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    Summary
    EudraCT Number:2014-003048-11
    Sponsor's Protocol Code Number:GIPIT002
    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:2015-06-22
    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 number2014-003048-11
    A.3Full title of the trial
    FEcal transplant, a Dazzling debut to Eradicate colonization with eXtreme drug resistant
    bacteria?
    La transplantation fécale, un brillant début pour éradiquer la colonisation à Bactéries
    Hautement Résistantes Emergentes ?
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    FEcal transplant, a hope to Eradicate colonization of patient harboring eXtreme drug resistant
    bacteria?
    La transplantation fécale, un espoir pour permettre d'éradiquer la colonisation des patients porteurs à Bactéries
    Hautement Résistantes Emergentes ?
    A.3.2Name or abbreviated title of the trial where available
    FEDEX
    A.4.1Sponsor's protocol code numberGIPIT002
    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 SponsorGIPIT
    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 supportGIPIT (Groupe d’Investigation en Pathologies Infectieuses et Tropicales)
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGIPIT (Groupe d’Investigation en Pathologies Infectieuses et Tropicales)
    B.5.2Functional name of contact pointPierre de Truchis (Trésorier)
    B.5.3 Address:
    B.5.3.1Street AddressHopital Raymond Poincaré
    B.5.3.2Town/ cityGarches
    B.5.3.3Post code92380
    B.5.3.4CountryFrance
    B.5.6E-mailp.de-truchis@rpc.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.2.5The 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 Transplant (feces)
    D.3.4Pharmaceutical form Oral/rectal solution
    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) 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 Yes
    D.3.11.13.1Other medicinal product typefeces
    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
    Patient harboring Extreme Drug Resistant (XDR) bacteria. Our trial try to eradicate this digestive tract colonization by performing a fecal transplantation.
    Etude réalisée chez des patients porteurs de bactéries hautement résistantes (BHRe)
    Notre étude tente d'eradiquer le portage digestif de ces bactéries par une transplantation fécale.
    E.1.1.1Medical condition in easily understood language
    Patient harboring Extreme Drug Resistant (XDR) bacteria. Our trial try to eradicate this digestive tract colonization by performing a fecal transplantation.
    Etude réalisée chez des patients porteurs de bactéries hautement résistantes (BHRe)
    Notre étude tente d'eradiquer le portage digestif de ces bactéries par une transplantation fécale.
    E.1.1.2Therapeutic area Diseases [C] - Bacterial Infections and Mycoses [C01]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Evaluate the eradication of the colonization of patient harboring XDR bacteria after a fecal transplantation from a healthy donor.
    Evaluer l’éradication et le délai de la colonisation digestive à BHRe
    après transplantation fécale de nos patients par un donneur sain.
    E.2.2Secondary objectives of the trial
    Evaluate the side effects of this procedure and tolerability.
    Evaluate the efficacy of the transplant if the patient is harboring glycopeptid resistant enteroccus (GRE) or carbapenem resistant enterobacteriae (CRE)
    Evaluation des effets indésirables et de la tolérance de la procédure,
    évaluation de l’efficacité fonction du type de BHRe (ERG, EPC).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patient aged over 18, harboring a GRE or CRE bacteria confirmed by our microbiology department (on 3 swabs performed every week during 3 weeks).
    Patient agreed and signed the consent form.
    Donor feces must be indemn of bacterial, viral or fungal infection (tested on feces or serology)
    Patient majeur, présentant une colonisation digestive à BHRe : EPC
    ou ERG confirmée par le laboratoire de microbiologie de l’hôpital Raymond Poincaré sur 3
    prélèvements à 1 semaine d’intervalle, ayant donné son consentement.
    Selon les recommandations de l’ANSM de Mars 2014, le donneur sera soumis à un
    ensemble d’examens sérologiques et des selles afin d’éliminer toute infection active au
    moment du don de selles.
    E.4Principal exclusion criteria
    Pregnant woman, breastfeeding, immunodepression including AIDS, corticosteroids over 60mg/day, antibiotic treatment at the day of inclusion, impossibility to obtain a signed consent form.
    femme enceinte ou allaitante, immunodépression dont VIH
    (CD4<200/mm3), traitement corticoïdes > 60mg/jour, traitement antibiotique en cours au
    moment de la transplantation refus du patient, impossibilité d’obtenir le consentement.
    E.5 End points
    E.5.1Primary end point(s)
    Negativation of the rectal swab performed.
    Négativation du portage digestif de BHRe par réalisation d’un écouvillonnage rectal.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Rectal swab will be performed at one week, 2 weeks, one month up to six months in order to assess the negativation of the XDR bacteria.
    Après transplantation, nous réaliserons un écouvillonnage rectal à 1 semaine, 2 semaines et
    1 mois puis tous les mois pendant 6 mois, chez le patient porteur de BHRe afin de surveiller
    la négativation de son portage digestif.
    E.5.2Secondary end point(s)
    Evaluate side effects of this procedure including digestive signs such as nausea, abdominal pain.
    Evaluate predictable factors of failure of this procedure.
    Evaluate efficacy of fecal transplant if the patient is harboring GRE or CRE
    Recherche effets indésirables et signes de mauvaise tolérance, analyse des facteurs de
    risques d’échec de la décolonisation, analyse de la décolonisation en fonction du type de
    BHRe (ERG, EPC).
    E.5.2.1Timepoint(s) of evaluation of this end point
    Evaluate side effects of this procedure including digestive signs such as nausea, abdominal pain.
    Evaluate predictable factors of failure of this procedure.
    Evaluate efficacy of fecal transplant if the patient is harboring GRE or CRE
    Recherche effets indésirables et signes de mauvaise tolérance, analyse des facteurs de
    risques d’échec de la décolonisation, analyse de la décolonisation en fonction du type de
    BHRe (ERG, EPC).
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    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 No
    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
    Trial will end for the patient once the swab 6 months after the fecal transplant has been performed
    L'étude s'arretera pour le patient après la réalisation de l'écouvillonage rectal a 6 mois de la transplantation.
    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 months
    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: 5
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 5
    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 No
    F.3.3.7Others Yes
    F.3.3.7.1Details of other specific vulnerable populations
    Patient harboring XDR bacteria in their digestive tract
    patient porteur de BHRe sur un ecouvillonnage
    F.4 Planned number of subjects to be included
    F.4.1In the member state10
    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)
    Patient will be monitored for 6 months until the last swab is performed.
    Les patients seront surveillés et inclus dans l'étude jusqu'a la réalisation de leur dernier prélèvement par écouvillon à 6 mois
    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 Decision2014-10-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-10-24
    P. End of Trial
    P.End of Trial StatusOngoing
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