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    Summary
    EudraCT Number:2016-000466-33
    Sponsor's Protocol Code Number:PT/11/2015
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2016-03-01
    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 number2016-000466-33
    A.3Full title of the trial
    Pharmacokinetics and pharmacodynamics of Piperacillin-Tazobactam (PT) in pediatric oncology patients with fever and neutropenia.
    Farmakokinetiske og farmakodynamiske studier af Piperacillin-Tazobactam (PT) til behandling af børn med cytostatika-induceret febril sygdom.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Investigation on how children with cancer and fever metabolise the
    antibiotic, Piperacillin-tazobactam (PT) to help optimize antibiotic treatment in this group of patients.
    Undersøgelse af, hvordan børn med kræft og feber omsætter et antibiotikum, Piperacillin-tazobactam (PT) med henblik på at optimere
    antibiotika-behandlingen hos denne grup
    A.4.1Sponsor's protocol code numberPT/11/2015
    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 SponsorDepartment of Pediatric oncology, Aarhus 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 supportDanish childhood Cancer foundation
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationDepartment of Pediatrics, Aarhus University Hospital, Skejby
    B.5.2Functional name of contact pointSabine Frølich Maarbjerg
    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-mailsabine.froelich@midt.rm.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 Tazocin
    D.2.1.1.2Name of the Marketing Authorisation holderPfizer Denmark
    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 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.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    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
    Pediatric oncology patients with fever and neutropenia
    Børn med cancer og febril neutropeni
    E.1.1.1Medical condition in easily understood language
    Children with cancer and fever
    Børn med kræft og feber
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.1
    E.1.2Level LLT
    E.1.2Classification code 10007050
    E.1.2Term Cancer
    E.1.2System Organ Class 100000004864
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The main objective of this trial is to optimize the dosing and interval regimen of empiric Tazocin treatment in pediatric oncology patients with fever and neutropenia.
    Det overordnede formål med vores projekt er at optimere dosis og indgiftsmetode for den empiriske Tazocin-behandling til børneonkologiske patienter ud fra farmakokinetiske og – dynamiske studier af Tazocin hos denne gruppe børn.
    E.2.2Secondary objectives of the trial
    To describe the pharmacokinetics of Tazocin in children with cancer and FN. We want to determine whether Tazocin dosing with bolus injection achieves concentrations associated with maximal activity in relation to MIC-levels.
    Formålet er at analysere, om nuværende behandlingsregime med bolusinjektion af Tazocin 100 mg/kg hver 8. time er forbundet med en hensigtsmæssig farmakokinetisk profil af stoffet i henhold til MiC-niveauerne.
    Desuden ønsker vi at analysere intrapatient variationen af PTs farmakokinetiske parametre og udfærdige en farmakokinetisk model. Samtidig vil vi relatere resultaterne af ovenstående til følgende parametre hos barnet: alder, vægt, overfladeareal, leukocyt- og neutrofiltal, nyrefunktion (glomerulær filtration (GFR) målt ved Schwartz’ formel), tilstedeværende bakteriæmi/sepsis, anden konkomitant antibiotikabehandling og se-albumin.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Title: "Determination of Minimal Inhibitory Concentration (MIC) of Tazocin in the most pathogenic bacteria in pediatric oncology patients" Version 3, 02-19-2016

    Objective of the sub-study: Determination of MIC-levels of the most pathogenic bacteria in blood cultures from children with cancer and febrile neutropenia who have been admitted to the department of Pediatric Oncology, Aarhus University Hospital.
    Titel: "Minimal Inhibitorisk Concentration (MIC) for isolater af patogene bakteriestammer dyrket fra blodet hos børn med cancer", version 3, 2016.02.19

