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    Clinical Trial Results:
    A Randomized, Double-Blinded, Active-Controlled Study of CB-183,315 in Patients With Clostridium Difficile Associated Diarrhea

    Summary
    EudraCT number
    		 2012-000252-34
    Trial protocol
    		 SE   BE   DE   CZ   PL   ES   AT   GB   IT   HU  
    Global end of trial date
    20 Mar 2015

    Results information
    Results version number
    		 v2(current)
    This version publication date
    05 Aug 2016
    First version publication date
    16 Mar 2016
    Other versions
    		 v1
    Version creation reason

    Trial information

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    Trial identification
    Sponsor protocol code
    4261-005
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01597505
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 Cubist Pharmaceuticals Holdings LLC: LCD-CDAD-10-07
    Sponsors
    Sponsor organisation name
    Cubist Pharmaceuticals LLC
    Sponsor organisation address
    2000 Galloping Hill Road, Kenilworth, NJ, United States, 07033
    Public contact
    Clinical Trials Disclosure, Merck Sharp & Dohme Corp., ClinicalTrialsDisclosure@merck.com
    Scientific contact
    Clinical Trials Disclosure, 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
    20 Mar 2015
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    20 Mar 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    606 participants with Clostridium Difficile Associated Diarrhea (CDAD) participated in this study and received either oral vancomycin or CB-183,315 (surotomycin) in a blinded fashion. Treatment lasted for 10 days and participants were followed up for at least 40 days and a maximum of 100 days. The purpose of this study was to evaluate how well surotomycin treats CDAD as compared to vancomycin.
    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
    16 May 2012
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Austria: 6
    Country: Number of subjects enrolled
    Belgium: 10
    Country: Number of subjects enrolled
    Canada: 122
    Country: Number of subjects enrolled
    Czech Republic: 28
    Country: Number of subjects enrolled
    France: 11
    Country: Number of subjects enrolled
    Germany: 39
    Country: Number of subjects enrolled
    Hungary: 35
    Country: Number of subjects enrolled
    Israel: 12
    Country: Number of subjects enrolled
    Italy: 9
    Country: Number of subjects enrolled
    Poland: 15
    Country: Number of subjects enrolled
    Spain: 43
    Country: Number of subjects enrolled
    Sweden: 4
    Country: Number of subjects enrolled
    United Kingdom: 5
    Country: Number of subjects enrolled
    United States: 267
    Worldwide total number of subjects
    606
    EEA total number of subjects
    205
    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)
    307
    From 65 to 84 years
    253
    85 years and over
    46

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Males and females aged 18 years or older with diarrhea at risk for CDAD were enrolled in this study

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Surotomycin
    Arm description
    		 250 mg Surotomycin over-encapsulated tablet administered orally, twice daily for a daily total dose of 500 mg; and Placebo over-encapsulated tablet administered orally, twice daily for 10 days
    Arm type
    		 Experimental

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Placebo for Surotomycin over-encapsulated tablet administered orally, twice daily for 10 days

    Investigational medicinal product name
    Surotomycin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    250 mg Surotomycin over-encapsulated tablet administered orally, twice daily for a daily total dose of 500 mg, for 10 days

    Arm title
    		 Vancomycin
    Arm description
    		 125 mg Vancomycin over-encapsulated tablet administered orally, four times daily for a daily total dose of 500 mg, for 10 days
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Vancomycin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    125 mg Vancomycin over-encapsulated capsule administered orally, four times daily for a daily total dose of 500 mg, for 10 days

    Number of subjects in period 1
    		Surotomycin Vancomycin
    Started
    308
    298
    Treated
    305
    286
    Completed
    261
    253
    Not completed
    47
    45
         Physician decision
    5
    -
         Consent withdrawn by subject
    10
    18
         Not Treated
    3
    12
         Unspecified
    5
    6
         Lost to follow-up
    4
    2
         Missing
    1
    -
         Adverse event, non-fatal + serious fatal
    19
    7

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Surotomycin
    Reporting group description
    		 250 mg Surotomycin over-encapsulated tablet administered orally, twice daily for a daily total dose of 500 mg; and Placebo over-encapsulated tablet administered orally, twice daily for 10 days

    Reporting group title
    Vancomycin
    Reporting group description
    		 125 mg Vancomycin over-encapsulated tablet administered orally, four times daily for a daily total dose of 500 mg, for 10 days

    Reporting group values
    		 Surotomycin Vancomycin Total
    Number of subjects
    		 308 298 606
    Age Categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 158 149 307
        From 65-84 years
    		 131 122 253
        85 years and over
    		 19 27 46
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 61.5 ± 17.5 61.8 ± 18.4 -
    Gender Categorical
    Units: Subjects
        Female
    		 185 175 360
        Male
    		 123 123 246

