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    Summary
    EudraCT Number:2019-004402-10
    Sponsor's Protocol Code Number:APHP180587
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2020-02-20
    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 ConcernedFrance - ANSM
    A.2EudraCT number2019-004402-10
    A.3Full title of the trial
    Fecal transplantation to Eradicate Colonizing Emergent Superbugs
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Fecal transplantation to Eradicate Colonizing Emergent Superbugs
    A.3.2Name or abbreviated title of the trial where available
    FECES
    A.4.1Sponsor's protocol code numberAPHP180587
    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 SponsorASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)
    B.1.3.4CountryFrance
    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 supportDGOS
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)
    B.5.2Functional name of contact pointDRCI Hôpital St Louis
    B.5.3 Address:
    B.5.3.1Street Address1 av. Claude Vellefaux
    B.5.3.2Town/ cityparis
    B.5.3.3Post code75010
    B.5.3.4CountryFrance
    B.5.4Telephone number+330140275724
    B.5.5Fax number+330144841701
    B.5.6E-mailisabellevivaldo@aphp.fr
    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.2.1.2Country which granted the Marketing AuthorisationFrance
    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 nameFecal microbiota
    D.3.4Pharmaceutical form Capsule
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    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 Yes
    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 placeboCapsule
    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
    Patients colonized with MDR-GNB (multi-drug resistant Gram Negative bacteria )
    E.1.1.1Medical condition in easily understood language
    Patients colonized with MDR-GNB (multi-drug resistant Gram Negative 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 20.1
    E.1.2Level LLT
    E.1.2Classification code 10028152
    E.1.2Term Multi-antibiotic resistance
    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 primary objective of this two-arm placebo-controlled randomized trial in subjects carrying ESBL-E or CRE in their stool, as determined by culture methods, is to assess whether FMT with frozen capsules from healthy donors is effective for decolonization at 30±10 days post-randomization.
    E.2.2Secondary objectives of the trial
    To determine whether FMT with frozen capsules from healthy donors is effective for the:
    • Decolonization of MDR-GNB carriers at 90±30 days post-randomization
    • Decolonization of MDR-GNB carriers at 30±10 days and 90± 30 days post-randomization
    • Prevention of MDR-GNB infections
    • Reduction of duration of MDR-GNB carriage
    • Reduction of duration of isolation precautions and hospital stay
    • Reduction of the relative abundance of resistant strains over the total Enterobacteriaceae
    • Reduction of antibiotic consumption
    • To assess the safety and tolerability of FMT
    • Assess the changes in the microbiota of subjects undergoing FMT
    • To assess the link between successful decolonization and microbiota profiles prior to FMT and/or microbiota profiles of the donors
    • To assess factors associated with failure (no decolonization)
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Ancillary genomic studies will include genomic characterization of the MDR-GNB (this part of the work will not be financed by the PHRC but will be the subject of a separate financing).

    The objective will be (i) to characterize in detail de MDR-GNB and determine whether the type of MDR-GNB or the mechanisms of resistance involved may be associated with a successful outcome and (ii) determine the intra-patient clonality of the strains in order to assess whether the strains identified during the follow-up period were similar to the strains identified at inclusion; and (iii) an interpatient, global clonality analysis will also be performed in order to assess the possible diffusion of clones among patients.
    E.3Principal inclusion criteria
    a) Donors:
    - Healthy subjects ≥18 years and < 50 years
    - Subjects acceptable for stool donation according to the published recommendations for clinical and microbiological screening of the subject and of the stool of the Agence nationale de sécurité du médicament et des produits de santé (ANSM) in 2016.
    - Written informed consent

    b) Patients:
    - ≥18 years and <105 years
    - Colonized with a carbapenem-resistant Enterobacteriaceae (CRE) at inclusion on stool culture, or colonized with ESBL-E at inclusion on stool culture AND having suffered from an infection with an ESBL-E in the previous 12 months
    - Capable of taking oral capsules (n=25 two days in a row) with no dysphagia or swallowing disorders.
    - Written informed consent
    E.4Principal exclusion criteria
    a) Donors:
    - Any history of, or current proctologic disease, or any acute condition, which in the investigator’s judgment could harm the volunteer and / or compromise or limit the evaluation of the protocol or data analysis (cf. protocole).
    - Non-affiliation to a social security scheme (AME excepted)

    b) Patients:
    - Antibiotic treatment on the day of inclusion except for long term antibiotic prophylaxis (for at least 3 months/year)
    - Patients hospitalized in the intensive care unit
    - Pregnancy or breastfeeding during the study (see definitions in annex 5)
    - Women of childbearing potential who are unwilling or unable to use an acceptable method of birth control [such as oral contraceptives, other hormonal contraceptives (vaginal products, skin patches, or implanted or injectable products), or mechanical products such as an intrauterine device or barrier methods (condoms)] to avoid pregnancy for the entire study
    - Patient under legal guardianship
    - Participation in another trial
    - Non-affiliation to a social security scheme (AME excepted)
    NB. If an antibiotic treatment can be anticipated (for ex. prophylaxis treatment for surgery, or expected neutropenia) inclusion should be delayed to limit the use of antibiotics just after FMT.
    E.5 End points
    E.5.1Primary end point(s)
    Proportion of subjects not carrying MDR-GNB (neither ESBL-E nor CRE) at day 30 (±10 days) after randomization as determined by culture methods.
    E.5.1.1Timepoint(s) of evaluation of this end point
    day 30
    E.5.2Secondary end point(s)
    Prevention of infections:
    • Occurrence of a clinical infection with ESBL-E or CRE, between inclusion and day 90
    • Number of days of use of systemic antibiotics between inclusion and day 90
    • Number of days of isolation precautions during the hospital stay
    • Length of stay in hospital

    Safety: Occurrence of any adverse event or severe adverse event
    Microbiology:
    • Proportion of subjects not carrying MDR-GNB (neither ESBL-E nor CRE) at day 90 after randomization
    • Relative abundance of resistant strains over the total Enterobacteriaceae (expressed as a ratio)
    • Concentration (expressed in colony-forming units per gram of feces) of resistant strains
    • Characteristics of ESBL-E/CPE strains (species identification, resistance mechanisms)
    • 16S microbiome analysis, analysis in terms of diversity and operational taxonomic unit (OTU) presence:
    o Intra-subject comparison of the microbiome before and after intervention (relative to baseline)
    o Inter-subjects comparison between donors and patients, donors and receivers, and patients with and without a successful outcome.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Day 90
    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) Yes
    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 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 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 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 concerned10
    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
    LPLV
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    E.8.9.1In the Member State concerned months3
    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: 143
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 71
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers Yes
    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 2020-02-20. Yes
    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 state214
    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 Decision2020-02-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-03-11
    P. End of Trial
    P.End of Trial StatusOngoing
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