Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43871   clinical trials with a EudraCT protocol, of which   7290   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2017-003147-38
    Sponsor's Protocol Code Number:MICRO.HGUGM.2017-14
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2017-10-20
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2017-003147-38
    A.3Full title of the trial
    Open, randomized clinical trial to evaluate the treatment of First Clostridium difficile infection episodes with bacteriotherapy
    Ensayo Clínico abierto para evaluar el tratamiento de Episodios Primarios de Infección por Clostridium difficile con Bacterioterapia
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    treatment of First Clostridium difficile infection episodes with bacteriotherapy
    tratamiento de Episodios Primarios de Infección por Clostridium difficile con Bacterioterapia
    A.4.1Sponsor's protocol code numberMICRO.HGUGM.2017-14
    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 SponsorEmilio Bouza Santiago
    B.1.3.4CountrySpain
    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 supportIIS Carlos III
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationEmilio Bouza Santiago
    B.5.2Functional name of contact pointElena Reigadas
    B.5.3 Address:
    B.5.3.1Street AddressDoctor Esquerdo
    B.5.3.2Town/ cityMadrid
    B.5.3.3Post code28007
    B.5.3.4CountrySpain
    B.5.4Telephone number34915868453
    B.5.6E-mailhelenrei@hotmail.com
    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 Vancomicina
    D.2.1.1.2Name of the Marketing Authorisation holderPfizer
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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 Concentrate for concentrate for solution for infusion
    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
    D.3.9.1CAS number 1404-90-6
    D.3.9.2Current sponsor code73785
    D.3.9.4EV Substance CodeSUB05076MIG
    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 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
    Clostridium difficile infection
    Infección por Clostridium difficile
    E.1.1.1Medical condition in easily understood language
    gastrointestinal Bacteria infection
    Infeccion gastrointestinalpor bacteria
    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 20.0
    E.1.2Level LLT
    E.1.2Classification code 10012748
    E.1.2Term Diarrhoea, Clostridium difficile
    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 compare the recurrence rate to treatment with bacteriotherapy versus conventional treatment with vancomycin
    Comparar la tasa de recurrencias del tratamiento con bacterioterapia frente al tratamiento convencional con vancomicina
    E.2.2Secondary objectives of the trial
    Compare the response rate and recurrences between the following subgroups:
    patients with ICD by "hypervirulent" ribotipos strains such as 027.
    To compare the evolution in economic and comorbidity, including the length of hospital stay and hospital admission rates among patients receiving treatment with bacteriotherapy and those receiving conventional treatment with Vancomycin.
    • To compare the composition of intestinal microbiota before and after treatment among patients receiving treatment with bacteriotherapy and those receiving conventional vancomycin treatment.
    • To compare the efficacy of treatment with bacteriotherapy against conventional treatment with oral vancomycin.
    Comparar la tasa de respuesta y de recurrencias entre en los siguientes subgrupos:
    Pacientes con ICD por cepas de ribotipos “hipervirulentos” como el 027.
    Comparar la evolución en términos económicos y de comorbilidad, incluyendo la duración de estancia hospitalaria y tasas de ingreso hospitalario entre los pacientes que reciben tratamiento con bacterioterapia y aquellos que reciben tratamiento convencional con vancomicina.
    Comparar la composición de la microbiota intestinal antes y después del tratamiento entre los pacientes que reciben tratamiento con bacterioterapia y aquellos que reciben tratamiento convencional con vancomicina.
    Comparar la eficacia del tratamiento con bacterioterapia frente a los tratamiento convencionales con vancomicina oral.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Compare the response rate and recurrences between the following subgroups:
    patients with ICD by "hypervirulent" ribotipos strains such as 027.
    Comparar la tasa de respuesta y de recurrencias entre en los siguientes subgrupos:
    Pacientes con ICD por cepas de ribotipos “hipervirulentos” como el 027.
    E.3Principal inclusion criteria
    Men and women
    • Age> 18 years
    • That they agree and are able to give their informed consent (patient or legal representative).
    • Microbiological Diagnosis of toxigenic Clostridium difficile (ICD) infection with direct positive toxin test and diarrhea (> 3 bowel movements / 24 hours) or colonoscopic or histopathological findings that demonstrate pseudomembranous colitis within the first 72 hours before receiving the first dose of treatment.
    • Patients who are in a first episode of ICD that meet criteria of risk of poor outcome.
    • Hombres y Mujeres
    • Edad >18 años
    • Que estén de acuerdo y sean capaces de prestar su consentimiento informado (paciente o representante legal).