    End points

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    End points reporting groups
    Reporting group title
    Surotomycin
    Reporting group description
    		 250 mg Surotomycin over-encapsulated tablet administered orally, twice daily for a daily total dose of 500 mg; and Placebo over-encapsulated tablet administered orally, twice daily for 10 days

    Reporting group title
    Vancomycin
    Reporting group description
    		 125 mg Vancomycin over-encapsulated tablet administered orally, four times daily for a daily total dose of 500 mg, for 10 days

    Subject analysis set title
    Surotomycin
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    250 mg Surotomycin tablet administered orally, twice daily for a daily total dose of 500 mg, for 10 days

    Subject analysis set title
    Vancomycin
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    125 mg Vancomycin tablet administered orally, four times daily for a daily total dose of 500 mg, for 10 days

    Subject analysis set title
    Surotomycin
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    250 mg Surotomycin tablet administered orally, twice daily for a daily total dose of 500 mg, for 10 days

    Subject analysis set title
    Vancomycin
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    125 mg Vancomycin tablet administered orally, four times daily for a daily total dose of 500 mg, for 10 days

    Primary: Adjusted percentage of participants with a clinical outcome of cure at the end of treatment (EOT)

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    End point title
    		 Adjusted percentage of participants with a clinical outcome of cure at the end of treatment (EOT)
    End point description
    A clinical outcome of cure at EOT was determined by resolution of diarrhea, defined as ≤ 2 loose stools per 24-hour period for at least 2 consecutive days and the lack of need for additional antibiotics to treat the current CDAD episode after completion of the study treatment period. Participants requiring a collection device were considered to have resolution of diarrhea when the volume of stool (over a 24-hour period) was decreased by 75% as compared to baseline or the participant was no longer passing liquid stool. The estimated adjusted percentage was a weighted average across all strata, constructed using Mehrotra-Railkar continuity-corrected minimum risk (MRc) stratum weights. The population analyzed is the Microbiological Modified Intent-To-Treat (mMITT) population consisting of all randomized participants who had a confirmed diagnosis of CDAD regardless of whether they received any amount of study drug, based on the treatment to which they were randomized.
    End point type
    Primary
    End point timeframe
    Up to 13 days
    End point values
    		 Surotomycin Vancomycin
    Number of subjects analysed
    290
    280
    Units: Percentage of participants
        number (confidence interval 95%)
    79 (73.9 to 83.2)
    83.6 (78.8 to 87.4)
    Statistical analysis title
    		 Difference in percentage of participants
    Statistical analysis description
    The 95% confidence interval (CI) were stratified Wilson intervals for the treatment group percentages and a stratified Newcombe interval for the treatment difference, constructed using the MRc stratum weights.
    Comparison groups
    Surotomycin v Vancomycin
    Number of subjects included in analysis
    570
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [1]
    Method
    Parameter type
    		 Difference in percentage of participants
    Point estimate
    -4.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -11
         upper limit
    		 1.9
    Notes
    [1] - Difference: Surotomycin minus Vancomycin. For surotomycin to be non-inferior to vancomycin the lower bound of a 2-sided 95% CI for the difference between treatment groups had to be ≥ -10%.

    Primary: Percentage of participants with at least one adverse event (AE)

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    End point title
    		 Percentage of participants with at least one adverse event (AE) [2]
    End point description
    An AE is any untoward medical occurrence in a participant administered a pharmaceutical product that does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product. AEs may be new events or may be pre-existing conditions that have become aggravated or have worsened in severity or frequency; or may be clinically significant changes from baseline in physical examination, laboratory tests, or other diagnostic investigation (e.g. laboratory results, x-ray findings). The analyzed population consisted of all randomized participants who received any amount of study drug.
    End point type
    Primary
    End point timeframe
    Up to Day 50
    Notes
    [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Statistical analyses for this end point were neither planned nor performed.
    End point values
    		 Surotomycin Vancomycin
    Number of subjects analysed
    305
    286
    Units: Percentage of participants
        number (not applicable)
    48.5
    55.2
    No statistical analyses for this end point

    Primary: Percentage of participants with at least one serious adverse event (SAE)

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    End point title
    		 Percentage of participants with at least one serious adverse event (SAE) [3]
    End point description
    A serious adverse event is any adverse experience occurring at any dose that results in any of the following outcomes: either death; a life-threatening experience, referring to a situation in which the participant was at risk of death at the time of the event; it does not refer to an event which might have caused death if it were more severe; requires in-patient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability or incapacity; is a congenital anomaly or birth defect; or is considered to be an important medical event. The analyzed population consisted of all randomized participants who received any amount of study drug.
    End point type
    Primary
    End point timeframe
    Up to Day 50
    Notes
    [3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Statistical analyses for this end point were neither planned nor performed.
    End point values
    		 Surotomycin Vancomycin
    Number of subjects analysed
    305
    286
    Units: Percentage of participants
        number (not applicable)
    14.4
    12.9
    No statistical analyses for this end point

