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    The EU Clinical Trials Register currently displays   44313   clinical trials with a EudraCT protocol, of which   7357   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2014-004961-26
    Sponsor's Protocol Code Number:12-009
    National Competent Authority:Austria - BASG
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2017-09-07
    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 ConcernedAustria - BASG
    A.2EudraCT number2014-004961-26
    A.3Full title of the trial
    Prophylactic Antibiotic Regimens in Tumor Surgery (PARITY): A Multi-Center Randomized Controlled Study Comparing Alternative Antibiotic Regimens in Patients Undergoing Tumor Resections with Endoprosthetic Replacements
    Prophylaktische Antibiotika-Regime in der Tumorchirurgie (PARITY): Eine multizentrische, randomisierte, kontrollierte Studie zum Vergleich von alternativen Antibiotika-Regime bei PatientInnen mit Tumor-Endoprothetik
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Clinical study in which patients with bone cancer in the leg and who are undergoing surgery to remove the tumor and reconstruct the leg using a metal implant are randomly assigned to 1 of 2 antibiotic regimens.
    Eine klinische Studie mit Patienten, die einen Knochentumor im Bein haben und, welche eine operative Behandlung mit einer Tumorprothese benötigen und eine unterschiedliche Dauer der Antibiotikatherapie benötigen.
    A.3.2Name or abbreviated title of the trial where available
    PARITY
    A.4.1Sponsor's protocol code number12-009
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01479283
    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 SponsorMcMaster University
    B.1.3.4CountryCanada
    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 supportCanadian Institutes of Health Research (CIHR)
    B.4.2CountryCanada
    B.4.1Name of organisation providing supportCanadian Cancer Society Research Institute (CCSRI)
    B.4.2CountryCanada
    B.4.1Name of organisation providing supportPhysicians? Services Incorporated (PSI) Foundation
    B.4.2CountryCanada
    B.4.1Name of organisation providing supportOrthopaedic Research and Education Foundation (OREF) / Musculoskeletal Tumor Society (MSTS)
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMcMaster University
    B.5.2Functional name of contact pointPARITY Methods Centre Project Manag
    B.5.3 Address:
    B.5.3.1Street Address293 Wellington Street North, Suite 110
    B.5.3.2Town/ cityHamilton, Ontario
    B.5.3.3Post codeL8L 8E7
    B.5.3.4CountryCanada
    B.5.4Telephone number001289244-687
    B.5.5Fax number001905523-8781
    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 Cefazolin
    D.2.1.1.2Name of the Marketing Authorisation holderAstro-Pharma
    D.2.1.2Country which granted the Marketing AuthorisationAustria
    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 nameCEFAZOLIN
    D.3.2Product code 15877
    D.3.4Pharmaceutical form Powder for solution for injection/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 INNCEFAZOLIN
    D.3.9.1CAS number 25953-19-9
    D.3.9.4EV Substance CodeSUB07379MIG
    D.3.10 Strength
    D.3.10.1Concentration unit g gram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection/infusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    * Patients with a primary bone malignancy or soft-tissue sarcoma that has invaded a lower extremity bone that are undergoing surgical treatment to resect the tumor and functionally reconstruct the limb using a modular metallic and polyethylene endoprosthetic implant to replace the surgically resected bones and joints.
    * Development of a surgical site infection according to the guidelines established by the Centers for Disease Control and Prevention (CDC)
    * PatientInnen mit primären malignen Knochentumor der unteren Extremität oder mit bösartigem Weichteiltumor inkl. Knocheninfiltration, bei denen eine chirurgische Exzision mit anschließender endoprothetischer Rekonstruktion des resezierten Knochens und Gelenks durchgeführt wird.

    * Entwicklung einer postoperativen Infektion entsprechend den Guidelines des Centers for Disease Control and Prevention (CDC).
