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    Clinical Trial Results:
    A randomised placebo controlled trial of follow on Rifaximin for the prevention of relapse of Clostridium difficile associated diarrhoea.

    Summary
    EudraCT number
    2012-003205-10
    Trial protocol
    GB  
    Global end of trial date
    14 Jul 2016

    Results information
    Results version number
    v3(current)
    This version publication date
    22 Sep 2019
    First version publication date
    31 Dec 2018
    Other versions
    v1 , v2
    Version creation reason
    • Correction of full data set
    Correction of dates in results analysis stage section Correction of p-value for primary analysis. Correction of adverse event data. Addition of protocol amendment information
    Summary report(s)
    RAPID trial published in Gut

    Trial information

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    Trial identification
    Sponsor protocol code
    12072
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    -
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    University of Nottingham
    Sponsor organisation address
    Kingsmeadow campus, Nottingham, United Kingdom, NG7 2NR
    Public contact
    Spiller, University of Nottingham, 44 01158231090, robin.spiller@nottingham.ac.uk
    Scientific contact
    Spiller, University of Nottingham, 44 01158231090, robin.spiller@nottingham.ac.uk
    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
    23 Aug 2016
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    14 Jul 2016
    Global end of trial reached?
    Yes
    Global end of trial date
    14 Jul 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To look at whether a course of Rifaximin after a patient has been successfully treated for C.difficile diarrhoeal infection with a standard course of antibiotics can reduce the rate of the infection returning (recurrence)
    Protection of trial subjects
    Usual measures Very safe drug so risk small
    Background therapy
    None
    Evidence for comparator
    Placebo controlled as unclear if intervention was beneficial
    Actual start date of recruitment
    11 Dec 2012
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United Kingdom: 151
    Worldwide total number of subjects
    151
    EEA total number of subjects
    151
    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)
    41
    From 65 to 84 years
    80
    85 years and over
    30

    Subject disposition

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    Recruitment
    Recruitment details
    Participants were recruited between 11 December 2012 and 7 March 2016. Those eligible for inclusion (see online supplementary file 1) were adults aged 18 years or older with a confirmed case of CDI that was successfully treated with metronidazole or vancomycin. This included primary, recurrent and multiply recurrent CDI episodes.

    Pre-assignment
    Screening details
    Participants were recruited between 11 December 2012 and 7 March 2016. Those eligible for inclusion (see online supplementary file 1) were adults aged 18 years or older with a confirmed case of CDI that was successfully treated with metronidazole or vancomycin. This included primary, recurrent and multiply recurrent CDI episodes.

    Pre-assignment period milestones
    Number of subjects started
    2157 [1]
    Number of subjects completed
    151

    Pre-assignment subject non-completion reasons
    Reason: Number of subjects
    did not meet eligibility: 736
    Reason: Number of subjects
    declined to participate: 460
    Reason: Number of subjects
    other: 443
    Reason: Number of subjects
    consent unobtainable: 138
    Reason: Number of subjects
    unable to contact: 136
    Reason: Number of subjects
    unknown: 93
    Notes
    [1] - The number of subjects reported to have started the pre-assignment period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: 2157 were screened but only 151 were randomised
    Period 1
    Period 1 title
    overall trial (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Randomised - controlled
    Blinding used
    Double blind
    Roles blinded
    Subject, Investigator, Monitor, Data analyst, Carer, Assessor
    Blinding implementation details
    Participants were given 126 tablets, containing either rifaximin 200 mg or an identical placebo formulation.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Placebo
    Arm description
    Identical tablets to active
    Arm type
    Placebo

    Investigational medicinal product name
    placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    2 tablets t.d.s. for 2 weeks then 1 tablet t.d.s. for 2 weeks

    Arm title
    Active
    Arm description
    The intended treatment regime was two tablets (400 mg rifaximin) taken three times a day for 14 days, reduced to one tablet (200 mg) three times a day for a further 14 days.
    Arm type
    Active comparator

    Investigational medicinal product name
    Rifaximin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    two tablets (400 mg rifaximin) taken three times a day for 14 days, reduced to one tablet (200 mg) three times a day for a further 14 days.

    Number of subjects in period 1
    Placebo Active
    Started
    74
    77
    Completed
    61
    69
    Not completed
    13
    8
         death
    5
    1
         Consent withdrawn by subject
    8
    7

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo
    Reporting group description
    Identical tablets to active

    Reporting group title
    Active
    Reporting group description
    The intended treatment regime was two tablets (400 mg rifaximin) taken three times a day for 14 days, reduced to one tablet (200 mg) three times a day for a further 14 days.

    Reporting group values
    Placebo Active Total
    Number of subjects
    74 77 151
    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)
    19 22 41
        From 65-84 years
    45 35 80
        85 years and over
    10 20 30
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    71.5 ± 14.8 72.2 ± 15.8 -
    Gender categorical
    Units: Subjects
        Female
    45 39 84
        Male
    29 38 67

    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    Identical tablets to active

    Reporting group title
    Active
    Reporting group description
    The intended treatment regime was two tablets (400 mg rifaximin) taken three times a day for 14 days, reduced to one tablet (200 mg) three times a day for a further 14 days.