    Primary: Percentage of participants who discontinued treatment due to an AE

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    End point title
    		 Percentage of participants who discontinued treatment due to an AE [4]
    End point description
    An AE is any untoward medical occurrence in a participant administered a pharmaceutical product that does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product. AEs may be new events or may be pre-existing conditions that have become aggravated or have worsened in severity or frequency; or may be clinically significant changes from baseline in physical examination, laboratory tests, or other diagnostic investigation (e.g. laboratory results, x-ray findings). The analyzed population consisted of all randomized participants who received any amount of study drug.
    End point type
    Primary
    End point timeframe
    Up to Day 13
    Notes
    [4] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Statistical analyses for this end point were neither planned nor performed.
    End point values
    		 Surotomycin Vancomycin
    Number of subjects analysed
    305
    286
    Units: Percentage of participants
        number (not applicable)
    5.6
    2.8
    No statistical analyses for this end point

    Secondary: Number of participants with clinical response over time measured by those without treatment failure, recurrence, death, or lost to follow-up

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    End point title
    		 Number of participants with clinical response over time measured by those without treatment failure, recurrence, death, or lost to follow-up
    End point description
    Clinical response over time, is measured as the number of participants without failure events (survivors) through the end of therapy (reported for Day 14) and from end of therapy to Day 40 (reported for Day 41). The population analyzed is the mMITT population consisting of all randomized participants who had a confirmed diagnosis of CDAD regardless of whether they received any amount of study drug, based on the treatment to which they were randomized
    End point type
    Secondary
    End point timeframe
    Up to Day 41
    End point values
    		 Surotomycin Vancomycin
    Number of subjects analysed
    290
    280
    Units: Participants
    number (not applicable)
        Day 14
    227
    231
        Day 41
    147
    151
    Statistical analysis title
    		 Surotomycin v Vancomycin
    Statistical analysis description
    Log-rank test of equality of survival times, stratified by age group (< 75, >= 75 years) and number of CDAD episodes (0, >= 1)
    Comparison groups
    Surotomycin v Vancomycin
    Number of subjects included in analysis
    570
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.832 [5]
    Method
    		 Log rank test
    Confidence interval
    Notes
    [5] - Significance cut-off = 0.05

    Secondary: Adjusted percentage of participants with sustained clinical response at the end of study (Days 40 - 50)

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    End point title
    		 Adjusted percentage of participants with sustained clinical response at the end of study (Days 40 - 50)
    End point description
    Sustained clinical response at the end of study was achieved by participants who had a clinical outcome of cure at the end of treatment (Days 40-50) and did not experience a recurrence of CDAD, did not die, were not lost to follow-up, and did not have end of study visit prior to Day 40. The estimated adjusted percentage was a weighted average across all strata, constructed using MRc stratum weights. The population analyzed is the mMITT population consisting of all randomized participants who had a confirmed diagnosis of CDAD regardless of whether they received any amount of study drug, based on the treatment to which they were randomized.
    End point type
    Secondary
    End point timeframe
    30 days after last dose of study drug: up to Day 50
    End point values
    		 Surotomycin Vancomycin
    Number of subjects analysed
    290
    280
    Units: Percentage of participants
        number (confidence interval 95%)
    60.6 (55 to 66)
    61.4 (55.9 to 66.8)
    Statistical analysis title
    		 Difference in percentage of participants
    Statistical analysis description
    The 95% CI was stratified Wilson intervals for the treatment group percentages and a stratified Newcombe interval for the treatment difference, constructed using the MRc stratum weights. Stratified by age group (< 75, >= 75 years) and number of CDAD episodes (0, >= 1).
    Comparison groups
    Surotomycin v Vancomycin
    Number of subjects included in analysis
    570
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [6]
    Method
    Parameter type
    		 Difference in percentage of participants
    Point estimate
    -0.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -8.8
         upper limit
    		 7.1
    Notes
    [6] - Difference: Surotomycin - Vancomycin. For surotomycin to be considered superior to vancomycin the lower bound of the 2-sided 95% CI had to be > 0%.

