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    The EU Clinical Trials Register currently displays   44335   clinical trials with a EudraCT protocol, of which   7366   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).

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    Summary
    EudraCT Number:2014-000202-35
    Sponsor's Protocol Code Number:I13018
    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:2015-06-22
    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 ConcernedFrance - ANSM
    A.2EudraCT number2014-000202-35
    A.3Full title of the trial
    Prevention of early ventilator-associated pneumonia with antibiotic therapy in patients treated with mild therapeutic hypothermia after cardiac arrest.
    Randomized, multicenter double-blind placebo-controlled trial.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    ANtibiotherapy during Therapeutic HypothermiA to pRevenT Infectious Complications.
    A.3.2Name or abbreviated title of the trial where available
    ANTHARTIC
    A.4.1Sponsor's protocol code numberI13018
    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 LIMOGES
    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 supportDGOS
    B.4.2CountryFrance
    B.4.1Name of organisation providing supportCHU de LIMOGES
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCHU de LIMOGES
    B.5.2Functional name of contact pointDirecteur Recherche et innovation
    B.5.3 Address:
    B.5.3.1Street Address2 Avenue Martin Luther King
    B.5.3.2Town/ cityLIMOGES
    B.5.3.3Post code87042
    B.5.3.4CountryFrance
    B.5.4Telephone number05 55 05 63 49
    B.5.5Fax number05 55 05 66 96
    B.5.6E-maildrc@chu-limoges.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 No
    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 nameAmoxicilline/Acide Clavulanique 1g/200mg
    D.3.4Pharmaceutical form Powder for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous bolus use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNAMOXICILLIN SODIUM
    D.3.9.1CAS number 34642-77-8
    D.3.9.4EV Substance CodeSUB00503MIG
    D.3.10 Strength
    D.3.10.1Concentration unit g gram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCLAVULANATE POTASSIUM
    D.3.9.1CAS number 61177-45-5
    D.3.9.4EV Substance CodeSUB01333MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Pneumonia
    E.1.1.1Medical condition in easily understood language
    pneumonia
    E.1.1.2Therapeutic area Diseases [C] - Respiratory Tract Diseases [C08]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.0
    E.1.2Level LLT
    E.1.2Classification code 10047263
    E.1.2Term Ventilation pneumonitis
    E.1.2System Organ Class 100000004855
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Incidence reduction of early VAP with short term amoxicillin-clavulanic acid in patients treated with hypothermia after out-of-hospital cardiac arrest
    E.2.2Secondary objectives of the trial
    Impact on :
    *Early nosocomial infectious complications
    *Incidence and epidemiology of late VAP
    *Mortality
    *Antibiotics consumption
    *Intestinal microbiota
    *Ventilator free days
    *Safety
    *Cost of each strategy
    *Biomarkers sub-study
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Prevention of early ventilator-associated pneumonia with antibiotic therapy in patients treated with mild therapeutic hypothermia after cardiac arrest : Interest of biomarkers.
    In this cohort of 192 out-of-hospital resuscitated cardiac arrest secondary to shockable rhythm patients and treated with therapeutic hypothermia, new inflammation or infection biomarkers could permit: 1/ to discriminate true infection (related to very early VAP occurrence, i.e. within 3 days post cardiac arrest) from isolated post-cardiac arrest inflammation syndrome (related to SIRS); 2/ to assess their prognostic value in terms of survival and favourable neurologic outcome predictions.
    E.3Principal inclusion criteria
    -Patients older than 18 years-old, mechanically ventilated after an out-of-hospital resuscitated cardiac arrest secondary to shockable rhythm
    -Hospitalized in an ICU
    -Mild therapeutic hypothermia procedure scheduled (24 to 36 hours) before randomization
    -Delay from ROSC to randomisation < 6 hours
    -Consent from family members or emergency consent
    E.4Principal exclusion criteria
    -Pregnant women
    -Out-of-hospital cardiac arrest secondary to non shockable rhythm (mild therapeutic hypothermia not yet “evidence based”)
    -In-hospital cardiac arrest
    -Need for cardiac support by cardiopulmonary bypass
    -Ongoing antibiotic therapy or during the week before
    -Ongoing or concomitant pneumonia
    -Known chronic colonization with MRB
    -Known severe allergy to beta-lactame antibiotics (Quincke edema, shock) and amoxicillin-clavulanic acid use contraindications
    -Previous lung disease making radiological interpretation difficult for VAP diagnosis
    -Predictable decision of early care limitation or withdrawal (< 7 days)
    -Moribund patient
    -Participation in any other clinical study that involves the administration of medication at the time of randomization or during the 30 days prior to study start or which can influence primary outcome
    - Patient under guardianship or curatorship
    E.5 End points
    E.5.1Primary end point(s)
    Onset of an early VAP (during 7 first days of hospitalization).
    As VAP definition remains controversial and difficult (overlap between colonization, VAT and VAP) with different approaches, some using scoring and others microbiological quantitative thresholds, sites will be asked to document all VAP or suspected VAP episode and use routine site diagnosis tools to treat patients.
    E.5.1.1Timepoint(s) of evaluation of this end point
    7 days
    E.5.2Secondary end point(s)
    -Nosocomial infectious complications not related to VAP
    -Late VAP (analysed by the independent blind adjudication committee)
    -Mortality at D28 and cause of death (neurological or extra-neurological)
    -Intestinal carriage of MRB at D7 which were not present at D0
    -Antibiotics consumption in ICU, expressed as the number of days with antibiotics
    -Length of stay in the ICU
    -Ventilator-free days at D28. This outcome will be assessed applying the following rules:
    oThe period of interest will begin at the randomization date
    oPatients who die before day 28 will be affected a 0 value
    oDays between two mechanical ventilation episode will be taken into account
    oA successful extubation will be defined as a spontaneous breathing 48h after extubation
    E.5.2.1Timepoint(s) of evaluation of this end point
    28 days
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    E.6.3Therapy No
    E.6.4Safety No
    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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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 Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    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 concerned16
    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
    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 months8
    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: 92
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 100
    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 Yes
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    patient received mechanically after out-of-hospital resuscitated cardiac arrest secondary to shockable rhythm
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state192
    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 Decision2014-09-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-01-30
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-09-14
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