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    Summary
    EudraCT Number:2019-000244-10
    Sponsor's Protocol Code Number:EGBAB
    National Competent Authority:Sweden - MPA
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2019-10-31
    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 ConcernedSweden - MPA
    A.2EudraCT number2019-000244-10
    A.3Full title of the trial
    Influence of antibiotic treatment on the normal flora and the presence of resistance genes in known carriers of ESBL and VRE
    Påverkan av antibiotikabehandling avseende normalflora och förekomst av resistensgener hos kända bärare av ESBL och VRE
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Once a carrier - always a carrier? How is the normal flora and the carriage of resistance genes affected by antibiotic treatment?
    En gång bärare - alltid bärare? Hur påverkas normalfloran och bärarskapet av resistensgener vid antibiotikabehandling?
    A.3.2Name or abbreviated title of the trial where available
    En gång bärare - alltid bärare
    A.4.1Sponsor's protocol code numberEGBAB
    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 SponsorRegion Uppsala
    B.1.3.4CountrySweden
    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 supportRegion Uppsala
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationRegion Uppsala
    B.5.2Functional name of contact pointInfektionsmottagningen
    B.5.3 Address:
    B.5.3.1Street AddressAkademiska sjukhuset ingång 31
    B.5.3.2Town/ cityUppsala
    B.5.3.3Post code75185
    B.5.3.4CountrySweden
    B.5.4Telephone number+46186110000
    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 Ciprofloxacin Ranbaxy
    D.2.1.1.2Name of the Marketing Authorisation holderRanbaxy (UK) Ltd
    D.2.1.2Country which granted the Marketing AuthorisationSweden
    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 nameCiprofloxacin Ranbaxy
    D.3.4Pharmaceutical form Tablet
    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 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 Vancomycin Xellia
    D.2.1.1.2Name of the Marketing Authorisation holderActavis AB
    D.2.1.2Country which granted the Marketing AuthorisationSweden
    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 nameVancomycin Xellia
    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 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
    Carriage of genes coding for vancomycin resistant enterococci (VRE) and extended spectrum betalactamase producing enterobacteriales (EPE) phenotypes.
    Bärarskap av gener som kodar för vankomycinresistenta enterokocker och extended spectrum betalaktamas-producerande enterobacteriales fenotyper.
    E.1.1.1Medical condition in easily understood language
    Carriage of resistant bacteria in the intestinal flora
    Bärarskap av resistenta bakterier i tarmfloran
    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
    To assess whether carriage of resistant bacteria that is not detectable by conventional methods can be detected by a new metagenomic method. Also, assessing out whether carriage can be provoked by antibiotic treatment
    Att kartlägga huruvida bärarskap av resistenta bakterier som ej är detekterbart med konventionella metoder kan detekteras med en ny metagenomisk metod. Även att kartlägga huruvida bärarskap kan provoceras fram med antibiotikabehandling
    E.2.2Secondary objectives of the trial
    To assess changes in intestinal the flora that occurs in carriers of resistant intestinal bacteria when treated with antibiotics
    Att kartlägga förändringen av tarmfloran som uppstår hos bärare av resistenta tarmbakterier vid antibiotikabehandling
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    -Signed consent
    -Above 18 years of age
    -Verified carrier of VRE/EPE in screening or Clinical Culture
    -Negative in latest screening for VRE or EPE (whichever is applicable)
    -For EPE Carriers, the bacterial strain must be resistant, R, for ciprofloxacin
    -Signerat samtycke
    -≥ 18 år
    -Verifierad bärare av VRE/EPE i screening eller klinisk odling
    -Negativ i senaste screening för VRE respektive EPE
    -För EPE-bärare krävs att stammen är resistent, R, för ciprofloxacin
    E.4Principal exclusion criteria
    -Ongoing antibiotic treatment or antibiotic treatment in the last month
    -Known allergic reaction or contraindication against ciprofloxacin (for the EPE branch)
    -Known allergic reaction or contraindication against vancomycin (for the VRE branch)
    -Severely reduced kidney function, defined as creatinin clearance <30 ml/min/1,73 m² or serum creatinin >168 µmol/l
    -Pågående antibiotikabehandling eller antibiotikabehandling senaste månaden
    -Känd allergi mot ciprofloxacin eller kontraindikation mot ciprofloxacin-behandling (för EPE-armen)
    -Gravt nedsatt njurfunktion, definierat som kreatininclearance ml/min/1,73 m² eller serumkreatinin >168 µmol/l (för EPE-armen)
    -Signifikant interaktion med ciprofloxacin (för EPE-armen)









    Känd allergi mot vancomycin eller kontraindikation mot vancomycin-behandling (för VRE-armen)







    E.5 End points
    E.5.1Primary end point(s)
    The trial has two primary endpoints:
    - 1 a) Patients who switch from negative to positive in faecal tests for VRE / ESBL before versus immediately after antibiotic provocation.
    - 1 b) Difference in the composition, diversity and profile of the intestinal flora, before compared to directly after antibiotic provocation.
    Studien har två primära effektmått:
    1 a) Omslag från negativ till positiv i fecesprov avseende VRE/ESBL före respektive direkt efter antibiotikaprovokation.
    1 b) Skillnad i tarmflorans sammansättning, diversitet och profil före jämfört med direkt efter antibiotikaprovokation.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Directly after antibiotic treatment
    Direkt efter antibiotikabehandlingen
    E.5.2Secondary end point(s)
    The trial has three secondary endpoints
    2 (a) Time until participants, who switched to positive VRE / ESBL test during antibiotic treatment, besome negative again
    - 2 b) Time until the composition, diversity and profile of the intestinal flora return to baseline.
    - 2 c) Difference in sensitivity with respect to detection of resistance genes of conventional compared to metagenomic method defined as discordant results.
    Studien har tre sekundära effektmått:
    - 2 a) Tid tills deltagare som slagit om till positiv återigen blir negativa avseende VRE/ESBL.
    - 2 b) Tid tills tarmflorans sammansättning, diversitet och profil återgår till baseline.
    2 c) Skillnad i känslighet avseende detektion av resistensgener med konventionell jämfört med metagenomisk metod, definierat som diskordanta resultat.
    E.5.2.1Timepoint(s) of evaluation of this end point
    2 a) After first negative test
    2 b) After one year
    2 c) Before and up to one year after antibiotic treatment
    2 a) Efter första negativa test
    2 b) Efter ett år
    2 c) Före och upp till ett år efter antibiotikabehandling
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Yes
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety No
    E.6.5Efficacy No
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic Yes
    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 No
    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 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 concerned2
    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
    When the last feces sample has been collected from a patient, a telephone interview is carried out. The last telephone interview with the last participant marks the end of the trial.
    Efter att en deltagare lämnat sitt sista fecesprov genomförs en telefonintervju. Sista intervjun med sista deltagaren definieras som sutdieavslut.
    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: 45
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 15
    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 No
    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
    Asymtomatic carriers of resistant intestinal bacteria. Volunteers
    Asymtomatiska bärare av resistenta tarmbakterier. Frivilliga
    F.4 Planned number of subjects to be included
    F.4.1In the member state60
    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
    Ej aktuellt
    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 Decision2019-12-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-03-13
    P. End of Trial
    P.End of Trial StatusOngoing
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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