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    Summary
    EudraCT Number:2014-000124-14
    Sponsor's Protocol Code Number:NL47077
    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:2014-10-21
    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 number2014-000124-14
    A.3Full title of the trial
    Antibiotic prophylaxis to prevent wound infections following implant removal after foot, ankle and lower leg fractures.
    Antibioticaprofylaxe ter preventie van wondinfecties na verwijderen osteosynthesemateriaal onder de knie.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Prevention of wound infections in implant removal following fracture surgery in the foot, ankle and lower leg.
    Voorkomen van wondontstekingen na verwijderen van lichaamsvreemd materiaal dat in het verleden geplaatst was bij een operatie aan een botbreuk aan de voet, enkel of het onderbeen.
    A.3.2Name or abbreviated title of the trial where available
    WIFI trial
    A.4.1Sponsor's protocol code numberNL47077
    A.5.4Other Identifiers
    Name:Nederlands Trial Register Number: NTR 4393
    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 SponsorAcademic Medical Center
    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 supportStichting AO Nederland
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAcademic Medical Center
    B.5.2Functional name of contact pointTrauma Unit
    B.5.3 Address:
    B.5.3.1Street AddressMeibergdreef 9
    B.5.3.2Town/ cityAmsterdam
    B.5.3.3Post code1105 AZ
    B.5.3.4CountryNetherlands
    B.5.4Telephone number0031205669111
    B.5.6E-mailt.schepers@amc.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 Cefalozin
    D.2.1.1.2Name of the Marketing Authorisation holderSandoz b.v.
    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.3.1Product nameKefzol
    D.3.2Product code RVG 25307
    D.3.4Pharmaceutical form Powder for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous bolus use (Noncurrent)
    Intravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCEFAZOLIN SODIUM
    D.3.9.1CAS number 27164-46-1
    D.3.9.2Current sponsor code1-20223
    D.3.9.3Other descriptive nameCEFAZOLIN SODIUM
    D.3.9.4EV Substance CodeSUB01107MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1.028
    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
    Postoperative wound infection following implant removal below the knee
    Postoperatieve wondinfectie na verwijderen van osteosynthesemateriaal onder de knie
    E.1.1.1Medical condition in easily understood language
    Postoperative wound infection
    Postoperatieve wondinfectie na verwijderen van lichaamsvreemd materiaal
    E.1.1.2Therapeutic area Body processes [G] - Microbiological Phenomena [G06]
    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
    the objective is to study the (cost-)effectiveness of a single intravenous gift of antibiotic
    prophylaxis with a first generation cephalosporin prior to implant removal following surgical fixation of foot, ankle and/or lower leg fractures
    Doel is om het effect van een eenmalige preoperatieve profylactische gift antibiotica op het voorkomen van een POWI na VOSM te beoordelen
    E.2.2Secondary objectives of the trial
    Health-related quality of life, functional outcome, health care utilization, including transmural care, and costs from a health care and societal perspective (secondary outcomes).
    Secundaire uitkomstmaten zijn kwaliteit van leven, functionele uitkomst en kosteneffectiviteit/besparing.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Consecutive patients of all ethnic backgrounds, aged 18 to 75 years, scheduled for implant removal
    following foot, ankle and/or lower leg fracture surgery are included after written informed consent.
    Patienten 18-75 jaar waarbij osteosynthesemateriaal onder de knie verwijderd wordt, van alle etnische achtergronden met informed consent.
    E.4Principal exclusion criteria
    Exclusion criteria are: removal and re-implanting of osteosynthetic material in the same session; an active wound infection or (plate) fistula; antibiotic treatment at time of elective implant removal for a concomitant disease or infection; a medical history of an allergic reaction to a cephalosporin; insufficient comprehension of the Dutch language to understand the patient information to make an informed decision to participate.
    opnieuw plaatsen OSM in zelfde sessie, actieve wondinfectie of fistel, antibiotische behandeling, allergie voor cefalosporine, onvoldoende beheersing van de Nederlandse taal om de formulieren te kunnen invullen.
    E.5 End points
    E.5.1Primary end point(s)
    A POWI within 30 days after implant removal as defined by the criteria applied by the CDC and diagnosed by the attending physician.
    Een POWI binnen 30 dagen gedefinieerd volgens de criteria van de CDC en gediagnosticeerd door een arts
    E.5.1.1Timepoint(s) of evaluation of this end point
    30 days postoperatively
    30 dagen postoperatief
    E.5.2Secondary end point(s)
    Secondary outcomes include:
    -health-related quality of life as measured by the EQ-5D questionnaire.
    -difference in functional outcome as assessed with the Lower Extremity Functional Scale (LEFS).
    -patient satisfaction as measured by a ten-point Visual Analog Scale.
    -health care resources utilization (including amongst others, number of visits to the general practitioner and use of home care organizations) as measured by way of a combination of patient questionnaires
    -costs (economic evaluation including budget impact analysis)
    E.5.2.1Timepoint(s) of evaluation of this end point
    0 days, 1 month, 6 months
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Yes
    E.6.2Prophylaxis Yes
    E.6.3Therapy No
    E.6.4Safety No
    E.6.5Efficacy No
    E.6.6Pharmacokinetic No
    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 Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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 Yes
    E.8.2.3.1Comparator description
    Natriumchloride 0.9%
    Sodiumchloride 0.9%
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned17
    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
    LVLS
    Laatste bezoek van laatste patient (dus 6 maanden na laatste inclusie)
    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 months6
    E.8.9.1In the Member State concerned days0
    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: 500
    F.1.3Elderly (>=65 years) No
    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 state500
    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)
    it is not different from the expected normal treatment of that condition
    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 Decision2014-10-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-10-08
    P. End of Trial
    P.End of Trial StatusOngoing
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