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    Summary
    EudraCT Number:2017-004531-36
    Sponsor's Protocol Code Number:MU1646
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2018-01-23
    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 ConcernedGermany - BfArM
    A.2EudraCT number2017-004531-36
    A.3Full title of the trial
    Escherichia coli strain Nissle 1917 - Suspension for treatment of patients with Clostridium difficile associated diarrhoea
    Escherichia coli Stamm Nissle 1917-Suspension zur Behandlung von Patienten mit Clostridium difficile-assoziierter Diarrhö
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Escherichia coli strain Nissle 1917 - Suspension for treatment of patients with Clostridium difficile associated diarrhoea
    Escherichia coli Stamm Nissle 1917-Suspension zur Behandlung von Patienten mit Clostridium difficile-assoziierter Diarrhö
    A.3.2Name or abbreviated title of the trial where available
    NIDIFF-Study
    NIDIFF-Studie
    A.4.1Sponsor's protocol code numberMU1646
    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 SponsorArdeypharm GmbH
    B.1.3.4CountryGermany
    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 supportArdeypharm GmbH
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationArdeypharm GmbH
    B.5.2Functional name of contact pointClinical research
    B.5.3 Address:
    B.5.3.1Street AddressLoerfeldstraße 20
    B.5.3.2Town/ cityHerdecke
    B.5.3.3Post code58313
    B.5.3.4CountryGermany
    B.5.4Telephone number+4923309770
    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 Mutaflor® Suspension
    D.2.1.1.2Name of the Marketing Authorisation holderArdeypharm GmbH
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 Oral suspension
    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 INNESCHERICHIA COLI STRAIN NISSLE 1917
    D.3.9.3Other descriptive nameESCHERICHIA COLI STRAIN NISSLE 1917
    D.3.9.4EV Substance CodeSUB76233
    D.3.10 Strength
    D.3.10.1Concentration unit CFU/ml colony forming unit(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1E08
    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 Yes
    D.3.11.13.1Other medicinal product typeprobiotic
    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 Vancomycin Dr. Eberth 125 mg Hartkapseln
    D.2.1.1.2Name of the Marketing Authorisation holderDr. Friedrich Eberth Arzneimittel GmbH
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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
    D.3.9.1CAS number 1404-90-6
    D.3.9.3Other descriptive nameVancomycin
    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 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.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboOral suspension
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule, hard
    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
    Clostridium difficile associated diarrhoea (CDAD)
    Clostridium difficile assoziierten Diarrhö (CDAD)
    E.1.1.1Medical condition in easily understood language
    Bacterial infection
    Bakterielle Infektion
    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
    Main objective of this study is to show that the administration of E. coli strain Nissle 1917 (EcN) results in a non-inferior CDAD healing rate compared to vancomycin treatment.
    Hauptziel der Studie ist es zu zeigen, dass die Gabe des E. coli Stammes Nissle 1917 (EcN) verglichen mit einer Vancomycin-Behandlung in einer nicht unterlegenen CDAD-Heilungsrate resultiert.
    E.2.2Secondary objectives of the trial
    o Showing that the administration of EcN results in a non-inferior CDAD relapse rate compared to vancomycin treatment
    o Showing that the administration of EcN results in a non-inferior CDAD healing rate without recurrence 30 days after treatment compared to vancomycin treatment
    o Showing that the administration of EcN results in a non-inferior CDAD healing rate without recurrence 90 days after treatment compared to vancomycin treatment
    o Analyses of the development of patients´ inflammatory markers
    o Assessment of safety and tolerability of the study medication
    o Presentation of the course of diarrhoea symptoms during the therapy phase
    o Presentation of the course of the abdominal pain related to CDAD during the therapy phase
    o Nachweis, dass die Gabe von EcN verglichen mit einer Vancomycin-Behandlung in einer nicht unterlegenen CDAD-Rezidivrate resultiert
    o Nachweis, dass die Gabe von EcN verglichen mit einer Vancomycin-Behandlung in einer nicht unterlegenen CDAD-Heilungsrate und 30-tägiger Rezidivfreiheit (nach Behandlungsende) resultiert
    o Nachweis, dass die Gabe von EcN verglichen mit einer Vancomycin-Behandlung in einer nicht unterlegenen CDAD-Heilungsrate und 90-tägiger Rezidivfreiheit (nach Behandlungsende) resultiert
    o Untersuchung von Entzündungsparametern
    o Bewertung der Sicherheit und Verträglichkeit der Studienmedikation
    o Analysen zum Verlauf der Stuhlfrequenzen und der abdominalen Schmerzen bzgl. CDAD während der Therapiephase
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    The microbiota of the trial subjects will be analysed regarding present C. difficile strains and microbiota composition/diversity.
