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    Summary
    EudraCT Number:2015-003062-82
    Sponsor's Protocol Code Number:RBI/FMT-CDI
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2016-11-01
    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 number2015-003062-82
    A.3Full title of the trial
    Rectal Bacteriotherapy, Faecal microbiota transplantation or oral vancomycin for the treatment of recurrent Clostridium Difficile infection: A randomised controlled trial
    Rektal bakterieinstillation, fækal mikrobiotisk transplantation eller oral vancomycin til behandling af rekurrente Clostridium difficile infektioner:
    Et randomiseret, kontrolleret forsøg
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Rectal enema with a mix of gut bacteria, rectal enema with feacal material from a healthy donor or oral given vancomycin for the treatment of patients with recurrent diarrhea caused by infection with the bacteria Clostridium Difficile.
    Indhældning i endetarmen med en bakterieblanding, indhældning i endetarmen med donorafføring eller behandling med vancomycin-kapsler til behandling af tilbagefald af diarré grundet infektion med bakterien Clostridium Difficile
    A.4.1Sponsor's protocol code numberRBI/FMT-CDI
    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 Medicine, Zealand University 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 supportDanish Ministry of Health
    B.4.2CountryDenmark
    B.4.1Name of organisation providing supportRegion Zealand
    B.4.2CountryDenmark
    B.4.1Name of organisation providing supportAmager and Hvidovre Hospitals Research Fund
    B.4.2CountryDenmark
    B.4.1Name of organisation providing supportThe Research Council for Naestved/Ringsted/Slagelse Hospitals
    B.4.2CountryDenmark
    B.4.1Name of organisation providing supportDepartment of Clinical Microbiology, Slagelse Hospital
    B.4.2CountryDenmark
    B.4.1Name of organisation providing supportDepartment of Clinical Microbiology, Hvidovre Hospital
    B.4.2CountryDenmark
    B.4.1Name of organisation providing supportDepartment of Gastroenterology, Hvidovre Hospital
    B.4.2CountryDenmark
    B.4.1Name of organisation providing supportThe Research fund for Department of Infectious diseases, Hvidovre Hospital
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationDepartment of Medicine
    B.5.2Functional name of contact pointClinical Trial Information
    B.5.3 Address:
    B.5.3.1Street AddressLykkebaekvej 1
    B.5.3.2Town/ cityKoege
    B.5.3.3Post code4600
    B.5.3.4CountryDenmark
    B.5.4Telephone number+4523345235
    B.5.6E-mailaala@regionsjaelland.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 Vancocin
    D.2.1.1.2Name of the Marketing Authorisation holderStrides Arcolab
    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 Capsule, hard
    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.3.8INN - Proposed INNvancomycin hydrochloride
    D.3.9.3Other descriptive nameVANCOMYCIN HYDROCHLORIDE
    D.3.9.4EV Substance CodeSUB05077MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number125
    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.IMP: 2
    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 No
    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 nameRBI bakteriekultur "MT-MicroSearch", væske til rektal instillation
    D.3.2Product code RBI
    D.3.4Pharmaceutical form Rectal solution
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPRectal use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNRectal bacteriotherapy instillation
    D.3.9.2Current sponsor codeRBI
    D.3.9.3Other descriptive nameFixed mix of gut bacteria
    D.3.10 Strength
    D.3.10.1Concentration unit ml millilitre(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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
    Recurrent infection with Clostridium Difficile
    E.1.1.1Medical condition in easily understood language
    Recurrent infection with the bacteria Clostridium Difficile
    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 19.0
    E.1.2Level LLT
    E.1.2Classification code 10072994
    E.1.2Term Clostridium difficile infection recurrence
    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
    To investigate the treatment effect of rectal bacteriotherapy instillation (RBI) and faecal microbiota transplantation /FMT) against the standard antibotic treatment with vancomycin for patients with recurrent Clostridium Difficile infection in a randomised controlled trial
    At undersøge effekten af rektal bakterieinstillation (RBI) og fækal mikrobiotisk transplantation (FMT) over for standard antibiotisk behandling til patienter med rekurrent CDI i et randomiseret klinisk forsøg
    E.2.2Secondary objectives of the trial
    Not applicable
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Age ≥ 18 years
    - Recurrent Clostridium Difficile infection with diarrhea (or toxic megacolon) and verified presence of Clostridium difficile in faeces, and/or pseudomembranoues colitis, diagnosed within 90 days of the last episode of Clostridium difficile infection
    - Having received at least one earlier specific treatment for Clostridium difficile infection (at least 10 days of vancomycin with at least 125 mg 4 times daily or at least 10 days of metronidazol with at least 500 mg 3 times a day)
    - The patient is allowed to have started treatment with oral vancomycin within 7 days, but does not need to have started treatment with oral vancomycin
    - Being able to give informed consent after information in danish
    - Alder ≥ 18 år.
