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The European Union Clinical Trials Register allows you to search for protocol and results information on:
  • interventional clinical trials that are conducted in the European Union (EU) and the European Economic Area (EEA);
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    The EU Clinical Trials Register currently displays   41232   clinical trials with a EudraCT protocol, of which   6757   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).


    Phase 1 trials conducted solely in adults and that are not part of an agreed PIP are not public in the EU CTR (refer to European Guidance 2008/C 168/02   Art. 3 par. 2 and   Commission Guideline 2012/C 302/03,   Art. 5) .
     
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    Summary
    EudraCT Number:2011-001114-33
    Sponsor's Protocol Code Number:DORIPED1002
    National Competent Authority:Poland - Office for Medicinal Products
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2012-03-21
    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 ConcernedPoland - Office for Medicinal Products
    A.2EudraCT number2011-001114-33
    A.3Full title of the trial
    An Open-Label Study to Evaluate the Penetration of Doripenem in Cerebrospinal Fluid After Doripenem Administration in Pediatric Subjects Less Than 1 Year
    Chronological Age
    Otwarte badanie kliniczne mające na celu ocenę penetracji doripenemu w płynie mózgowo-rdzeniowym po podaniu doripenemu u pacjentów pediatrycznych w wieku metrykalnym poniżej 1 roku
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study of Doripenem in Cerebrospinal
    Fluid After Doripenem Administration in Pediatric Patients Less Than 1 Year of Age
    A.4.1Sponsor's protocol code numberDORIPED1002
    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 SponsorJanssen-Cilag International NV,
    B.1.3.4CountryBelgium
    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 supportJanssen-Cilag International NV
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationJanssen-Cilag International NV
    B.5.2Functional name of contact pointClinica Registry Group
    B.5.3 Address:
    B.5.3.1Street AddressJanssen Biologics BV-Clinical Registry Group, Archimdesweg 29
    B.5.3.2Town/ city2333CM Leiden
    B.5.3.4CountryNetherlands
    B.5.4Telephone number+31(0)715242166
    B.5.5Fax number+31(0)715242110
    B.5.6E-mailClinicalTrialsEU@its.jnj.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 DORIBAX
    D.2.1.1.2Name of the Marketing Authorisation holderJanssen-Cilag International NV - BE
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 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.3.9.1CAS number 364622-82-2
    D.3.9.3Other descriptive nameDORIPENEM MONOHYDRATE
    D.3.9.4EV Substance CodeSUB26847
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number500
    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
    Meningitis
    zapalenie opon mózgowych
    E.1.1.1Medical condition in easily understood language
    Meningitis
    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 16.0
    E.1.2Level PT
    E.1.2Classification code 10027202
    E.1.2Term Meningitis bacterial
    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
    The primary objective of this study is to evaluate the penetration of doripenem in
    cerebrospinal fluid (CSF) after administration of doripenem to pediatric subjects less than 1 year of age with or without a ventriculoperitoneal (VP) shunt who are scheduled for a
    LP or VP shunt tap.
    Celem głównym tego badania klinicznego jest ocena penetracji doripenemu w płynie mózgowo rdzeniowym (PMR) po podaniu doripenemu u pacjentów pediatrycznych w wieku poniżej 1 roku z założonym drenażem komorowo-otrzewnowym lub bez niego, u których planowane jest pobranie płynu mózgowo-rdzeniowego drogą nakłucia lędźwiowego (LP) lub upustu z drenażu komorowo-otrzewnowego.
    E.2.2Secondary objectives of the trial
    Safety and tolerability will also be assessed
    Oceniane będą również bezpieczeństwo i tolerancja leczenia.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    -Patient is expected to require hospitalization for the entire open-label phase of the study.
    - Patient must be scheduled to have cerebral spinal fluid obtained via a lumbar puncture (referred to as a "spinal tap") or ventriculoperitoneal (VP) shunt tap within 3 days of enrollment into this study.
    - Patient must have documented or suspected infection and is planning to, or undergoing treatment with IV
    antibiotics.
    - Parent or the patient's legally acceptable representative must have signed an informed consent document indicating they understand the purpose of and procedures required for the study and are willing to allow the infant to participate in the study
    • U pacjenta spodziewana jest konieczność hospitalizacji w całym czasie trwania fazy leczenia otwartego w ramach badania.
    • Konieczne jest, aby u pacjenta planowane było pobranie płynu mózgowo-rdzeniowego drogą nakłucia lędźwiowego (określanego też mianem punkcji lędźwiowej) lub z drenażu komorowo-otrzewnowego w czasie do 3 dni po włączeniu do tego badania klinicznego.
    • Konieczna jest udokumentowana obecność lub podejrzenie u pacjenta zakażenia, a także planowane lub aktualnie stosowane leczenie antybiotykami podawanymi dożylnie.
