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    Clinical Trial Results:
    Treatment of MRSA throat carriage with mupirocin irrigation

    Summary
    EudraCT number
    		 2014-005308-12
    Trial protocol
    		 DK  
    Global end of trial date
    01 Dec 2020

    Results information
    Results version number
    		 v1(current)
    This version publication date
    19 Dec 2021
    First version publication date
    19 Dec 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    1111
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Region Sjælland, Slagelse Hospital
    Sponsor organisation address
    Ingemannsvej 18, Slagelse, Denmark, 4200
    Public contact
    Head of Research and Innovation, Region Sjælland, Operations, Research and Innovation, 45 58559404, insp@regionsjaelland.dk
    Scientific contact
    Head of Research and Innovation, Region Sjælland, Operations, Research and Innovation, 45 58559404, insp@regionsjaelland.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
    01 Jun 2021
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    17 Sep 2020
    Global end of trial reached?
    Yes
    Global end of trial date
    01 Dec 2020
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To determine if irrigation and wash of, respectively, the rhinopharynx and mouth with dissolved mupirocin is a feasible and potentially effi cacious supplementary strategy against treatment resistant MRSA throat carriage.
    Protection of trial subjects
    The patient was given all treatment instruction, including irrigation technique by a personal visit of the sponsor. Furthermore, the infection control nurse contacted the patient by phone in the beginning, in the middle and in the end of the treatment period, to ask how the treatment was going and to answer any questions the patient might have.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 May 2018
    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
    Denmark: 20
    Worldwide total number of subjects
    20
    EEA total number of subjects
    20
    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)
    14
    From 65 to 84 years
    6
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 The study was performed at the outpatient MRSA sections of three Departments of Clinical Microbiology (Slagelse Hospital, Herlev Hospital, and Hvidovre Hospital) covering all outpatients in two neighboring regions of East-Denmark; Region Zealand and The Capital Region. Approximately 2,7 million citizens live in these two regions.

    Pre-assignment
    Screening details
    		 The design and study group was an open, non-blinded, trial of a cohort of 20 patients. None of the patients were hospitalized and all were living in their own home. All patients received the same treatment. Inclusion of patients was done by medical assessment in the two regions in the participating MRSA units and microbiological departments.

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded
    Blinding implementation details
    No blinding

    Arms
    Arm title
    		 End-point data
    Arm description
    		 -
    Arm type
    		 All subjects

    Investigational medicinal product name
    mupirocin ointment (22 g 2% ointment per liter of isotonic sterile saline solution) in a 37 degrees Celsius solution
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Nasal/oromucosal spray, solution, Gargle/mouthwash
    Routes of administration
    Other use
    Dosage and administration details
    For each patient, mupirocin ointment 2% (GlaxoSmithKline) was dispensed into 28 small bottles for treatments twice a day in 14 days, each bottle with an amount of ointment equivalent to a treatment. The ointment from a bottle was by the patient mixed with 37o C 120 ml of a sterile fluid of saline 0.9% prior to each treatment to achieve the right amount of mupirocin solution (22 g 2% ointment per liter of isotonic sterile saline solution) [9]. The temperature of the solution was controlled by a thermometer that each patient received prior to the treatment. The patient performed rhinopharynx irrigation and mouth gurgling with a mupirocin solution every morning and evening for 14 days. Rhinopharynx irrigation was performed using a Neti pot (Rhinohorn, Yogaprosess AS, Norway) through each nostril with 50 mL mupirocin solution twice daily, and also mouth gurgle with 20 ml mupirocin solution in 20 seconds was done twice daily.

    Number of subjects in period 1
    		End-point data
    Started
    20
    Completed
    18
    Not completed
    2
         Protocol deviation
    2

    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
    		 20 20
    Age categorical
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 14 14
        From 65-84 years
    		 6 6
        85 years and over
    		 0 0
    Gender categorical
    Units: Subjects
        Female
    		 12 12
        Male
    		 8 8

    End points

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    End points reporting groups
    Reporting group title
    End-point data
    Reporting group description
    		 -

    Primary: Number of trail subjects with negativ MRSA podning at 6 months

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    End point title
    		 Number of trail subjects with negativ MRSA podning at 6 months [1]
    End point description
    Before start of treatment, as well as six months after end of treatment, swabs were collected from nose, throat and perineum (the latter only one time before start of treatment) by the patients general practitioner as recommended in “Guidance on preventing the spread of MRSA” by the Danish Health Authority [2]. All samples were collected using ESwab (COPAN Diagnostics, Murrieta, California).
    End point type
    Primary
    End point timeframe
    6 months after intervention
    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: Please see the attachment. Result
    End point values
    		 End-point data
    Number of subjects analysed
    15
    Units: Number
    7
    Attachments
    		 Result
    No statistical analyses for this end point

    Secondary: Number of trail subjects with negativ MRSA podning at 1 month

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    End point title
    		 Number of trail subjects with negativ MRSA podning at 1 month
    End point description
    Before start of treatment and after one month after end of treatment, swabs were collected from nose, throat and perineum (the latter only one time before start of treatment) by the patients general practitioner as recommended in “Guidance on preventing the spread of MRSA” by the Danish Health Authority [2]. All samples were collected using ESwab (COPAN Diagnostics, Murrieta, California).
    End point type
    Secondary
    End point timeframe
    Number of subjects with a negative MRSA podning one month after intervention
    End point values
    		 End-point data
    Number of subjects analysed
    18
    Units: Number
    15
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From informed consent to end of intervention
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    0
    Reporting groups
    Reporting group title
    All trail
    Reporting group description
    		 -

    Serious adverse events
    		 All trail
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 18 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 1%
    Non-serious adverse events
    		 All trail
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    7 / 18 (38.89%)
    Nervous system disorders
    headache
         subjects affected / exposed
    3 / 18 (16.67%)
         occurrences all number
    2
    Respiratory, thoracic and mediastinal disorders
    Fluid running from the nose
         subjects affected / exposed
    3 / 18 (16.67%)
         occurrences all number
    2
    Few episodes with sneezing
         subjects affected / exposed
    2 / 18 (11.11%)
         occurrences all number
    2
    Metabolism and nutrition disorders
    Bad taste in the mouth
         subjects affected / exposed
    2 / 18 (11.11%)
         occurrences all number
    2

    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.
    None reported

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/34699965
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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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