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    Clinical Trial Results:
    A Phase 2, Randomized, Open-Label, Active-Controlled Clinical Study to Investigate the Safety and Efficacy of SMT19969 (200 mg BID) for 10 days Compared with Fidaxomicin (200 mg BID) for 10 days for the Treatment of Clostridium difficile Infection (CDI)

    Summary
    EudraCT number
    		 2013-005483-25
    Trial protocol
    		 GB   CZ  
    Global end of trial date
    08 Aug 2016

    Results information
    Results version number
    		 v1(current)
    This version publication date
    25 Oct 2017
    First version publication date
    25 Oct 2017
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    SMT19969/C003
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02784002
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Summit (Oxford) Limited
    Sponsor organisation address
    136a Eastern Avenue, Milton Park, Abingdon, United Kingdom, OX14 4SB
    Public contact
    Clinical Operations, Summit (Oxford) Limited, 0044 1235443939, codify@summitplc.com
    Scientific contact
    Clinical Operations, Summit (Oxford) Limited, 0044 1235443939, codify@summitplc.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 Sep 2016
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    08 Aug 2016
    Global end of trial reached?
    Yes
    Global end of trial date
    08 Aug 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the safety and tolerability of 10 days of dosing with ridinilazole (200mg BID) compared to fidaxomicin (200mg BID) in the treatment of subjects with CDI
    Protection of trial subjects
    This clinical study was written, conducted and reported in accordance with the protocol, ICH GCP Guidelines, and applicable local regulations, including the European Directive 2001/20/EC, on the protection of human rights, and with the ethical principles that have their origin in the Declaration of Helsinki. Summit ensures that the use and disclosure of protected health information (PHI) obtained during a research study complies with the federal, national and/or regional legislation related to the privacy and protection of personal information.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    19 Feb 2015
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United Kingdom: 12
    Country: Number of subjects enrolled
    Czech Republic: 4
    Country: Number of subjects enrolled
    United States: 11
    Worldwide total number of subjects
    27
    EEA total number of subjects
    16
    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)
    11
    From 65 to 84 years
    14
    85 years and over
    2

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Only subjects with signs and symptoms consistent with CDI and a positive local diagnostic result for C. difficile and who met all inclusion/exclusion criteria were randomized to one of the 2 treatment groups. Four subjects failed screening for not meeting an inclusion criteria.

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Ridinilazole
    Arm description
    		 Subjects in this group received ridinilazole 200 mg BID for 10 days
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ridinilazole
    Investigational medicinal product code
    SMT19969
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    For the entire 10 day treatment period subjects were asked to take 2 doses (capsules) of study drug each day. One capsule every 12 hours.

    Arm title
    		 Fidaxomicin
    Arm description
    		 Subjects in this group received fidaxomicin 200 mg BID for 10 days
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Fidaxomicin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    For the entire 10 day treatment period subjects will be asked to take 2 doses (tablets) of study drug each day. One tablet every 12 hours.

    Number of subjects in period 1
    		Ridinilazole Fidaxomicin
    Started
    14
    13
    Completed
    12
    10
    Not completed
    2
    3
         Consent withdrawn by subject
    1
    1
         Physician decision
    -
    1
         Adverse event, non-fatal
    1
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall trial
    Reporting group description
    		 -

    Reporting group values
    		 Overall trial Total
    Number of subjects
    		 27 27
    Age categorical
    Units: Subjects
        <65
    		 11 11
        65 to <75
    		 8 8
        >=75
    		 8 8
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 67.3 ± 15.37 -
    Gender categorical
    Units: Subjects
        Female
    		 11 11
        Male
    		 16 16
    History of recurrent CDI in the last 12 months
    Units: Subjects
        none
    		 20 20
        1 previous
    		 7 7
    Baseline Severity - Modified ESCMID scale
    Units: Subjects
        Mild
    		 18 18
        Moderate
    		 7 7
        Severe
    		 2 2
    Prior antibiotic treatments for current CDI occurence
    Units: Subjects
        Vancomycin
    		 7 7
        Metronidazole
    		 6 6
        Fidaxomicin
    		 3 3
        Vancomycin + Metronidazole
    		 2 2
        None
    		 9 9
    Subject analysis sets

