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    Clinical Trial Results:
    Tick borne diseases in norwegian general practice. A randomized, controlled trial for treatment of erythema migrans in norwegian general practice. A comparison of phneoxymetylpenicillin, amoxicillin and doxycycline.

    Summary
    EudraCT number
    		 2010-023747-15
    Trial protocol
    		 NO  
    Global end of trial date
    10 Dec 2014

    Results information
    Results version number
    		 v1(current)
    This version publication date
    22 Feb 2020
    First version publication date
    22 Feb 2020
    Other versions
    Summary report(s)
    		 Paper

    Trial information

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    Trial identification
    Sponsor protocol code
    070411
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01368341
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    University of Oslo
    Sponsor organisation address
    HELSAM/ASP, Oslo, Norway, 0318
    Public contact
    Antibiotic centre of Primary Care, University of Oslo, +47 22 85 06 55, post@antibiotikasenteret.no
    Scientific contact
    Antibiotic centre of Primary Care, University of Oslo, +47 22 85 06 55, post@antibiotikasenteret.no
    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
    02 Mar 2015
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    10 Dec 2013
    Global end of trial reached?
    Yes
    Global end of trial date
    10 Dec 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Compare three antibiotic regimes for treatment of erythema migrans (EM). Main objective is duration of Erythema migrans (EM). On day 1 duration until first the consulation is registered. Day 1-14 the EM is registered in a patient diary. On day 14 the doctor is asked whether the EM has disseapeared. If not the patient is followed by phone from the researchers. On day 90 they are additionally asked for how long it lasted.
    Protection of trial subjects
    All patients received active treatment for their EM
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Jun 2011
    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
    Norway: 188
    Worldwide total number of subjects
    188
    EEA total number of subjects
    188
    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)
    130
    From 65 to 84 years
    55
    85 years and over
    3

    Subject disposition

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    Recruitment
    Recruitment details
    		 All patients aged at least 18 years with clinical diagnosis of erythema migrans ("a macular rash expanding from the site of the tick bite") were eligible for inclusion.

    Pre-assignment
    Screening details
    		 Please see screening details elsewhere

    Period 1
    Period 1 title
    2011-2013 (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Single blind
    Roles blinded
    		 Subject
    Blinding implementation details
    Patients were given a neutral carton of medication to be opened after the first consultation. The carton contained information about the trial and the study medication, and whom to contact in case of any adverse event. The original medication package from the manufacturer, with the original product information, was included. Patients therefore knew which study drug they were given, but their GP and the researchers did not. Randomisation lists were available after the complete follow up.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Phenoxymethylpenicillin
    Arm description
    		 -
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Phenoxymethylpenicillin
    Investigational medicinal product code
    J01CE02
    Other name
    Weifapenin Weifa 650 mg
    Pharmaceutical forms
    Tablet
    Routes of administration
    Gastroenteral use
    Dosage and administration details
    650 mg, two tablets three times daily

    Arm title
    		 Amoxicillin
    Arm description
    		 -
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Amoxicillin
    Investigational medicinal product code
    J01CA04
    Other name
    Amoxicillin Mylan 500 mg
    Pharmaceutical forms
    Capsule
    Routes of administration
    Gastroenteral use
    Dosage and administration details
    one capsule three times daily

    Arm title
    		 Doxycycline
    Arm description
    		 -
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Doxycycline
    Investigational medicinal product code
    J01AA02
    Other name
    Doxycyklin Hexal 100 mg
    Pharmaceutical forms
    Tablet
    Routes of administration
    Gastroenteral use
    Dosage and administration details
    one tablet twice daily

    Number of subjects in period 1
    		Phenoxymethylpenicillin Amoxicillin Doxycycline
    Started
    56
    64
    68
    Completed
    47
    56
    58
    Not completed
    9
    8
    10
         Lost to follow-up
    9
    8
    10

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    2011-2013
    Reporting group description
    		 -

    Reporting group values
    		 2011-2013 Total
    Number of subjects
    		 188 188
    Age categorical
    Patients included were 18-85 years of age
    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)
    		 130 130
        From 65-84 years
    		 55 55
        85 years and over
    		 3 3
    Gender categorical
    Units: Subjects
        Female
    		 113 113
        Male
    		 75 75

