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The European Union Clinical Trials Register   allows you to search for protocol and results information on:
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    The EU Clinical Trials Register currently displays   43865   clinical trials with a EudraCT protocol, of which   7286   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:2008-002019-42
    Sponsor's Protocol Code Number:2008-13
    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:2009-05-28
    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 number2008-002019-42
    A.3Full title of the trial
    Effet de l’association d’une statine au traitement antibiotique sur le pronostic des suspicions de pneumonies acquises sous ventilation mécanique
    A.3.2Name or abbreviated title of the trial where available
    STATIN-VAP
    A.4.1Sponsor's protocol code number2008-13
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorASSISTANCE PUBLIQUE HOPITAUX DE MARSEILLE
    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 organisation
    B.5.2Functional name of contact point
    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 SIMVASTATINE BIOGARAN
    D.2.1.1.2Name of the Marketing Authorisation holder BIOGARAN
    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 nameSIMVASTATINE BIOGARAN
    D.3.2Product code SIMVASTATINE
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPParenteral use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNsimvastatine
    D.3.9.2Current sponsor codesimvastatine
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number60
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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 placeboTablet
    D.8.4Route of administration of the placeboParenteral use (Noncurrent)
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    pneumonies acquises sous ventilation mécanique
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Evaluer l’intérêt d’une stratégie associant d’emblée antibiotiques et statine sur la mortalité à J28 de patients ventilés plus de 48 heures présentant une suspicion de pneumonie bactérienne acquise sous ventilation mécanique.
    E.2.2Secondary objectives of the trial
    - Evaluer l’intérêt de l’adjonction d’une statine au traitement antibiotique sur la mortalité à J14 après la randomisation ainsi qu’à la sortie de réanimation
    - Evaluer l’intérêt de l’adjonction d’une statine au traitement antibiotique sur le nombre de jours vivants sans ventilation mécanique durant les 28 jours qui suivent la randomisation (ventilator-free days à J 28)
    - Evaluer l’intérêt de l’adjonction d’une statine au traitement antibiotique sur la mortalité (J14, J28, sortie de réanimation) et le nombre de jours vivants sans ventilation mécanique à J28 restreints aux PAVM certaines et probables en fonction de la technique de diagnostic microbiologique
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - une durée de ventilation mécanique invasive d’au moins 48 h
    - un âge d’au moins 18 ans
    - une suspicion de premier épisode de PAVM basée sur un score CPIS modifié supérieur ou égal à 5
    - la réalisation d’un LBA fibroscopique et/ou d’un prélèvement distal protégé (PDP) et/ou d’une aspiration endotrachéale (AT) avec culture quantitative. La préférence ira au LBA puis au PDP puis à l’AT
    - l’obtention du consentement écrit du patient d’un de ses proches ou de la personne de confiance préalablement désignée. A défaut, une procédure d’inclusion en urgence par le médecin investigateur en charge du patient pourra être faite. Dés que possible, le proche et le patient seront informés et leur consentement écrit sera recueilli pour la poursuite éventuelle de la recherche.
    E.4Principal exclusion criteria
    - Statine instaurée ou poursuivie depuis l’instauration de la ventilation mécanique
    - Episode préalable de PAVM au cours de l’hospitalisation en cours (y compris s’il y a eu un transfert d’une réanimation à une autre)
    - Les patients âgés de moins de 18 ans
    - Les femmes enceintes
    - Les patients hospitalisés pour une aplasie médullaire
    - Les patients moribonds définis par un IGS II calculé sur les 6 premières heures avant inclusion > 75 points
    - Les patients pour lesquels il existe une décision de limitation des soins
    - L’absence de sonde gastrique associée à l’impossibilité de prise orale
    - La nécessité de maintien de la sonde gastrique en aspiration permanente
    - Un syndrome de malabsorption digestive
    - Une hypersensibilité à la simvastatine ou à l'un des constituants du médicament
    - Une décompensation aiguë d’une cirrhose ou une insuffisance hépatique aiguë
    - L’administration concomitante avec des puissants inhibiteurs du CYP3A4 (itraconazole, kétoconazole, inhibiteurs de protéase du VIH, érythromycine, clarithromycine, télithromycine, néfazodone, verapamil, diltiazem)
    - L’administration de ciclosporine
    - Une élévation des CPK > 5 fois la limite supérieure de la normale
    - Une élévation des transaminases > 3 x la limite supérieure de la normale du laboratoire (mention Vidal®)
    - Inclusion dans un autre essai thérapeutique dans les 30 jours précédents
    E.5 End points
    E.5.1Primary end point(s)
    mortalité à J28 après la randomisation
    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 No
    E.6.5Efficacy Yes
    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 Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    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 Yes
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    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.8.3 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 concerned46
    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 Information not present in EudraCT
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    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 years3
    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 Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    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 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
    malades ventilés plus de 48 heures présentant une suspicion de pneumonie bactérienne acquise sous ventilation mécanique
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state992
    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 Decision2009-07-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-06-04
    P. End of Trial
    P.End of Trial StatusOngoing
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