    Subject analysis set title
    Ridinilazole
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Subjects from ridinilazole arm

    Subject analysis set title
    Fidaxomicin
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Subjects from fidaxomicin arm

    Subject analysis sets values
    		 Ridinilazole Fidaxomicin
    Number of subjects
    14
    13
    Age categorical
    Units: Subjects
        <65
    4
    7
        65 to <75
    6
    2
        >=75
    4
    4
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    68.1 ± 17.82
    66.3 ± 12.89
    Gender categorical
    Units: Subjects
        Female
    7
    4
        Male
    7
    9
    History of recurrent CDI in the last 12 months
    Units: Subjects
        none
    10
    10
        1 previous
    4
    3
    Baseline Severity - Modified ESCMID scale
    Units: Subjects
        Mild
    9
    9
        Moderate
    3
    4
        Severe
    2
    0
    Prior antibiotic treatments for current CDI occurence
    Units: Subjects
        Vancomycin
    4
    3
        Metronidazole
    4
    2
        Fidaxomicin
    1
    2
        Vancomycin + Metronidazole
    0
    2
        None
    5
    4

    End points

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    End points reporting groups
    Reporting group title
    Ridinilazole
    Reporting group description
    		 Subjects in this group received ridinilazole 200 mg BID for 10 days

    Reporting group title
    Fidaxomicin
    Reporting group description
    		 Subjects in this group received fidaxomicin 200 mg BID for 10 days

    Subject analysis set title
    Ridinilazole
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Subjects from ridinilazole arm

    Subject analysis set title
    Fidaxomicin
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Subjects from fidaxomicin arm

    Primary: Safety as assessed by the number of adverse events and SAEs reported during the study

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    End point title
    		 Safety as assessed by the number of adverse events and SAEs reported during the study [1]
    End point description
    The primary endpoint was the occurrence of adverse events and SAEs reported during the study. Treatment-emergent adverse events (TEAEs) were adverse events that started or increased in severity on or after the first dose of study drug. Adverse events were reported as study drug related (DR) if the Investigator judged them as at least possibly related to study drug.
    End point type
    Primary
    End point timeframe
    From first dose of study drug to 30 days after last dose of study drug (up to 40 days)
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The data were summarised and no statistical analyses were performed.
    End point values
    		 Ridinilazole Fidaxomicin
    Number of subjects analysed
    14
    13
    Units: Subjects
        Deaths
    1
    1
        Number of subjects with TEAEs
    14
    11
        Maximum Severity: Mild
    4
    6
        Maximum Severity: Moderate
    5
    2
        Maximum Severity: Severe
    5
    3
        Number of subjects with DR TEAEs
    3
    1
        DR Maximum Severity: Mild
    0
    0
        DR Maximum Severity: Moderate
    2
    1
        DR Maximum Severity: Severe
    1
    0
        Number of subjects with serious TEAEs
    4
    3
        Number of subjects with serious DR TEAEs
    1
    0
        Number of discontinuations due to TEAEs
    0
    0
    No statistical analyses for this end point

    Secondary: Sustained Clinical Response

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    End point title
    		 Sustained Clinical Response
    End point description
    Sustained clinical response was defined as clinical cure at test-of-cure (TOC) and no recurrence of CDI within 30 days post end of treatment (EOT). Clinical cure at TOC was assessed by the investigator and was defined as the resolution of diarrhoea (<=3 UBMs in a 24-hour period or 200 mL unformed stool for subjects using rectal collection devices) while on treatment that was maintained until TOC (Day 12). Recurrence was defined as a new episode of diarrhoea between TOC and End of Study (Day 40 [ie, 30 days post-EOT]) that resulted in the subject receiving antimicrobial treatment active against C. difficile prior to EOS.
    End point type
    Secondary
    End point timeframe
    Till 30 days post End of Treatment (EOT)
    End point values
    		 Ridinilazole Fidaxomicin
    Number of subjects analysed
    14
    13
    Units: Percentage
    number (confidence interval 95%)
        Success Rate (%)
    50 (23 to 77)
    46.2 (19.2 to 74.9)
    Statistical analysis title
    		 Comparison of Success Rates
    Statistical analysis description
    95% CI was obtained based on the stratified (<75 and ≥ 75 years of age) Miettinen and Nurminen method.
    Comparison groups
    Fidaxomicin v Ridinilazole
    Number of subjects included in analysis
    27
    Analysis specification
    Pre-specified
    Analysis type
    		 other [2]
    Method
    Parameter type
    		 Difference (Ridinilazole - Fidaxomicin)
    Point estimate
    2.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -30.8
         upper limit
    		 36.7
    Notes
    [2] - Estimated difference (Ridinilazole - Fidaxomicin) between percentage success rates.