    End points

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

    Reporting group title
    Amoxicillin
    Reporting group description
    		 -

    Reporting group title
    Doxycycline
    Reporting group description
    		 -

    Primary: Duration of EM after treatment

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    End point title
    		 Duration of EM after treatment
    End point description
    xx
    End point type
    Primary
    End point timeframe
    Patients were followed for 1 year. We found a wide range of duration of EM: 3-293 days. As the median duration were 13-14 days in all Groups, duration was verified in half of the patients at the day 14 Control. The rest were followed regularly until time
    End point values
    		 Phenoxymethylpenicillin Amoxicillin Doxycycline
    Number of subjects analysed
    56 [1]
    64
    68
    Units: Days
    56
    64
    68
    Attachments
    		 Duration EM
    Notes
    [1] - One lost to follow-up by day 14, but the main end point of EM duration was registered.
    Statistical analysis title
    		 Kaplan-Meier
    Statistical analysis description
    The primary outcome is shown in a Kaplan-Meier plot and tested using the log-rank test.
    Comparison groups
    Phenoxymethylpenicillin v Amoxicillin v Doxycycline
    Number of subjects included in analysis
    188
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 ≤ 0.05
    Method
    		 Logrank
    Confidence interval

    Secondary: concomittant symptoms

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    End point title
    		 concomittant symptoms
    End point description
    Tiredness Headache Joint pain Neck stiffness Fever Palpitations Myalgia Sore throat Tender skin Dizziness Nausea Chest pain Diarrhea Chills Hot flushes Coughing (Multiple EMs)
    End point type
    Secondary
    End point timeframe
    During treatment day 1-14
    End point values
    		 Phenoxymethylpenicillin Amoxicillin Doxycycline
    Number of subjects analysed
    55
    64
    67
    Units: concomittant symptoms
    17
    17
    17
    Statistical analysis title
    		 ANOVA
    Statistical analysis description
    means were compared using ANOVA, and categorical data were analyzed using c-square tests. Multiple pair-wise comparisons were carried out if the c-square test rejected the null hypothesis of equality of the proportions. The method is also called post-hoc c-square test of proportions.
    Comparison groups
    Phenoxymethylpenicillin v Amoxicillin v Doxycycline
    Number of subjects included in analysis
    186
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 < 0.05
    Method
    		 ANOVA
    Parameter type
    		 Mean difference (final values)
    Confidence interval

    Secondary: Side effects

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    End point title
    		 Side effects
    End point description
    Diarrhea Nausea Skin rash Other
    End point type
    Secondary
    End point timeframe
    During treatment days 1-14
    End point values
    		 Phenoxymethylpenicillin Amoxicillin Doxycycline
    Number of subjects analysed
    55
    64
    67
    Units: Number
    55
    64
    67
    Statistical analysis title
    		 ANOVA
    Statistical analysis description
    means were compared using ANOVA, and categorical data were analyzed using c-square tests. Multiple pair-wise comparisons were carried out if the c-square test rejected the null hypothesis of equality of the proportions
    Comparison groups
    Phenoxymethylpenicillin v Amoxicillin v Doxycycline
    Number of subjects included in analysis
    186
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence [2]
    P-value
    		 < 0.05
    Method
    		 ANOVA
    Confidence interval
    Notes
    [2] - means were compared using ANOVA, and categorical data were analyzed using c-square tests. Multiple pair-wise comparisons were carried out if the c-square test rejected the null hypothesis of equality of the proportions

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Patients were followed for 1 year
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 Reported
    Dictionary version
    1
    Reporting groups
    Reporting group title
    Phenoxymethylpenicillin
    Reporting group description
    		 -

    Reporting group title
    Amoxicillin
    Reporting group description
    		 -

    Reporting group title
    Doxycycline
    Reporting group description
    		 -

    Serious adverse events
    		 Phenoxymethylpenicillin Amoxicillin Doxycycline
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 64 (0.00%)
    0 / 68 (0.00%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Frequency threshold for reporting non-serious adverse events: 1%
    Non-serious adverse events
    		 Phenoxymethylpenicillin Amoxicillin Doxycycline
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 56 (0.00%)
    1 / 64 (1.56%)
    1 / 68 (1.47%)
    Gastrointestinal disorders
    Diarrea
         subjects affected / exposed
    0 / 56 (0.00%)
    1 / 64 (1.56%)
    0 / 68 (0.00%)
         occurrences all number
    0
    1
    0
    Skin and subcutaneous tissue disorders
    Sunburn
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 64 (0.00%)
    1 / 68 (1.47%)
         occurrences all number
    0
    0
    1

    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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    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.

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