonitis
         subjects affected / exposed
    4 / 357 (1.12%)
    0 / 361 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Pneumonia
         subjects affected / exposed
    4 / 357 (1.12%)
    6 / 361 (1.66%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 6
         deaths causally related to treatment / all
    0 / 3
    0 / 3
    Pneumonia acinetobacter
         subjects affected / exposed
    1 / 357 (0.28%)
    0 / 361 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia bacterial
         subjects affected / exposed
    2 / 357 (0.56%)
    2 / 361 (0.55%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Postoperative wound infection
         subjects affected / exposed
    3 / 357 (0.84%)
    0 / 361 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary sepsis
         subjects affected / exposed
    1 / 357 (0.28%)
    2 / 361 (0.55%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Sepsis
         subjects affected / exposed
    6 / 357 (1.68%)
    5 / 361 (1.39%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 5
         deaths causally related to treatment / all
    0 / 5
    0 / 4
    Septic shock
         subjects affected / exposed
    16 / 357 (4.48%)
    18 / 361 (4.99%)
         occurrences causally related to treatment / all
    0 / 16
    0 / 18
         deaths causally related to treatment / all
    0 / 10
    0 / 12
    Staphylococcal bacteraemia
         subjects affected / exposed
    1 / 357 (0.28%)
    1 / 361 (0.28%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Toxic shock syndrome
         subjects affected / exposed
    1 / 357 (0.28%)
    0 / 361 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tuberculosis
         subjects affected / exposed
    0 / 357 (0.00%)
    1 / 361 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    2 / 357 (0.56%)
    1 / 361 (0.28%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urosepsis
         subjects affected / exposed
    0 / 357 (0.00%)
    1 / 361 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Electrolyte imbalance
         subjects affected / exposed
    0 / 357 (0.00%)
    1 / 361 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypokalaemia
         subjects affected / exposed
    0 / 357 (0.00%)
    1 / 361 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolic acidosis
         subjects affected / exposed
    1 / 357 (0.28%)
    0 / 361 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Propofol infusion syndrome
         subjects affected / exposed
    1 / 357 (0.28%)
    0 / 361 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Tedizolid Linezolid
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    176 / 357 (49.30%)
    175 / 361 (48.48%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    19 / 357 (5.32%)
    14 / 361 (3.88%)
         occurrences all number
    20
    14
    Hypotension
         subjects affected / exposed
    27 / 357 (7.56%)
    25 / 361 (6.93%)
         occurrences all number
    28
    26
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    56 / 357 (15.69%)
    51 / 361 (14.13%)
         occurrences all number
    66
    52
    Gastrointestinal disorders
    Constipation
         subjects affected / exposed
    31 / 357 (8.68%)
    28 / 361 (7.76%)
         occurrences all number
    33
    31
    Diarrhoea
         subjects affected / exposed
    34 / 357 (9.52%)
    49 / 361 (13.57%)
         occurrences all number
    36
    52
    Vomiting
         subjects affected / exposed
    19 / 357 (5.32%)
    15 / 361 (4.16%)
         occurrences all number
    19
    16
    Skin and subcutaneous tissue disorders
    Decubitus ulcer
         subjects affected / exposed
    22 / 357 (6.16%)
    26 / 361 (7.20%)
         occurrences all number
    26
    31
    Infections and infestations
    Urinary tract infection
         subjects affected / exposed
    26 / 357 (7.28%)
    20 / 361 (5.54%)
         occurrences all number
    26
    20
    Metabolism and nutrition disorders
    Hypokalaemia
         subjects affected / exposed
    38 / 357 (10.64%)
    34 / 361 (9.42%)
         occurrences all number
    49
    38

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    26 Aug 2013
    AM01: The primary purpose of the amendment was to clarify inclusion criteria and that participants with bacteremia would receive 14 days of treatment.
    15 Jan 2014
    AM02: The primary purpose of the amendment was to add the EudraCT number and clarify method of analysis of secondary objectives.
    11 Nov 2014
    AM03: The primary purpose of the amendment was to update contact information and to clarify the statistics reporting group would be part of the data monitoring committee charter.
    24 Jan 2017
    AM04: The primary purpose of the amendment was to move the CE population analysis to secondary status.

    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

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/16600048
    http://www.ncbi.nlm.nih.gov/pubmed/15699079
    http://www.ncbi.nlm.nih.gov/pubmed/14625336
    http://www.ncbi.nlm.nih.gov/pubmed/3390511
    http://www.ncbi.nlm.nih.gov/pubmed/16652315
    http://www.ncbi.nlm.nih.gov/pubmed/19759040
    http://www.ncbi.nlm.nih.gov/pubmed/18989656
    http://www.ncbi.nlm.nih.gov/pubmed/21911576
    http://www.ncbi.nlm.nih.gov/pubmed/21555763
    http://www.ncbi.nlm.nih.gov/pubmed/21217178
    http://www.ncbi.nlm.nih.gov/pubmed/21163725
    http://www.ncbi.nlm.nih.gov/pubmed/22354302
    http://www.ncbi.nlm.nih.gov/pubmed/22247123
    For support, Contact us.
    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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