    Primary: CDI recurrence within 12 weeks of randomisation.

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    End point title
    CDI recurrence within 12 weeks of randomisation.
    End point description
    The primary outcome was CDI recurrence within 12 weeks of randomisation. A recurrence was defined as three or more loose stools for two or more days in conjunction with a positive stool toxin assay. The primary outcome was determined by research nurses in each site confirming stool frequency with the study subject by direct questioning, together with the laboratory results.
    End point type
    Primary
    End point timeframe
    12 weeks
    End point values
    Placebo Active
    Number of subjects analysed
    61 [1]
    69
    Units: number of patients in whom CDI recurred
        CDI recurrence within 12 weeks
    18
    11
    Notes
    [1] - 8 withdrew 5 died
    Statistical analysis title
    Primary analysis
    Statistical analysis description
    All analyses were conducted according to allocated group (placebo or rifaximin) regardless of the amount of tablets actually taken. The primary analysis estimated the difference in percentage CDI recurrence between rifaximin and placebo groups at 12 weeks without imputation of missing outcome data. A generalised estimating equation was used with binomial family, identity link and an exchangeable correlation matrix to account for randomisation being stratified by hospital.
    Comparison groups
    Placebo v Active
    Number of subjects included in analysis
    130
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.06
    Method
    Generalised Estimating Equations
    Parameter type
    Risk difference (RD)
    Point estimate
    -13.7
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -28.1
         upper limit
    0.7

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Serious adverse events reported up to 6 month visit Non serious adverse events reported up to week 8 visit
    Adverse event reporting additional description
    In the results paper in Gut (2018, http:// dx.doi.org/10. 1136/gutjnl-2018-316794), SAEs and AEs were reported according to date of onset: starting up to 28 days post-randomisation (ie, during the treatment period) and starting 29 days or more after randomisation.
    Assessment type
    Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    15/17.1
    Reporting groups
    Reporting group title
    placebo
    Reporting group description
    Participants taking at least one dose

    Reporting group title
    rifaximin
    Reporting group description
    Participants taking at least one dose