    Secondary: Investigator-assessed Clinical Response at Test-of-Cure (TOC)

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    End point title
    		 Investigator-assessed Clinical Response at Test-of-Cure (TOC)
    End point description
    Clinical cure at TOC was assessed by the investigator and was defined as the resolution of diarrhoea (<= 3 UBMs in a 24-hour period or 200 mL unformed stool for subjects using rectal collection devices) while on treatment that was maintained until TOC (Day 12).
    End point type
    Secondary
    End point timeframe
    Day 12, test-of-cure (TOC) 48 hours after last treatment
    End point values
    		 Ridinilazole Fidaxomicin
    Number of subjects analysed
    14
    13
    Units: Percentage
    number (confidence interval 95%)
        Success Rate (%)
    85.7 (57.2 to 98.2)
    61.5 (31.6 to 86.1)
    Statistical analysis title
    		 Comparison of Success Rates
    Statistical analysis description
    95% CI was obtained based on the stratified (<75 and ≥ 75 years of age) Miettinen and Nurminen method.
    Comparison groups
    Ridinilazole v Fidaxomicin
    Number of subjects included in analysis
    27
    Analysis specification
    Pre-specified
    Analysis type
    		 other [3]
    Method
    Parameter type
    		 Difference (Ridinilazole - Fidaxomicin)
    Point estimate
    21.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -9.7
         upper limit
    		 52.7
    Notes
    [3] - Estimated difference (Ridinilazole - Fidaxomicin) between percentage success rates.

    Secondary: Ridinilazole plasma Concentrations (Sparse Sampling)

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    End point title
    		 Ridinilazole plasma Concentrations (Sparse Sampling) [4]
    End point description
    Values below the limit of quantification (0.1 ng/mL) have been taken as 0 in the calculations.
    End point type
    Secondary
    End point timeframe
    Sparse samples collected till Day 12. Samples could be taken on Day 1 or Day 2, as well as Days 5, 10 and 12.
    Notes
    [4] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Only Ridinilazole treated subjects would have Ridinilazole concentrations.
    End point values
    		 Ridinilazole
    Number of subjects analysed
    14
    Units: ng/mL
    median (full range (min-max))
        Day 1/2 - 4 hours post-dose
    0 (0 to 0.279)
        Day 5 - 4 hours post-dose
    0.162 (0 to 0.515)
        Day 10 (EOT) - 4 hours post-dose
    0.149 (0 to 0.418)
        Day 12 (TOC)
    0 (0 to 0.157)
    No statistical analyses for this end point

    Secondary: Ridinilazole Faecal Concentrations (Sparse Sampling)

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    End point title
    		 Ridinilazole Faecal Concentrations (Sparse Sampling) [5]
    End point description
    Values below the limit of quantification (20.0 mcg/g) have been taken as 0 in the calculations.
    End point type
    Secondary
    End point timeframe
    Sparse samples collected till Day 12.
    Notes
    [5] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Only Ridinilazole treated subjects would have Ridinilazole concentrations.
    End point values
    		 Ridinilazole
    Number of subjects analysed
    14
    Units: μg/g
    median (full range (min-max))
        Screening
    0 (0 to 0)
        Day 5
    530 (0 to 5570)
        Day 10 (EOT)
    1060 (169 to 2400)
        Day 12 (TOC)
    47 (0 to 2790)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From first dose of study drug to 30 days after last dose of study drug (up to 40 days)
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    17.0
    Reporting groups
    Reporting group title
    Ridinilazole
    Reporting group description
    		 Subjects in this group received ridinilazole 200 mg BID for 10 days

