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    Clinical Trial Results:
    Multicenter, prospective, randomized, double-blind, two-armed phase IV clinical study for efficacy and safety assessment of two 2% mupirocin containing nasal ointments (MupiroNasal 20mg/g, nasal ointment, Antibiotic-Razgrad AD, Bulgaria as test product and Bactroban 2%, nasal ointment, GlaxoSmithKline, United Kingdom as reference product), applied to the anterior nares in healthy subjects with nasal carriage of Staphylococcus aureus (S. aureus).

    Summary
    EudraCT number
    		 2018-002913-37
    Trial protocol
    		 BG  
    Global end of trial date
    11 Nov 2019

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

    Trial information

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    Trial identification
    Sponsor protocol code
    MPN-001-07-2018
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Antibiotic-Razgrad AD
    Sponsor organisation address
    68 "Aprilsko vastanie" blvd., office 201, Razgrad, Bulgaria, 7200
    Public contact
    Medical and Regulatory Affairs, Antibiotic-Razgrad AD, +359 897967097, bhodzhova@antibiotic.bg
    Scientific contact
    Medical and Regulatory Affairs, Antibiotic-Razgrad AD, +359 897967097, bhodzhova@antibiotic.bg
    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
    22 Nov 2019
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    11 Nov 2019
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    - To evaluate the efficacy of MupiroNasal 2% nasal ointment in healthy subjects with nasal carriage of Staphylococcus aureus (S. aureus). - To compare the efficacy of MupiroNasal 2% nasal ointment with respect to the Reference medicinal product.
    Protection of trial subjects
    Protection of trial subjects: Prior to the start of the study, the study protocol, the informed consent and assent documents, patient instruction sheets, as well as any advertising materials used to recruit patients were submitted to Bulgarian Drug Agency (BDA) and ethics committees for mulricenter trials (ECMT). The BDA/ECMTs reviewed all documents and approved required documents. Consistent with both the BDA/ECMT's requirements and all applicable regulations, the Investigators periodically provided study updates to the BDA/ECMT's . A patient provided informed consent, and children signed an approved assent form when appropriate. This study was conducted in accordance with Good Clinical Practices (GCP) and the ethical principles that have their origins in the Declaration of Helsinki.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    28 Jan 2019
    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
    Bulgaria: 258
    Worldwide total number of subjects
    258
    EEA total number of subjects
    258
    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)
    240
    From 65 to 84 years
    18
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Subjects were recruited from 4 study centers located in Bulgaria. Patients were recruited to cover the age range from 18-75 years.

    Pre-assignment
    Screening details
    		 The study population consisted of healthy adult subject, male or female, for whom the carriage of S. aureus has been established. Screening Visit – part A • Medical history; • Medical examination; • Microbiological swab – both nares Screening Visit – part B • Medical history; • Medical examination; • Microbiological swab – both nares;

    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
    Blinding implementation details
    This design is chosen in order to eliminate any potential influence of the knowledge (by either the investigator or the participant) of the treatment used on the compliance to the study procedures or the reported results.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Test arm
    Arm description
    		 MupiroNasal 20 mg/g nasal ointment, Antibiotic-Razgrad AD, Bulgaria, Batch № 403718; Expiry date: 05.2021
    Arm type
    		 Experimental

    Investigational medicinal product name
    MupiroNasal 20 mg/g nasal ointment, Antibiotic-Razgrad AD
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Nasal ointment
    Routes of administration
    Intranasal use
    Dosage and administration details
    Selection of doses to be administered - during the study the dose were as per the information of the SmPC – either of both investigation products (test or reference according to the randomization scheme) were applied for a five-day period, two applications daily. The subjects performed the therapy by themselves. A small amount of the ointment about the size of a match head was placed on the little finger and applied to the inside of each nostril. The nostrils was closed by pressing the sides of the nose together; this spreads the ointment throughout the nares A whole pack of the IMP was provided to each participant. The storage of the product and its use were in accordance with the approved SmPC.

    Arm title
    		 Reference arm
    Arm description
    		 Bactroban 2% nasal ointment, GlaxoSmithKline, United Kingdom, Batch № GP7G; Expiry date: 03.2021
    Arm type
    		 Experimental

    Investigational medicinal product name
    Bactroban 2% nasal ointment, GlaxoSmithKline
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Nasal ointment
    Routes of administration
    Intranasal use
    Dosage and administration details
    Selection of doses to be administered - during the study the dose were as per the information of the SmPC – either of both investigation products (test or reference according to the randomization scheme) were applied for a five-day period, two applications daily. The subjects performed the therapy by themselves. A small amount of the ointment about the size of a match head was placed on the little finger and applied to the inside of each nostril. The nostrils was closed by pressing the sides of the nose together; this spreads the ointment throughout the nares A whole pack of the IMP was provided to each participant. The storage of the product and its use were in accordance with the approved SmPC.