    Die Mikrobiota der Studienteilnehmer soll hinsichtlich der vorhandenen C. difficile-Stämme und der Diversität/Komposition untersucht werden.
    E.3Principal inclusion criteria
    o Signed informed consent form by the patient
    o C. difficile associated diarrhoea (illnesses of mild to moderate severity)
    o Age ≥ 18 years with life expectancy of 3 months or more
    o Positive detection of C. difficile protein GDH and toxin A and / or B and diarrhoea (definition: ≥ 3 liquid or watery stools per day or ≥ 8 in 48 h)
    • Vorliegen der unterschriebenen Einverständniserklärung des Patienten.
    • CDAD (leichte bis moderate Fälle)
    • 18 Jahre oder älter, mit einer Lebenserwartung von ≥ 3 Monaten
    • Positiver Nachweis von C. difficile-Protein GDH und Toxin A und oder B und Diarrhö (Definition: ≥ 3 dünnflüssige oder wässrige Stühle pro Tag oder ≥ 8 in 48 h)
    E.4Principal exclusion criteria
    o Non-fulfilment of at least one inclusion criterion
    o Participation in an interventional clinical trial according to the German medicines act (AMG) within the last 30 days or simultaneously
    o Expectable lack of cooperation/compliance
    o Women of childbearing potential without conceptual protection
    o Pregnancy and breast feeding period
    o Abuse of alcohol (daily intake of 20 g of pure alcohol in women and 30 g of pure alcohol in men), medications or drugs
    o Limited legal capacity
    o Housing in an institution as a result of official or court orders
    o Dependency of a person on sponsor, trial site or investigator
    o Incompatibility with study medication
    o Necessity of intake of other antidiarrhoeals, especially antimotility agents
    o Other reasons that, in the opinion of the examiner, speak against inclusion of the patient to the trial
    o The presence of more than 2 of the following predictors of increased risk of a severe CDAD progression:
    ▶ Fever > 38.5 °C
    ▶ Leucocytosis > 15 × 10^9/L
    ▶ Left shift > 20% rod meaty granulocytes
    ▶ Hypoalbuminemia < 30 g/L
    ▶ Creatinine increase > 50% of initial value
    ▶ Lactate boost ≥ 5mmol/l
    ▶ Age > 75 years
    ▶ Significant morbidity (e.g. renal failure, immune suppression, etc.)

    o Severe form of the CDAD/ C. difficile infection (CDI):
    Severe CDAD/CDI is defined as an episode of CDAD/CDI with (one or more specific signs and symptoms of) severe colitis or a complicated course of disease, with significant systemic toxin effects and shock, resulting in need for intensive care unit (ICU) admission, colectomy or death
    o Enterocolitis that is not associated with C. difficile infection, such as active Crohn's disease*, active ulcerative colitis*, colitis caused by radiation or other pathogen-induced colitis
    o Positive TPER-Test (test will only be performed on patients with community acquired CDAD)
    o Other serious comorbidities, which, in the opinion of the investigator, call into question the protocol-compliant implementation of the study. This applies in particular to comorbidities, which could worsen if there is an aggravation of the CDAD.
    o Non-deductibility of a current antibiotic treatment of a disease other than the CDAD.
    o Intake of more than three 400 mg-doses of metronidazole (daily dose) or longer than 24 hours of metronidazole therapy to treat the acute CDAD episode before enrolment into the study.
    o Intake of more than four 125 mg-doses of vancomycin (daily dose) or longer than 24 hours of vancomycin therapy to treat the acute CDAD episode before enrolment into the study.
    o Taking more than three doses or longer than 24 hours of a probiotic drug to treat the acute CDAD episode before enrolment into the study.

