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    Clinical Trial Results:
    Three versus five days of pivmecillinam 400 mg three times daily for community-acquired uncomplicated lower urinary tract infection: A randomised, double-blind, placebo-controlled superiority trial

    Summary
    EudraCT number
    2014-001321-32
    Trial protocol
    DK  
    Global end of trial date
    22 Dec 2017

    Results information
    Results version number
    v1(current)
    This version publication date
    18 Dec 2019
    First version publication date
    18 Dec 2019
    Other versions
    Summary report(s)
    Summary

    Trial information

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    Trial identification
    Sponsor protocol code
    198809
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    -
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Department of Clinical Microbiology
    Sponsor organisation address
    Kettegård allé, Hvidovre, Denmark, 2650
    Public contact
    Department of Clinical Microbiology, Department of Clinical Microbiology, Hvidovre Hospital, 0045 36322428, Inge.Jenny.Dahl.Knudsen@regionh.dk
    Scientific contact
    Department of Clinical Microbiology, Department of Clinical Microbiology, Hvidovre Hospital, 0045 36322428, Inge.Jenny.Dahl.Knudsen@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
    12 Apr 2018
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    31 Oct 2017
    Global end of trial reached?
    Yes
    Global end of trial date
    22 Dec 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Identify and compare the efficacy of pivmecillinam 400 mg t.i.d in a 3-day respectively 5-day regimen, against community acquired lower urinary tract infections i.e. in women at the age of 18-70 years old.
    Protection of trial subjects
    Diagnosis, treatment and management according to national guidelines for uncomplicated cystitis in primary care settings.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    01 Jul 2015
    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: 368
    Worldwide total number of subjects
    368
    EEA total number of subjects
    368
    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)
    366
    From 65 to 84 years
    2
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    See open acces protocol and open acces manuscript publication: MANUSCRIPT: https://www.thelancet.com/journals/eclinm/article/PIIS2589-5370(19)30102-6/fulltext Jansaker F, et al. 2019. eClinicalMedicine PROTOCOL: https://bmcinfectdis.biomedcentral.com/articles/10.1186/s12879-016-2022-0 Jansaker F, et al. 2016. BMC inf dis.

    Pre-assignment
    Screening details
    PROTOCOL: https://bmcinfectdis.biomedcentral.com/articles/10.1186/s12879-016-2022-0 Jansaker F, et al. 2016. BMC inf dis.

    Period 1
    Period 1 title
    12-05-2015 to 31-10-2017 (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
    See open acces protocol and open acces manuscript publication: MANUSCRIPT: https://www.thelancet.com/journals/eclinm/article/PIIS2589-5370(19)30102-6/fulltext Jansaker F, et al. 2019. eClinicalMedicine PROTOCOL: https://bmcinfectdis.biomedcentral.com/articles/10.1186/s12879-016-2022-0 Jansaker F, et al. 2016. BMC inf dis.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    3-day
    Arm description
    3 days of pivmecillinam 400 mg three times daily followed by two days of placebo (identical to pivmecillinam i coat, packing, color and look). Danish guidelines at the time.
    Arm type
    Experimental

    Investigational medicinal product name
    pivmecillinam
    Investigational medicinal product code
    Other name
    pivmecillinam
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    400 mg tablet three times daily every 8th hour

    Arm title
    5-day
    Arm description
    5 days of pivmecillinam 400 mg three times daily
    Arm type
    Experimental

    Investigational medicinal product name
    pivmecillinam
    Investigational medicinal product code
    Other name
    pivmecillinam
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    400 mg tablet three times daily every 8th hour

    Number of subjects in period 1
    3-day 5-day
    Started
    188
    180
    Completed
    163
    161
    Not completed
    25
    19
         Lost to follow-up
    25
    19

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    3-day
    Reporting group description
    3 days of pivmecillinam 400 mg three times daily followed by two days of placebo (identical to pivmecillinam i coat, packing, color and look). Danish guidelines at the time.

    Reporting group title
    5-day
    Reporting group description
    5 days of pivmecillinam 400 mg three times daily

    Reporting group values
    3-day 5-day Total
    Number of subjects
    188 180 368
    Age categorical
    See table Table 1 and Appendix Table 2 in open acces manuscript publication: MANUSCRIPT: https://www.thelancet.com/journals/eclinm/article/PIIS2589-5370(19)30102-6/fulltext Jansaker F, et al. 2019. eClinicalMedicine
    Units: Subjects
        women 18-70
    188 180 368
    Gender categorical
    Women 18-70 years
    Units: Subjects
        Female
    188 180 368
    Subject analysis sets

    Subject analysis set title
    Analysed
    Subject analysis set type
    Per protocol
    Subject analysis set description
    368 women (18–70 years)

    Subject analysis sets values
    Analysed
    Number of subjects
    368
    Age categorical
    See table Table 1 and Appendix Table 2 in open acces manuscript publication: MANUSCRIPT: https://www.thelancet.com/journals/eclinm/article/PIIS2589-5370(19)30102-6/fulltext Jansaker F, et al. 2019. eClinicalMedicine
    Units: Subjects
        women 18-70
    368
    Age continuous
    (Table 1) and (Appendix Table 2) in open acces manuscript publication: MANUSCRIPT: https://www.thelancet.com/journals/eclinm/article/PIIS2589-5370(19)30102-6/fulltext Jansaker F, et al. 2019. eClinicalMedicine
    Units: years
        geometric mean (standard deviation)
    ±
    Gender categorical
    Women 18-70 years
    Units: Subjects
        Female
    368

    End points

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    End points reporting groups
    Reporting group title
    3-day
    Reporting group description
    3 days of pivmecillinam 400 mg three times daily followed by two days of placebo (identical to pivmecillinam i coat, packing, color and look). Danish guidelines at the time.

