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    Summary
    EudraCT Number:2014-002999-83
    Sponsor's Protocol Code Number:UmUDURONORR1
    National Competent Authority:Sweden - MPA
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2014-12-03
    Trial 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 ConcernedSweden - MPA
    A.2EudraCT number2014-002999-83
    A.3Full title of the trial
    Ciprofloxacin vs Trimetoprim/Sulfametoxazol for transrectal prostate biopsy - a randomized double blind phaze IV multicentre clinical trial
    Ciprofloxacin vs Trimetoprim/Sulfametoxazol vid transrektal prostatabiopsi - en randomiserad dubbelblindad fas IV multicenterläkemedelsprövning
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Ciprofloxacin vs Trimetoprim/Sulfametoxazol for prostate biopsy - a clinical trial
    Ciprofloxacin vs Trimetoprim/Sulfametoxazol vid prostatabiopsi - en läkemedelsprövning
    A.3.2Name or abbreviated title of the trial where available
    DURONORR 1
    DURONORR 1
    A.4.1Sponsor's protocol code numberUmUDURONORR1
    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 SponsorJohan Styrke
    B.1.3.4CountrySweden
    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 supportVästernorrland County Council
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationJohan Styrke
    B.5.2Functional name of contact pointClinical trial information
    B.5.3 Address:
    B.5.3.1Street AddressLassarettsvägen 21
    B.5.3.2Town/ citySundsvall
    B.5.3.3Post code85186
    B.5.3.4CountrySweden
    B.5.4Telephone number+46060181000
    B.5.6E-mailjohan.styrke@umu.se
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    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 Bactrim Forte
    D.2.1.1.2Name of the Marketing Authorisation holderRoche AB
    D.2.1.2Country which granted the Marketing AuthorisationSweden
    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
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Prophylaxis of bacterial infektions of the prostate following transrectal prostate biopsy
    Antibiotikaprofylax mot bakteriella infektioner efter transrektal prostatabiopsi
    E.1.1.1Medical condition in easily understood language
    Antibiotics for bacterial infektions of the prostate following prostate biopsy
    Antibiotika mot bakteriella infektioner efter prostatabiopsi
    E.1.1.2Therapeutic area Diseases [C] - Bacterial Infections and Mycoses [C01]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To investigage if Trimetoprim/Sulfametoxazol is non inferior campared to Ciprofloxacin as antibiotic prophylaxis for transrectal prostate biopsy
    Att undersöka om Trimetoprim/Sulfametoxazol vid transrectal prostatabiopsi inte är ett sämre alternativ än Ciprofloxacin
    E.2.2Secondary objectives of the trial
    To asses after prostate biopsy:
    1, Mortality
    2, Bacteriological carachteristisc
    3, Time to desease
    4, Number of inpatient days
    5, The given number of doses of antibiotics if infection occurrs.
    6, Riskfactors for infection.
    Ytterligare mål med studien är att studera:
    1, Mortalitet
    2, Bakteriologiska karakteristika
    3, Tid till sjukdomsdebut
    4 Vårdtid
    5 Antal doser av antibiotika vid infektion
    6, riskfaktorer
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Indication for prostate biopsy
    Informed consent
    • Indikation för prostatabiopsi: doktorns bedömning
    • Informerat samtycke
    E.4Principal exclusion criteria
    • Diabetes Mellitus
    • Kateter à demeure
    • Urinary tract infection (past 6 months)
    • Positive nitritis on urinary dipstick
    • Allergy for Ciprofloxacin, Trimetoprim/Sulfametoxazol or other agents in the IMP
    • Liver damage
    • Use of Tizanidine
    • Immunosuppression
    • Diabetes Mellitus
    • Kateter à demeure
    • Urinvägsinfektion (UVI) senaste 6 månaderna
    • Nitritpositiv
    • Allergi mot Ciprofloxacin, TMX eller något hjälpämne
    • Svår leverskada
    • Användning av Tizanidine
    • Immunosuppression
    E.5 End points
    E.5.1Primary end point(s)
    • Subscribed urinary tract antibiotics within 2 weeks following prostate biopsy
    • Submission to inpatient hospital care within 2 weeks after prostate biopsy for urinary tract infektion or sepsis.
    • Förskriven urinvägsantibiotika inom 30 dagar från biopsitillfälle.
    • Inlagd på sjukhus med diagnos som överensstämmer med urinvägsinfektion eller sepsis, inom två veckor efter prostatabiopsi.
    E.5.1.1Timepoint(s) of evaluation of this end point
    2 weeks after prostete biopsy. The first primary endpoint will be avaluated in an interim analysis every 6 months of the trial.
    Två vedckor efter biopsi. En interimanalys kommer att utföras för endpiont 1 varje halvår under studiens gång.
    E.5.2Secondary end point(s)
    • Mortalitet (3 mån efter biopsi)
    • Bakteriologisk karaktäristika på fallens blod- respektive urinodlingar.
    • Tid till sjukdomsdebut.
    • Vårdtid på sjukhus.
    • Antal dygnsdoser antibiotika.
    • Den exkluderade riskgruppens infektionsfrekvens.
    • Riskgruppens inbördes riskstratifiering.
    • Riskfaktorer för infektion, analys av baslinjevariabler.
    • Mortality (3 månths post biopsy)
    • Microbiological characteristics (urinary or blood culture)
    • Time to presentation of infection
    • Days in hospital
    • Number of daily doses of antibiotics
    • Infection rates for persons excluded from the trial due to risk factors for infection
    • Riskstratification of the excluded group
    • Risk factors for infection.
    E.5.2.1Timepoint(s) of evaluation of this end point
    The secondary end points will be evaluated after the trial is closed for inclusion, approximately 2-3 years after the start of the trial.
    Utvärdering av sekundära endpoints kommer att ske efter studeians avslut.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    E.6.3Therapy No
    E.6.4Safety Yes
    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 No
    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) Yes
    E.8.2.2Placebo No
    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 concerned3
    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
    The trial ends when subject number 2550 has been included (the last visit of the last subject undergoing the trial).
    Studien stängs när den person nummer 2550 har inkluderats.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    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: 1275
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 1275
    F.2 Gender
    F.2.1Female No
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state2550
    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)
    None
    Inga
    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 Decision2015-01-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-09-09
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2021-12-31
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