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    Summary
    EudraCT Number:2020-003078-36
    Sponsor's Protocol Code Number:727258
    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:2020-07-13
    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 number2020-003078-36
    A.3Full title of the trial
    The RAS-study
    A reverse and anatomical prosthesis shoulder study

    Can we improve the prophylactic profile of antibiotic treatment in shoulder prosthesis surgery?
    - A clinical microdialysis study assessing antibiotic concentrations in deadspace, bone, and soft tissue following weight-based cefuroxime dosage in both anatomic and reverse shoulder prosthesis surgery.
    RAS-studiet
    Et revers protese og anatomisk protese skulderstudie

    Kan vi forbedre den infektionsforbyggende antibiotikabehandling ved skulderprotesekirurgi?
    - Et klinisk mikrodialysestudie med måling af antibiotikakoncentrationer i deadspace, knogle, og bløddele efter vægtbaseret antibiotikadosering ved både anatomisk og revers skulderprotesekirurgi.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Can we improve the prophylactic profile of antibiotic treatment in shoulder prosthesis surgery?
    - A clinical microdialysis study assessing antibiotic concentrations in deadspace, bone, and soft tissue following weight-based cefuroxime dosage in both anatomic and reverse shoulder prosthesis surgery.
    Kan vi forbedre den infektionsforbyggende antibiotikabehandling ved skulderprotesekirurgi?
    - Et klinisk mikrodialysestudie med måling af antibiotikakoncentrationer i deadspace, knogle, og bløddele efter vægtbaseret antibiotikadosering ved både anatomisk og revers skulderprotesekirurgi.
    A.3.2Name or abbreviated title of the trial where available
    RAS
    RAS
    A.4.1Sponsor's protocol code number727258
    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
    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
    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 pointSara Kousgaard Tøstesen
    B.5.3 Address:
    B.5.3.1Street AddressPalle Juul-Jensens Boulevard 99
    B.5.3.2Town/ cityAarhus N
    B.5.3.3Post code8200
    B.5.3.4CountryDenmark
    B.5.4Telephone number004542202469
    B.5.6E-mail201510204@post.au.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 Cefuroxime
    D.2.1.1.2Name of the Marketing Authorisation holderB. Braun
    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 Powder 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.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNcefuroxime
    D.3.9.1CAS number 55268-75-2
    D.3.9.3Other descriptive nameCEFUROXIME
    D.3.9.4EV Substance CodeSUB07433MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number15
    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
    Orthopedic infections
    Ortopædkirurgiske infektioner
    E.1.1.1Medical condition in easily understood language
    Infektions related to orthopedic surgery
    Infektioner som er relateret til ortopædkirurgiske indgreb
    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 21.0
    E.1.2Level LLT
    E.1.2Classification code 10021799
    E.1.2Term Infection and inflammatory reaction due to other internal orthopedic device, implant, and graft
    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 main objective of this clinical cohort study is to determine local tissue concentrations of cefuroxime in deadspace, bone, muscle and subcutaneous tissue using micro dialysis in patients having either anatomic (ASA) or reverse (RSA) shoulder prosthesis surgery at Aarhus University Hospital.

    Approximate 30 min. prior to surgery, a weight-based dose of cefuroxime (20 mg / kg) is administered as a bolus infusion over 10 min intravenously. At the end of surgery micro dialysis catheters are placed in the deadspace, in the coracoid bone process, in the deltoid muscle and in subcutaneous tissue. The second cefuroxime dose is administered 8 hours after the first dose.

    Deadspace: At RSA, one catheter is placed in the large deadspace above the joint. At ASA, one catheter is placed in the prosthetic joint (intra-articular) and one above the rotator cuff (subacromial). In total, 4 catheters per patient in group 1 (RSA), and 5 catheters per patient in group 2 (ASA).
    Hovedformålet med dette kliniske kohorte studie er at bestemme lokale vævskoncentrationer af cefuroxim i deadspace, knogle, muskel samt subcutis vha. mikrodialyse hos patienter der skal have foretaget enten anatomisk eller revers skulderprotesekirurgi på Aarhus Universitets Hospital.