    * Patients in remission are not excluded from the study!
    o Nicht-erfüllung mindestens eines der Einschlusskriterien
    o Teilnahme an einer klinischen Studie innerhalb der letzten 30 Tage oder gleichzeitige Teilnahme an einer anderen interventio-nellen und nach dem AMG durchgeführten klinischen Prüfung
    o Zu erwartende mangelnde Kooperationsfähigkeit
    o Frauen im gebärfähigen Alter ohne Konzeptionsschutz
    o Schwangerschaft und Stillzeit
    o Alkoholmissbrauch (tägl. Einnahme von 20g reinen Alkohols bei Frauen und 30 g reinen Alkohols bei Männern), Medikamenten- oder Drogenmissbrauch des potentiellen Patienten
    o Eingeschränkte Geschäftsfähigkeit des Patienten
    o Unterbringung in einer Anstalt aufgrund behördlicher oder richterlicher Anordnung
    o Abhängigkeit vom Sponsor, der Prüfstelle oder vom Prüfer
    o Unverträglichkeit gegenüber der Studienmedikation
    o Notwendigkeit der Gabe von Antidiarrhoika, speziell motolitätshemmenden
    o Sonstige Gründe, die nach Einschätzung des Prüfers gegen die Aufnahme des Patienten in die Prüfung sprechen
    o Vorhandensein von mehr als 2 der folgenden Prädiktoren eines erhöhten Risikos für einen schweren Verlauf der CDAD
    ▶ Fieber > 38,5 °C
    ▶ Leukocytose > 15 × 10^9/L
    ▶ Linksverschiebung > 20% stabkerniger Granulozyten
    ▶ Hypoalbuminemie < 30 g/L
    ▶ Kreatininanstieg > 50% des Ausgangswertes
    ▶ Kreatininanstieg ≥ 5mmol/l
    ▶ Alter > 75 Jahre
    ▶ Signifikante Komorbiditäten (z.b. Nierenversagen, Immunsupprimierung, etc.)
    o Schwere Form der CDAD/CDI:
    Die Schwere Form der CDI ist definiert als eine Episode der CDI mit (einem oder mehreren spezifischen Zeichen und Symptomen) einer schweren Kolitis oder einem komplizierten Krankheitsverlauf, mit signifikanten systemischen Toxineffekten und Schock, welche entweder in der Aufnahme auf die Intensivstation, einer Kolektomie oder dem Tod des Patienten resultieren.
    o Enterokolitiden, die nicht im Zusammenhang mit einer C.-difficile-Infektion stehen, wie z. B. aktiver Morbus Crohn*, aktive Colitis ulcerosa*, Strahlenkolitis oder andere Erreger-induzierte Kolitiden
    o Positiver TPER-Test (Kontrolle erfolgt bei Patienten, die die CDAD ambulant erworben haben)
    o Andere schwere Begleiterkrankungen, die nach Einschätzung des Prüfers eine Prüfplan-gerechte Durchführung der Studie in Frage stellen. Das gilt insbesondere für Begleiterkrankungen, die sich durch einen schweren Verlauf der CDAD verschlechtern würden.
    o Nicht-Absetzbarkeit einer vorausgegangenen Antibiose zur Therapie einer anderen Erkrankung als der CDAD.
    o Einnahme von mehr als drei 400 mg-Metronidazol-Dosen oder eine länger als 24h dauernde Metronidazol-Behandlung der akuten CDAD-Episode vor Einschluss in die Studie.
    o Einnahme von mehr als vier 125 mg-Vancomycin-Dosen oder eine länger als 24h dauernde Vancomycin-Behandlung der akuten CDAD-Episode vor Einschluss in die Studie.
    o Einnahme von mehr als drei Probiotika-Dosen oder eine länger als 24h dauernde Probiotika-Einnahme zur Behandlung der akuten CDAD-Episode vor Einschluss in die Studie.

    * Patienten in Remission werden nicht von der Studie ausgeschlossen!
    E.5 End points
    E.5.1Primary end point(s)
    Primary end point of this study is the CDAD healing rate after 14 days of treatment.