    Serious adverse events
    placebo rifaximin
    Total subjects affected by serious adverse events
         subjects affected / exposed
    32 / 68 (47.06%)
    32 / 73 (43.84%)
         number of deaths (all causes)
    7
    9
         number of deaths resulting from adverse events
    7
    9
    Vascular disorders
    Deep vein thrombosis
         subjects affected / exposed
    1 / 68 (1.47%)
    0 / 73 (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 / 68 (0.00%)
    1 / 73 (1.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Surgical and medical procedures
    Prepuce dorsal slit
         subjects affected / exposed
    1 / 68 (1.47%)
    0 / 73 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Stent placement
         subjects affected / exposed
    1 / 68 (1.47%)
    0 / 73 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ureteric calculus removal
         subjects affected / exposed
    1 / 68 (1.47%)
    0 / 73 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Chest pain
         subjects affected / exposed
    0 / 68 (0.00%)
    3 / 73 (4.11%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Adverse drug reaction
         subjects affected / exposed
    1 / 68 (1.47%)
    0 / 73 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Asthenia
         subjects affected / exposed
    1 / 68 (1.47%)
    0 / 73 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Death
         subjects affected / exposed
    0 / 68 (0.00%)
    1 / 73 (1.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Pyrexia
         subjects affected / exposed
    2 / 68 (2.94%)
    2 / 73 (2.74%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Suprapubic pain
         subjects affected / exposed
    1 / 68 (1.47%)
    0 / 73 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    Confusional state
         subjects affected / exposed
    0 / 68 (0.00%)
    1 / 73 (1.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Fall
         subjects affected / exposed
    3 / 68 (4.41%)
    0 / 73 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Hip fracture
         subjects affected / exposed
    0 / 68 (0.00%)
    1 / 73 (1.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Overdose
         subjects affected / exposed
    0 / 68 (0.00%)
    1 / 73 (1.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pelvic fracture
         subjects affected / exposed
    0 / 68 (0.00%)
    1 / 73 (1.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Subdural haematoma
         subjects affected / exposed
    0 / 68 (0.00%)
    1 / 73 (1.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Toxicity to various agents
         subjects affected / exposed
    0 / 68 (0.00%)
    1 / 73 (1.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary tract stoma complication
         subjects affected / exposed
    1 / 68 (1.47%)
    0 / 73 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Cardiac failure
         subjects affected / exposed
    0 / 68 (0.00%)
    1 / 73 (1.37%)
         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
    0 / 68 (0.00%)
    1 / 73 (1.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Chronic obstructive pulmonary disease
         subjects affected / exposed
    2 / 68 (2.94%)
    1 / 73 (1.37%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Dyspnoea
         subjects affected / exposed
    1 / 68 (1.47%)
    2 / 73 (2.74%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia aspiration
         subjects affected / exposed
    0 / 68 (0.00%)
    1 / 73 (1.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Nervous system disorders
    Dementia Alzheimer's type
         subjects affected / exposed
    0 / 68 (0.00%)
    1 / 73 (1.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    1 / 68 (1.47%)
    1 / 73 (1.37%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ascites
         subjects affected / exposed
    1 / 68 (1.47%)
    0 / 73 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal haemorrhage
         subjects affected / exposed
    0 / 68 (0.00%)
    1 / 73 (1.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Intestinal perforation
         subjects affected / exposed
    1 / 68 (1.47%)
    0 / 73 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Megacolon
         subjects affected / exposed
    1 / 68 (1.47%)
    0 / 73 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancreatitis
         subjects affected / exposed
    0 / 68 (0.00%)
    1 / 73 (1.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Retroperitoneal fibrosis
         subjects affected / exposed
    0 / 68 (0.00%)
    1 / 73 (1.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Upper gastrointestinal haemorrhage
         subjects affected / exposed
    1 / 68 (1.47%)
    0 / 73 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Renal failure
         subjects affected / exposed
    2 / 68 (2.94%)
    1 / 73 (1.37%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haematuria
         subjects affected / exposed
    0 / 68 (0.00%)
    1 / 73 (1.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal injury
         subjects affected / exposed
    1 / 68 (1.47%)
    0 / 73 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Alcoholic liver disease
         subjects affected / exposed
    1 / 68 (1.47%)
    0 / 73 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Chronic hepatic failure
         subjects affected / exposed
    1 / 68 (1.47%)
    0 / 73 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    0 / 68 (0.00%)
    1 / 73 (1.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal chest pain
         subjects affected / exposed
    0 / 68 (0.00%)
    1 / 73 (1.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Dehydration
         subjects affected / exposed
    1 / 68 (1.47%)
    0 / 73 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypoglycaemia
         subjects affected / exposed
    1 / 68 (1.47%)
    0 / 73 (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
    Pneumonia
         subjects affected / exposed
    1 / 68 (1.47%)
    1 / 73 (1.37%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Diverticulitis
         subjects affected / exposed
    0 / 68 (0.00%)
    1 / 73 (1.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cellulitis
         subjects affected / exposed
    0 / 68 (0.00%)
    2 / 73 (2.74%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infection
         subjects affected / exposed
    1 / 68 (1.47%)
    0 / 73 (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 / 68 (1.47%)
    0 / 73 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Clostridium difficile colitis
         subjects affected / exposed
    5 / 68 (7.35%)
    3 / 73 (4.11%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Clostridium difficile infection
         subjects affected / exposed
    4 / 68 (5.88%)
    7 / 73 (9.59%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 8
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    2 / 68 (2.94%)
    1 / 73 (1.37%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis viral
         subjects affected / exposed
    0 / 68 (0.00%)
    1 / 73 (1.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Klebsiella infection
         subjects affected / exposed
    0 / 68 (0.00%)
    1 / 73 (1.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lower respiratory tract infection
         subjects affected / exposed
    1 / 68 (1.47%)
    2 / 73 (2.74%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Sepsis
         subjects affected / exposed
    2 / 68 (2.94%)
    2 / 73 (2.74%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Septic shock
         subjects affected / exposed
    0 / 68 (0.00%)
    1 / 73 (1.37%)
         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
    1 / 68 (1.47%)
    2 / 73 (2.74%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Urinary tract infection fungal
         subjects affected / exposed
    1 / 68 (1.47%)
    0 / 73 (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
    placebo rifaximin
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    9 / 68 (13.24%)
    8 / 73 (10.96%)
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    6 / 68 (8.82%)
    3 / 73 (4.11%)
         occurrences all number
    7
    5
    Infections and infestations
    Urinary tract infection
         subjects affected / exposed
    4 / 68 (5.88%)
    5 / 73 (6.85%)
         occurrences all number
    4
    5

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    23 Aug 2013
    The diaries, blood and stool sampling were made optional; and the protocol, PIS and CFs amended to reflect this. Some of the secondary endpoints and eligibility criteria re-worded to reflect this or to provide clarification.
    13 Jan 2015
    Removal of the exclusion criterion: ‘5) unable to stop chronic antibiotic use’. Update so that Patient Invite Letter could be sent directly to community patients testing positive for C. difficile (previously through GP practices). Notification of extension of trial to September 2016.
    02 Oct 2015
    Addition of the exclusion criterion: ‘8) Taking ciclosporin’ Introduction of voucher payments to participants in recognition of their contribution to the trial.

    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.
    did not achieve intended recruitment numbers which were 180

    Online references

    http://www.ncbi.nlm.nih.gov/pubmed/30254135
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