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    The EU Clinical Trials Register currently displays   38177   clinical trials with a EudraCT protocol, of which   6271   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2016-003917-83
    Sponsor's Protocol Code Number:CHAVANET-BASILEA-2016
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2017-09-20
    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 ConcernedFrance - ANSM
    A.2EudraCT number2016-003917-83
    A.3Full title of the trial
    Open and exploratory trial to investigate the pharmacokinetic of ceftobiprole medocaril in patients with CSF device
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Etude de la pénétration méningée de la ceftobiprole chez les patients porteurs d'un dispositif intracranien
    A.4.1Sponsor's protocol code numberCHAVANET-BASILEA-2016
    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 SponsorCHU de DIJON
    B.1.3.4CountryFrance
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCHU de DIJON
    B.5.2Functional name of contact pointChef de projets recherche
    B.5.3 Address:
    B.5.3.1Street Address14, rue Paul Gaffarel
    B.5.3.2Town/ cityDIJON
    B.5.3.3Post code21079
    B.5.3.4CountryFrance
    B.5.4Telephone number038029561833
    B.5.5Fax number038029369033
    B.5.6E-mailmaud.carpentier@chu-dijon.fr
    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 Mabelio
    D.2.1.1.2Name of the Marketing Authorisation holderBASILEA MEDICAL LTD
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    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 nameMabelio
    D.3.4Pharmaceutical form Solution for 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 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
    Infection ou inflammation méningée
    E.1.1.1Medical condition in easily understood language
    méningites
    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 10027199
    E.1.2Term Meningitis
    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 characterize the PK of ceftobiprole after one intravenous infusion of ceftobiprole medocaril in patients with indwelling external CSF shunts who had suspected or documented meningitis or ventriculitis and to characterize the PK of ceftobiprole in the cerebrospinal fluid.
    E.2.2Secondary objectives of the trial
    To evaluate the safety and tolerability of a single intravenous infusion of ceftobiprole medocaril (one 500 mg 2h-infusion) in patients with indwelling external CSF shunts.
    To characterize the PK of Ceftobiprole after a single intravenous infusion over 2 hours.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Adult patients (> 18 years)
    o Provision of informed consent prior to any study specific procedures
    o Female patients of childbearing potential may be entered if pregnancy testing is negative and the patient agrees to abstain from procreational sexual intercourse or must use double-barrier contraceptive measures for the duration of the study
    - Presence of an indwelling external CSF access device (ventriculostomy or lumbar drain)
    - Presence of inflamed meninges as a result of documented or suspected meningitis or ventriculitis. Patients with both clinical symptoms (fever, headache, meningismus, and altered mentation) and laboratory parameters (CSF leukocytosis, defined as a CSF white blood cell count [WBC] of >103, elevated CSF protein, defined as CSF protein of >1g/l, reduced CSF glucose, defined as CSF glucose of <0.3g/l, or a positive CSF Gram stain or
    culture) indicative of CNS infection were deemed to have definitive bacterial meningitis/ventriculitis. Inflamed meninges were defined as the presence of >5 leukocytes/mm3 of CSF.
    E.4Principal exclusion criteria
    - Hypersensitivity to MABELIO® (ceftobiprole) or to one of its excipient or another 3rd cephalosporin
    - Hypersensitivity to cephalosporin
    - Imeediate or severe hypersensitivity to β-lactam antimicrovial
    - Pregnant or breast feeding women
    - Renal insufficiency defined as creatinine clearance < 50 mL/min
    - Patient with creatinine clearance > 150 mL/min
    - patients with conditions known or suspected to alter pharmacokinetics (i.e., burn or cystic fibrosis patients)
    - refusal to participate
    - person not affiliated to the social security
    - person with antibacterial treatment
    E.5 End points
    E.5.1Primary end point(s)
    Mesure de la concentration dans le sang et dans le LCR de la ceftobiprole
    E.5.1.1Timepoint(s) of evaluation of this end point
    Après injection
    E.5.2Secondary end point(s)
    Evaluation de la tolérance et de la sécurité. La tolérance et la sécurité de la perfusion (500 mg sur 2 heures) de ceftobiprole seront évaluées sur les reports des évènements indésirables, les signes vitaux, électrocardiogrammes, résultats biologiques, et les résultats des examens physiques. Ces évaluations seront faites en prenant en compte les comorbidités et maladies des patients. Les évaluations auront lieu avant l’administration de la drogue, immédiatement après la perfusion de la ceftobiprole et à J3.
    Les participants à l’étude seront suivis tout au long de la perfusion et les jours suivants pour déceler d’éventuels effets indésirables. Les relations entre évènements indésirables et produit expérimental seront évaluées par un médecin qualifié et seront en général basées sur des considérations telles que la relation temporelle avec l'administration du produit expérimental, les antécédents médicaux pertinents du sujet, et si l’évènement peut être lié à un état préexistant. Une attention toute particulière sera prêtée aux effets indésirables les plus fréquemment observés.

    Pharmacocinétique: la pharmacocinétique de la ceftobiprole sera établie par des mesures de sa concentration aux temps 0h, 0.5h, 1h, 3h, 6h, 12h et 24h
    E.5.2.1Timepoint(s) of evaluation of this end point
    Avant injection et jusqu'à 3 jours après l'injection
    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) 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) Yes
    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 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
    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 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 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: 10
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    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
    Patients de réanimation
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state10
    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
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2017-08-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-04-05
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-10-21
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