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    Summary
    EudraCT Number:2011-001521-25
    Sponsor's Protocol Code Number:2011-001521-25
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2012-02-01
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2011-001521-25
    A.3Full title of the trial
    Pharmacokinetics and safety of meropenem in infants below 90 days of age (inclusive) with probable and confirmed meningitis: a European multicentre phase I-II trial
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Pharmacokinetics and safety of meropenem in the treatment of meningitis in neonates and young infants
    A.3.2Name or abbreviated title of the trial where available
    NEOMERO2
    A.4.1Sponsor's protocol code number2011-001521-25
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/001/2010
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorPENTA Foundation (Fondazione Penta Onlus)
    B.1.3.4CountryItaly
    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 supportFP7 grant
    B.4.2CountryEuropean Union
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationFondazione PENTA Onlus
    B.5.2Functional name of contact pointFondazione PENTA Onlus
    B.5.3 Address:
    B.5.3.1Street AddressVia Giustiniani 3
    B.5.3.2Town/ cityPadova
    B.5.3.3Post code35128
    B.5.3.4CountryItaly
    B.5.4Telephone number0498213585
    B.5.5Fax number0498753865
    B.5.6E-mailcarlog@pediatria.unipd.it
    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 MERREM*EV FL 1g+F 20 ml
    D.2.1.1.2Name of the Marketing Authorisation holderASTRAZENECA SpA
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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 and solution for solution for injection
    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 INNMEROPENEM
    D.3.9.1CAS number 96036-03-2
    D.3.9.4EV Substance CodeSUB08778MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number1000
    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
    proven or suspected bacterial meningitis in neonates and infants up to 90 days of age
    E.1.1.1Medical condition in easily understood language
    meningitis in neonates and infants
    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 14.1
    E.1.2Level LLT
    E.1.2Classification code 10004049
    E.1.2Term Bacterial 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 study the pharmacokinetics (plasma and cerebrospinal fluid) of meropenem in infants ≤ 90 days of postnatal age with probable or confirmed bacterial meningitis and to characterize the safety profile of meropenem in the treatment of infants ≤ 90 days of postnatal age with probable or confirmed bacterial meningitis.
    E.2.2Secondary objectives of the trial
     To describe the efficacy of meropenem on day 3, at end of allocated treatment (EOAT), at test of cure (TOC) and at follow up (FU).
     To evaluate survival at FU
     To evaluate further episodes of meningitis (relapse or new infection) occurring between TOC and FU visits
     To define the organisms causing neonatal meningitis
     To describe the antibacterial susceptibility of meningitis-causing organisms and to describe the clinical and microbiological response according to this
     To evaluate mucosal colonization by resistant organisms before and after treatment with meropenem
     To evaluate bacterial eradication
     To evaluate functional genetic parameters that may affect response to 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
    Pharmacokinetics of meropenem in neonates infants ≤ 90 days of
    postnatal age with bacterial meningitis. 08.07.2011/ version 2.0
    Microbiology substudy: gut colonisation with resistant microorganisms in neonates and infants treated with meropenem for bacterial meningitis. 08.07.2011/ version 2.0
    Genetic determinants of susceptibility to meningitis and to differential responses to Meropenem. 08.07.2011/ version 2.0
    E.3Principal inclusion criteria
     Informed consent form signed by the parents/carers
     Chronological age below 90 days inclusive
     The presence of: clinical signs consistent with bacterial meningitis (clinical signs of meningitis are: fever or hypothermia or temperature instability PLUS 1 or more neurological findings e.g. coma, seizures, neck stiffness, apnoea, bulging fontanelle) OR CSF pleocytosis (≥ 20 cells / mm3 OR a positive Gram stain of CSF.
    E.4Principal exclusion criteria
     Presence of a CSF device
     Proven viral or fungal meningitis
     Severe congenital malformations if the infant is not to expect to survive for more than 3 months
     Other situations where the treating physician considers a different empiric antibiotic regimen necessary
     Known intolerance or contraindication to the study medication
     Participation in any other clinical study of an investigational medicinal product
     Renal failure and requirement of haemofiltration or peritoneal dialysis
     Meningitis with an organism known to be resistant to meropenem
    E.5 End points
    E.5.1Primary end point(s)
     The PK of meropenem (plasma and CSF) in infants ≤ 90 days of age diagnosed with probable and confirmed BM
     Adverse events experienced by infants receiving meropenem.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Meropenem PK will be studied in steady state on the 3rd study day.
    Clinical and biological adverse events will be recorded until follow-up visit on Day 45 +/- 3
    E.5.2Secondary end point(s)
     A favourable outcome defined at Test of Cure visit (TOC), 2 days after EOAT as an infant fulfilling the following criteria: Alive with clinical and bacteriological resolution of the abnormalities that defined BM at entry and no occurrence of any new clinical or laboratory abnormalities requiring a new course of antibiotic therapy and no modification of the initial meropenem therapy (for more than 24 hours).
     Clinical, biological and microbiological response at day 3, at EOAT, at TOC and at FU;
     Survival at FU visit;
     Auditory function as assessed by brain-stem auditory evoked potentials between COT and FU visits;
     Neurological evaluation as assessed by cerebral ultrasound (and if persistently abnormal, by MRI or CT) at any time up until the FU visit;
     The organisms causing neonatal meningitis;
     The antibiotic susceptibility of bacteria causing BM;
     Mucosal colonisation with antibiotic resistant bacteria or fungi at enrolment, EOAT and FU / discharge (whichever is earlier)
     Genetic parameters that can affect response to therapy
    E.5.2.1Timepoint(s) of evaluation of this end point
    End of allocated treatment (EOAT) -- the point in time when allocated therapy for meningitis is stopped, that means the last day of allocated treatment.
    TOC visit is performed 2 ± 1 days after EOAT
    Follow up (FU) visit is performed at Day 45 ± 3.
    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 Yes
    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 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 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 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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA61
    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
    IDMC performs an interim review of the trial's progress including
    updated figures on recruitment, data quality, and main safety outcomes. Based on its review, the IDMC will provide within 15 days after each of its meetings a written report with recommendations to the sponsor regarding study modification, continuation or termination.
    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 months2
    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 months2
    E.8.9.2In all countries concerned by the trial 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: 8
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Yes
    F.1.1.2.1Number of subjects for this age range: 8
    F.1.1.3Newborns (0-27 days) Yes
    F.1.1.3.1Number of subjects for this age range: 8
    F.1.1.4Infants and toddlers (28 days-23 months) Yes
    F.1.1.4.1Number of subjects for this age range: 8
    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
    neonates and infants aged up to 90 days
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state8
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 60
    F.4.2.2In the whole clinical trial 60
    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
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation Fondazione PENTA Onlus
    G.4.3.4Network Country Italy
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2012-02-01
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-12-06
    P. End of Trial
    P.End of Trial StatusCompleted
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