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    The EU Clinical Trials Register currently displays   41449   clinical trials with a EudraCT protocol, of which   6808   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2017-004281-10
    Sponsor's Protocol Code Number:PT/11/2017
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2017-12-06
    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
    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 number2017-004281-10
    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) for the purpose of optimising the 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 antibiotikabehandlingen hos denne gruppe
    A.4.1Sponsor's protocol code numberPT/11/2017
    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 Pediatric Oncology, 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.3.1Product nameTazocin: Piperacillin/Tazobactam
    D.3.4Pharmaceutical form Concentrate 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 INNTazobactam
    D.3.9.3Other descriptive nameTAZOBACTAM SODIUM
    D.3.9.4EV Substance CodeSUB04682MIG
    D.3.10 Strength
    D.3.10.1Concentration unit g gram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0,5
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPiperacillin
    D.3.9.3Other descriptive namePIPERACILLIN SODIUM
    D.3.9.4EV Substance CodeSUB03840MIG
    D.3.10 Strength
    D.3.10.1Concentration unit g gram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number4
    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
    Pediatric oncology patients with fever
    Børn med cancer og kemoinduceret feber
    E.1.1.1Medical condition in easily understood language
    Children with cancer and fever
    Børn med kræft og feber under kemoterapi
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10051312
    E.1.2Term Neutropenic fever
    E.1.2System Organ Class 100000004851
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10076734
    E.1.2Term Chemotherapy induced neutropenia
    E.1.2System Organ Class 100000004851
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    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 the PhD study is to optimize the dosing regimen of empiric Tazocin treatment in pediatric oncology patients with fever.

    In sub-study 3, the main purpose is to determine whether continuous Tazocin infusion provide antibiotic concentrations associated with maximal activity in relation to MIC-levels. Furthermore, we want to find the most optimal dosing schedule.
    Det overordnede formål med dette PhD-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.

    Det primære formål med delstudie 3 er at undersøge om kontinuerlig infusion af Tazocin giver en mere optimal antibiotikaprofil sammenlignet med det nuværende bolusregime. Vi ønsker at bestemme den dosis af Tazocin givet som kontinuerlig infusion efter en bolusindgift af stoffet, der resulterer i den mest optimale antibiotikaprofil i relation til MIC-værdierne.
    E.2.2Secondary objectives of the trial
    We conducted a clinical trial to describe the pharmacokinetics of Tazocin in the present Tazocin bolus regimen in children with cancer and fever (sub-study 2). Our preliminary results show that the children have Tazocin concentrations below the target range in above 50% of the time. The results also indicate that continuous Tazocin infusion would be more optimal.
    Therefore, in sub-study 3, we want to investigate whether continuous infusion of Tazocin can optimize the antibiotic treatment in this group of children by providing a more stable Tazocin level above MIC.
    Vi har udført et studie (delstudie 2) omkring farmakokinetik for det nuværende standardregime hvor Tazocin indgives som bolusinfusion 3 gange i døgnet til børn med cancer og feber. Vores foreløbige resultater fra delstudie 2 (fra 56 feberepisoder) peger på, at den nuværende behandling med bolusindgift af Tazocin ikke er optimal. Børnene har kun anbitiotikakoncentrationer i det optimale niveau i under halvdelen af tiden. I stedet tyder data på, at kontinuerlig infusion af Tazocin på infusionspumpe over 24 timer vil medføre en mere optimal antibiotika-behandling.
    I delstudie 3 vil vi derfor undersøge, om kontinuerlig infusion giver en mere optimal antibiotikadækning med Tazocin-koncentrationer over MIC.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    The PhD study is divided into three sub-studies. With this application we apply for approval of the third sub-study. The second sub-study has already been approved and we will soon finish the data collection in this sub-study.


    Sub-study 1

    Title:"Determination of Minimal Inhibitory Concentration (MIC) of Tazocin in the most pathogenic bacteria in pediatric oncology patients" Version 3, 02-19-2016

    Objective: 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 from 2000-2015. The MIC-levels will form the basis of the target Tazocin concentration I the two subsequent studies.


    Sub-study 2

    Title: Pharmacokinetics of Piperacillin-Tazobactam (Tazocin) in the present bolus regimen in children with cancer and fever

    Objective: We want to determine whether the present Tazocin dosing program achieves concentrations associated with maximal antibiotic activity in relation to MIC-levels. We want to perform pharmacokinetic analysis and make a population model.

