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    Summary
    EudraCT Number:2014-000826-39
    Sponsor's Protocol Code Number:S-20130165
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2014-04-23
    Trial results Removed from public view
    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 number2014-000826-39
    A.3Full title of the trial
    Determining the tissue concentration of dicloxacillin using Microdialysis (on healthy male subjects)
    Bestemmelse af vævskoncentrationen af dicloxacillin med Mikrodialyse (på mandlige frivillige forsøgspersoner)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Determining the tissue concentration of the antibiotic, dicloxacillin, using the Microdialysis technique (on healthy male subjects)
    Bestemmelse af vævskoncentrationen af antibiotikummet, dicloxacillin, med Mikrodialyse metoden (på mandlige frivillige forsøgspersoner)
    A.4.1Sponsor's protocol code numberS-20130165
    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 SponsorOrtopædkirurgisk afdeling Odense Universitetshospital
    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 supportDepartment of orthopedic surgery Odense university hospital
    B.4.2CountryDenmark
    B.4.1Name of organisation providing supportUniversity of southern Denmark
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationDepartment of orthopedic surgery Odense university hospital
    B.5.2Functional name of contact pointOrthopedic research unit
    B.5.3 Address:
    B.5.3.1Street AddressSdr. Boulevard 29
    B.5.3.2Town/ cityOdense C
    B.5.3.3Post code5000
    B.5.3.4CountryDenmark
    B.5.6E-mailkrhan09@gmail.com
    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 Diclocil®
    D.2.1.1.2Name of the Marketing Authorisation holderBristol-Myers Squibb
    D.2.1.2Country which granted the Marketing AuthorisationDenmark
    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 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 typeup to
    D.3.10.3Concentration number2,5
    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
    The trial is conducted on healthy male volunteers. An intravenous dose of 2 grams of dicloxacillin is administered intravenously and the muscle- and subcutaneous tissue concentrations are measured using Microdialysis. Plasma concentrations are also measured and the tissue concentration is compared to the plasma concentration to evaluate the tissue distribution of dicloxacillin. A small amount of dicloxacillin (0,25 g) is administered via the Microdialysis catheter as part of the investigation.
    Forsøget udføres på raske, mandlige forsøgspersoner. 2 g dicloxacillin gives intravenøst og muskel- og fedtvævskoncentrationen måles med Mikrodialyse. Plasma koncentrationen måles også, således at vævskoncentrationen kan sammenlignes med plasma koncentrationen og vævsdistributionen af dicloxacillin kan vurderes. En lille mængde dicloxacillin (0,25 g) gives desuden via Mikrodialyse kateteret som en del af forsøget.
    E.1.1.1Medical condition in easily understood language
    The tissue distribution of the antibiotic dicloxacillin is determined in healthy male volunteers, using the Microdialysis technique.
    Vævsdistributionen af antibiotikummet dicloxacillin bestemmes hos raske, mandlige forsøgspersoner, ved hjælp af Mikrodialyse metoden.
    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 17.0
    E.1.2Level LLT
    E.1.2Classification code 10059428
    E.1.2Term Postoperative infection
    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
    The primary objective of the trial is to investigate and validate a method for measuring the local concentration of antibiotics in muscle- and subcutaneous tissue, in human subjects.

    In addition we want to investigate the tissue distribution of dicloxacillin locally in muscle- and subcutaneous tissue, to evaluate whether or not the local tissue concentration, after a standard dose of 2 g of dicloxacillin, is sufficiently high to prevent infections of s. aureus and s. epidermidis.
    Det primære formål med projektet er at undersøge og validere en metode til at måle den lokale koncentration af antibiotika i muskelvæv og fedtvæv hos forsøgspersoner.