    • Diagnóstico confirmado por microbiología de infección por Clostridium difficile toxigénico (ICD) con prueba de toxina directa positiva y diarrea (>3 deposiciones /24horas) o hallazgos colonoscópicos o histopatológicos que demuestren colitis pseudomembranosa dentro de las primeras 72 horas antes de recibir la primera dosis de tratamiento.
    • Pacientes que se encuentren en un primer episodio de ICD que cumplan criterios de riesgo de mala evolución.
    E.4Principal exclusion criteria
    • Intensive care unit admission
    • Pregnant or breatsfeeding patients at the signing of consent.
    • Patients with neutropenia (with a total neutrophil count <0.5 x 109 / L)
    • Enteritis by Salmonella, Shigella, E. coli 0157H7, Yersinia or Campylobacter.
    • Severe baseline disease whose expected survival is less than three months.
    • Patients with Child C cirrhosis
    • Patients with current or recent (<3 months) treatment with antineoplastic agents or immunosuppressive medication (including but not limited to monoclonal antibodies to B and T cells, anti-TNF agents, antimetabolites (azathioprine, 6-mercaptopurine), inhibitors of calcineurin (tacrolimus, cyclosporine) mycophenolate mofetil.
    • Patients with a history of severe allergy (anaphylactic) to food.
    • Patients with known allergy or hypersensitivity to vancomycin or fidaxomicin.
    • Patients with fever on the day planned for bacteriotherapy
    • Gastroparesis
    • known Chronic aspiration
    • Dysfunction when swallowing or not oral-motor coordination
    • Patients with any condition, which in the opinion of their physician, bacteriotherapy may endanger the health of the patient.
    • Administration of any investigational antibiotic drug during the 30 days prior to inclusion in the study.
    Criterios de exclusión:
    • Ingreso en unidad de cuidados intensivos
    • Pacientes embarazadas o en periodo de lactancia a la firma del consentimiento.
    • Pacientes con neutropenia (con un recuento total de neutrofilos <0,5 x 109/L.)
    • Enteritis activa por Salmonella, Shigella, E. coli 0157H7, Yersinia o Campylobacter.
    • Enfermedad de base grave cuya supervivencia esperada sea menor de tres meses.
    • Pacientes con cirrosis hepática Child C.
    • Pacientes con tratamiento actual o reciente (<3 meses) con agentes antineoplásicos o medicación inmunosupresora (incluyendo, pero no limitado a, anticuerpos monoclonales frente a células B y T, agentes anti-TNF, antimetabolitos (azatioprina, 6-mercaptopurina), inhibidores de la calcineurina (tacrolimus, ciclosporina) micofenolato de mofetilo.
    • Pacientes con antecedentes de alergia grave (anafiláctica) a alimentos.
    • Pacientes con alergia o hipersensibilidad conocida a vancomicina o que por cualquier otro motivo no puedan recibir vancomicina
    • Pacientes con fiebre en el día planeado para la bacterioterapia
    • Gastroparesis
    • Aspiración crónica conocida
    • Disfunción al tragar o no coordinación oral-motora
    • Pacientes con cualquier condición, que en la opinión de su médico, la bacterioterapia pueda poner en peligro la salud del paciente.
    • Administración de cualquier fármaco antibiótico en investigación durante los 30 días previos a la inclusión en el estudio.
    E.5 End points
    E.5.1Primary end point(s)
    poor outcome (therapeutic failure, progression of infection to complicated severe forms, recurrence or mortality associated with infection)
    mala evolución(fallo terapéutico, progresión de la infección a formas graves complicadas, recurrencia o mortalidad asociada a la infección)
    E.5.1.1Timepoint(s) of evaluation of this end point
    every study visit
    en cada una de las visitas
    E.5.2Secondary end point(s)
    Resolution of the episode, patient well-being and hospital stay
    Resolución del episodio, bienestar del paciente y estancia hospitalaria
    E.5.2.1Timepoint(s) of evaluation of this end point
    Visits: post treatment visit, early follow-up day 30, late follow up day 60
    Visitas: seguimiento post tratamiento, seguimiento precoz día 30 y seguimiento tardío días 60
    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 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 Yes
    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 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) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Bacterioterapia(trasplante fecal)
    Bacteriotherapy(fecal transplant)
    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.8.5The 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
    LPLV
    UVUP
    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 months3
    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 months3
    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: 20
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 50
    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 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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    in case of incapable patients legal representative will sign the INFORMED CONSENT FORM
    EN CASO DE PACIENTES INCAPACES EL REPRESENTANTE LEGAL FIRMARÁ EL CONSENTIMIENTO INFORMADO
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state70
    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
    NINGUNO
    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 Decision2018-02-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-02-12
    P. End of Trial
    P.End of Trial StatusOngoing
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Sun May 05 05:20:37 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA