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    Summary
    EudraCT Number:2018-000010-38
    Sponsor's Protocol Code Number:PAEDMED_v1.0
    National Competent Authority:Austria - BASG
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2018-02-02
    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 ConcernedAustria - BASG
    A.2EudraCT number2018-000010-38
    A.3Full title of the trial
    Development of intravascular microdialysis as a tool for therapeutic drug monitoring in children.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Development of a device to measure concentrations of drugs in the blood of children.
    A.3.2Name or abbreviated title of the trial where available
    PAEDMED
    A.4.1Sponsor's protocol code numberPAEDMED_v1.0
    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 SponsorDepartment of Clinical Pharmacology/Medical University of Vienna
    B.1.3.4CountryAustria
    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 supportDepartment of Clinical Pharmacology/Medical University of Vienna
    B.4.2CountryAustria
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationDepartment of Clinical Pharmacology/Medical University of Vienna
    B.5.2Functional name of contact pointOffice
    B.5.3 Address:
    B.5.3.1Street AddressWähringer Gürtel 18-20
    B.5.3.2Town/ cityVienna
    B.5.3.3Post code1090
    B.5.3.4CountryAustria
    B.5.4Telephone number0043014040029810
    B.5.5Fax number0043014040029980
    B.5.6E-mailklin-pharmakologie@meduniwien.ac.at
    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 Gentamicin
    D.2.1.1.2Name of the Marketing Authorisation holderB. Braun Melsungen AG
    D.2.1.2Country which granted the Marketing AuthorisationAustria
    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 Solution for 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 INNGENTAMICIN SULFATE
    D.3.9.1CAS number 1405-41-0
    D.3.9.4EV Substance CodeSUB02327MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    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 Vancomycin
    D.2.1.1.2Name of the Marketing Authorisation holderHikma Farmacêutica (Portugal), S.A.
    D.2.1.2Country which granted the Marketing AuthorisationAustria
    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 Powder for concentrate for solution for 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 INNVANCOMYCIN
    D.3.9.3Other descriptive nameVANCOMYCIN HYDROCHLORIDE
    D.3.9.4EV Substance CodeSUB05077MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1000
    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: 3
    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 Cefuroxim
    D.2.1.1.2Name of the Marketing Authorisation holderAstro-Pharma GmbH
    D.2.1.2Country which granted the Marketing AuthorisationAustria
    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 Powder 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 INNCEFUROXIME SODIUM
    D.3.9.1CAS number 56238-63-2
    D.3.9.3Other descriptive namecefuroxime
    D.3.9.4EV Substance CodeSUB01140MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1577,7
    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
    cohort A: We will administer a single dose of vancomycin, cefuroxime or gentamicin to healthy volunteers. The administration of the antibiotics in cohort A is for study purposes only.

    cohort B: We will obtain plasma pharmacokinetic data of vancomycin, cefuroxime and gentamicin in sick children using the modified microdialysis probes and blood sampling. The children will be receiving the drug for treatment of infection at the discretion of their treating physicians.
    E.1.1.1Medical condition in easily understood language
    Concentrations of vancomycin, cefuroxime or gentamicin in plasma of a) healthy volunteers and b) sick children.
    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 develop and validate a practical method for pharmacokinetic measurements in children

    In detail:
    Cohort A: We will administer a single dose of vancomycin, cefuroxime or gentamicin to healthy volunteers. We will then take serial blood samples and plasma microdialysis samples using our modified microdialysis probes. The PK values obtained using the plasma microdialysis probes will be compared to the values obtained through blood sampling and evaluated according to the bioequivalence criteria published by the European Medicines Agency (EMA).

    Cohort B: We will perform PK measurements of the three antibiotics in sick children using the modified microdialysis probe and blood sampling. We will use the compiled data to compare the PK parameters obtained through the different methods and evaluate evaluate the measurements of the modified microdialysis probe for accuracy.
    E.2.2Secondary objectives of the trial
    • To assess the appropriateness of existing dosing therapies of vancomycin, cefuroxime and gentamicin in children
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Cohort A:
    • Age: 18 – 55 years 

    • Healthy male subjects 

    • Good state of health (mentally and physically) 

    • A signed and dated written informed consent form 

    • The subject is able to understand and willing to comply with protocol 
requirements and timetables, instructions and protocol-stated 
restrictions 

    • Negative serology (human immunodeficiency virus, hepatitis B-AG 
and C-AB) at screening 

    • Vital signs should be within the following range: 

    - Systolic blood pressure, 90-140 mmHg
    - Diastolic blood pressure, 45-90 mmHg
    - Puls rate, 45-90 bpm

    Cohort B:
    • Female of male, aged between 0 and 6 years
    • Clinical diagnosis of infection, requiring antibiotic therapy
    • Prescription of cefuroxime, gentamicin or vancomycin for therapeutic reasons.
    • Signed informed consent by at least one parent or legal representative
    E.4Principal exclusion criteria
    Cohort A:
    • Any acute or chronic illness or clinically relevant (Investigator’s judgment) abnormality identified on the screening medical assessment, laboratory tests or ECG, unless in the opinion of the Investigator it will not interfere with the study procedures, affect the outcome of the study or compromise the safety of the subject. 

    • Use of prescription or non-prescription drugs within 7 days or 10 times the elimination half-life (whichever is longer) prior to the first dose of study medication unless considered irrelevant by the investigator.
    • Intake of grapefruit juice within 1 week prior to study day.
    • A blood donation within 4 weeks prior to study day
    • Participation at another study as healthy volunteer within 4 weeks prior to study day
    • History of severe allergic or anaphylactic reactions to any medication
    • Any disease or medical condition considered relevant for proper performance of the study or risk to the patient at the discretion of the investigator

    Cohort B:
    • Allergy or hypersensitivity against study drug.
    • Severe renal impairment, defined by a serum creatinine level to more than 200% of age-specific reference values, or urinary output <0,5ml/kg/h for >12 hours
    • Severe thrombocytopenia <50.000/µl
    • Any disease considered a risk for proper performance of the study or risks to the patient, at the discretion of the investigator

    Comments:
    As the treating physicians prescribe the medication for therapeutic reasons independently of the trial, contraindications for that drug will not be separately checked by the study staff. Administration of any other drugs or of other required antibiotics per se is no exclusion criterion.
    E.5 End points
    E.5.1Primary end point(s)
    cohort A: Area under the concentration time curve (AUC) from 0 to 8 hours for cefuroxime (AUC0-8), AUC from 0 to 10 hours for gentamicin (AUC0-10), AUC from 0 to 24 hours for vancomycin (AUC0-24), Maximum concentration (Cmax)
    cohort B: Area under the concentration time curve (AUC) from 0 to 8 hours for cefuroxime and vancomycin (AUC0-8), AUC from 0 to 12 hours for gentamicin (AUC0-12), Maximum concentration (Cmax)
    E.5.1.1Timepoint(s) of evaluation of this end point
    defined time points during and after therapy with the study drug
    E.5.2Secondary end point(s)
    - AUC from 0 to 24 hours (AUC0-24 calculated with the use of the measured AUCs as a very conservative estimate), time to maximum concentration (tmax), half-life (t1/2), apparent volume of distribution (Vd), clearance (Cl)
    E.5.2.1Timepoint(s) of evaluation of this end point
    defined time points during and after therapy with the study drug
    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 No
    E.6.4Safety No
    E.6.5Efficacy No
    E.6.6Pharmacokinetic Yes
    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) Yes
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other Yes
    E.7.1.3.1Other trial type description
    Prospective, open-labelled, single-center exploratory pharmacokinetic study
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    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
    LVLS
    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 months24
    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 Yes
    F.1.1Number of subjects for this age range: 36
    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) Yes
    F.1.1.4.1Number of subjects for this age range: 36
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 36
    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: 30
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers Yes
    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
    children
    F.4 Planned number of subjects to be included
    F.4.1In the member state66
    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 Decision2018-03-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-02-13
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2019-07-25
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