    Reporting group title
    Fidaxomicin
    Reporting group description
    		 Subjects in this group received fidaxomicin 200 mg BID for 10 days

    Serious adverse events
    		 Ridinilazole Fidaxomicin
    Total subjects affected by serious adverse events
         subjects affected / exposed
    4 / 14 (28.57%)
    3 / 13 (23.08%)
         number of deaths (all causes)
    1
    1
         number of deaths resulting from adverse events
    1
    1
    Investigations
    Hepatic enzyme increased
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 13 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Acute myocardial infarction
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 13 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac failure
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 13 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Acute coronary syndrome
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 13 (7.69%)
         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
    Bone marrow failure
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 13 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Gastritis
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 13 (7.69%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haematemesis
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 13 (7.69%)
         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 / 14 (0.00%)
    1 / 13 (7.69%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Respiratory, thoracic and mediastinal disorders
    Chronic obstructive pulmonary disease
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 13 (7.69%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Lobar pneumonia
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 13 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lower respiratory tract infection
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 13 (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: 0%
    Non-serious adverse events
    		 Ridinilazole Fidaxomicin
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    14 / 14 (100.00%)
    10 / 13 (76.92%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Oesophageal adenocarcinoma
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    1
    Vascular disorders
    Hypotension
         subjects affected / exposed
    2 / 14 (14.29%)
    0 / 13 (0.00%)
         occurrences all number
    2
    0
    General disorders and administration site conditions
    Application site pain
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 13 (0.00%)
         occurrences all number
    1
    0
    Catheter site haemorrhage
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 13 (0.00%)
         occurrences all number
    1
    0
    Chest pain
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 13 (0.00%)
         occurrences all number
    1
    0
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 13 (0.00%)
         occurrences all number
    1
    0
    Lung consolidation
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    1
    Psychiatric disorders
    Disorientation
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 13 (0.00%)
         occurrences all number
    1
    0
    Investigations
    Blood albumin decreased
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 13 (0.00%)
         occurrences all number
    1
    0
    Blood potassium decreased
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 13 (0.00%)
         occurrences all number
    1
    0
    Haemoglobin decreased
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 13 (0.00%)
         occurrences all number
    1
    0
    Pus in stool
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    1
    Weight decreased
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    1
    Injury, poisoning and procedural complications
    Accidental overdose
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 13 (0.00%)
         occurrences all number
    1
    0
    Arthropod sting
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 13 (0.00%)
         occurrences all number
    1
    0
    Sunburn
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 13 (0.00%)
         occurrences all number
    1
    0
    Laceration
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    1
    Nervous system disorders
    Headache
         subjects affected / exposed
    1 / 14 (7.14%)
    1 / 13 (7.69%)
         occurrences all number
    3
    2
    Dizziness
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 13 (0.00%)
         occurrences all number
    2
    0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    2 / 14 (14.29%)
    0 / 13 (0.00%)
         occurrences all number
    2
    0
    Eye disorders
    Dry eye
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 13 (0.00%)
         occurrences all number
    1
    0
    Eye pruritus
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 13 (0.00%)
         occurrences all number
    1
    0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    5 / 14 (35.71%)
    2 / 13 (15.38%)
         occurrences all number
    8
    2
    Diarrhoea
         subjects affected / exposed
    3 / 14 (21.43%)
    1 / 13 (7.69%)
         occurrences all number
    4
    1
    Frequent bowel movements
         subjects affected / exposed
    2 / 14 (14.29%)
    0 / 13 (0.00%)
         occurrences all number
    2
    0
    Nausea
         subjects affected / exposed
    2 / 14 (14.29%)
    0 / 13 (0.00%)
         occurrences all number
    2
    0
