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    Summary
    EudraCT Number:2013-000469-35
    Sponsor's Protocol Code Number:4
    National Competent Authority:Norway - NOMA
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2013-05-15
    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 ConcernedNorway - NOMA
    A.2EudraCT number2013-000469-35
    A.3Full title of the trial
    Peroral antibiotic treatment of endocarditis
    Peroral antibiotisk behandling av endocarditis
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Peroral antibiotic treatment of heart valve infection
    Peroral antibiotisk behandling av hjerteklapinfektion
    A.3.2Name or abbreviated title of the trial where available
    POET
    POET
    A.4.1Sponsor's protocol code number4
    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 SponsorHillerød Hospital
    B.1.3.4CountryDenmark
    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 supportRigshospitalet
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationRigshospitalet
    B.5.2Functional name of contact pointKasper Iversen
    B.5.3 Address:
    B.5.3.1Street AddressBlegdamsvei 9
    B.5.3.2Town/ cityCopenhagen
    B.5.3.3Post code2100
    B.5.3.4CountryDenmark
    B.5.6E-mailkasper.k.iversen@gmail.com
    D. IMP Identification
    D.IMP: 1
    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.2.5The 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 nameAntibacterial for systemic use
    D.3.4Pharmaceutical form Concentrate and solvent for concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous 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.2.1.2Country which granted the Marketing AuthorisationNorway
    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 nameAntibacterials for systemic use
    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.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
    Bacterial endocarditis caused by streptococci, enterococci, staphylococcus aureus or coagulase-negative staphylococci
    E.1.1.1Medical condition in easily understood language
    Bacterial infections of the heart valves
    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 examine if oral antibacterial treatment in the last part of the treatment period is equally safe and efficient as intravenous treatment in bacterial endocarditis
    At undersøge sikkerhet og effektivitet ved peroral behandling av endocarditis i den sidste delen av behandlingsperioden
    E.2.2Secondary objectives of the trial
    1. To examine i partly peroral antibiotic tretment and out-patient treatment has any effect on patients quality of life comparing full-time intravenous treatment as in-patient
    2. To examine any economical consequences of partly peroral treatment comparing full-time intravenous treatment as an in-patient
    1. At undersøge betydingen af delvis peroralt antibiotikaregime og ambulant behandling sammenlignet med fuld intravenøs behandling under indlæggelse for patientenes livskvalitet
    2. At undersøge de økonomiske konsekvenser af delvis peroral behandling sammenlignet med fuld intravenøs behandling under indlægelse
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patient admitted to hospital with a diagnosis of left-sided endocarditis as evaluated by a project responsible physician in one of the study sites:
    -A diagnosis of endocarditis as evaluated by the Duke criteria
    - Endocarditis with any of the following bacteria:
    - streptococci
    -staphylococci
    -enterococci
    -Patients >=18 years
    -Patient has received at least 10 days of correct intravenous antibiotic treatment for bacterial endocarditis, or at least 7 days treatment after surgical intervention
    -At least 10 days of the antibiotic therapy is left
    -Temperatur <=37.5 C for 2 days
    -Decline in blood inflammation parameters (serum-CRP at least 75% comparing peak-value or<;4 x upper limit of normal, and leucocytes at least 25% of peak-value or 15 mia/L) during the antibiotic treatment
    -No signs of abscess or any worsening of valve function as assessed by transthoracal or transoesophageal ekkocardiography<;48 hours prior to randomisation
    -Patients that beside the above mentioned also fulfill the modified OPAT (out-patient antibiotic therapy) criteria may be included in the part of the study concerning ambulatory therapy
    Patienter indlagt og diagnosticeret med bakteriel venstresidig endocarditis vurderet af
    projekt-ansvarlig kliniker på deltagende center.
    • Der er sikker endocarditis vurderet ud fra Duke kriterierne (se bilag 5)
    • Endocarditis med en af følgende mikroorganismer:
    o Streptokokker
    o Enterokokker
    o Staphylococcus aureus
    o Koagulase-negative stafylokokker.
    • Patienter >18 år
    • Der er givet mindst 10 døgns relevant parenteral antibiotisk behandling (type og dosis)
    samlet og mindst 1 uges relevant behandling efter kirurgisk intervention
    • Der resterer mindst 10 dages planlagt antibiotika-behandling
    • Temperatur < 37.5 i &gt; 2 døgn
    • Faldende infektionstal (CRP faldet mindst 75% i forhold til peak-værdi eller < 4 x øvre
    reference niveau, samt leukocytter faldet mindst 25% af peak-værdi eller <15 mia/l) under
    antibiotisk behandling
    • Ingen tegn på abscedering eller anden nytilkommet forværring i klap-affektionen ved
    transthorakal og transesofagal (TTE/TEE) ekkokardiografi < 48 timer før randomisering.