    Ca. 30 min forud for operationen administreres en vægtbaseret dosis af cefuroxim(20 mg/kg), som en bolusinfusion over 10 min intravenøst. Ved operationens afslutning placeres mikrodialysekatetre i deadspace, i processus coracoideus, i deltoideus musklen og i subcutis. Anden cefuroxim dosis administreres 8 timer efter første dosis.

    Deadspace: Ved RSA placeres ét kateter i det store deadspace over leddet. Ved ASA placeres ét kateter i proteseleddet (intraartikulært) og ét over rotator cuffen (subacromialt). I alt anlægges 4 katetre pr. patient i gruppe 1 (RSA), og 5 katetre pr. patient i gruppe 2 (ASA).
    E.2.2Secondary objectives of the trial
    - To use the pharmacokinetic results to evaluate current guidelines for perioperative dosing of cefuroxime.

    - To investigate local ischemic markers (lactate, glycerol, pyruvate and glucose) and inflammation-specific proteins in the examined compartments.
    - At anvende de farmakokinetiske resultater til at vurdere nuværende retningslinjer for perioperativ dosering af cefuroxim.

    - At undersøge de lokale iskæmimarkører (laktat, glycerol, pyruvat og glukose) og inflammationsspecifikke proteiner i de undersøgte vævskompartementer.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Signed informed consent.

    - Age minimum 18 years.

    - Elektiv RSA or ASA at the Department of Orthopedic Surgery, Aarhus University Hospital.

    - Normal kidney numbers prior to surgery(eGFR and kreatinin).

    - Fertile women have to use safe contraception prior to surgery, or a negative pregnancy-test on the day of surgery.
    - Underskrevet samtykkeerklæring.

    -Alder minimum 18 år.

    - Planlagt RSA eller ASA på Ortopædkirurgisk Afdeling, Aarhus Universitetshospital.

    - Normale nyretal præoperativt (eGFR og kreatinin).

    - Fertile kvinder skal anvende sikker anti-konception præoperativt, ellers skal der forelægge negativ graviditetstest på operationsdagen.
    E.4Principal exclusion criteria
    - Allergy towards cefuroxime.

    - Treatment with cefuroxime or meropeneme 4 days prior to the surgery.
    - Allergi for cefuroxim.

    - Behandling med cefuroxim eller meropenem 4 dage forud for operationen.
    E.5 End points
    E.5.1Primary end point(s)
    The Primary End Point is the time for which the cefuroxime concentration is maintained above the minimal inhibitory concentration, T>MIC, measured during the two dosing intervals in plasma, deadspace, bone, muscle and subcutaneous tissue
    Det primære endepunkt er den tid, hvor cefuroximkoncentrationen er over minimal inhibitory concentration, T>MIC, målt over de to doseringsintervaller i hhv. plasma, deadspace, knoglevæv, muskelvæv og subcutis.
    E.5.1.1Timepoint(s) of evaluation of this end point
    End Points will be evaluated at the end of the study.
    Endepunkter bliver evalueret ved studiets afslutning.
    E.5.2Secondary end point(s)
    - Standard pharmacokinetic parametres in plasma, deadspace, bone, muscle and subcutaneous tissue.

    - Ischemic markers: lactate, glycerol, pyruvate and glucose in muscle, bone and subcutaneous tissue.

    - Specific proteins of inflammation.
    - Standard farmakokinetiske parametre i plasma, deadspace, knoglevæv, muskelvæv og subcutis.

    - iskæmimarkører: laktat, glycerol, pyruvat og glukose i subcutis, muskel- og knoglevæv.

    - Inflammations specifikke proteiner.
    E.5.2.1Timepoint(s) of evaluation of this end point
    End Points will be evaluated at the end of the study.
    Endepunkter bliver evalueret ved studiets afslutning.
    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 Yes
    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 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.8.2.4Number of treatment arms in the trial1
    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
    LVLS
    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 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: 10
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    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 No
    F.3.3.2Women of child-bearing potential using contraception Yes
    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)
    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 Decision2020-08-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-09-14
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2023-01-01
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