    E.1.1.1Medical condition in easily understood language
    * Patients with bone cancer of the leg that are undergoing surgery to remove the tumor and reconstruct the leg using a metal implant
    * Development of a surgical site infection
    PatientInnen mit Knochentumor der unteren Extremität, die eine chirurgische Exzision und Rekonstruktion des Beines mittels Metallimplantat erhalten.
    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 PT
    E.1.2Classification code 10064736
    E.1.2Term Antibiotic prophylaxis
    E.1.2System Organ Class 10042613 - Surgical and medical procedures
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level LLT
    E.1.2Classification code 10056641
    E.1.2Term Post procedural site wound infection
    E.1.2System Organ Class 100000004862
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level PT
    E.1.2Classification code 10068943
    E.1.2Term Limb reconstructive surgery
    E.1.2System Organ Class 10042613 - Surgical and medical procedures
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10036894
    E.1.2Term Prophylactic antibiotic therapy
    E.1.2System Organ Class 10042613 - Surgical and medical procedures
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10005978
    E.1.2Term Bone lesion excision
    E.1.2System Organ Class 10042613 - Surgical and medical procedures
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10073235
    E.1.2Term Bone prosthesis insertion
    E.1.2System Organ Class 10042613 - Surgical and medical procedures
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10006007
    E.1.2Term Bone sarcoma
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To determine whether a 5-day regimen of post-operative prophylactic antibiotics in comparison to the standard 24-hour regimen decreases the rate of surgical site infections after limb salvage surgery within 1-year of follow-up.
    Bestimmung, ob die postoperaptive Antibiotikagabe über 5 Tage im Vergleich zur Antibiotikaverabreichung über 24 Stunden zu einer reduzierten Infektionsrate nach chirurgischer Extremitätenerhaltung innerhalb eines Follow-Ups von 1 Jahr führt.
    E.2.2Secondary objectives of the trial
    to evaluate whether the use of a 5-day regimen of post-operative prophylactic antibiotics in comparison to the standard 24-hour regimen in patients that are surgically treated for bone tumors of the lower extremity followed by limb reconstruction using an endoprostheses has an impact on (A) the development of antibiotic-related complications (such as gastrointestinal or fungal infections); (B) patient functional outcomes and quality of life; (C) the rate of re-operations; (D) the rate of oncologic recurrence and/or metastases; and (D) the rate of mortality after one year.
    Evaluierung, ob die postoperative prophylaktische Antibiotikagabe über 5 Tage im Vergleich zur Antibiotikaverabreichung über postoperativ 24-Stunden bei PatientInnen mit chirurgischer Behandlung eines Knochentumors der unteren Extremität mittels endoprothetischer Rekonstruktion einen Einfluss auf (A) die Entstehung von antibiotikabezogenen Komplikationen (wie gastrointestinale oder Pilz-Infektionen), (B) das funktionelle Outcome und die Lebensqualität der PatientInnen, (C) die Rate der Reoperationen, (D) die Rate der onkologischen Rezidive und/oder Metastasen und (E) die Rate der Mortalität nach einem Jahr hat.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1) Males and females 12 years of age or older;
    2) Primary bone malignancies or benign aggressive tumors of the lower extremity, or soft-tissue sarcomas which have invaded the bone;
    3) Treatment by excision and endoprosthetic reconstruction*; and
    4) Provision of informed consent
    1) Männer und Frauen 18 Jahre oder älter (in den USA und Kanada: ab 12 Jahren)
    2) primärer Knochentumor oder benigner aggressiver Tumor der unteren Extremität oder Weichteilsarkome mit Knocheninfiltrationen
    3) Behandlung mittels Exzision und Tumor-Endoprothetik
    4) Einholung der informierten Zustimmung der PatientInnen.
