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    Summary
    EudraCT Number:2020-004591-17
    Sponsor's Protocol Code Number:ICD-01
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2020-11-11
    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 number2020-004591-17
    A.3Full title of the trial
    A randomised, controlled, open-label phase III clinical trial in patients with recurrent Clostridioides difficile (CD) infection, to evaluate the efficacy and safety of capsules of lyophilised faecal microbiota vs fidaxomicin
    Ensayo clínico fase III aleatorizado, controlado y abierto en pacientes con infección recurrente por Clostridioides difficile (CD) para evaluar la eficacia y la seguridad de cápsulas de microbiota fecal liofilizada vs fidaxomicina
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A phase III clinical trial in patients with recurrent Clostridioides difficile (CD) infection, to evaluate the treatment with capsules of lyophilised faecal microbiota vs fidaxomicin
    Ensayo clínico fase III en pacientes con infección recurrente por Clostridioides difficile (CD) para evaluar el tratamiento con cápsulas de microbiota fecal vs fidaxomicina
    A.4.1Sponsor's protocol code numberICD-01
    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 SponsorMikrobiomik Healthcare Company S.L.
    B.1.3.4CountrySpain
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportMikrobiomik
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSERMES PLANIFICACION S.L
    B.5.2Functional name of contact pointSTART UP UNIT
    B.5.3 Address:
    B.5.3.1Street AddressCalle Rufino González, 14-2º D
    B.5.3.2Town/ cityMadrid
    B.5.3.3Post code28037
    B.5.3.4CountrySpain
    B.5.4Telephone number+3491327 50 25
    B.5.5Fax number+3491754 27 21
    B.5.6E-mailstart-up@sermescro.com
    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 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 nameMBK-01
    D.3.4Pharmaceutical form Capsule
    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 INNALLOGENEIC FAECAL MICROBIOTA, POOLED
    D.3.9.3Other descriptive nameALLOGENEIC FAECAL MICROBIOTA, POOLED
    D.3.9.4EV Substance CodeSUB193130
    D.3.10 Strength
    D.3.10.1Concentration unit billion organisms billion organisms
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number0.052 to 0.062
    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.IMP: 2
    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 Dificlir
    D.2.1.1.2Name of the Marketing Authorisation holderAstellas Pharma Europe B.V.
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 Film-coated 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.3.8INN - Proposed INNFIDAXOMICIN
    D.3.9.1CAS number 873857-62-6
    D.3.9.3Other descriptive nameFIDAXOMICIN
    D.3.9.4EV Substance CodeSUB31455
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(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 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
    Recurrent Clostridioides difficile (CD) infection
    Infección recurrente por Clostridioides difficile
    E.1.1.1Medical condition in easily understood language
    Recurrent Clostridioides difficile (CD) infection
    Infección recurrente por Clostridioides 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 20.1
    E.1.2Level LLT
    E.1.2Classification code 10053021
    E.1.2Term Gram-positive bacterial 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
    The main purpose of the study is to evaluate the efficacy of the investigational medicinal product (MBK-01) compared to the control medication (fidaxomicin), 8 weeks after the treatment completion.
    El objetivo principal del estudio es evaluar la eficacia del medicamento en investigación (MBK-01) comparado con el control (fidaxomicina) a las 8 semanas tras finalizar el tratamiento.
    E.2.2Secondary objectives of the trial
    Secondary purposes entail evaluating the safety of the investigational medicinal product and the quality of life for patients participating in the study.
    Los objetivos secundarios suponen evaluar la seguridad del medicamento en investigación y la calidad de vida de los pacientes participantes en el estudio.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Patients of both genders, over 18 years.
    2. Patients that undergo the first, second or subsequent recurrences of CD infection, as long as they have completed at least one course of treatment with standard oral antibiotic (vancomycin) in the primary episode and which has ended at least 48 hours before the enrollment of the subject in the study.
    3. Confirmation of the presence of CD toxin A in faeces, by a direct toxin detection test or by the PCR technique for the detection of toxin producing genes, within 48 hours prior to the enrolment of the subject in the clinical trial.
    1. Pacientes de ambos sexos, mayores de 18 años.
    2. Pacientes que presenten la primera, segunda o posteriores recurrencias de infección por CD, siempre que en el episodio primario hayan completado al menos un ciclo de tratamiento con antibiótico oral estándar (vancomicina) y el cual haya terminado al menos 48 horas antes de la inclusión del sujeto en el estudio.
    3. Confirmación de la presencia de la toxina A de CD en heces, mediante una prueba de detección directa de toxinas o mediante PCR para la detección de los genes productores de la toxina, en las 48 horas anteriores a la inclusión del sujeto en el ensayo clínico.
    E.4Principal exclusion criteria
    1. Previous faecal microbiota transfer.
    2. History of inflammatory bowel disease (ulcerative colitis, Crohn’s disease, or microscopic colitis).
    3. Diagnosis of irritable bowel syndrome (IBS) according to Rome III criteria.
    4. Compromised immune system: immunosuppressed due to a medical condition or medicine in the last 5 years; current or recent (less than 90 days) chemotherapy treatment.
    5. Absolute neutrophil count <1.000 cells /µL at the time of the enrolment in the study.
    6. Pregnancy, breastfeeding, or pregnancy intentions over the course of the study.
    7. Use of bile acid sequestrants (for instance: cholestyramine).
    8. Use of proton-pump inhibitors (PPIs).
    9. Human immunodeficiency virus (HIV).
    10. Current radiotherapy or in the last 5 years.
    11. History of cancer in the last 5 years.
    12. Swallowing dysfunction or no oral motor coordination.
    13. Admission or expected admission in an intensive care unit for medical reasons, for a treatment with antibiotics.
    1. Transferencia de microbiota fecal previa.
    2. Antecedentes de enfermedad inflamatoria intestinal (colitis ulcerosa, enfermedad de Crohn o colitis microscópica).
    3. Diagnóstico de síndrome de intestino irritable (SII) según los criterios de Roma III.
    4. Sistema inmunitario comprometido: inmunodeprimidos debido a una afección médica o medicamento en los últimos 5 años; tratamiento actual o reciente (menos de 90 días) con quimioterapia.