    Reporting group title
    5-day
    Reporting group description
    5 days of pivmecillinam 400 mg three times daily

    Subject analysis set title
    Analysed
    Subject analysis set type
    Per protocol
    Subject analysis set description
    368 women (18–70 years)

    Primary: Primary Clinical Outcome, Bacterial Outcome

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    End point title
    Primary Clinical Outcome, Bacterial Outcome [1]
    End point description
    Clinical success at the end of treatment occurred for 117 of 153 (76%) receiving the 5d-course and for 115 of 157 (73%) receiving the 3d course (difference 3.2% [95% CI -7.1% - 13.5%]; P = .601). Mean time to symptom resolution was 2.91 (SD 1.46; [5d]) days and 2.94 (SD 1.42; [3d]) days (P = .894). Bacteriological success was seen in 92 of 104 (88%) participants given the 5d course and in 86 of 99 (87%) given the 3d course (difference 1.6% [95% CI -8.4%-11.6%]; P = .895). Please see final publication in open access journal for full details, supplementary data och RAW data fully available.
    End point type
    Primary
    End point timeframe
    Clinical cure after end of intervention (i.e. five days therapy).
    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: For correct and to minimize risk of incorrect translation, please see statistical plan and statistical method under open access publication, which is done and written by professional statistican, which the uploader is not. https://www.thelancet.com/journals/eclinm/article/PIIS2589-5370(19)30102-6/fulltext (full article) https://www.thelancet.com/journals/eclinm/article/PIIS2589-5370(19)30102-6/fulltext#secst0215 (here you find the statistical descriptions; supplementary data to article)
    End point values
    3-day 5-day
    Number of subjects analysed
    157
    153
    Units: 310
    117
    115
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    See open acces protocol and open acces manuscript publication: MANUSCRIPT: https://www.thelancet.com/journals/eclinm/article/PIIS2589-5370(19)30102-6/fulltext Jansaker F, et al. 2019. eClinicalMedicine PROTOCOL: https://bmcinfectdis.biomedcentral.com/
    Adverse event reporting additional description
    Appendix Table 8 in open acces manuscript publication: MANUSCRIPT: https://www.thelancet.com/journals/eclinm/article/PIIS2589-5370(19)30102-6/fulltext Jansaker F, et al. 2019. eClinicalMedicine
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    Selexid label 2015
    Dictionary version
    1
    Reporting groups
    Reporting group title
    Adverse events
    Reporting group description
    Appendix Table 8 in open acces manuscript publication: MANUSCRIPT: https://www.thelancet.com/journals/eclinm/article/PIIS2589-5370(19)30102-6/fulltext Jansaker F, et al. 2019. eClinicalMedicine "A total of 306 participants reported on adverse events in the diary (Appendix Table 8). There were no serious adverse events and no reported cases of Clostridium difficile associated diarrhoea"

    Serious adverse events
    Adverse events
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 368 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    Adverse events
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    117 / 368 (31.79%)
    Investigations
    Any known adverse reaction
         subjects affected / exposed
    112 / 368 (30.43%)
         occurrences all number
    112
    Any unknown adverse reaction
    Additional description: Depressive-like symptoms (n=1); palpitations (n=2); hot-flush/sweating (n=1); nosebleed (n=1); shaking hands (n=1); malaise (n=1).
         subjects affected / exposed
    14 / 368 (3.80%)
         occurrences all number
    14
    Nervous system disorders
    Mild only
    Additional description: Headach, tiredness, dizziness
         subjects affected / exposed
    52 / 368 (14.13%)
         occurrences all number
    52
    Gastrointestinal disorders
    Gastrointestinal symptoms mild
    Additional description: Diarrhoea; nausea; vomiting; stomach-ache; stomach-discomfort.
         subjects affected / exposed
    72 / 368 (19.57%)
         occurrences all number
    72
    Skin and subcutaneous tissue disorders
    Skind mild
    Additional description: Rashes; urticaria; pruritus; angioneurotic oedema
         subjects affected / exposed
    7 / 368 (1.90%)
         occurrences all number
    7
    Infections and infestations
    Fungal infection
    Additional description: Symptoms of vaginal candidiasis (n=17); symptoms of oral candidiasis (n=1).
         subjects affected / exposed
    18 / 368 (4.89%)
         occurrences all number
    18

    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.
    See discuss section in open acces manuscript publication: MANUSCRIPT: https://www.thelancet.com/journals/eclinm/article/PIIS2589-5370(19)30102-6/fulltext Jansaker F, et al. 2019. eClinicalMedicine

    Online references

    http://www.ncbi.nlm.nih.gov/pubmed/31388664
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