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    The EU Clinical Trials Register currently displays   39229   clinical trials with a EudraCT protocol, of which   6426   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2011-000808-18
    Sponsor's Protocol Code Number:Concisus2012
    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:2012-01-12
    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 ConcernedDenmark - DHMA
    A.2EudraCT number2011-000808-18
    A.3Full title of the trial
    Et randomiseret, dobbelt blindet, placebo kontrolleret, parallel gruppe klinisk studie af azithromycin hos patienter med Campylobacter concisus og diarré
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Campylobacter concisus placebokontrolleret behandlingsstudie
    A.3.2Name or abbreviated title of the trial where available
    Campylobacter concisus placebokontrolleret behandlingsstudie
    A.4.1Sponsor's protocol code numberConcisus2012
    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 SponsorAalborg Universitetshospital
    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 supportAalborg Sygehus
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationInfektionsmedicinsk Afd. Aalborg Sygehus
    B.5.2Functional name of contact pointLæge, Hans Linde Nielsen
    B.5.3 Address:
    B.5.3.1Street AddressHobrovej 18-22
    B.5.3.2Town/ cityAalborg
    B.5.3.3Post code9000
    B.5.3.4CountryDenmark
    B.5.4Telephone number+4599326532
    B.5.5Fax number+4599326407
    B.5.6E-mailhalin@rn.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 Azithromycin ”Ratiopharm”
    D.2.1.1.2Name of the Marketing Authorisation holderSlotsmarken 12, st. tv. 2970 Hørsholm Denmark
    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.3.1Product nameAzithromycin ”Ratiopharm”
    D.3.2Product code 22913
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 83905-01-5
    D.3.9.3Other descriptive nameAZITHROMYCIN
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number500
    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 Yes
    D.3.11.13.1Other medicinal product typeAntibiotika tilhørende makrolid gruppen
    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 placeboTablet
    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
    Et randomiseret, dobbelt blindet, placebo kontrolleret studie af azithromycin hos patienter med Campylobacter concisus og diarré.
    Symptombilledet for den nyopdagede Campylobacter concisus er opkastning og diarré. Om patienterne kan have effekt af antibiotisk behandling er uafklaret. Formålet med undersøgelsen er derfor at undersøge om antibiotisk behandling af C. concisus diarré kan bedre diarré tilstanden og afkorte sygdomsvarigheden.
    E.1.1.1Medical condition in easily understood language
    Formålet med undersøgelsen er at undersøge om antibiotisk behandling af diarré pga. C. concisus kan bedre diarré tilstanden og afkorte sygdomsvarigheden.
    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 14.1
    E.1.2Level LLT
    E.1.2Classification code 10007046
    E.1.2Term Campylobacter diarrhoea
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Formålet med dette studie er, at undersøge effekten af den antibiotiske behandling med azithromycin hos patienter med diarré hvor Campylobacter concisus er isoleret fra patientens afføringsprøve som den eneste mikroorganisme. Der må således ikke være en anden kendt tarmpatogen mikroorganisme som konkurrende årsag til patientens symptomer. Effekten bestemmes ud fra spørgeskemaer, der belyser patientens almene helbredstilstand samt udvikling i diarré-sygdom.


    E.2.2Secondary objectives of the trial
    Parallelt gennemføres et studie med dyrkning af C. concisus fra spyt og afføring, før og efter behandling, for at belyse om eradikation af C. concisus er mulig ved behandling med azithromycin.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Inklusionkriterier
    • Diarré patienter over 18 år med positiv dyrkning af Campylobacter concisus dyrkning i fæces.
    • Fortsat diarré defineret som 3 eller flere vandtynde til grødede afføringer dagligt
    eller
    • 2 vandtynde til grødede afføringer, samt minimum et eller flere ledsagesymptomer, såsom mavesmerter, kvalme, opkastning eller feber.
    • Symptomer igennem minimum 24 timer.
    • Symptomdebut på maximalt 14 dage.
    • Mundligt og skriftligt samtykke, med dokumentation for at alle relevante oplysninger om studiet er givet til patienten.
    • Patienten skal være villig til og have mulighed for at møde til det planlagte besøg og overholde den planlagte studieplan.
    E.4Principal exclusion criteria
    Eksklusionskriterier
    • Allergi overfor azithromycin.
    • Alder under 18.
    • Graviditet eller amning.
    • Positiv afføringsprøve for anden tarmpatogen mikroorganisme.
    • Behandling med andet antibiotikum (på et hvilket som helst tidspunkt fra 14 dage før første afføringsprøve).
    • Kronisk inflammatorisk tarmsygdom
    • Kronisk diare af anden kendt årsag.
    • Demens.
    • Alvorlig sygdom mindre end 14 dage fra planlagt indgang i studiet.
    • Patienten er i behandling med medicin, der har interaktion med azithromycin f.eks. ciclosporin eller amiodaron.
    • Patienter involveret i planlægning eller udførelse af studiet.
    E.5 End points
    E.5.1Primary end point(s)
    Endepunkter
    Endepunktet er ”ændring i daglige antal afføringer”, og sygdomsvarighed.
    Effekten måles ved spørgeskemaer inklusiv ”diarré-dagbog”.

    Det primære endepunkt:

    • Antal dage til opnåelse af symptomfrihed = ”normal afføringsfrekvens”, tolket som < 3 afføringer/dag.

    Sekundære endepunkter er:

    • Antallet af daglige afføringer, indtil opnåelse af symptomfrihed.

    • Forekomst af sekundære symptomer i form af mavesmerter, kvalme og opkastning

    • Forekomst af bivirkninger sammenlignet med placebogruppen.

    • Eradikation af C. concisus fra spyt og afføring.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Vil blive evalueret straks ved forsøget afslutning i Januar 2013.
    Desuden vil Sponsorinvestigator naturligvis følge anbefalinger fra GCP-enheden.
    E.5.2Secondary end point(s)
    Sekundære endepunkter er:

    • Antallet af daglige afføringer, indtil opnåelse af symptomfrihed.

    • Forekomst af sekundære symptomer i form af mavesmerter, kvalme og opkastning

    • Forekomst af bivirkninger sammenlignet med placebogruppen.

    • Eradikation af C. concisus fra spyt og afføring.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Vil blive evalueret straks ved forsøget afslutning i Januar 2013.
    Desuden vil Sponsorinvestigator naturligvis følge anbefalinger fra GCP-enheden.
    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 Yes
    E.6.4Safety No
    E.6.5Efficacy No
    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) Yes
    E.7.4Therapeutic use (Phase IV) No
    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 Yes
    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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.4.1Number of sites anticipated in Member State concerned1
    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
    Projektet afsluttes når i alt 100 patienter er færdiginkluderet.
    Projektet er tænkt at forløbe over et år i perioden 01022012 til 31012013
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months1
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial 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: 80
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 20
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    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 2012-01-12. Yes
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women Yes
    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 state100
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 100
    F.4.2.2In the whole clinical trial 100
    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)
    Sponsorinvestigator har telefonisk kontakt med patienten på 10.dagen efter studiestart. Ved fortsatte diarré-symptomer tilbydes ny klinisk kontrol ved Sponsorinvestigator og tilbud om "Cross-over" medicin, og der aftales ny kontakt 10 dage herefter. Ved fortsatte symptomer herudover, kan patienten evt blive henvist til udredning på Gastroenterologisk afd. hvis der skønnes behov herfor.
    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 Decision2012-01-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-04-15
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2013-12-31
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