    5. Recuento absoluto de neutrófilos <1.000 células /µL en el momento de la inclusión en el estudio.
    6. Embarazo, lactancia o intención de quedarse embarazada durante el tiempo de transcurso del estudio.
    7. Uso de secuestradores de ácidos biliares (por ejemplo: colestiramina).
    8. Uso de inhibidores de la bomba de protones (IBPs).
    9. Virus de inmunodeficiencia humana (VIH).
    10. Radioterapia actual o en el transcurso de los 5 últimos años.
    11. Antecedentes de Cáncer en los últimos 5 años.
    12. Disfunción al tragar o no coordinación oral-motora.
    13. Ingreso o se espera que sea admitido en una UCI por razones médicas con indicación de tratamiento con antibióticos.
    E.5 End points
    E.5.1Primary end point(s)
    Absence of diarrhea: Number of episodes of diarrhea (3 or more stools/24 hours)
    Ausencia de diarrea: Nº de episodios de diarrea (3 o más deposiciones/24 horas)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Time 0, 1 week, 4 weeks, 8 weeks, 3 months, and 6 months
    Tiempo 0, 1 semana, 4 semanas, 8 semanas, 3 meses y 6 meses
    E.5.2Secondary end point(s)
    - Duration of hospitalisation: time, in days, that the patient remains in the hospital, from the moment the informed consent is signed until they are discharged after receiving the investigational medicinal product
    - Good/bad progress of the patient. A bad progress of the patient is defined as the appearance of complications requiring an admission in an ICU
    - Time to recurrence/relapse depending on ramdomisation groups
    - Duration of treatment (days)
    - Overall survival: percentage of patients that are still alive after a defined period of time from the beginning of the treatment
    - Number of Adverse Events per ramdomisation group
    - Type of Adverse Events per ramdomisation group
    - Number of Serious Adverse Events per ramdomisation group
    - Type of Serious Adverse Events per ramdomisation group
    - Adverse Events related to the treatment
    - Adverse Event Seriousness
    - Adverse Events related to the CDI
    - Mortality associated with CDI
    - Intensive Care Unit admissions (ICU)
    - Adverse Events of special interest
    - SF36 questionnaire to evaluate the quality of life
    - Duración de la hospitalización: tiempo, en días, que el paciente permanece ingresado en el centro hospitalario, desde que firma el consentimiento informado hasta que es dado de alta tras recibir la medicación del estudio
    - Buena/Mala evolución del paciente: Se define como mala evolución del paciente la aparición de complicaciones que requieran un ingreso en UCI
    - Tiempo hasta recurrencia/recaída en función de los grupos de aleatorización
    - Duración del tratamiento (días)
    - Supervivencia global: porcentaje de pacientes que siguen vivos transcurrido un periodo de tiempo definido desde que comenzaron el tratamiento
    - Número de Acontecimientos Adversos por grupo de aleatorización
    - Tipo de Acontecimientos Adversos por grupo de aleatorización
    - Número de Acontecimientos Adversos Graves por grupo de aleatorización
    - Tipo de Acontecimientos Adversos Graves por grupo de aleatorización
    - Acontecimientos Adversos en relación con el tratamiento
    - Gravedad de los Acontecimientos Adversos
    - Acontecimientos Adversos en relación con la ICD
    - Mortalidad asociada a la ICD
    - Ingresos en Unidad de Cuidados Intensivos (UCI)
    - Acontecimientos Adversos de especial interés
    - Cuestionario SF36 para evaluar la calidad de vida
    E.5.2.1Timepoint(s) of evaluation of this end point
    - From time 0 until the patient is discharged
    - From time 0 to the end of the study
    - From time 0 to the end of the study
    - From time 0 to the treatment completion
    - From time 0 to the end of the study
    - From time 0 to the end of the study
    - From time 0 to the end of the study
    - From time 0 to the end of the study
    - From time 0 to the end of the study
    - From time 0 to the end of the study
    - From time 0 to the end of the study
    - From time 0 to the end of the study
    - From time 0 to the end of the study
    - From time 0 to the end of the study
    - From time 0 to the end of the study
    - Time 0, 8 weeks, and 6 months
    - Desde tiempo 0 hasta el alta del paciente
    - Desde tiempo 0 hasta fin de estudio
    - Desde tiempo 0 hasta fin de estudio
    - Desde tiempo 0 hasta finalización del tratamiento
    - Desde tiempo 0 hasta fin de estudio
    - Desde tiempo 0 hasta fin de estudio
    - Desde tiempo 0 hasta fin de estudio
    - Desde tiempo 0 hasta fin de estudio
    - Desde tiempo 0 hasta fin de estudio
    - Desde tiempo 0 hasta fin de estudio
    - Desde tiempo 0 hasta fin de estudio
    - Desde tiempo 0 hasta fin de estudio
    - Desde tiempo 0 hasta fin de estudio
    - Desde tiempo 0 hasta fin de estudio
    - Desde tiempo 0 hasta fin de estudio
    - Tiempo 0, 8 semanas y 6 meses
    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 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) 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 concerned15
    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
    Última visita del último paciente
    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 months11
    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: 32
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 66
    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 Yes
    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 Yes
    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 state98
    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 Decision2021-04-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-01-22
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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