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    Summary
    EudraCT Number:2016-004381-25
    Sponsor's Protocol Code Number:1608170
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2017-08-31
    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 number2016-004381-25
    A.3Full title of the trial
    Study of the impact of a targeted decolonization of S. aureus in persistent carriers on the occurrence of S. aureus infections in hemodialysis patients
    Evaluation de l’impact d’une stratégie de décolonisation ciblée des porteurs persistants de Staphylococcus aureus sur la survenue d’infections à S. aureus en hémodialyse
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study of the impact of a decolonization of S. aureus in carriers on the occurrence of S. aureus infections in hemodialysis patients
    Evaluation de l’impact d’une décolonisation chez des patients porteurs de Staphylococcus aureus sur la survenue d’infections à S. aureus en hémodialyse
    A.3.2Name or abbreviated title of the trial where available
    CIBERSTAPH
    CIBERSTAPH
    A.4.1Sponsor's protocol code number1608170
    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 SponsorCHU de Saint-Etienne
    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 supportCHU de SAint-Etienne
    B.4.2CountryFrance
    B.4.1Name of organisation providing supportMinistère de la Santé
    B.4.2CountryFrance
    B.4.1Name of organisation providing supportCepheid France
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCHU de Saint-Etienne
    B.5.2Functional name of contact pointGARCIN
    B.5.3 Address:
    B.5.3.1Street AddressURCIP - Hôpital NORD
    B.5.3.2Town/ citySAINT-ETIENNE Cedex 2
    B.5.3.3Post code42055
    B.5.3.4CountryFrance
    B.5.4Telephone number+33(0)477120286
    B.5.6E-mailarnauld.garcin@chu-st-etienne.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 Yes
    D.2.1.1.1Trade name BACTROBAN 2%
    D.2.1.1.2Name of the Marketing Authorisation holderGLAXOSMITHKLINE
    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.3.4Pharmaceutical form Nasal cream
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPNasal use
    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.IMP: 2
    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 HIBISCRUB 4%
    D.2.1.1.2Name of the Marketing Authorisation holderRegent Medical Overseas Limited
    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.3.4Pharmaceutical form Cutaneous solution
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPCutaneous use
    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
    Hemodialysis patients
    Patients hémodialysés
    E.1.1.1Medical condition in easily understood language
    Hemodialysis patients
    Patients hémodialysés
    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 10066622
    E.1.2Term Chronic hemodialysis
    E.1.2System Organ Class 100000022103
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To reduce S. aureus infections incidence (Methicillin susceptible S. aureus (MSSA) or methicillin resistant (MRSA)) in decolonization strategy (targeted decolonization of persistent carriers) compared to therapeutic conventional strategy (=decolonization of nobody)
    Montrer qu’une stratégie de décolonisation ciblée par mupirocine + chlorhexidine uniquement des porteurs persistants de S. aureus comparée à l’absence de décolonisation chez les patients hémodialysés chroniques permet de réduire significativement l’incidence des infections à S. aureus (SAMS ou SAMR) à 1 an.
    E.2.2Secondary objectives of the trial
    To show that a strategy of decolonization targeted compared with the absence of decolonization allows to reduce to 1 year:
    · the incidence of the endogenous infections to aureus S. (SASM or SARM),
    · the incidence of bactériémies to aureus S. (SASM or SARM),

    To estimate over 1 year:
    · the incidence of strain of S. aureus resistant in the mupirocine ( mupirocine-R ) and/or in the chlorhexidine ( chlorhexidine-R ) in the group strategy decolonization targeted compared with)the group comparator.
    · the epidemiology of the carriage of aureus S. within 2 groups and their evolution during the follow-up,
    · the epidemiology of the other bacterial infections within 2 groups during the follow-up.
    Montrer qu’une stratégie de décolonisation ciblée par rapport à l’absence de décolonisation permet de réduire à 1 an :
    • l’incidence des infections endogènes à S. aureus (SASM ou SARM),
    • l’incidence des bactériémies à S. aureus (SASM ou SARM),

    Evaluer sur 1 an:
    • l’incidence de souches de S. aureus (souche d’infection ou de portage) résistante à la mupirocine (mupirocine-R) et/ou à la chlorhexidine (chlorhexidine-R) dans le groupe stratégie décolonisation ciblée par rapport au groupe comparateur.
    • l’épidémiologie du portage de S. aureus au sein des 2 groupes et leur évolution au cours du suivi,
    • l’épidémiologie des autres infections bactériennes au sein des 2 groupes au cours du suivi.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - age > 18
    -Patient under chronic hemodialysis
    -Affiliated to French « Sécurité Sociale » regimen
    -Patent that accepted to participate in the study with a written consent form signed
    - Patient affilié ou ayant droit d’un régime de sécurité sociale
    - Agé > 18 ans
    - Patient hémodialysé chronique quel que soit l’abord utilisé pour la dialyse (cathéter, fistule artério-veineuse….)
    - Patient acceptant de participer à l’étude et ayant signé le consentement éclairé
    E.4Principal exclusion criteria
    -Patients under peritoneal dialysis
    -Patients with an active infection at the time of inclusion
    -Patients previously treated by mupirocin and chlorhexidine for decolonization purpose
    -Patients that received antimicrobials active on S. aureus during the month before the inclusion
    -Patients with allergy to mupirocin or chlorhexidine
    -Patients treated by hemodialysis transiently (non-terminal kidney failure)
    -Pregnancy
    - Patients sous dialyse péritonéale
    - Patients présentant une infection bactérienne active traitée (supposée ou documentée) dans le mois précèdent l’inclusion
    - Patients ayant reçu un traitement par mupirocine ou chlorhexidine pour décolonisation dans les 5 ans
    - Patients allergiques ou intolérants à la mupirocine ou chlorhexidine
    - Patients hémodialysés de façon provisoire (insuffisance rénale non terminale)
    - Patients hémodialysés en autodialyse
    - femme enceinte
    E.5 End points
    E.5.1Primary end point(s)
    Number of the infections to S. aureus (SAMS or SAMR) up to 12 months in hemodialysis patients between the 2 groups
    Nombre total des infections à S. aureus (SAMS ou SAMR) à 12 mois chez les patients en hémodialyse selon les 2 stratégies
    E.5.1.1Timepoint(s) of evaluation of this end point
    12 months
    12 mois
    E.5.2Secondary end point(s)
    - incidence of the endogenous infections to aureus S..
    - incidence of bactériémies to aureus S.,
    - percentage of strain of S. aureus resistant in the mupirocine and the strain of S. aureus resistant in the chlorhexidine
    - percentage of persistent, occasional and not carriers of S. aureus,
    - incidence of the bacterial infections other than aureus S..
    -Incidence des infections endogènes à S. aureus.
    -Incidence des bactériémies à S. aureus,
    -Pourcentage de souches de S. aureus résistantes à la mupirocine et des souches résistantes à la chlorhexidine
    -Pourcentage de porteurs persistants, intermittents et non porteurs de S. aureus,
    -Incidence des infections bactériennes autres que S. aureus.
    E.5.2.1Timepoint(s) of evaluation of this end point
    12 months
    12 mois
    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 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 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) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Aucune intervention
    No intervention
    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 concerned11
    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
    End of the centralised microbiological analyses (after LVLS)
    Fin des analyses microbiologiques centralisées (après LVLS)
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months0
    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: 210
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 640
    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 No
    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 No
    F.4 Planned number of subjects to be included
    F.4.1In the member state850
    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
    Aucun
    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 Decision2017-08-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-11-24
    P. End of Trial
    P.End of Trial StatusCompleted
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