    • Patienter der udover ovenstående også opfylder de modificerede OPAT (out-patient antibiotic therapy) kriterier
    kan ligeledes indgå i den del af studiet, der omhandler ambulant behandling.
    E.4Principal exclusion criteria
    Previous endocarditis within the last year with the same bacteria
    (endocarditis-relapse)
    -Body mass index >40 kg/m2
    -Heart surgery planned within 6 weeks from randomisation
    -Any other concurrent infection that needs intravenous antibiotic
    therapy
    -Any abdominal/ bowel disease that may reduce uptake of oral
    medication
    - Known reduced immunocompetence such as HIV, or treatment with chemotherapeutics or prednisolon >20mg/day
    -Subjects incapable of giving informed consent
    -Subjects with low complience included inravenous drug users
    • BMI > 40 kg/m2
    • Hjertekirurgi planlagt inden for 6 uger fra randomiseringstidspunktet
    • Anden samtidig infektion, der kræver intravenøs antibiotisk behandling
    • Abdominal lidelse, der giver mistanke om reduceret optagelse af perorale lægemidler
    • Kendt/formodet immunkompetance (HIV, kemoterapeutisk behandling, prednisolon behandling (> 20 mg/døgn)
    • Manglende evne til at give informeret samtykke til deltagelse
    • Reduceret compliance, herunder intravenøst medicinmisbrug
    E.5 End points
    E.5.1Primary end point(s)
    -death <6 months after end of treament
    -Heart surgery, not planned at randomisation, <6 monts after end of
    treatment
    -Emboli after randomisation until <6 months after end of treatment
    -Bacteremia with the same bacteria <6 months after end of treatment
    Det primære endepunkt er et kombineret endepunkt bestående af følgende events efter
    randomisering
    o Død < 6 måneder efter ophør af antibiotika-behandlingen
    o Hjertekirurgi, ikke planlagt ved randomisering <6 måneder efter ophør af antibiotika-
    behandlingen
    o Embolier fra randomiseringen til <6 måneder efter ophør af antibiotika-behandlingen
    o Bakteriæmi med den pågældende ætiologiske mikroorganisme <6 mdr efter ophør af
    antibiotika-behandlingen.

    E.5.1.1Timepoint(s) of evaluation of this end point
    Consecutively
    Fortløbende
    E.5.2Secondary end point(s)
    Quality of life assessed by
    -SF36 version2
    -Hospital anxiety and depression scale
    -Impact of event scale
    -Sate Trait anxiety inventory
    -Economical burden of inpatient treatment
    -Switch of therapy during treatment due to
    a) Therapeutic failure
    b)allergy
    c) other complication or interaction with other drugs given
    - Duration of antibiotic treatment after randomisation
    -Number of cerebral infarctions during therapy assessed by cerebral MRI scan
    -Complications of the intravenous catheters
    -Quality of life vurderet ved udfyldelse af SF 36 version 2, Hospital anxiety and depression scale, Impact of event scale samt Sate Trait anxiety inventory efter a) randomisering b) efter
    endt antibiotisk behandling og c) 3 måneder og d) 6 måneder efter ophør af antibiotika- behandlingen
    • Udgifter i forbindelse med indlæggelse for og behandling af sygdommen
    • Skift af antibiotika under behandlingen pga a) behandlingssvigt, b) allergi c) anden komplikation eller interaktion med andet lægemiddel
    • Varighed af antibiotisk behandling efter randomisering
    • Antallet af cerebrale infarkter udviklet i forbindelse med behandlingen vurderet ved MR
    scanning af cerebrum i forbindelse med randomisering (+/- 4 dage) og igen efter afslutning
    af den antibiotiske behandling.
    • Intravenøs kateter-komplikation (infektion og/eller behov for kateterskift).
    E.5.2.1Timepoint(s) of evaluation of this end point
    For the Quality of life assessement: a)at randomisation b) at end-of treatment c) after 3 and d) after 6 months
    For the MRI scan: At randomisation and at end of treatment
    For the economic calculation: at 6 month after end of treatment
    For the others: consecutively
    For livskvalitetsvurderingene: a) ved randomisering b) ved behandlingsavslutning c) etter 3 og d) etter 6 måneder
    For MRI cerebrum: Ved randomisering og behandlingsavslutning
    For de økomomiske kalkuleringer: 6 måneder
    For de andre: fortløbende
    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 Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence Yes
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic Yes
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Quality of life
    Livskvalitet
    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) Yes
    E.8.2.2Placebo No
    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 concerned8
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA8
    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
    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 months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years3
    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: 15
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 35
    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 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 2013-05-15. Yes
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women Yes
    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 state50
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 400
    F.4.2.2In the whole clinical trial 400
    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)
    Contact with family doctor or hospital according to patient´s reques
    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 Decision2013-09-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-03-13
    P. End of Trial
    P.End of Trial StatusOngoing
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