    Abdominal distension
         subjects affected / exposed
    1 / 14 (7.14%)
    1 / 13 (7.69%)
         occurrences all number
    1
    4
    Constipation
         subjects affected / exposed
    1 / 14 (7.14%)
    1 / 13 (7.69%)
         occurrences all number
    2
    1
    Flatulence
         subjects affected / exposed
    1 / 14 (7.14%)
    1 / 13 (7.69%)
         occurrences all number
    1
    1
    Haematochezia
         subjects affected / exposed
    1 / 14 (7.14%)
    1 / 13 (7.69%)
         occurrences all number
    1
    1
    Abdominal pain upper
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 13 (0.00%)
         occurrences all number
    1
    0
    Gastrointestinal sounds abnormal
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 13 (0.00%)
         occurrences all number
    1
    0
    Tongue ulceration
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 13 (0.00%)
         occurrences all number
    1
    0
    Gastrooesophageal reflux disease
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    1
    Haematemesis
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    1
    Haemorrhoids
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    1
    Odynophagia
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    1
    Rectal discharge
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    1
    Hepatobiliary disorders
    Biliary dilatation
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    1
    Skin and subcutaneous tissue disorders
    Rash
         subjects affected / exposed
    1 / 14 (7.14%)
    1 / 13 (7.69%)
         occurrences all number
    1
    1
    Blister
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 13 (0.00%)
         occurrences all number
    1
    0
    Erythema
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 13 (0.00%)
         occurrences all number
    1
    0
    Renal and urinary disorders
    Micturition urgency
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 13 (0.00%)
         occurrences all number
    1
    0
    Tubulointerstitial nephritis
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 13 (0.00%)
         occurrences all number
    1
    0
    Renal injury
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    1
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 13 (0.00%)
         occurrences all number
    1
    0
    Musculoskeletal pain
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 13 (0.00%)
         occurrences all number
    1
    0
    Osteoarthritis
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 13 (0.00%)
         occurrences all number
    1
    0
    Pain in extremity
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 13 (0.00%)
         occurrences all number
    1
    0
    Musculoskeletal chest pain
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    1
    Neck pain
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    1
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    2 / 14 (14.29%)
    0 / 13 (0.00%)
         occurrences all number
    2
    0
    Urosepsis
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 13 (0.00%)
         occurrences all number
    1
    0
    Genital candidiasis
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    1
    Influenza
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    1
    Wound infection
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    1
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    3 / 14 (21.43%)
    0 / 13 (0.00%)
         occurrences all number
    3
    0
    Dehydration
         subjects affected / exposed
    2 / 14 (14.29%)
    0 / 13 (0.00%)
         occurrences all number
    2
    0
    Gout
         subjects affected / exposed
    2 / 14 (14.29%)
    0 / 13 (0.00%)
         occurrences all number
    2
    0
    Hypokalaemia
         subjects affected / exposed
    1 / 14 (7.14%)
    1 / 13 (7.69%)
         occurrences all number
    1
    1
    Hypophosphataemia
         subjects affected / exposed
    1 / 14 (7.14%)
    1 / 13 (7.69%)
         occurrences all number
    1
    1
    Hypomagnesaemia
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 13 (0.00%)
         occurrences all number
    1
    0
    Hyponatraemia
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 13 (0.00%)
         occurrences all number
    1
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    21 Jul 2015
    The main changes to the protocol are: - Removing reference to a modified ITT. - The Intensive PK sampling was changed from required to optional with only a sparse PK sampling required. - Location for the clinical study was expanded to Europe. - Allows a subject to have legal representative provide consent if they are unable to due to their medical condition. - Allows for positive CDI diagnostics to be within the 72 hours prior to randomization instead of 48 hours. - Widened visit windows for Day 5, 7, 10 and 12.
    30 Mar 2016
    The changes to the protocol are summarised below: - Removal of reference to the faecal test by Glutamate Dehydrogenase due to inclusion of sites from outside Europe. This has been replaced by a requirement for a positive diagnostic result. This affects inclusion criteria number 2 and the recurrence definition. - Inclusion of Alere C Diff Quik Check to determine free toxin status at baseline and recurrence. - Removal of cytokine analysis.

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

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

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