    Dernæst vil vi forsøge at undersøge vævsdistributionen af dicloxacillin lokalt i muskelvæv og fedtvæv og forsøge at vurdere om den lokale vævskoncetration, efter en standard dosering på 2g dicloxacillin, er tilstrækkelig høj til at forebygge infektioner med s. aureus og s. epidermidis.
    E.2.2Secondary objectives of the trial
    1) Determine the in vitro and in vivo recovery of dicloxacillin when using the Microdialysis technique

    2) Determine the reproducibility of the Microdialysis technique when measuring dicloxacillin concentrations

    3) Compare the plasma and tissueconcentrations of dicloxacillin after intravenous administration

    4) Compare dicloxacillin concentrations in muscle- and subcutaneous tissue

    5) Investigate dicloxacillin concentration as a function of time after intravenous administration
    1) Bestemme in vitro og in vivo recovery for mikrodialyse ved måling af dicloxacillin
    2) Bestemme reproducerbarheden for mikrodialyse ved måling af dicloxacillin
    3) Sammenligne plasma og vævskoncentrationerne af dicloxacillin efter i.v. indgift
    4) Sammenligne dicloxacillin koncentrationen i muskel- og fedtvæv
    5) Undersøge dicloxacillin koncentrationen i relation til tiden efter i.v. indgift
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Healthy male with no comorbidity
    - No allergies or intolerance to dicloxacillin or lidocaine
    - Age between 18 and 30 years
    - Ability to, and willingness to follow instructions during the trial
    - Informed, written consent, has been read, understood and signed
    - Rask mand uden komorbiditeter
    - Tåler dicloxacillin og lidocain
    - Alder mellem 18 og 30 år
    - Mulighed for, og villighed til, at følge instrukser i forbindelse med projektet
    - Samtykkeerklæring og fuldmagt er læst, forstået og underskrevet af forsøgspersonen
    E.4Principal exclusion criteria
    - Persons who do not speak or understand Danish
    - Persons with known acute or chronic illness
    - Persons who are currently using medication
    - Persons who are severely adipose
    - Persons who are current smokers
    - Personer som ikke forstår eller taler dansk
    - Personer med kendt akut eller kronisk sygdom
    - Personer som aktuelt tager medicin
    - Svært adipøse personer
    - Personer som er nuværende rygere
    E.5 End points
    E.5.1Primary end point(s)
    The primary end point is tissue concentrations of dicloxacillin in muscle- and subcutaneous tissue. The tissue concentrations are compared to the plasma concentration and a statistically significant difference is evaluated using students t-test at a significance level of 5 %

    In addition the tissue concentrations and plasma concentration are showed as a function of time. Time to peak concentration is measured and compared using the students t-test at a significance level of 5 %
    Den primære måle parameter er vævskoncentrationen af dicloxacillin i henholdsvis muskel- og fedtvæv. Vævskoncentrationerne sammenlignes med plasmakoncentrationen og statistisk signifikant forskel vurderes med students t-test på 5 % signifikans niveau.

    Desuden vises vævskoncentrationen og plasmakoncentrationen som funktion af tiden. Tid til peak koncentration bestemmes og sammenlignes ligeledes med students t-test på 5 % signifikans niveau.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Samples of the microdialysis fluid are taken at intervals during the 9 hour trial period. At the same time points blood samples are drawn. All samples are cooled with dry ice during storage and are analyzed as soon as possible
    Prøver fra mikrodialysatet tages med bestemte intervaller i løbet af de 9 timer som forsøget varer. På samme tidspunkter tages blodprøver. Alle prøver opbevares kølet med tør is og analyseres så hurtigt som muligt.
    E.5.2Secondary end point(s)
    The measured tissue concentration of dicloxacillin is compared to the MIC values for s. aureus and s. epidermidis.
    De målte vævskoncentrationer af dicloxacillin sammenlignes med MIC værdierne for s. aureus og s. epidermidis.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Same timepoints as for the primary endpoints.
    Samme tidspunkter som for de primære slut mål
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    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 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
    The in vivo trial is planned during July and August. In this period the 10 volunteers are recruited. The in vivo trials are carried out in September and October. Each volunteer only participates 1 day. After all volunteers have participated the data are analyzed and the projected is expected to be completed at the end of January 2015.
    In vivo forsøget planlægges i juli og august måned. I denne periode Rekrutteres de 10 forsøgspersoner. In vivo forsøget udføres i september og oktober måned. Hvad forsøgsperson deltager kun 1 dag. Derefter analyseres data og hele projektet forventes afsluttes ved udgangen af januar 2015.
    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 months2
    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) No
    F.2 Gender
    F.2.1Female No
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers Yes
    F.3.2Patients No
    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 state10
    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
    Ingen
    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 Decision2014-05-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-06-17
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-01-30
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