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    The EU Clinical Trials Register currently displays   36835   clinical trials with a EudraCT protocol, of which   6081   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2014-001321-32
    Sponsor's Protocol Code Number:198809
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2015-04-14
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedDenmark - DHMA
    A.2EudraCT number2014-001321-32
    A.3Full title of the trial
    The efficacy of pivmecillinam 3 days respectively 5 days t.i.d against community acquired uncomplicated urinary tract infections
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The efficacy of pivmecillinam 3 days respectively 5 days three times daily against community acquired uncomplicated urinary tract infections
    A.4.1Sponsor's protocol code number198809
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorDepartment of Clinical Microbiology, Hvidovre Hospital
    B.1.3.4CountryDenmark
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportDepartment of Clinical Microbiology, Hvidovre Hospital, Denmark
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationDepartment of Clinical Microbiology, Hvidovre Hospital
    B.5.2Functional name of contact pointDepartment of Clinical Microbiology
    B.5.3 Address:
    B.5.3.1Street AddressKettegård Allé 30
    B.5.3.2Town/ cityHvidovre
    B.5.3.3Post code2650
    B.5.3.4CountryDenmark
    B.5.4Telephone number004536322428
    B.5.6E-mailInge.Jenny.Dahl.Knudsen@regionh.dk
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleComparator
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Selexid 400 mg
    D.2.1.1.2Name of the Marketing Authorisation holderLEO Pharma
    D.2.1.2Country which granted the Marketing AuthorisationDenmark
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMP
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPIVMECILLINAM
    D.3.9.1CAS number 32886-97-8
    D.3.9.3Other descriptive namepivmecillinamhydrochlorid
    D.3.9.4EV Substance CodeSUB09951MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number400
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCoated tablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Lower Uncomplicated Urinary Tract Infection
    E.1.1.1Medical condition in easily understood language
    Lower Uncomplicated Urinary Tract Infection
    E.1.1.2Therapeutic area Diseases [C] - Bacterial Infections and Mycoses [C01]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.1
    E.1.2Level LLT
    E.1.2Classification code 10024981
    E.1.2Term Lower urinary tract infection
    E.1.2System Organ Class 100000004862
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main 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.
    E.2.2Secondary objectives of the trial
    Not applicable
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Women in the age of 18-70 years old, with clinical features of community acquired uncomplicated UTI and ability to understand the study and give written consent. Patients should have a symptom cumulative score of ≥ 2 p (i.e. none, mild, moderate or severe, scoring 0-3, respectively) in accordance to the validated questionnaires for uncomplicated UTI. The following signs and symptoms are included:
    • Dysuria (i.e. pain or burning sensation on urination)
    • Urgency (i.e. feeling an increased and more frequent need to urinate)
    • Pollakisuria/frequency (i.e. urinating more frequently than usually)
    An accepted definition of uncomplicated urinary tract infections is symptoms in concordance with uUTI and significant bacteriuria of uropathogenic bacteria1, but we have chosen not include the latter criteria in our ITT analysis. This is because we want the included patients in the ITT group to mimic the realistic settings as much as possible (i.e. in which patients with uUTI will receive antibiotic therapy without urine samples in most primary care settings).
    E.4Principal exclusion criteria
    Absolute exclusion criteria are:

    • Clear signs of pyelonephritis (high fever ≥38,5°C or back/flank pain), or high suspicion of pyelonephritis
    • Allergy to penicillins
    Symptom related exclusion criteria:
    • Clear vaginal symptoms, i.e. discharge and/or pain
    Any condition that may lead or predispose to complicated urinary infection:
    • Indwelling urinary catheter
    • Pregnancy
    • Immunosuppressive therapy
    • Abnormal/pathological urinary tracts (e.g. renal disease, known presence of urinary stones, past urinary interventions/surgery, genetic aciduria)
    • Hard treated recurrent UTIs
    • Serious neurological disease affecting the bladder (i.e. paraplegia, multiple sclerosis, epilepsy)
    Other complicating or contradictive conditions:
    • Ongoing breastfeeding
    • Ongoing/current antibiotic therapy
    • Oesophageal stricture
    • Current intake of allopurinol (i.e. increases the risk of allergic skin reaction to mecillinam) or probenecid (i.e. decrease the renal excretion of mecillinam)
    • Currently part of another clinical trail
    • Unwilling to participate in study (i.e. not wanting to sign consent form)
    • Inability/unable to understand and/or take part in the clinical trial
    • Incapable of following the instructions of the study
    There are no known drugs beside those listed in the exclusion criteria to have significant interaction with mecillinam. Thus, all other drugs (prescribed or non-prescription) should be taken as usual throughout the study (which will be explained by the GP). However, all drugs should be registered in the diary and/or given permission by the patient for us to look it up on the national database of medicine prescriptions.
    E.5 End points
    E.5.1Primary end point(s)
    We have 2 co-primary endpoints
    Co-primary endpoint no. 1 – initial clinical cure (i.e. what group experience clinical cure fastest).
    Co-primary endpoint no. 2 – initial bacteriological cure rate (i.e. control urine sample no. 1 compared to pre-treatment urine sample).
    E.5.1.1Timepoint(s) of evaluation of this end point
    Both primary endpoints will be evaluated at the intervene analysis (i.e. the first 300 included patients to see if there is a large difference that will make it unethical for us to proceed with the study), and finally at the end of the trail (i.e. after the last patient is included
    E.5.2Secondary end point(s)
    1. Clinical signs and symptoms in uncomplicated urinary tract infections in women.
    2. Frequency and timing of relapse of symptoms and/or bacteriuria.
    3. Bacteriological findings (i.e. ESBL producing bacteria)
    4. Complications (i.e. urosepsis and/or pyelonephritis)
    E.5.2.1Timepoint(s) of evaluation of this end point
    All secondary endpoints will be evaluated at the intervene analysis (i.e. the first 300 included patients to see if there is a large difference that will make it unethical for us to proceed with the study), and finally at the end of the trail (i.e. after the last patient is included
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety No
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned6
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months8
    E.8.9.1In the Member State concerned days
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 425
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 75
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male No
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2015-04-14. Yes
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state500
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    Patients are told at recruitment to visit the GP again if she would keep having ongoing or even develop worsening of symptoms during the study period, just as she normally would do. In that case the GP would be able to choose a new treatment strategy for the patient and will have the potential microbiological diagnostic answers (i.e. from pre-treatment urine sample) to take in consideration in this approach.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2015-04-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-08-20
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-12-22
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