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    Summary
    EudraCT Number:2014-004628-23
    Sponsor's Protocol Code Number:M000507_6004
    Clinical Trial Type:Outside EU/EEA
    Date on which this record was first entered in the EudraCT database:2015-03-17
    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
    H.4 THIRD COUNTRY IN WHICH THE TRIAL WAS FIRST AUTHORISED
    Expand All   Collapse All
    A. Protocol Information
    A.2EudraCT number2014-004628-23
    A.3Full title of the trial
    Comparison of Teicoplanin and Vancomycin in Terms of Efficacy and Side Effect Profile During Initial Antibiotic Treatment of Febrile Neutropenic Patients at High Risk For Gram-Positive Infection: Multi-Center, Prospective, Randomized study.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Comparison of Teicoplanin and Vancomycin in Initial Empirical Antibiotic Regimen for Febrile Neutropenic Patients
    A.3.2Name or abbreviated title of the trial where available
    TARGOFEN
    A.4.1Sponsor's protocol code numberM000507_6004
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT00454272
    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 SponsorSanofi
    B.1.3.4CountryTurkey
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportSanofi
    B.4.2CountryTurkey
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSanofi Aventis Recherche & Developpement
    B.5.2Functional name of contact pointTrial Transparency Team
    B.5.3 Address:
    B.5.3.1Street Address-
    B.5.3.2Town/ city-
    B.5.3.4CountryUnited States
    B.5.6E-mailContact-US@sanofi.com
    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 Targocid
    D.2.1.1.2Name of the Marketing Authorisation holderSanofi aventis İlacları Ltd Sti
    D.2.1.2Country which granted the Marketing AuthorisationTurkey
    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 nameTargocid
    D.3.2Product code M000507
    D.3.4Pharmaceutical form Concentrate and solvent 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 INNTEICOPLANIN
    D.3.9.1CAS number 61036-64-4
    D.3.9.4EV Substance CodeSUB04714MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number400
    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.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    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.2.5The 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 nameVancomycin
    D.3.4Pharmaceutical form Powder 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 INNVANCOMYCIN
    D.3.9.1CAS number 1404-90-6
    D.3.9.2Current sponsor codeVANCOMYCIN
    D.3.9.4EV Substance CodeSUB05076MIG
    D.3.10 Strength
    D.3.10.1Concentration unit g gram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    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
    Neutropenic and febrile patients with hematological or solid tumors, who are at high risk for gram-positive bacterial infection.
    E.1.1.1Medical condition in easily understood language
    Patients with neutropenic (low white blood cells) fever, who are at high risk of bacterial infection induced by cancer treatment.
    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 17.1
    E.1.2Level PT
    E.1.2Classification code 10060945
    E.1.2Term Bacterial infection
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate whether or not the use of Teicoplanin during initial empirical antibiotic treatment of febrile neutropenic patients at high risk for gram-positive infection was at least equivalent to Vancomycin in terms of fever remission or eradication of isolated gram-positive bacteria.
    E.2.2Secondary objectives of the trial
    To evaluate whether or not there was any difference between the two regimens in terms of side effect profiles.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. In neutropenic and febrile patients with hematological or solid tumors
    • Absolute neutrophil counts (ANC) of less than or equal to 500/mm3 in peripheral blood was considered as neutropenia Patients with absolute neutrophil counts between 500 and 1000/mm3 which was expected to fall below 500/mm3 in the next 24 hours due to chemotherapy were also be considered as neutropenic.
    2. In order for a patient to be considered febrile, body temperature measured by oral or axillary method should be over 38.3 ºC once or over 38.0 ºC twice in at least half an hour intervals in a 12 hour period.
    3. Patients were included in the study in their first fever attack of febrile neutropenic episodes. Therefore patients who were febrile for at least 3 days after the empirical treatment of previous febrile attack have been included in the study. Each patient was only included once in this study.
    E.4Principal exclusion criteria
    1. Patients or legal representatives who did not provide informed consent to participate in the study
    2. Pregnant or lactating women.
    3. Patients previously enrolled in this study
    4. Patients with neutropenia due to reasons other than cancer chemotherapy (i.e. aplastic anemia)
    5. Patients in blastic phase of chronic myeloblastic leukemia
    6. Patients with known HIV infection
    7. Patients with central venous catheter in which prophylactic “antibiotic lock” was used
    8. Patients with possible infections due to anaerobic bacteria, fungus, mycoplasma, virus, protozoa or rickettsia.
    9. Patients requiring initiation of concomitant anti-anaerobic, anti-viral or anti-fungal medication at the beginning of treatment
    10. More than one dose of antimicrobial medication use 3 days prior to the use of study medications (quinolone and/or trimethoprim/sulphamethoxazole use due to bone marrow transplantation did not preclude to participate in the study).
    11. Patients receiving antifungal fluconazole and itraconazole for treatment purposes (Patients receiving these agents for prophylactic purposes were included in the study).
    12. Patients with a life expectancy of less than 48 hours.
    13. Patients with lung infiltration
    14. Patients with necrotizing colitis, liver abscess or perirectal infections
    15. Patients with any known allergy to beta-lactam antibiotics, aminoglycosides, Vancomycin or Teicoplanin.
    16. Patients with severe renal (serum creatinine level of >2 mg/dL or creatinine clearance of <40 ml/min) or hepatic failure (serum transaminase level of 4 times normal or higher).
    17. Patients with alcohol or drug dependency or personality disorder or other psychological disorder that might render adherence to protocol requirements or influence the process of consent.
    18. Patients who, within one month before this study, have used any medications for experimental purposes in some other study.
    E.5 End points
    E.5.1Primary end point(s)
    Number of subjects according to treatment response.
    E.5.1.1Timepoint(s) of evaluation of this end point
    5 days after the completion of treatment maximum of 26 days.
    E.5.2Secondary end point(s)
    Percentage of subjects with new infection.
    Percentage of subjects with protocol treatment modification or alteration.
    Survival at 30 days.
    E.5.2.1Timepoint(s) of evaluation of this end point
    At the end of treatment maximum 21 days.
    We propose 30 Days.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    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) 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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 Will this trial be conducted at a single site globally? No
    E.8.4 Will this trial be conducted at multiple sites globally? Yes
    E.8.6 Trial involving sites outside the EEA
    E.8.6.2Trial being conducted completely outside of the EEA Yes
    E.8.6.3Specify the countries outside of the EEA in which trial sites are planned
    Turkey
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months8
    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: 37
    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) Yes
    F.1.1.5.1Number of subjects for this age range: 22
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 15
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 138
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 15
    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 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 Yes
    F.3.3.7.1Details of other specific vulnerable populations
    minors
    F.4 Planned number of subjects to be included
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 190
    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
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation Febrile Neutropenia Association
    G.4.3.4Network Country Turkey
    H.4 Third Country in which the Trial was first authorised
    H.4.1Third Country in which the trial was first authorised: Turkey
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