    Secondary: Adjusted percentage of participants with sustained clinical response at Day 24

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    End point title
    		 Adjusted percentage of participants with sustained clinical response at Day 24
    End point description
    Sustained clinical response at Day 24 was defined as participants who had a clinical outcome of cure at Day 24, who did not experience a recurrence of CDAD, did not die, were not lost to follow-up. Only the first failure event was counted per participant. The estimated adjusted percentage was a weighted average across all strata, constructed using MRc stratum weights. The population analyzed was the mMITT population consisting of all randomized participants who had a confirmed diagnosis of CDAD regardless of whether they received any amount of study drug, based on the treatment to which they were randomized.
    End point type
    Secondary
    End point timeframe
    Day 24
    End point values
    		 Surotomycin Vancomycin
    Number of subjects analysed
    290
    280
    Units: Percentage of participants
        number (confidence interval 95%)
    66.6 (61.1 to 71.8)
    66.1 (60.5 to 71.3)
    Statistical analysis title
    		 Difference in percentage of participants
    Statistical analysis description
    The 95% CI was stratified Wilson intervals for the treatment group percentages and a stratified Newcombe interval for the treatment difference, constructed using the MRc stratum weights. Stratified by age group (< 75, >= 75 years) and number of CDAD episodes (0, >= 1).
    Comparison groups
    Surotomycin v Vancomycin
    Number of subjects included in analysis
    570
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [7]
    Method
    Parameter type
    		 Difference in percentage of participants
    Point estimate
    0.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -7.2
         upper limit
    		 8.3
    Notes
    [7] - Difference: Surotomycin - Vancomycin. For surotomycin to be considered superior to vancomycin the lower bound of the 2-sided 95% CI had to be > 0%.

    Secondary: Adjusted percentage of participants with recurrence of CDAD at end of study (Days 40 to 50)

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    End point title
    		 Adjusted percentage of participants with recurrence of CDAD at end of study (Days 40 to 50)
    End point description
    Participants with recurrences were defined as those who were cured at the end of therapy and had a recurrence or were lost to follow-up, died or had a Day 40 -50 contact prior to Day 40. The estimated adjusted percentage was a weighted average across all strata, constructed using MRc stratum weights. The population analyzed is the mMITT population consisting of all randomized participants who had a confirmed diagnosis of CDAD regardless of whether they received any amount of study drug, based on the treatment to which they were randomized.
    End point type
    Secondary
    End point timeframe
    30 days after last dose of study drug: up to Day 50
    End point values
    		 Surotomycin Vancomycin
    Number of subjects analysed
    290
    280
    Units: Percentage of participants
        number (confidence interval 95%)
    17.7 (13.8 to 22.4)
    21.2 (16.9 to 26.1)
    Statistical analysis title
    		 Difference in percentage of participants
    Statistical analysis description
    The 95% CI was stratified Wilson intervals for the treatment group percentages and a stratified Newcombe interval for the treatment difference, constructed using the MRc stratum weights. Stratified by age group (< 75, >= 75 years) and number of CDAD episodes (0, >= 1).
    Comparison groups
    Surotomycin v Vancomycin
    Number of subjects included in analysis
    570
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [8]
    Method
    Parameter type
    		 Difference in percentage of participants
    Point estimate
    -3.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -10
         upper limit
    		 3
    Notes
    [8] - Difference: Surotomycin - Vancomycin. For surotomycin to be considered superior to vancomycin the lower bound of the 2-sided 95% CI had to be > 0%.

    Secondary: Time to Resolution of Diarrhea

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    End point title
    		 Time to Resolution of Diarrhea
    End point description
    Time to resolution of diarrhea with =< 2 unformed bowel movements (UBM) per 24-hour period was calculated as the date/time of last UBM minus the date/time of the first dose of study drug. The population analyzed is the mMITT population consisting of all randomized participants who had a confirmed diagnosis of CDAD regardless of whether they received any amount of study drug, based on the treatment to which they were randomized.
    End point type
    Secondary
    End point timeframe
    Up to Day 13
    End point values
    		 Surotomycin Vancomycin
    Number of subjects analysed
    290
    280
    Units: days
        median (confidence interval 95%)
    2.8 (2.2 to 3.3)
    3 (2.2 to 3.3)
    Statistical analysis title
    		 Surotomycin v Vancomycin
    Statistical analysis description
    Log-rank test of equality of survival times, stratified by age group (< 75, >= 75 years) and number of CDAD episodes (0, >= 1)
    Comparison groups
    Surotomycin v Vancomycin
    Number of subjects included in analysis
    570
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.431 [9]
    Method
    		 Log-rank test
    Confidence interval
    Notes
    [9] - Significance cut-off = 0.05

    Secondary: Time to reappearance of diarrhea from end of treatment to the end of study (days 40 to 50)