    Number of subjects in period 1
    		Test arm Reference arm
    Started
    129
    129
    Completed
    128
    128
    Not completed
    1
    1
         Consent withdrawn by subject
    1
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Test arm
    Reporting group description
    		 MupiroNasal 20 mg/g nasal ointment, Antibiotic-Razgrad AD, Bulgaria, Batch № 403718; Expiry date: 05.2021

    Reporting group title
    Reference arm
    Reporting group description
    		 Bactroban 2% nasal ointment, GlaxoSmithKline, United Kingdom, Batch № GP7G; Expiry date: 03.2021

    Reporting group values
    		 Test arm Reference arm Total
    Number of subjects
    		 129 129 258
    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)
    		 120 120 240
        From 65-84 years
    		 9 9 18
        85 years and over
    		 0 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 44.6 ± 14.2 44.8 ± 12.9 -
    Gender categorical
    Units: Subjects
        Female
    		 95 92 187
        Male
    		 34 37 71
    Subject analysis sets

    Subject analysis set title
    MupiroNasal
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    MupiroNasal 20mg/g, nasal ointment

    Subject analysis set title
    Bactroban
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Bactroban 2%, nasal ointment

    Subject analysis sets values
    		 MupiroNasal Bactroban
    Number of subjects
    129
    129
    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)
    120
    120
        From 65-84 years
    9
    9
        85 years and over
    0
    0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    44.6 ± 14.2
    44.8 ± 12.9
    Gender categorical
    Units: Subjects
        Female
    95
    92
        Male
    34
    37

    End points

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    End points reporting groups
    Reporting group title
    Test arm
    Reporting group description
    		 MupiroNasal 20 mg/g nasal ointment, Antibiotic-Razgrad AD, Bulgaria, Batch № 403718; Expiry date: 05.2021

    Reporting group title
    Reference arm
    Reporting group description
    		 Bactroban 2% nasal ointment, GlaxoSmithKline, United Kingdom, Batch № GP7G; Expiry date: 03.2021

    Subject analysis set title
    MupiroNasal
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    MupiroNasal 20mg/g, nasal ointment

    Subject analysis set title
    Bactroban
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Bactroban 2%, nasal ointment

    Primary: Apparent Eradication of Nasal Carriage of SA (measured as care rate, i.e. number of cured subjects in each treatment group)

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    End point title
    		 Apparent Eradication of Nasal Carriage of SA (measured as care rate, i.e. number of cured subjects in each treatment group)
    End point description
    End point type
    Primary
    End point timeframe
    Five day treatment period and follow-up 5 days after the end of the treatment.
    End point values
    		 Test arm Reference arm MupiroNasal Bactroban
    Number of subjects analysed
    129
    129
    129
    129
    Units: Subjects
    129
    129
    129
    129
    Statistical analysis title
    		 Distribution of Staphylococcus Aureus
    Comparison groups
    MupiroNasal v Bactroban
    Number of subjects included in analysis
    258
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [1]
    P-value
    		 = 0.8019 [2]
    Method
    		 Fisher exact
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.1
    Confidence interval
         level
    		 95%
         sides
    1-sided
         lower limit
    		 -0.2
         upper limit
    		 -
    Variability estimate
    Standard error of the mean
    Notes
    [1] - For both populations (PP and mITT) the criterion for non-inferiority is satisfied. So, decision can be made that the test product (MupiroNasal 20mg/g, nasal ointment, Antibiotic-Razgrad AD, Bulgaria ) is noninferior than the reference product (Bactroban 2%, nasal ointment, GlaxoSmithKline, United Kingdom).
    [2] - Avalfinal MB Result at Last Visit

    Secondary: Number of Subjects with Adverse Events

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    End point title
    		 Number of Subjects with Adverse Events
    End point description
    End point type
    Secondary
    End point timeframe
    Complete study period.
    End point values
    		 MupiroNasal Bactroban
    Number of subjects analysed
    129
    129
    Units: Subjects
    129
    129
    Statistical analysis title
    		 Frequencies of adverse events
    Statistical analysis description
    Frequencies of adverse events by arm are compared.
    Comparison groups
    MupiroNasal v Bactroban
    Number of subjects included in analysis
    258
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.095
    Method
    		 Chi-squared
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    The Number of Subjects With Adverse Events and Changes in Vital Signs and Routine Haematology, Clinical Chemistry and Urinalysis Tests Assessed Over the Five Day Treatment Period and Follow-up 5 days after the end of the treatment.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    16
    Reporting groups
    Reporting group title
    All participants
    Reporting group description
    		 -

    Serious adverse events
    		 All participants
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 258 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 All participants
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    3 / 258 (1.16%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    3 / 258 (1.16%)
         occurrences all number
    3
    Migraine
         subjects affected / exposed
    3 / 258 (1.16%)
         occurrences all number
    3
    Immune system disorders
    Allergic reaction to excipient
         subjects affected / exposed
    3 / 258 (1.16%)
         occurrences all number
    3

    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
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