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    Summary
    EudraCT Number:2020-004004-34
    Sponsor's Protocol Code Number:005965
    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:2020-08-30
    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 number2020-004004-34
    A.3Full title of the trial
    Prevention of infection in orthopaedic spine surgery - a clinical study antibiotic concentrations of in spine tissue after administration of weight-dosed antibiotics
    Forebyggelse af infektion ved ortopædiske rygoperationer – en klinisk undersøgelse af antibiotikakoncentrationer i rygsøjlens væv efter vægtjusteret antibiotikadosering
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Prevention of infection in orthopaedic spine surgery - a clinical study of antibiotic concentrations spine tissue after administration of antibiotics dosed by bodyweight
    Forebyggelse af infektion ved ortopædiske rygoperationer – en klinisk undersøgelse af antibiotikakoncentrationer i rygsøjlens væv efter vægtjusteret antibiotikadosering
    A.3.2Name or abbreviated title of the trial where available
    SPINE STUDY
    RYG-STUDIET
    A.4.1Sponsor's protocol code number005965
    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 pointMagnus A. Hvistendahl
    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.5.6E-mail201709851@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/kg milligram(s)/kilogram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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
    Orthopaedic infections.
    Ortopædkirurgiske infektioner.
    E.1.1.1Medical condition in easily understood language
    Infections that are either related to orthopaedic surgery or simply affect the bones and adjacent tissue.
    Infektioner relateret til ortopædkirurgiske indgreb eller infektioner lokaliseret i knogler og omkringliggende væv.
    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 20.0
    E.1.2Level LLT
    E.1.2Classification code 10049130
    E.1.2Term Back surgery
    E.1.2System Organ Class 100000004865
    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 concentrations of the antibiotic cefuroxime in tissue of the spine in patients (adolescents and adults) undergoing spine deformity surgery after administration of weight-dosed cefuroxime.
    At undersøge, koncentrationen af cefuroxim i rygsøjlens væv hos patienter (unge og voksne) der skal have foretaget operation af rygdeformiteter efter administration af vægtjusteret cefuroxim.
    E.2.2Secondary objectives of the trial
    Use the pharmacokinetic results to evaluate the current guidelines for perioperative dosing of cefuroxime.
    At benytte de farmakokinetiske resultater til at vurdere de nuværende retningslinjer for perioperativ dosering af cefuroxim.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Sign informed consent (and sign informed consent by parents with child custody when participants are under 18 years of age).
    - Planned spine deformity surgery at the Department of Orthopaedic Surgery, Aarhus University Hospital
    - Normal preoperative kidney function (assessed by eGFR, P-creatinin)
    - Underskrevet samtykkeerklæring (samt underskrevet samtykke erklæring fra forældre med forældremyndighed ved deltagere under 18 år).
    - Planlagt rygdeformitetskirurgi på Ortopædkirurgisk Afdeling, Aarhus Universitetshospital.
    - Normal nyrefunktion præoperativt (vurderet ved biokemi: eGFR, P-kreatinin).
    E.4Principal exclusion criteria
    - Fertile women may not be pregnant (asked about the likelihood of pregnancy at preliminary visit and offered preoperative plasma hCG for clarification if in doubt).
    - Allergy towards cefuroxime.
    - Antibiotic treatment with cefuroxime 4 days prior to surgery.
    - Fertile kvinder må ikke være gravide (ved indledende besøg spørges ind til sandsynlighed for graviditet og tilbydes præoperativ plasma hCG for evt. afklaring ved tvivl).
    - Allergi overfor cefuroxim.
    - Antibiotikabehandling med cefuroxim i de foregående 4 dage inden operation.
    E.5 End points
    E.5.1Primary end point(s)
    The time for which the concentration of cefuroxime is maintained above minimal inhibitory concentration (T>MIC) measured over a maximum of 12 hours after placement of microdialysis catheter in bone, paravertebral muscle, subcutis and wound.
    Den tid koncentrationen af cefuroxime er over den minimalt inhibotoriske concentration (T>MIC) målt over maksimalt 12 timer efter anlæggelse af mikrodialysekatetre i hhv. knoglevæv, paravertebral muskulatur, subcutis og cikatrice.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Endpoints will be evaluated at the end of the study.
    Endepunkter vil blive vurderet ved studiets ende.
    E.5.2Secondary end point(s)
    - Pharmacokinetic parameters in plasma, bone tissue, paravertebral muscle, subcutaneous tissue and the wound.
    - Parameters of ischemia and inflammation in plasma, bone tissue, paravertebral muscle, subcutaneous tissue and the wound.
    - Farmakokinetiske parametre i hhv. plasma, knoglevæv, paravertebral muskulatur, subcutis og cikatrice.
    - Iskæmi- og inflammationsmarkører i plasma, knoglevæv, paravertebral muskulatur, subcutis og cikatrice.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Endpoints will be evaluated at the end of the study.
    Endepunkter vil blive vurderet ved studiets ende.
    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 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 Yes
    E.8.1.7.1Other trial design description
    Kohortestudie. To grupper af hver 10 (10 unge, 10 voksne)
    Cohort study. Two groups of each 10 (10 adolescents, 10 adults)
    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
    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 Yes
    F.1.1Number of subjects for this age range: 10
    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) Yes
    F.1.1.6.1Number of subjects for this age range: 10
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 5
    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 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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Parents with child custody of adolescents (12-17 years of age) have to give informed consent on behalf of the adolescent.
    Forældre med forældremyndighed over unge (12-17-årige) skal give informeret samtykke på vegne af den unge.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state20
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 20
    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 Decision2020-10-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-11-11
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2022-12-31
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