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    End point title
    		 Time to reappearance of diarrhea from end of treatment to the end of study (days 40 to 50)
    End point description
    Time to reappearance of diarrhea with >= 3 UBM per 24-hour period was calculated as the last date/time of study drug dose to the date/time of first reappearance of 3 or more UBMs among participants who were cured. The population analyzed is the mMITT population consisting of all randomized participants who had a confirmed diagnosis of CDAD regardless of whether they received any amount of study drug, based on the treatment to which they were randomized; and includes cures at end of study only. The Number At Risk is the number of participants who entered the interval without having a reappearance of diarrhea. Results were shown as "0" because median time to reappearance and the 95% Confidence Interval (CI) could not be determined.
    End point type
    Secondary
    End point timeframe
    Up to day 50
    End point values
    		 Surotomycin Vancomycin
    Number of subjects analysed
    229
    234
    Units: Days
        median (confidence interval 95%)
    0 (0 to 0)
    0 (0 to 0)
    Statistical analysis title
    		 Surotomycin v Vancomycin
    Statistical analysis description
    Log-rank test of equality of survival times, stratified by age group (< 75, >= 75 years) and number of CDAD episodes (0, >= 1)
    Comparison groups
    Surotomycin v Vancomycin
    Number of subjects included in analysis
    463
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.011 [10]
    Method
    		 Log-rank test
    Confidence interval
    Notes
    [10] - Significance cut-off = 0.05

    Secondary: Adjusted percentage of participants with a clinical response at the end of treatment for infections deemed to be caused by the C. difficile BI/NAP1/027 strain at baseline

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    End point title
    		 Adjusted percentage of participants with a clinical response at the end of treatment for infections deemed to be caused by the C. difficile BI/NAP1/027 strain at baseline
    End point description
    Clinical response corresponded to a clinical outcome of cure at the end of treatment, and was achieved by participants who did not fail treatment, did not die, or were not lost to follow-up at the end of treatment. The estimated adjusted percentage was a weighted average across all strata, constructed using MRc stratum weights. The population analyzed is the mMITT population consisting of all randomized participants who had a confirmed diagnosis of CDAD regardless of whether they received any amount of study drug, based on the treatment to which they were randomized. The Number At Risk is the number of participants with infections deemed to be caused by the C. difficile BI/NAP1/027 strain at baseline.
    End point type
    Secondary
    End point timeframe
    Up to Day 13
    End point values
    		 Surotomycin Vancomycin
    Number of subjects analysed
    59
    67
    Units: Percentage of participants
        number (confidence interval 95%)
    88.5 (75.8 to 92.4)
    86.3 (76.2 to 92.6)
    Statistical analysis title
    		 Difference in percentage of participants
    Statistical analysis description
    Analyses were performed separately for each indicated strain or subgroup. Treatment group percentages were stratified by age group (< 75, ≥ 75) and number of previous CDAD episodes (0, ≥ 1). The 95% CIs were stratified Wilson intervals for the treatment group percentages.
    Comparison groups
    Surotomycin v Vancomycin
    Number of subjects included in analysis
    126
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [11]
    Method
    Parameter type
    		 Difference in percentage of participants
    Point estimate
    2.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -10.7
         upper limit
    		 14.8
    Notes
    [11] - Difference: Surotomycin - Vancomycin. For surotomycin to be considered superior to vancomycin the lower bound of the 2-sided 95% CI had to be > 0%.

    Secondary: Adjusted percentage of participants Per Protocol 1 population with a clinical response at the end of treatment

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    End point title
    		 Adjusted percentage of participants Per Protocol 1 population with a clinical response at the end of treatment
    End point description
    Clinical response corresponded to a clinical outcome of cure at the end of treatment, and was achieved by participants who did not fail treatment, did not die, or were not lost to follow-up at the end of treatment. The estimated adjusted percentage was a weighted average across all strata, constructed using MRc stratum weights. The population analyzed is the Per Protocol 1 (PP1) population composed of participants from the mMITT population, according to the actual treatment they received; without any protocol deviations from enrollment through 2 days after end of treatment, which could affect the efficacy conclusions.
    End point type
    Secondary
    End point timeframe
    Up to Day 13
    End point values
    		 Surotomycin Vancomycin
    Number of subjects analysed
    252
    243
    Units: Percentage of participants
        number (confidence interval 95%)
    89.1 (84.5 to 92.2)
    91.5 (87.2 to 94.3)
    Statistical analysis title
    		 Difference in percentage of participants
    Statistical analysis description
    Treatment group proportions were stratified by age group (< 75, ≥ 75) and number of previous CDAD episodes (0, ≥1). The 95% CIs were stratified Wilson intervals for the treatment group proportions.
    Comparison groups
    Surotomycin v Vancomycin
    Number of subjects included in analysis
    495
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [12]
    Method
    Parameter type
    		 Difference in percentage of participants
    Point estimate
    -2.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -7.8
         upper limit
    		 3
    Notes
    [12] - Difference: Surotomycin - Vancomycin. For surotomycin to be considered superior to vancomycin the lower bound of the 2-sided 95% CI had to be > 0%.