    - Rekurrent CDI med diarré (eller toksisk megacolon), samt mikrobiologisk verificeret tilstedeværelse af CD i fæces (ved PCR analyse for toxiner) og/eller fund af pseudomembranøs colitis (ved endoskopi/histopatologi), påvist indenfor 90 dage efter det seneste tilfælde af CDI.
    - Have modtaget én eller flere tidligere specifikke behandlinger for CDI (mindst 10 dages vancomycin med dosis af mindst 125 mg x 4 daglig eller mindst 10 dages behandling med metronidazol i dosis 500 mg x 3 daglig).
    - Patienten kan være startet behandling med peroral vancomycin af behandlende læge (indenfor 7 dage), men behøver ikke være startet behandling med peroral vancomycin.
    - Patienten skal være i stand til at give informeret samtykke ud fra dansksproget deltagerinformation.
    E.4Principal exclusion criteria
    - Terminal illness with a life expectancy less than 3 months.
    - Allergy to vancomycin.
    - Other clinically significant gastrointestinal infections.
    - Other antibacterial treatment planned for a duration of more than 14 days from time of inclusion (for example for spondylodiscitis, endocarditis or tuberculosis).
    - Gastrointestinal disease, which can cause diarrhea or in other way affects symptom reporting, including patients that have undergone colectomy.
    - Severely compromised immune system, which makes faecal microbiota transplantation/rectal bacteriotherapy releatively contraindicated by clinical judgement.
    - Pregnancy, planned pregnancy or breast feeding.
    - Terminal sygdom med forventet levetid <3 måneder.
    - Allergi overfor vancomycin.
    - Anden klinisk betydende gastrointestinal infektion.
    - Anden antibakteriel behandling, der er planlagt til over 14 dages varighed fra inklusionstidspunktet (f.eks. i forbindelse med spondylodiskit, endocarditis eller tuberkulose).
    - Gastrointestinal sygdom, der forårsager diarré eller kan påvirke symptom rapportering, herunder kolektomerede patienter.
    - Svær immunsvækkelse, som gør FMT/RBI relativt kontraindiceret ved klinisk bedømmelse.
    - Graviditet, planlagt graviditet og amning.
    E.5 End points
    E.5.1Primary end point(s)
    Clinical cure, defined as the absence of Clostridium Difficile infection, in 90 days after the end of treatment
    Klinisk behandlingssucces, defineret som fravær af Clostridium Difficile infektion, i perioden op til 90 dage efter endt behandling i de tre arme.
    E.5.1.1Timepoint(s) of evaluation of this end point
    A interim analysis will be done when 30 patients in each treatment group has been followed for 90 days.
    Final evaluation will be done after 180 days of follow-up after treatment on all patients.
    Vi planlægger en interimanalyse af cure rate (efter 90 dages opfølgning) i de tre behandlingsarme efter 30 patienter i hver behandlingsarm. Endelig evaluering foretages efter 180 dages opfølgning af alle patienter.
    E.5.2Secondary end point(s)
    - Early (Between 14-30 days after) and late (after 31-180 days) recurrence of CDI after end of treatment.
    - Days with diarrhea in week 1, 4, 8, 12 after end of treatment.
    - CDI-associated hospitalization and hospitalization of other causes in the 180 days of follow-up after end of treatment.
    - CDI-associated outpatient hospital contact and outpatient hospital contact of other causes in the 180 days of follow-up after end of treatment.
    - CDI-associated mortality and all-cause mortality 30, 90 and 180 days after end of treatment.
