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    Summary
    EudraCT Number:2013-002807-32
    Sponsor's Protocol Code Number:CONTENT-0001
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2013-09-03
    Trial results View 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 ConcernedDenmark - DHMA
    A.2EudraCT number2013-002807-32
    A.3Full title of the trial
    Antibiotic treatment for patients with infectious endocarditis: continuous infusion, guided by therapeutic drug monitoring, versus intermittent infusions (the CONTENT study).
    Antibiotikabehandling ved infektiøs endokarditis: kontinuerlig infusion, vejledt af koncentrationsmålinger af antibiotika i plasma, sammenlignet med konventionel behandling med regelmæssige infusioner (CONTENT-studiet)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Antibiotic treatment for patients with infectious endocarditis: continuous infusion, guided by measurements of the antibiotic concentration in the blood, versus intermittent infusions (the CONTENT study).
    Antibiotikabehandling ved infektiøs endokarditis: kontinuerlig infusion, vejledt af koncentrationsmålinger af antibiotika i plasma, sammenlignet med konventionel behandling med regelmæssige infusioner (CONTENT-studiet)
    A.3.2Name or abbreviated title of the trial where available
    CONTENT
    A.4.1Sponsor's protocol code numberCONTENT-0001
    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 SponsorAarhus University Hospital, Department of Cardiology
    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 supportAarhus University Hospital, Department of Cardiology
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAarhus University Hospital
    B.5.2Functional name of contact pointKristina Öbrink-Hansen
    B.5.3 Address:
    B.5.3.1Street AddressBrendstrupgaardsvej 100
    B.5.3.2Town/ cityAarhus N
    B.5.3.3Post code8200
    B.5.3.4CountryDenmark
    B.5.4Telephone number+4526 13 37 05
    B.5.6E-mailkrisoebr@rm.dk
    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 Benzylpenicillin
    D.2.1.1.2Name of the Marketing Authorisation holderPanPharma
    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 nameBenzylpenicillin
    D.3.4Pharmaceutical form Concentrate for solution for injection/infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNBenzylpenicillin
    D.3.9.1CAS number 61-33-6
    D.3.9.3Other descriptive nameBENZYLPENICILLIN
    D.3.9.4EV Substance CodeSUB05772MIG
    D.3.10 Strength
    D.3.10.1Concentration unit g gram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number3
    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 Diclocil
    D.2.1.1.2Name of the Marketing Authorisation holderBristol-Myers Squibb
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    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 Concentrate for solution for injection/infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNDICLOXACILLIN
    D.3.9.1CAS number 3116-76-5
    D.3.9.4EV Substance CodeSUB07099MIG
    D.3.10 Strength
    D.3.10.1Concentration unit g gram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    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
    Infectious Endocarditis
    Infektiøs endokarditis
    E.1.1.1Medical condition in easily understood language
    Inflammation of the inner tissue of the heart, such as its valves, caused by infectious agents.
    Infektiøs endokarditis er en tilstand hvor hjerteklapper og/eller omkringliggende væv er inficeret med en bakterie.
    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 16.1
    E.1.2Level LLT
    E.1.2Classification code 10000667
    E.1.2Term Acute and subacute infective endocarditis in diseases classified elsewhere
    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
    To investigate if Benzylpenicillin and Diclocil, given as continuous infusion to patients with infectious endocarditis, leads to a bigger decline in C-reactive protein after 7 days of treatment, compared to Benzylpenicillin and Diclocil given as intermittent infusions to patients with infectious endocarditis.
    E.2.2Secondary objectives of the trial
    To evaluate the effect of Benzylpenicillin and Diclocil, given as continuous infusion to patients with infectious endocarditis, on the following:
    • Decline in White blood cell count
    • Drop in body temperature
    • The concentration of antibiotics in blood plasma and comparison of this concentration to the Minimal Inhibitory Concentration (MIC).
    • The time the concentration of the given antibiotic remains above the MIC (in short, the T > MIC)
    • Side effects and complications due to the treatment.
    • Persisting blood stream infection during the first 3 days of treatment.
    • The size of valve vegetations at the start and at the end of the trial, examined by ultrasound.
    • The number of silent cerebral embolisms, valve oedema and valve destruction, at the start and at the end of the trial, examined by magnetic resonance.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Verified infectious endocarditis, with bacteria in the blood, susceptible for either Benzylpenicillin or Diclocil.
    2. Less than 96 hours since the onset of intra venous antibiotic treatment.
    3. Use of contraception (for fertile women)
    E.4Principal exclusion criteria
    1. Negative blood cultures.
    2. More than 96 hours since the onset of intra venous antibiotic treatment.
    3. Planned valve surgery.
    4. Planned extraction of a pace maker.
    5. Allergy to Benzylpenicillin or Diclocil.
    6. Unability to understand information about the study and to give informed consent.
    7. Age under 18.
    8. Preagnancy.
    9. Breastfeeding.
    E.5 End points
    E.5.1Primary end point(s)
    The decline in C-reactive protine, given in percentage, 7 days after the start of the trial. This will be compared between the patientes who recieve intermittent infusion and the patients who recieve continuous infusion.
    E.5.1.1Timepoint(s) of evaluation of this end point
    7 days
    E.5.2Secondary end point(s)
    Potentially differences between the patients who recieve intermittent infusion, and the patientes who recieve continuous infusion, regarding:
    1. Decline in white blood cell count.
    2. Drop in body temperature.
    3. The concentration of antibiotics in blood plasma and comparison of this concentration to the Minimal Inhibitory Concentration (MIC).
    4. The time the concentration of the given antibiotic remains above the MIC (in short, the T > MIC)
    5. Side effects and complications due to the treatment.
    6. Persisting blood stream infection during the first 3 days of treatment.
    7. The size of valve vegetations at the start and at the end of the trial, examined by ultrasound.
    8. The number of silent cerebral embolisms, valve oedema and valve destruction, at the start and at the end of the trial, examined by magnetic resonance.
    E.5.2.1Timepoint(s) of evaluation of this end point
    14 days.
    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 Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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 No
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Prospective cohort study
    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
    Same medicinal product, just given to the patient in a different way.
    E.8.2.4Number of treatment arms in the trial4
    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
    Last day of treatment for the last subject undergoing the trial.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    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: 10
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 30
    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 state40
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 40
    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 Decision2013-09-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-10-07
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2014-11-11
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