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    Clinical Trial Results:
    Immunoglobulin for Necrotizing Soft Tissue Infections: a Randomised Controlled Trial

    Summary
    EudraCT number
    		 2013-003556-20
    Trial protocol
    		 DK  
    Global end of trial date
    28 Aug 2016

    Results information
    Results version number
    		 v1(current)
    This version publication date
    31 Mar 2018
    First version publication date
    31 Mar 2018
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    RH4131-03
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02111161
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Dept. of Intensive Care 4131, Copenhagen University Hospital, Rigshospitalet
    Sponsor organisation address
    Blegdamsvej 9, Copenhagen, Denmark, 2100
    Public contact
    Forskningskontoret, Dept. of Intensive Care 4131, Copenhagen University Hospital, Rigshospitalet, 0045 35454131, martin.bruun.madsen.01@regionh.dk
    Scientific contact
    Forskningskontoret, Dept. of Intensive Care 4131, Copenhagen University Hospital, Rigshospitalet, 0045 35454131, martin.bruun.madsen.01@regionh.dk
    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
    27 Sep 2016
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    28 Aug 2016
    Global end of trial reached?
    Yes
    Global end of trial date
    28 Aug 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To estimate the effect of intravenous, polyspecific immunoglobulin G compared with placebo on the patient reported outcome measure Physical Component Summary Score (PCS) of the Short Form-36 (SF-36) in patients with necrotizing soft tissue infections.
    Protection of trial subjects
    Stanard care.
    Background therapy
    		 Standard care.
    Evidence for comparator
    		 -
    Actual start date of recruitment
    07 Apr 2014
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Efficacy
    Long term follow-up duration
    		 6 Months
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Denmark: 100
    Worldwide total number of subjects
    100
    EEA total number of subjects
    100
    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)
    62
    From 65 to 84 years
    34
    85 years and over
    4

    Subject disposition

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    Recruitment
    Recruitment details
    		 Patients recruited at Copenhagen University Hospital, Rigshospitalet. First patient included 7 April 2014, last patient included 1 March 2016.

    Pre-assignment
    Screening details
    		 All patients with suspected necrotizing soft tissue infection were screened. A total of 129 patients were screened.

    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
    A ICU nurse not otherwise involved in the care of the patient who both IVIG and 0.9% saline in a black, opaque plastic bag, inserted an orange-coloured infusion set into the allocated intervention (IVIG or saline) and sealed the bag with a plastic strip.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 IVIG
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Intravenous, polyspecific immunoglobulin G
    Investigational medicinal product code
    Other name
    IVIG
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    IVIG (Privigen, CSL Behring, Bern, Switzerland), 25 g/day for three consecutive days.

    Arm title
    		 Placebo
    Arm description
    		 -
    Arm type
    		 Placebo

    Investigational medicinal product name
    Saline 0.9%
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Saline 0.9%, 250 ml for three consecutive days.

    Number of subjects in period 1
    		IVIG Placebo
    Started
    50
    50
    Completed
    50
    50

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    IVIG
    Reporting group description
    		 -

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Reporting group values
    		 IVIG Placebo Total
    Number of subjects
    		 50 50 100
    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)
    		 30 32 62
        From 65-84 years
    		 16 18 34
        85 years and over
    		 4 0 4
    Age continuous
    Units: years
        median (inter-quartile range (Q1-Q3))
    		 59 (50 to 69) 61 (50 to 71) -
    Gender categorical
    Units: Subjects
        Female
    		 20 18 38
        Male
    		 30 32 62

    End points

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    End points reporting groups
    Reporting group title
    IVIG
    Reporting group description
    		 -

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Primary: PCS score of SF-36v2 6 months after randomisation

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    End point title
    		 PCS score of SF-36v2 6 months after randomisation
    End point description
    End point type
    Primary
    End point timeframe
    6 months after randomisation
    End point values
    		 IVIG Placebo
    Number of subjects analysed
    42
    45
    Units: No unit
        median (inter-quartile range (Q1-Q3))
    36 (0 to 43)
    31 (0 to 47)
    Statistical analysis title
    		 Primary analysis
    Statistical analysis description
    The primary analysis of the primary outcome was a regres- sion analysis adjusted for the stratification variable (site of NSTI) in the intention-to-treat population. In
    Comparison groups
    IVIG v Placebo
    Number of subjects included in analysis
    87
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.05
    Method
    		 Regression, Linear
    Parameter type
    		 Mean difference (final values)
    Point estimate
    1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -7
         upper limit
    		 10

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    In the ICU
    Adverse event reporting additional description
    Only SARs and SUSARs were collected as patients were ICU patients
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 Own
    Dictionary version
    1
    Reporting groups
    Reporting group title
    IVIG
    Reporting group description
    		 -

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: Data not collected.
    Serious adverse events
    		 IVIG Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    8 / 50 (16.00%)
    11 / 50 (22.00%)
         number of deaths (all causes)
    6
    6
         number of deaths resulting from adverse events
    0
    0
    Blood and lymphatic system disorders
    Thrombosis
         subjects affected / exposed
    2 / 50 (4.00%)
    3 / 50 (6.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 6
    0 / 6
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    6 / 50 (12.00%)
    8 / 50 (16.00%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 IVIG Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 50 (0.00%)
    0 / 50 (0.00%)

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    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.
    A number of patients recieved IVIG before randomisation.

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/28421246
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