    Formålet med første delstudie er bestemmelse af MIC-niveauer for de mest patogene bakteriestammer, der er dyrket fra blodet hos børn med cancer og febril neutropeni. På baggrund af MIC-værdierne vil vi undersøge, hvilken koncentration af Tazocin i blodet, man skal stile mod for at opnå maksimal effekt af stoffet hos børn i behandling med empirisk Tazocin.
    E.3Principal inclusion criteria
    -Children aged 6 months - 18 years with cancer and febrile neutropenia during chemotherapy who starts empiric Tazocin treatment
    - Admission to the department of pediatric oncology A20, Aarhus University hospital
    - independent of cancer type
    - Each child can participate every more than one time if he/she has several episodes of fever during chemotherapy
    - Has CVK or other central venous catheter
    -Børn med cancer, som bliver indlagt på Børneonkologisk afdeling, A20, AUH med kemoinduceret febril neutropeni og opstartes i empirisk antibiotikabehandling med Tazocin.
    - Alderskriterium: ½ – 18 år
    - Inklusion uafhængigt af underliggende cancerform
    - Hvert barn kan indgå flere gange i forbindelse med hver antibiotikabehandlingsperiode og kan indgå selvom barnet får anden type antibiotika samtidigt.
    E.4Principal exclusion criteria
    - Children that are solely breastfeed
    - Children who do not have a central venous catheter or another central catheter (CVK)
    - Children were it is not possible to draw blood from the CVK

    - Småbørn, der ammes fuldt
    - Børn, der ikke har CVK eller anden central adgang
    - Børn, hvor det ikke er praktisk muligt at tage blodprøver fra CVK
    E.5 End points
    E.5.1Primary end point(s)
    Our primary outcome or endpoint is to investigate if the children in the study group reach Tazocin levels > 4 x MIC for the most pathogenic bacteria in > 50% of the dosing interval or > 1 x MIC i 100 % of the dosing interval. The overall goal is to optimize the Tazocin treatment in this group of children.
    Dvs. at vores outcome i dette studie er at undersøge, hvor stor en andel af børnene, der opnår Tazocin koncentrationer > 4 x MIC for de mikroorganismer, der er beskrevet i delstudie 1 i > 50% af doseringsintervallet eller > 1 x MIC i 100 % af doseringsintervallet
    E.5.1.1Timepoint(s) of evaluation of this end point
    The timepoint of evaluation of this end point is jan-feb. 2018. By this time all blood samples should be gathered and analyzed.
    Data forventes indsamlet og analyseret, herunder udarbejdelse af en farmakokinetisk model, januar-februar 2018.
    E.5.2Secondary end point(s)
    In the third sub-study we aim to investigate whether continuous Tazocin infusion is associated with prolonged time of PT concentration above MIC. Furthermore we will determine the most optimal dosing of Tazocin administered as continous infusion.
    I det trejde delstudie ønsker vi at undersøge, om kontinuerlig infusion af Tazocin resulterer i en mere optimal antibiotikaprofil i henhold til MIC-værdierne. Vi vil endvidere bestemme hvilken dosis af Tazocin givet som bolus efterfulgt af kontinuerlig infusion, der giver den mest optimale farmakokinetiske profil i relation til MIC værdierne for de patogene mikroorganismer beskrevet i delstudie 1.
    E.5.2.1Timepoint(s) of evaluation of this end point
    October 2018
    Oktober 2018
    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 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 Information not present in EudraCT
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Deskriptivt og prospektivt studie
    Descriptive + prosepctive study
    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
    farmakokinetik og farmakodynamik af Tazocin hos børneonkologiske patienter
    We investigate tha pharmacokinetics and pharmacodynamics of Tazocin in pediatric oncology patients
    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
    Sidste besøg/indlæggelse for sidste patient afslutter forsøget.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    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: 100
    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) Yes
    F.1.1.4.1Number of subjects for this age range: 10
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 70
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 20
    F.1.2Adults (18-64 years) No
    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 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
    The trial subjects include underaged children (< 15 years) who are not allowed to give informed consent themselves.
    The parents or guardians have to give consent on behalf of the child.
    Børn under 15 år kan ikke selv give samtykke, idet de er mindreårige. Derfor er deltagelse i forsøget betinget af informeret samtykke fra begge indehavere af forældremyndigheden.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state100
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 100
    F.4.2.2In the whole clinical trial 100
    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 Decision2016-03-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-12-22
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2018-02-01
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