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    Summary
    EudraCT Number:2017-002888-18
    Sponsor's Protocol Code Number:CHAVANET-PHRC-2016
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2017-07-21
    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 number2017-002888-18
    A.3Full title of the trial
    Adjunction of daptomycin for the treatment of pneumococcal meningitis
    AddaMAP study
    Daptomycine en traitement adjuvant des méningites à pneumocoque.
    Etude ADDAMAP
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Traitement des méningites à pneumocoque
    A.3.2Name or abbreviated title of the trial where available
    ADDAMAP Study
    A.4.1Sponsor's protocol code numberCHAVANET-PHRC-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 Dijon Bourgogne
    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 Dijon Bourgogne
    B.5.2Functional name of contact pointChef de projets recherche
    B.5.3 Address:
    B.5.3.1Street Address1, boulevard Jeanne d'Arc
    B.5.3.2Town/ cityDijon
    B.5.3.4CountryFrance
    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 CUBICIN
    D.2.1.1.2Name of the Marketing Authorisation holderMerck Sharp & Dohme Ltd
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 nameDaptomycine
    D.3.4Pharmaceutical form Powder 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 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
    méningite à pneumocoque
    E.1.1.1Medical condition in easily understood language
    méningite bactérienne
    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 10027253
    E.1.2Term Meningitis pneumococcal
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the impact of the adjunction of daptomycin (10 mg/kg/d for 8 days) to the recommended treatment (corticotherapy + third generation cephalosporin) on disability-free survival (DFS) 30 days after treatment initiation (D30) in adult patients with pneumococcal meningitis.
    E.2.2Secondary objectives of the trial
    EFFICACY: To evaluate the impact of the adjunction of daptomycin to the recommended treatment on mortality, disability, hearing loss measured, quality of life, length of hospital stay at D30 and D90, and the number of days without antibiotics at D30.

    SAFETY: To assess the safety of the daptomycin add-on therapy
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    - Physiopathological study:
    1) To characterize the in situ antibacterial activity by measuring the evolution of the pneumococcal concentration in the CSF between first daptomycin infusion and D3 and between first daptomycin infusion and D8.
    2) To describe the evolution of CSF surrogate markers of cellular suffering and inflammation while taking into account the antipneumococcal vaccination status and the treatment completeness
    - Pharmacokinetic study :
    1)to determine the pharmacokinetic parameters of daptomycin in plasma in patients with meningitis
    2)to describe the link between daptomycin plasma concentration and daptomycin concentration in the CSF
    E.3Principal inclusion criteria
    - Persons aged over 18 years
    - With Suspected pneumococcal meningitis :
    o clinical presentation evocative of pneumococcal meningitis : acute onset of meningeal signs, history of cranial trauma or fistula, knowledge of alteration of humoral immunity,, asplenia, alcoholism with/or

    o clearly purulent CSF with/ or,
    o presence of diplococcus on the Gram stain of CSF or positive pneumococcal antigen in the CSF, or polymorphonuclear cells in CSF > 100

    - Written consent or inclusion in an emergency
    - Affiliation to a social security system

    All patients full-filling inclusion criteria and who will receive at least one injection of daptomycin will represent the safety population. The efficacy population will be composed of patients with proven pneumococcal meningitis (positive culture or PCR of the CSF or positive blood culture).
    E.4Principal exclusion criteria
    MAIN NON-INCLUSION CRITERIA
    1) Contraindication to cephalosporin
    2) Immediate and severe hypersensitivity to β-lactam antimicrobial
    3) Contraindication to dexamethasone
    4) Contraindication to daptomycin
    5) Previous exposition to daptomycin (within one year)
    6) Pregnant or breastfeeding women

    EXCLUSION CRITERIA
    - Patients under ward of court
    - Refusal at any time after acceptation of the study from the patient or her/his legal representative.
    E.5 End points
    E.5.1Primary end point(s)
    Disability-free survival (survival with a modified Rankin scale ≤ 2)
    E.5.1.1Timepoint(s) of evaluation of this end point
    at D30
    E.5.2Secondary end point(s)
    EFFICACY
    1) Overall mortality at D30 and D90
    2) Disability level assessed with i) the mRS at D30 and at D90 in surviving patients, ii) the Glasgow Coma Scale and the Glasgow Outcome Scale at D30 and D90 in the overall efficacy population and iii) mini-mental score at D30 and D90 in surviving patients.
    3) Hearing loss assessed with the Hearing Handicap Inventory test at D30 and D90 and with routine audiometric tests and the Hein test at D30
    4) Quality of life assessed with SF12 and WHO QOL BREF at D30 and at D90
    5) Number of days without hospitalisation (including ICU) at D30 and D90) Number of days without antimicrobial therapy at D30

    SAFETY
    Frequency and type of side effects related to daptomycin within 90 days after inclusion
    E.5.2.1Timepoint(s) of evaluation of this end point
    EFFICACY:
    1) at D30 and D90
    2) at D30 and D90
    3) at D30 and D90 for the Hearing Handicap Inventory / at D30 for routine audiometric tests and the Hein test
    4) at D30 and D90
    5) at D30 and D90 for number of days without hospitalisation / at D30 for number of days without antimicrobial therapy
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    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.8.2.4Number of treatment arms in the trial1
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned14
    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 Yes
    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.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months39
    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.1.3Elderly (>=65 years) Yes
    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 No
    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
    Subjects incapable of giving consent for physical or physiological reasons, or reasons linked to their medical condition
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state128
    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 Decision2017-09-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-01-16
    P. End of Trial
    P.End of Trial StatusOngoing
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