    Secondary: Adjusted percentage of participants with a sustained clinical response at the end of study (Days 40 - 50) for infections deemed to be caused by the C. difficile BI/NAP1/027 strain at baseline

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    End point title
    		 Adjusted percentage of participants with a sustained clinical response at the end of study (Days 40 - 50) for infections deemed to be caused by the C. difficile BI/NAP1/027 strain at baseline
    End point description
    Sustained clinical response at the end of study was achieved by participants who had a clinical outcome of cure at the end of treatment (Days 40-50) and did not experience a recurrence of CDAD, did not die, were not lost to follow-up, and did not have end of study visit prior to Day 40. The estimated adjusted percentage was a weighted average across all strata, constructed using MRc stratum weights. The population analyzed is the mMITT population consisting of all randomized participants who had a confirmed diagnosis of CDAD regardless of whether they received any amount of study drug, based on the treatment to which they were randomized. The Number At Risk is the number of participants with infections deemed to be caused by the C. difficile BI/NAP1/027 strain at baseline.
    End point type
    Secondary
    End point timeframe
    Up to Day 50
    End point values
    		 Surotomycin Vancomycin
    Number of subjects analysed
    59
    67
    Units: Percentage of participants
        number (confidence interval 95%)
    66.1 (53.6 to 76.7)
    51.5 (40.5 to 63.1)
    Statistical analysis title
    		 Difference in percentage of participants
    Statistical analysis description
    Analyses were performed separately for each indicated strain or subgroup. Treatment group percentages were stratified by age group (< 75, ≥ 75) and number of previous CDAD episodes (0, ≥ 1). The 95% CIs were stratified Wilson intervals for the treatment group percentages.
    Comparison groups
    Surotomycin v Vancomycin
    Number of subjects included in analysis
    126
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [13]
    Method
    Parameter type
    		 Difference in percentage of participants
    Point estimate
    14.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.7
         upper limit
    		 30.7
    Notes
    [13] - Difference: Surotomycin - Vancomycin. For surotomycin to be considered superior to vancomycin the lower bound of the 2-sided 95% CI had to be > 0%.

    Secondary: Adjusted percentage of participants from the Per Protocol 2 population with a sustained clinical response at the end of study (Days 40 - 50)

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    End point title
    		 Adjusted percentage of participants from the Per Protocol 2 population with a sustained clinical response at the end of study (Days 40 - 50)
    End point description
    Sustained clinical response at the end of study was achieved by participants who had a clinical outcome of cure at the end of treatment (Days 40-50) and did not experience a recurrence of CDAD, did not die, were not lost to follow-up, and did not have end of study visit prior to Day 40. Only the first failure event per participant was counted. The estimated adjusted percentage was a weighted average across all strata, constructed using MRc stratum weights. The population analyzed is the Per Protocol 2 (PP2) population composed of cures and failures from the PP1 population. Additionally, to be included in the PP2 population, PP1 participants who were cured at end of treatment must not have had any protocol deviations which could affect the assessment of recurrence and have had follow-up contact through at least Day 40.
    End point type
    Secondary
    End point timeframe
    Up to Day 50
    End point values
    		 Surotomycin Vancomycin
    Number of subjects analysed
    233
    227
    Units: Percentage of participants
        number (confidence interval 95%)
    70.8 (64.8 to 76.2)
    66.5 (60.6 to 72.2)
    Statistical analysis title
    		 Difference in percentage of participants
    Statistical analysis description
    Treatment group percentages were stratified by age group (< 75, ≥ 75) and number of previous CDAD episodes (0, ≥ 1). The 95% CIs were stratified Wilson intervals for the treatment group percentages.
    Comparison groups
    Surotomycin v Vancomycin
    Number of subjects included in analysis
    460
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [14]
    Method
    Parameter type
    		 Difference in percentage of participants
    Point estimate
    4.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.2
         upper limit
    		 12.7
    Notes
    [14] - Difference: Surotomycin - Vancomycin. For surotomycin to be considered superior to vancomycin the lower bound of the 2-sided 95% CI had to be > 0%.

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    All AEs were collected up to Day 13; only SAEs and drug related AEs were collected thereafter 30 days after end of treatment (up to Day 50)
    Adverse event reporting additional description
    All randomized participants who received any amount of study drug.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    15.0
    Reporting groups
    Reporting group title
    Vancomycin
    Reporting group description
    		 125 mg Vancomycin over-encapsulated tablet administered orally, four times daily for a daily total dose of 500 mg, for 10 days

    Reporting group title
    Surotomycin
    Reporting group description
    		 250 mg Surotomycin over-encapsulated tablet administered orally, twice daily for a daily total dose of 500 mg; and Placebo over-encapsulated tablet administered orally, twice daily for 10 days