    • Konieczne jest uprzednie podpisanie przez rodziców lub opiekuna prawnego pacjenta dokumentu świadomej zgody na udział w badaniu i wskazanie w ten sposób, że rozumieją oni cel badania i procedury wymagane w ramach badania oraz że wyrażają oni zgodę na udział dziecka w tym badaniu klinicznym.
    E.4Principal exclusion criteria
    -Clinically significant abnormal values for hematology or clinical chemistry at screening that, at the option of the investigator, are not consistent with the patient's underlying disease(s) or therapies.
    - Any condition at screening that, in the
    opinion of the investigator, may interfere with the assessments of this study.
    - Patients with substantially compromised renal (kidney) function: e.g., urine output is <0.25cc/kg/hr within the 24 hours before
    screening.
    - History of clinically significant allergies to medications, especially known hypersensitivity or intolerance to carbapenems, penicillins, or other Beta-lactam antibiotics.
    - Known allergy to heparin or history of heparin-induced thrombocytopenia, if an in-dwelling cannula (e.g., heparin lock) or central line is used.
    - Patients concomitantly treated with or having received imipenem/cilastin within 48 hours before study drug administration.
    - Patients concomitantly treated with probenecid or valproic acid (VPA).
    • Klinicznie istotne wartości nieprawidłowe parametrów hematologicznych lub klinicznych oznaczeń chemicznych podczas przesiewu, które – według opinii badacza – nie są spójne z chorobą podstawową pacjenta lub sposobami leczenia stosowanymi u pacjenta.
    • Dowolne zaburzenie podczas przesiewu, które – według opinii badacza – może zakłócać pomiary i oceny dokonywane w ramach tego badania klinicznego.
    • Pacjenci ze znacznym upośledzeniem czynności nerek: np. diureza <0,25 ml/kg/h w okresie do 24 godzin przed przesiewem.
    • Obecność w wywiadzie klinicznie istotnych alergii (uczuleń) na leki, szczególnie stwierdzona nadwrażliwość lub nietolerancja karbapenemów, penicylin lub innych antybiotyków beta-laktamowych.
    • Stwierdzona alergia (uczulenie) na heparynę lub obecność w wywiadzie małopłytkowości indukowanej heparyną, jeżeli stosowana jest kaniula dożylna/wenflon (np. heparin lock) lub centralny żylny dostęp naczyniowy (tzw. wkłucie centralne).
    • Pacjent jest równolegle leczony imipenemem/cilastyną lub otrzymał te leki w czasie do 48 godzin przed podaniem leku badanego.
    • Pacjent jest równolegle leczony probenecydem lub kwasem walproinowym (ang. VPA).
    E.5 End points
    E.5.1Primary end point(s)
    Doripenem concentrations in CSF and plasma
    stężenie/ zawartość doripememu w płynie mózgowo-rzdzeniowym i osoczu w trakcie leczenia
    E.5.1.1Timepoint(s) of evaluation of this end point
    For up to 2 days
    do 2 dni
    E.5.2Secondary end point(s)
    -Number of patients with adverse events
    -Changes in clinical laboratory test results
    -Changes in physical examination results reported as adverse events
    -Changes in vital signs measurements
    -Changes in concomitant therapy
    -The number of patients with changes from baseline in clinical laboratory
    test results
    -The number of patients who receive concomitant therapy
    Drugorzędowe punkty końcowe:
    Liczba pacjentów ze zdarzeniami niepożądanymi
    Zmiany wyników klinicznych oznaczeń laboratoryjnych
    Zmiany wyników badania przedmiotowego (fizykalnego) raportowane jako zdarzenia niepożądane
    Zmiany wyników pomiarów oznak życiowych
    Zmiany w równolegle stosowanym leczeniu
    Liczba pacjentów ze zmianami wyników klinicznych oznaczeń laboratoryjnych względem wartości wyjściowych
    Liczba pacjentów otrzymujących równoległe leczenie
    E.5.2.1Timepoint(s) of evaluation of this end point
    -Up to Day 9
    -From Day -1 to Day 9
    -From Day -1 to Day 9
    -From Day -1 to Day 9
    -From Day -1 to Day 9
    -From Day -1 to Day 9
    -From Day -1 to Day 9
    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 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 Yes
    E.7.1.3.1Other trial type description
    Pharmacokinetics
    Farmakokinetyka
    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 Yes
    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 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 No
    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 EEA2
    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
    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 months7
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months9
    E.8.9.2In all countries concerned by the trial days15
    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: 10
    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) Yes
    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) No
    F.1.1.6Adolescents (12-17 years) No
    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 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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Pediatric patients involved. The parent or the patient's legally acceptable representative must have signed an informed consent document stating that they are willing to allow infants to participate in the study
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state2
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 10
    F.4.2.2In the whole clinical trial 10
    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 Decision2012-07-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-03-29
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2013-07-01
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