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    Summary
    EudraCT Number:2019-001134-33
    Sponsor's Protocol Code Number:012329
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2019-03-15
    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 ConcernedDenmark - DHMA
    A.2EudraCT number2019-001134-33
    A.3Full title of the trial
    Does repeated administration of cefuroxime after orthopedic surgery provide a better prophylactic profile regarding postoperativ infection than a single administration of preoperative antimicrobial ?
    - A micro dialysis study assessing the concentration of antibiotics in bone, synovial sheath, and subcutaneous tissue after trapeziectomy
    Medfører gentagen dosis af cefuroxim efter ortopædkirurgisk operation en bedre forebyggelse af infektion end præoperativ antibiotikaprofylakse alene?
    ‐ Et mikrodialysestudie med måling af antibiotikakoncentration i knogle, seneskede og bløddele efter trapezektomi

    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Does repeated administration of cefuroxime after orthopedic surgery provide a better prophylactic profile regarding postoperativ infection than a single administration of preoperative antimicrobial ?
    - A micro dialysis study assessing the concentration of antibiotics in bone, synovial sheath, and subcutaneous tissue after trapeziectomy
    Medfører gentagen dosis af cefuroxim efter ortopædkirurgisk operation en bedre forebyggelse af infektion end præoperativ antibiotikaprofylakse alene?
    ‐ Et mikrodialysestudie med måling af antibiotikakoncentration i knogle, seneskede og bløddele efter trapezektomi
    A.3.2Name or abbreviated title of the trial where available
    MANUS
    MANUS
    A.4.1Sponsor's protocol code number012329
    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 pointAndrea René Jørgensen
    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 number004551955640
    B.5.6E-mailanjo@clin.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 milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1500
    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
    Infections that are either related to orthopedic surgery or simply affects the bone.
    Infektioner som er relateret til ortopædkirurgiske indgreb eller infektioner lokaliseret i knoglen.
    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 10043658
    E.1.2Term Thumb osteoarthritis
    E.1.2System Organ Class 100000004859
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The objectives of the trial are to asses the penetration of cefuroxime when it is administered as either a single administration or as repeated administration, into bone, synovial sheath, and subcutaneous tissue with the use of the pharmacokinetic sampling method, micro dialysis. The primary endpoints are the time for which the concentration of cefuroxime is above the minimal inhibitory concentration (T>MIC) and penetration ratios. The secondary endpoints are standard pharmacokinetic parametres such as; half-life, Cmax, Tmax and AUC.
    Formålet med dette studie er at undersøge penetrationen af cefuroxim til knogle- og senevæv samt subcutis, når det administreres hhv. én eller to gange, sidstnævnt med et doseringsinterval på 4 timer. Dette undersøges vha. mikrodialyse. De primære endepunkter er tiden, hvor koncentrationen af cefuroxim ligger over minimal inhibitory concentration (T>MIC) samt penetrations ratioer. Sekundære endepunkter er farmakokinetiske parametre så som: halveringstid, Cmax, Tmax og AUC.
    E.2.2Secondary objectives of the trial
    not applicable.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - signed informed consent
    - age minimun 18 years
    - elective trapeziectomy at the Department of Orthopedic Surgery, Aarhus University Hospital
    - Normal liver- and kidney numbers
    - Fertile women have to use safe contraception. Fertile women, who do not use safe contraception will have to perform a urin-hCG.
    - Underskrevet informeret samtykke.
    - Planlagt trapezektomi på Ortopædkirurgisk Afdeling, Aarhus Universitetshospital.
    - Alder minimum 18 år.
    - Normale nyre- og levertal præoperativt.
    - Fertile kvinder skal anvende sikker anti-konception præoperativt. Fertile kvinder, som ikke anvender sikker anti-konception vil få foretaget graviditetstest ved hCG-urinstix.
    E.4Principal exclusion criteria
    - Allergy towards antibiotics from the group of beta-lactams (penicillins, cephalosporins, and carbapenems)
    - Diabetes
    - Previous surgery of the 1. metacarp (concerns the operated hand)
    - Previous fracture of the 1. metacarp (concerns the operated hand)
    - Previous surgery of the arteries in the arm (concerns the operated hand)
    - Treatment with cefuroxime 4 days prior to the surgery
    - Allergi for antibiotika fra beta-laktam gruppen (penicilliner, cephalosporiner og carbapenemer).
    - Diabetes.
    - Tidligere kirurgi i 1. metacarp (gælder den side der skal opereres).
    - Tidligere fraktur i 1. metacarp (gælder den side der skal opereres).
    - Tidligere arteriel karkirurgi i armen (gælder den side der skal opereres).
    - Behandling med cefuroxim de 4 forudgående dage før operationen.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoints are the time for which the concentration of cefuroxime is maintained above til minimal inhibitory concentration (T>MIC) and penetration ratios.
    De primære endepunkter er den tid, hvor koncentrationen af cefuroxim er over minimal inhibtory concentration (T>MIC) og penetrationsratioer.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Endpoints will be evaluated at the end of the study.
    Endepunkterne vil blive evalueret vil studiets ende.
    E.5.2Secondary end point(s)
    Standard pharmacokinetic parametres: half life, Cmax, Tmax, and AUC.
    Standard farmakokinetiske parametre: halveringstid, Cmax, Tmax og AUC.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Endpoints will be evaluated at the end of the study.
    Endepunkterne vil blive evalueret vil 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 Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    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 Yes
    E.8.2.3.1Comparator description
    cefuroxime in other dose.
    E.8.2.4Number of treatment arms in the trial2
    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 years1
    E.8.9.1In the Member State concerned months9
    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: 6
    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 state16
    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 Decision2019-04-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-06-18
    P. End of Trial
    P.End of Trial StatusOngoing
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