    Serious adverse events
    		 Vancomycin Surotomycin
    Total subjects affected by serious adverse events
         subjects affected / exposed
    37 / 286 (12.94%)
    44 / 305 (14.43%)
         number of deaths (all causes)
    9
    18
         number of deaths resulting from adverse events
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Adenocarcinoma of colon
         subjects affected / exposed
    0 / 286 (0.00%)
    1 / 305 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lung neoplasm malignant
         subjects affected / exposed
    0 / 286 (0.00%)
    1 / 305 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Plasma cell myeloma
         subjects affected / exposed
    0 / 286 (0.00%)
    1 / 305 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Vascular disorders
    Deep vein thrombosis
         subjects affected / exposed
    0 / 286 (0.00%)
    1 / 305 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypertensive emergency
         subjects affected / exposed
    1 / 286 (0.35%)
    0 / 305 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypotension
         subjects affected / exposed
    0 / 286 (0.00%)
    1 / 305 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral vascular disorder
         subjects affected / exposed
    1 / 286 (0.35%)
    0 / 305 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Shock haemorrhagic
         subjects affected / exposed
    0 / 286 (0.00%)
    1 / 305 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Venous thrombosis limb
         subjects affected / exposed
    0 / 286 (0.00%)
    1 / 305 (0.33%)
         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
    Death
         subjects affected / exposed
    1 / 286 (0.35%)
    1 / 305 (0.33%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Pyrexia
         subjects affected / exposed
    1 / 286 (0.35%)
    1 / 305 (0.33%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sudden cardiac death
         subjects affected / exposed
    1 / 286 (0.35%)
    2 / 305 (0.66%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 2
    Respiratory, thoracic and mediastinal disorders
    Acute respiratory distress syndrome
         subjects affected / exposed
    0 / 286 (0.00%)
    1 / 305 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chronic obstructive pulmonary disease
         subjects affected / exposed
    3 / 286 (1.05%)
    1 / 305 (0.33%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Dyspnoea exertional
         subjects affected / exposed
    0 / 286 (0.00%)
    1 / 305 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lung disorder
         subjects affected / exposed
    0 / 286 (0.00%)
    1 / 305 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Pneumonia aspiration
         subjects affected / exposed
    1 / 286 (0.35%)
    0 / 305 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Pulmonary embolism
         subjects affected / exposed
    1 / 286 (0.35%)
    0 / 305 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory failure
         subjects affected / exposed
    2 / 286 (0.70%)
    1 / 305 (0.33%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Psychiatric disorders
    Suicidal ideation
         subjects affected / exposed
    1 / 286 (0.35%)
    0 / 305 (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
    Abdominal wound dehiscence
         subjects affected / exposed
    0 / 286 (0.00%)
    1 / 305 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fall
         subjects affected / exposed
    0 / 286 (0.00%)
    1 / 305 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hip fracture
         subjects affected / exposed
    0 / 286 (0.00%)
    1 / 305 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lumbar vertebral fracture
         subjects affected / exposed
    0 / 286 (0.00%)
    1 / 305 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Angina pectoris
         subjects affected / exposed
    0 / 286 (0.00%)
    1 / 305 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrial fibrillation
         subjects affected / exposed
    1 / 286 (0.35%)
    0 / 305 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac arrest
         subjects affected / exposed
    1 / 286 (0.35%)
    3 / 305 (0.98%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 4
         deaths causally related to treatment / all
    0 / 1
    0 / 2
    Cardiac failure
         subjects affected / exposed
    0 / 286 (0.00%)
    1 / 305 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Cardiac failure congestive
         subjects affected / exposed
    1 / 286 (0.35%)
    0 / 305 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardio-respiratory arrest
         subjects affected / exposed
    1 / 286 (0.35%)
    0 / 305 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ventricular fibrillation
         subjects affected / exposed
    0 / 286 (0.00%)
    1 / 305 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Ventricular tachycardia
         subjects affected / exposed
    0 / 286 (0.00%)
    1 / 305 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Hypoxic-ischaemic encephalopathy
         subjects affected / exposed
    1 / 286 (0.35%)
    0 / 305 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Syncope
         subjects affected / exposed
    1 / 286 (0.35%)
    0 / 305 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tonic convulsion
         subjects affected / exposed
    0 / 286 (0.00%)
    1 / 305 (0.33%)
         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
    Anaemia
         subjects affected / exposed
    0 / 286 (0.00%)
    3 / 305 (0.98%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Febrile neutropenia
         subjects affected / exposed
    1 / 286 (0.35%)
    0 / 305 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Leukopenia
         subjects affected / exposed
    0 / 286 (0.00%)
    1 / 305 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal wall haematoma
         subjects affected / exposed
    0 / 286 (0.00%)
    1 / 305 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ascites
         subjects affected / exposed
    0 / 286 (0.00%)
    1 / 305 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diarrhoea
         subjects affected / exposed
    1 / 286 (0.35%)
    0 / 305 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Duodenal ulcer haemorrhage
         subjects affected / exposed
    0 / 286 (0.00%)
    1 / 305 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ileus
         subjects affected / exposed
    0 / 286 (0.00%)