    - CDI-associated morbidity, CDI-associated mortality and all-cause mortality 3 years and 5 years after end of treatment (as part of a prospective registerbased study after end of trial).

    Subgroup analyzes:
    - The effect of treatment (primary endpoint) in the three treatment arms by stratification of patients in groups with 1 recurrence and with ≥2 recurrences.
    - The effect of treatment (primary endpoint), depending on the CD strain - respectively toxin B CDI cases, toxin B plus binary toxin CDI cases and CD027 CDI cases.
    - Treatment effect (primary endpoint), depending on the patients' serum level of antibodies to Toxin A and B, anti-TcdA and anti-TcdB, at inclusion.

    Other analyzes:
    - Registration of antibiotic treatments and temporal association with new recurrences of CDI in 180 days after the end of treatment.
    - Identification of demographic and clinical factors associated with treatment success / failure.
    - Characterization of the intestinal microbiota before and after FMT / RBI, in conjunction with characterization of intestinal microbiota in donors / RBI mixture. This will only be carried out in a subset of patients.
    - Measurement of the bile acid composition before and after FMT / RBI. Comparing with microbiota composition and treatment efficacy. Will be conducted on the same subset of patients as above.
    - Characterization of the CD strain in the case of recurrence after treatment to determine whether it is a relapse (same strain) or a reinfection (with new strain).
    - Side effects in the three treatment arms for 14 days after treatment.
    - Tidlig (inden for 14-30 dage) og sen (inden for 180 dage) rekurrent CDI efter endt behandling.
    - Dage med diarré i uge 1, 4, 8 og 12 efter endt behandling.
    - CDI-associeret hospitalsindlæggelse og hospitalsindlæggelse af anden årsag i opfølgningsperioden på 180 dage efter endt behandling.
    - CDI-associeret ambulant kontakt og ambulant kontakt af anden årsag i opfølgningsperioden på 180 dage efter endt behandling.
    - CDI-associeret mortalitet og all-cause mortalitet ved henholdsvis 30, 90 og 180 dage efter afsluttet behandling.
    - 3 års og 5 års opfølgning af CDI-associeret morbiditet og mortalitet, samt all-cause mortalitet(som led i efterfølgende prospektivt registerstudie). .

    Subgruppeanalyser:
    - Behandlingseffekt (primære effektmål) i de tre behandlingsarme ved stratificering af patienterne i grupper med 1. recurrente tilfælde og med ≥2 recurrente tilfælde.
    - Behandlingseffekt (primære effektmål) afhængigt af CD stamme – hhv. toxin B CDI cases, toxin B plus binært toxin CDI cases og CD027 CDI cases.
    - Behandlingseffekt (primære effektmål) afhængig af patienternes serumniveau af antistoffer mod toxin A og B, anti-TcdA og anti-TcdB, ved inklusion.

    Øvrige analyser:
    - Registrering af antibiotiske behandlinger og sammenhæng med eventuelle recurrente tilfælde af CDI i 180 dage efter endt behandling.
    - Identifikation af demografiske og kliniske faktorer associeret til behandlingssucces/behandlingssvigt.
    - Karakterisering af den intestinale mikrobiota før og efter FMT/RBI sammenholdt med karakterisering af den intestinale mikrobiota hos donorer/RBI-blandingen. Foretages i en undergruppe af patienterne.
    - Bestemmelse af galdesyresammensætningen før og efter FMT/RBI. Sammenholdes med mikrobiota-sammensætningen og behandlingseffekt. Foretages i samme undergruppe som ovenstående.
    - Karakterisering af stammer ved rekurrent CDI efter behandling for at fastslå, om der er tale om recidiv eller re-infektion (med ny stamme).
    - Opgørelse af bivirkninger i de tre behandlingsarme i 14 dage efter endt behandling.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Evaluation after 180 days of follow-up
    Evaluering foretages efter 180 dages opfølgning
    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 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) 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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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 trial3
    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 concerned2
    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 No
    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 (i.e. 180 days follow-up on the last subject)
    Sidste patients sidste opfølgning, dvs. sidste patients 180 dages opfølgning
    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 months6
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months6
    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: 50
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 400
    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 No
    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 state450
    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
    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 Decision2016-11-01
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-11-05
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2019-09-18
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