    Healing is defined as:
    o < 3 liquid/mushy or watery stools per day
    AND
    o Assessment of abdominal pain related to CDAD is 0 or 1
    AND
    o Assessment of the investigator, that the patient does not need further therapy to treat CDAD

    Classification:
    o Assessment of abdominal pain (strongest pain episode of the day related to CDAD) by the patient:
    None = 0 ; Mild = 1 ; Moderate = 2 ; Severe = 3
    Hauptzielkriterium: Heilungsrate nach 14 Tagen Behandlung
    Definition der Heilung:
    o Stuhlfrequenz: < 3 flüssige/breiige oder wässrige Stühle an Tag 14
    und
    o Bewertung der abdominalen Schmerzen bzgl. CDAD: 0 oder 1
    und
    o Beurteilung des Arztes, dass der Patient keine weitere Therapie zur Behandlung der CDAD benötigt

    Klassifikationen:
    o Bewertung der abdominalen Schmerzen (stärkste Schmerzepisode bzgl. CDAD am Tag) durch den Patienten:
    keine = 0 ; leicht = 1 ; mäßig = 2 ; stark = 3
    E.5.1.1Timepoint(s) of evaluation of this end point
    after 14 days of treatment with IMP
    nach 14-tägiger IMP-Behandlung
    E.5.2Secondary end point(s)
    o Rate of CDAD relapse for different treatment groups
    o Rate of CDAD healing and CDAD recurrence rate within 30 or 90 days after treatment, respectively
    o Values of different inflammatory markers
    o Reports of adverse events (AEs) and adverse drug reactions (ADRs)
    o The entries of the patients in the diary regarding defecation frequency and consistency of the faeces
    o The entries of the patients in the diary regarding abdominal pain related to CDAD
    o Rezidivrate bzgl. CDAD für die verschiedenen Behandlungsgruppen
    o CDAD Heilungsrate und CDAD Rückfallrate innerhalb von 30 bzw. 90 Tagen nach Behandlungsende
    o Werte für verschiedene Entzündungsmarker
    o Auftreten von unerwünschten Ereignissen (UEs) und Nebenwirkungen
    o Tagebucheinträge der Studienteilnehmer bzgl. Stuhlfrequenz, Stuhlkonsistenz und abominaler Schmerzen im Zusammenhang mit CDAD
    E.5.2.1Timepoint(s) of evaluation of this end point
    o Rate of CDAD relapse for different treatment groups: within/after an observation period of not longer than 13 weeks after treatment period
    o Rate of CDAD healing and CDAD recurrence rate within 30 or 90 days after treatment, respectively: after treatment period and 30 or 90 days after treatment, respectively
    o Values of different inflammatory markers: over the entire course of the supject participation
    o Reports of adverse events (AEs) and adverse drug reactions (ADRs): over the entire course of the subject participation
    o The entries of the patients in the diary regarding defecation frequency and consistency of the faeces: after 14 days of treatment with IMP
    o The entries of the patients in the diary regarding abdominal pain related to CDAD: after 14 days of treatment with IMP
    o Rezidivrate bzgl. CDAD für die verschiedenen Behandlungsgruppen: während/nach enier längstens 13-wöchigen Beobachtungsphase nach der Behandlungsphase
    o CDAD Heilungsrate und CDAD Rückfallrate innerhalb von 30 bzw. 90 Tagen nach Behandlungsende: nach 14-tägiger IMP-Behandlung und 30 bzw. 90 Tage nach Ende der Behandlung
    o Werte für verschiedene Entzündungsmarker: über den Gesamten Zeitraum der Studienteilnahme
    o Auftreten von unerwünschten Ereignissen (UEs) und Nebenwirkungen: über den Gesamten Zeitraum der Studienteilnahme
    o Tagebucheinträge der Studienteilnehmer bzgl. Stuhlfrequenz, Stuhlkonsistenz und abominaler Schmerzen im Zusammenhang mit CDAD nach 14-tägiger IMP-Behandlung
    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 Yes
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 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 trial4
    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 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
    LVLS
    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
    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: 18
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 90
    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 state108
    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)
    If further treatment of Clostridium deficile infection is necessary, the subject will get an antibiotic treatment according to relevant ESCMID guidelines.
    Falls eine Weiterbehandlung der Clostridium difficile Infektion nötig ist, wird der Patient eine Antibiotikatherapie Gemäß ESCMID-Leitlinie erhalten.
    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 Decision2018-09-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-03-05
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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