    2 / 305 (0.66%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Inguinal hernia, obstructive
         subjects affected / exposed
    0 / 286 (0.00%)
    1 / 305 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intestinal ischaemia
         subjects affected / exposed
    0 / 286 (0.00%)
    1 / 305 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Irritable bowel syndrome
         subjects affected / exposed
    0 / 286 (0.00%)
    1 / 305 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Jejunal ulcer perforation
         subjects affected / exposed
    0 / 286 (0.00%)
    1 / 305 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Megacolon
         subjects affected / exposed
    1 / 286 (0.35%)
    0 / 305 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nausea
         subjects affected / exposed
    1 / 286 (0.35%)
    0 / 305 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oesophagitis
         subjects affected / exposed
    0 / 286 (0.00%)
    1 / 305 (0.33%)
         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 / 286 (0.35%)
    0 / 305 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vomiting
         subjects affected / exposed
    1 / 286 (0.35%)
    0 / 305 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Hepatorenal syndrome
         subjects affected / exposed
    1 / 286 (0.35%)
    0 / 305 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Renal and urinary disorders
    Hydronephrosis
         subjects affected / exposed
    1 / 286 (0.35%)
    0 / 305 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal failure
         subjects affected / exposed
    1 / 286 (0.35%)
    0 / 305 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal failure acute
         subjects affected / exposed
    2 / 286 (0.70%)
    1 / 305 (0.33%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal failure chronic
         subjects affected / exposed
    1 / 286 (0.35%)
    0 / 305 (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
    Muscular weakness
         subjects affected / exposed
    0 / 286 (0.00%)
    1 / 305 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Systemic lupus erythematosus
         subjects affected / exposed
    1 / 286 (0.35%)
    0 / 305 (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
    Abscess
         subjects affected / exposed
    1 / 286 (0.35%)
    0 / 305 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arthritis bacterial
         subjects affected / exposed
    1 / 286 (0.35%)
    0 / 305 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchitis
         subjects affected / exposed
    0 / 286 (0.00%)
    1 / 305 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchopneumonia
         subjects affected / exposed
    1 / 286 (0.35%)
    1 / 305 (0.33%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Cellulitis
         subjects affected / exposed
    1 / 286 (0.35%)
    0 / 305 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Device related sepsis
         subjects affected / exposed
    1 / 286 (0.35%)
    0 / 305 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Escherichia sepsis
         subjects affected / exposed
    0 / 286 (0.00%)
    1 / 305 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Escherichia urinary tract infection
         subjects affected / exposed
    0 / 286 (0.00%)
    1 / 305 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fungal peritonitis
         subjects affected / exposed
    0 / 286 (0.00%)
    1 / 305 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    1 / 286 (0.35%)
    0 / 305 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis viral
         subjects affected / exposed
    0 / 286 (0.00%)
    1 / 305 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lobar pneumonia
         subjects affected / exposed
    1 / 286 (0.35%)
    0 / 305 (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
    0 / 286 (0.00%)
    1 / 305 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peritonitis bacterial
         subjects affected / exposed
    0 / 286 (0.00%)
    1 / 305 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    1 / 286 (0.35%)
    3 / 305 (0.98%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Pseudomembranous colitis
         subjects affected / exposed
    0 / 286 (0.00%)
    1 / 305 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    0 / 286 (0.00%)
    2 / 305 (0.66%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Septic shock
         subjects affected / exposed
    1 / 286 (0.35%)
    0 / 305 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Strongyloidiasis
         subjects affected / exposed
    0 / 286 (0.00%)
    1 / 305 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Urinary tract infection
         subjects affected / exposed
    2 / 286 (0.70%)
    1 / 305 (0.33%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urosepsis
         subjects affected / exposed
    1 / 286 (0.35%)
    0 / 305 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Dehydration
         subjects affected / exposed
    3 / 286 (1.05%)
    1 / 305 (0.33%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypoglycaemia
         subjects affected / exposed
    1 / 286 (0.35%)
    0 / 305 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypokalaemia
         subjects affected / exposed
    1 / 286 (0.35%)
    0 / 305 (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
    		 Vancomycin Surotomycin
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    38 / 286 (13.29%)
    38 / 305 (12.46%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    18 / 286 (6.29%)
    12 / 305 (3.93%)
         occurrences all number
    21
    13
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    6 / 286 (2.10%)
    16 / 305 (5.25%)
         occurrences all number
    6
    20
    Nausea
         subjects affected / exposed
    21 / 286 (7.34%)
    20 / 305 (6.56%)
         occurrences all number
    21
    23

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    28 Feb 2012
    Amendment 1: Addition of objective and endpoint to assess health economic outcomes
    15 May 2013
    Amendment 2: Addition of other glycopeptides (in addition to vancomycin) and fidaxomixin to list of disallowed concurrent medications. Pharmacokinetic sampling times further defined with tolerance times added. Statistical text revised to provide additional information on general methodology and clarity regarding efficacy endpoints and analyses

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

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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