    E.4Principal exclusion criteria
    1) Current known Methicillin-Resistant Staphylococcus Aureus (MRSA), or Vancomycin Resistant Enterococcus (VRE) skin colonization*;
    2) Documented anaphylaxis or angioedema to penicillin or the study antibiotic [cefazolin, or equivalent gram-positive coverage (i.e., cefuroxime)];
    3) Prior surgery within the surgical field of the affected limb (excluding a biopsy)**;
    4) Prior local infection within the surgical field of the limb**;
    5) Current known immunologically-deficient disease conditions (not including recent chemotherapy) ***;
    6) Known renal insufficiency with estimated creatinine clearance (eGRF) of less than 54 mL/min for drug clearance;
    7) Reconstruction to include a structural allograft (bone transplant);
    8) Likely problems, in the judgement of the investigator, with maintaining follow-up;
    9) Enrolled or previously randomized in a competing study; and
    10) Patients who weigh less than or equal to 45kg****
    11) Pregnancy
    1) Bekannte MRSA oder VRE Haut-Kolonisation
    2) Allergie gegen Penicillin oder Studien-Antibiotika (Cefazolin)
    3) Vorhergegangene Operationen der betroffenen Extremität (exkl. Biopsie)
    4) Vorhergegangene Infektionen innerhalb des Operationsgebietes
    5) Bekannte immunologisch-defiziente Krankheit bzw. Bestehende Immunschwäche (exkl. Chemotherapie)
    6) Bekannte Niereninsuffizienz mit eGRF weniger als 54 ml/min
    7) Verwendung von Allograft in der Knochenrekonstruktion
    8) Mangelnde Compliance der PatientInnen (nach Einschätzung des Prüfers)
    9) Einschluss oder kürzliche Randomisierung der PatientInnen in einer anderen konkurrierenden Studie
    10) PatientInnen, die weniger also der gleich 45 kg wiegen.
    11) Schwangere und stillende Frauen dürfen nicht teilnehmen. Gebärfähige Frauen dürfen an der klinischen Prüfung nur teilnehmen, wen nein Arzt vor der klinischen Prüfung das Nichtvorliegen einer Schwangerschaft mittels Schwangerschaftstest feststellt.
    E.5 End points
    E.5.1Primary end point(s)
    The development of a surgical site infection (SSI)
    Die Entwicklung einer postoperativen Infektion
    E.5.1.1Timepoint(s) of evaluation of this end point
    within 12 months following the initial surgery
    innerhalb von 12 Monaten nach der ersten Operation
    E.5.2Secondary end point(s)
    Functional outcomes, antibiotic-related complications, adverse events, serious adverse events, re-operations, complications of wound healing, tumor recurrence or metastasis, and mortality
    Funktionelle Outcomes, antibiotikabezogenen Komplikationen, Nebenwirkungen (AEs), ernsthafte Nebenwirkungen (SAEs), Reoperationen, Komplikationen der Wundheilung, Tumorrezidiv oder Metastasen, Mortalität
    E.5.2.1Timepoint(s) of evaluation of this end point
    Patient will participant one year post-operativ in all and we come to follow up visits at 2 week after, 6 Week, 3 months, 6 months, 9 months and 1 year
    Die teilnehmen PatientInnen werden für insgesamt 1 Jahr postoperativ zu folgenden Intervallen untersucht: 2 Wochen, 6 Wochen, 3 Monate, 6 Monate, 9 Monate, 1 Jahr
    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 Yes
    E.6.4Safety No
    E.6.5Efficacy Yes
    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) Yes
    E.7.4Therapeutic use (Phase IV) No
    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 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 Yes
    E.8.2.3Other No
    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 Yes
    E.8.5.1Number of sites anticipated in the EEA15
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA Yes
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Argentina
    Australia
    Brazil
    Canada
    South Africa
    Spain
    United States
    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
    letzte Visite des letzten Patienten
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years8
    E.8.9.2In all countries concerned by the trial months3
    E.8.9.2In all countries concerned by the trial 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: 450
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 100
    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 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.4.2 For a multinational trial
    F.4.2.1In the EEA 175
    F.4.2.2In the whole clinical trial 600
    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)
    As per routine clinical practice
    ärztliche Routine Visiten
    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 Decision2017-10-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-07-25
    P. End of Trial
    P.End of Trial StatusCompleted
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