Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43865   clinical trials with a EudraCT protocol, of which   7286   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Download PDF

    Clinical Trial Results:
    Carriage of S. aureus and interaction with the nasal microbiome

    Summary
    EudraCT number
    		 2018-002119-81
    Trial protocol
    		 NL  
    Global end of trial date
    01 Sep 2020

    Results information
    Results version number
    		 v1(current)
    This version publication date
    20 Nov 2021
    First version publication date
    20 Nov 2021
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    MEC-2018-091
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Erasmus MC
    Sponsor organisation address
    Dr. Molewaterplein 40, Rotterdam, Netherlands, 3015 GD
    Public contact
    Medisch Ethische Toetsings Commissie, Erasmus MC, 0031 107033625, metc@erasmusmc.nl
    Scientific contact
    Medisch Ethische Toetsings Commissie, Erasmus MC, 0031 107033625, metc@erasmusmc.nl
    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 Sep 2021
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    01 Sep 2020
    Global end of trial reached?
    Yes
    Global end of trial date
    01 Sep 2020
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To identify nasal microbial communities associated with S. aureus carriage and to study the influence over time of S. aureus targeted decolonization treatment on these microbial communities.
    Protection of trial subjects
    Monitoring of AEs and SAEs, as well as known hypersensitivity reactions and undesirable effects described in the SmPC of the intervention drugs
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Sep 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
    Netherlands: 35
    Worldwide total number of subjects
    35
    EEA total number of subjects
    35
    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)
    34
    From 65 to 84 years
    1
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 Subjects were recruited from the Netherlands between february and june 2019

    Pre-assignment
    Screening details
    		 All subjects were screened for S. aureus carrier status. Max 35 carriers and 35 noncarriers could be included in their respective cohorts for the intervention study. Inclusion: subjects must be over 18 years old Exclusion: antimicrobial drug use, known allergy to the intervention drug, pregnant/breastfeeding women, chronic illness

    Pre-assignment period milestones
    Number of subjects started
    		 35
    Number of subjects completed
    		 19

    Pre-assignment subject non-completion reasons
    Reason: Number of subjects
    		 Consent withdrawn by subject: 4
    Reason: Number of subjects
    		 Not eligible after screening: 11
    Reason: Number of subjects
    		 Lost to follow-up: 1
    Period 1
    Period 1 title
    Intervention period
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Intervention overall
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Bactroban nasal ointment 2%
    Investigational medicinal product code
    RVG13761
    Other name
    Pharmaceutical forms
    Cutaneous/nasal ointment
    Routes of administration
    Cutaneous use, Intranasal use
    Dosage and administration details
    Apply intranasally twice daily for 5 days

    Investigational medicinal product name
    Hibiscrub 4% w/v cutaneous solution
    Investigational medicinal product code
    RVG10156
    Other name
    Pharmaceutical forms
    Cutaneous solution, Cutaneous/oromucosal solution
    Routes of administration
    Cutaneous use
    Dosage and administration details
    Apply on body and hair daily for 5 days

    Number of subjects in period 1 [1]
    		Intervention overall
    Started
    19
    Completed
    18
    Not completed
    1
         Lost to follow-up
    1
    Notes
    [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: The intended target group showed little interest to participate in the study. We were unable to reached the expected number of participants as reported before
    Period 2
    Period 2 title
    Follow-up period
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Follow-up overall
    Arm description
    		 -
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 2
    		Follow-up overall
    Started
    18
    Completed
    17
    Not completed
    1
         Lost to follow-up
    1

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    Intervention period
    Reporting group description
    		 -

    Reporting group values
    		 Intervention period Total
    Number of subjects
    		 19 19
    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)
    		 18 18
        From 65-84 years
    		 1 1
        85 years and over
    		 0 0
    Gender categorical
    Units: Subjects
        Female
    		 13 13
        Male
    		 6 6
    Subject analysis sets

    Subject analysis set title
    Carrier cohort
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Subjects that were defined S. aureus carriers during the screening period

    Subject analysis set title
    Noncarrier cohort
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Subjects that were defined noncarriers during the screening period

    Subject analysis sets values
    		 Carrier cohort Noncarrier cohort
    Number of subjects
    11
    8
    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)
    10
    8
        From 65-84 years
    1
    0
        85 years and over
    0
    0
    Age continuous
    Units:
        
    ±
    ±
    Gender categorical
    Units: Subjects
        Female
    7
    6
        Male
    4
    2

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    Intervention overall
    Reporting group description
    		 -
    Reporting group title
    Follow-up overall
    Reporting group description
    		 -

    Subject analysis set title
    Carrier cohort
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Subjects that were defined S. aureus carriers during the screening period

    Subject analysis set title
    Noncarrier cohort
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Subjects that were defined noncarriers during the screening period

    Primary: Microbiome composition of the nose

    		 Close Top of page
    End point title
    		 Microbiome composition of the nose [1]
    End point description
    Bacterial abundance counted as the number of bacterial species identified in the nasal microbiota of the subjects. Identified species: S. aureus, D. pigrum, M. nonliquefaciens, C. propinquum, C. accolens, C. pseudodiphtheriticum, C. macginleyi, S. epidermidis, C. acnes and others
    End point type
    Primary
    End point timeframe
    Intervention and follow-up period
    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: Form is not suitable to describe our statistical analyses done for the microbiota composition of S. aureus carriers and noncarrier, before and after decolonisation treatment. All statistical analyses will be included in the manuscript, which is currently in preparation
    End point values
    		 Intervention overall Follow-up overall Carrier cohort Noncarrier cohort
    Number of subjects analysed
    19
    18
    9
    8
    Units: Bacterial abundance
    9
    10
    9
    10
    Attachments
    		 Bacterial abundance in carriers and noncarriers
    No statistical analyses for this end point

    Adverse events

    		 Close Top of page
    Adverse events information [1]
    Timeframe for reporting adverse events
    February 2019 until January 2020
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    6.1
    Frequency threshold for reporting non-serious adverse events: 0%
    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: Due to the general good health of the subjects, method of self-reporting and low risk of the trial, no non-serious adverse events were reported

    More information

    		 Close Top of page

    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    10 Jan 2019
    Change in study protocol causing reducing the required samples by 50%
    11 Apr 2019
    Change to subject information regarding the option to inform their general practitioner about their participation
    09 Sep 2019
    Request to change the end date of 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.
    Manuscript describing the results of this study is in preparation
    For support, Contact us.
    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.

    European Medicines Agency © 1995-Tue Apr 30 00:07:33 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA