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    Summary
    EudraCT Number:2019-003933-40
    Sponsor's Protocol Code Number:2019-064
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2020-01-14
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2019-003933-40
    A.3Full title of the trial
    Prediction of Flucloxacillin Absorption and %time/MIC using the Flucloxacillin absorption test
    Voorspelbaarheid van de absorptie van flucloxacilline en %tijd/MIC van de flucloxacilline absorptietest
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Flucloxacillin absorption test validation and optimalisation.
    Flucloxaciline absorptietest validatie en optimalisatie.
    A.3.2Name or abbreviated title of the trial where available
    PFAF
    A.4.1Sponsor's protocol code number2019-064
    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 SponsorHaaglanden Medisch Centrum
    B.1.3.4CountryNetherlands
    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 supportwetenschapsfonds HMC
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationHaaglanden Medisch Centrum
    B.5.2Functional name of contact pointEveline Roelofsen
    B.5.3 Address:
    B.5.3.1Street Addresslijnbaan 32
    B.5.3.2Town/ cityDen Haag
    B.5.3.3Post code2512AV
    B.5.3.4CountryNetherlands
    B.5.4Telephone number+31889793175
    B.5.6E-maile.roelofsen@haaglandenmc.nl
    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 FLUCLOXACILLINE CAPSULE 500MG Mylan RVG10928 FLUCLOXACILLINE CAPSULE 500MG Apotex RVG 18564 FLUCLOXACILLINE CAPSULE 500MG Aurobindo RVG 16940 FLUCLOXACILLINE CAPSULE 500MG Sandoz RVG 32165 FLUCLOXACILLINE CAPSULE 500MG Eureco pharma RVG120122/18564
    D.2.1.1.2Name of the Marketing Authorisation holdersee trade name
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    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 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 Yes
    D.3.11.13.1Other medicinal product typeantibiotic
    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
    S Aureus bacteraemia (indirectly)
    S Aureus bacteriemie ( indirect)
    E.1.1.1Medical condition in easily understood language
    blood infection with S Aureus ( indirectly)
    S aureus infectie in het bloed (indirect)
    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
    Our aim is to evaluate whether the current flucloxacillin absorption test is able to adequately predict the absorption of flucloxacillin compared to an absorption test after switch.
    Ons doel is om te kijken of de huidige flucloxacilline absorptietest de absorptie van flucloxacilline goed voorspelt tov van een absorptie test uitgevoerd na overgang op oraal flucloxacilline
    E.2.2Secondary objectives of the trial
    Our secondary objective is to identify co-variants in order to improve the predictability, optimize and/or simplify the test.
    Het identificeren van co-varianten om de voorspelbaarheid van de absorptie van test te verbeteren en de test optimalizeren dan wel versimpelen.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    >18 years
    Admitted to the hospital
    S aureus infection with continuous infusion of flucloxacillin
    Clinically eligible to be switched to oral flucloxacillin
    >18 years
    Opgenomen in het ziekenhuis
    S aureus infectie waarvoor flucloxacilline per continu infuus
    komt klinisch in aanmerking om te switchen naar oraal
    E.4Principal exclusion criteria
    ICU admittance
    Pregnancy
    IC opname
    zwangerschap
    E.5 End points
    E.5.1Primary end point(s)
    The prediction of time above MIC of both the 3 point concentration curves and 7 point concentration curves per patient before and after switch to oral flucloxacillin will be compared. > 50% time above MIC is considered sufficient
    De tijd boven de de MIC van zowel de 3 als 7 punts curves zowel voor als na switch zullen per patient worden vergeleken.> 50% tijd boven MIC wordt als voldoende beschouwd
    E.5.1.1Timepoint(s) of evaluation of this end point
    not applicable
    niet van toepassing
    E.5.2Secondary end point(s)
    Population pharmacokinetic analysis will be performed by use of NONMEM to develop an integrated model for total and free concentration en covarianten
    populatie farmacokinetiek zal worden uitgevoerd dmv NONMEM om een geintergreerd model te mken voor totale en vrije fractie en covarianten
    E.5.2.1Timepoint(s) of evaluation of this end point
    not applicable
    niet van toepassing
    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) 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 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 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
    this study will last one year or shorter if before one year inclusion has been reached
    een jaar of korter als de inclusie eerder gehaald wordt
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    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: 15
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 5
    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 state20
    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)
    not applicable pharmacokinetic study; treatment according to standard protocol
    niet van toepassing farmacokinetische studie. Elke patiënt krijgt de standaard behandeling
    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 Decision2020-01-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-06-24
    P. End of Trial
    P.End of Trial StatusOngoing
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