    PhD studiet består af tre delstudier. Med denne ansøgning søger vi om godkendelse af det tredje delstudie. Delstudie 2 er allerede blevet godkendt og vi nærmer os afslutningen af dataindsamlingen.

    Delstudie 1
    Titel: "Minimal Inhibitorisk Concentration (MIC) for isolater af patogene bakteriestammer dyrket fra blodet hos børn med cancer", version 3, 2016.02.19

    Formål: 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.

    Delstudie 2

    Titel: Farmakokinetik af bolusinjektion af Piperacillin-tazobactam (Tazocin) til børn med cancer og feber

    Formål: I det andet delstudie er formålet at analysere, om det nuværende behandlingsregime med bolusinjektion af Tazocin 100 mg/kg 3 gange i døgnet er forbundet med en hensigtsmæssig farmakokinetisk profil af stoffet.
    Det primære outcome i dette delstudie er at undersøge, hvor stor en andel af børnene, der opnår Tazocin-koncentrationer > 4 x MIC i > 50% af doseringsintervallet eller > 1 x MIC i 100 % af tiden
    E.3Principal inclusion criteria
    - Children with cancer and fever who get admitted to the paediatric oncology department and start Tazocin treatment
    - 6 months - 18 years
    - All cancer types can be included
    - A child can participate a maximum of 3 times in case of several fever episodes
    - Børn med cancer, som bliver indlagt på Børneonkologisk afdeling, A20, AUH med kemoinduceret feber og opstartes i empirisk antibiotikabehandling med Tazocin.
    - Alderskriterium: 6 måneder – 18 år
    - Alle cancertyper kan indgå
    - Et barn kan indgå flere gange i forbindelse med en ny antibiotikabehandlingsperiode og kan indgå selvom barnet får anden type antibiotika samtidigt. Hvert barn kan max. indgå i studiet 3 gange.
    E.4Principal exclusion criteria
    - Babies that are only breast or bottle feed
    - Not possible to take blood samples from the child's central venuous catheter
    - Weight < 8 kg
    - Småbørn, der ammes fuldt
    - Hvis det ikke er praktisk muligt at tage blodprøver fra barnets CVK
    - Vægt < 8 kg
    E.5 End points
    E.5.1Primary end point(s)
    For continuous infusion of Tazocin, our primary endpoint is to investigate if the children 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. We want to determine, if continuous infusion of this drug provides a more stable antibiotic concentration above MIC compared to the current bolus regimen.
    So, the overall endpoint is to optimize the Tazocin treatment in this group of children.
    Dvs. at vores primære endpoint er at undersøge om børnene, med kontinuerlig infusion af Tazocin opnår 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. Vi vil således undersøge, om kontinuerlig infusion af stoffet resulterer i staibile antibiotika koncentrationer over MIC og dermed optimal effekt af stoffet.
    E.5.1.1Timepoint(s) of evaluation of this end point
    The timepoint of evaluation of this endpoint is spring/summer 2019. By this
    time all blood samples should be gathered and analyzed.
    Data forventes indsamlet og analyseret i løbet af forår/sommer 2019.
    E.5.2Secondary end point(s)
    In sub-study 3, we want to determine if continuous infusion of this drug provides a more stable antibiotic concentration above MIC compared to the current bolus regimen. Furthermore,
    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. 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 for de patogene mikroorganismer beskrevet i delstudie 1. 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 .
    E.5.2.1Timepoint(s) of evaluation of this end point
    Spring/summer 2019
    Forår/sommer 2019
    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 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) Yes
    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) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Longitudinelt observationsstudie
    Observational 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
    Farmakokinetisk studie af Tazocin hos børn med cancer og feber
    We investigate the pharmacokinetics of Tazocin in pediatric oncology patients
    E.8.2.4Number of treatment arms in the trial1
    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/feberepisode afslutter forsøget
    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 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 Yes
    F.1.1Number of subjects for this age range: 50
    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: 5
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 25
    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 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 state50
    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. The study participants will be treated according to the standard treatment for this patient group.
    Ingen. De inkluderede patienter vil modtage standardbehandlingen efter deltagelse i projektet.
    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 Decision2018-01-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-01-10
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2020-06-30
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