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    The EU Clinical Trials Register currently displays   36100   clinical trials with a EudraCT protocol, of which   5935   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2007-005446-20
    Sponsor's Protocol Code Number:P061014
    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:2008-07-15
    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 number2007-005446-20
    A.3Full title of the trial
    Impact de la variabilité des paramètres pharmacocinétiques et pharmacodynamiques de l'imipénème en association avec l'amikacine sur l'évolution des pneumonies acquises sous ventilation mécanique à bacilles à Gram négatif - Etude IMPACT
    A.4.1Sponsor's protocol code numberP061014
    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 PARIS (AP-HP)
    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 TIENAM
    D.2.1.1.2Name of the Marketing Authorisation holderMerck Sharp Dohme Chibret
    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 nameTIENAM
    D.3.4Pharmaceutical form Powder for infusion*
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INNImipénème monohydrate exprimé en produit anhydre
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number250 - 500
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCilastatine sodique exprimée en cilastatine
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number250 - 500
    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.IMP: 2
    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 Amiklin
    D.2.1.1.2Name of the Marketing Authorisation holderBristol Myers Squibb
    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 nameAmiklin
    D.3.4Pharmaceutical form Powder and solvent for solution for infusion
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INNamikacine
    D.3.10 Strength
    D.3.10.1Concentration unit mg/kg milligram(s)/kilogram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Pneumonies à gram négatif 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'impact de la variabilité des facteurs pharmacocinétiques et pharmacodynamiques de l'imipénème sur l'évolution microbiologique des PAVM 48 heures après l'initiation du traitement
    E.2.2Secondary objectives of the trial
    1- Décrire les paramètres pharmacocinétiques de l'imipénème et de l'amikacine chez le patient de réanimation à la phase initiale du traitement des PAVM. 2- Décrire les paramètres pharmacodynamiques pour l'imipénème et pour l'amikacine chez le patient de réanimation à la phase initiale du traitement des PAVM. 3- Déterminer la proportion de patients pour lesquels les objectifs pharmacodynamiques proposés dans la littérature pour les aminosides et les ß lactamines sont atteints. 4- Identifier les sources de variabilité des paramètres pharmacocinétiques et pharmacodynamiques de l'imipénème et de l'amikacine chez le patient de réanimation. 5- Déterminer la relation entre les paramètres pharmacocinétiques et pharmacodynamiques de l'imipénème et de l'amikacine et la guérison microbiologique de la PAVM à J3. 6- Evaluer l'impact de la variabilité des paramètres pharmacocinétiques et pharmacodynamiques de l'imipénème et de l'amikacine sur le score CPIS, score clinique de PAVM, mesuré 48 heures
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1- Recours à la ventilation mécanique depuis plus de 48 heures.
    2- Suspicion clinique de PAVM définie par un nouvel infiltrat radiologique persistant (ou SDRA) et l'un des signes suivants : aspirations trachéales purulentes ou température = à 38°3 ou leucocytose > 10000/ml.
    3- PAVM à risque de bactérie(s) multi résistante(s) définie comme suit : au moins 6 jours de ventilation mécanique ou traitement antibiotique dans les 15 jours précédents.
    4- Réalisation préalable d'un prélèvement respiratoire distal pour diagnostic microbiologique par lavage broncho alvéolaire (LBA) sous bronchoscopie ou prélèvement distal par cathéter protégé (PDP) dirigé sous bronchoscopie ou PDP à l'aveugle.
    5- Age = 18 ans.
    6- Réalisation d'un examen médical préalable.
    7- Présence de BGN à l'examen direct du prélèvement respiratoire distal diagnostic
    8- Patient affilié à un régime de sécurité sociale
    E.4Principal exclusion criteria
    Critère d'exclusion secondaire : Absence de bacilles à Gram négatif (BGN) en quantité (numération) supérieure aux seuils définis par le protocole (seuils : 10exp4 cfu/ml dans un LBA et 10exp3 cfu/ml dans un PDP) sur la culture du prélèvement respiratoire diagnostic, lavage broncho alvéolaire (LBA) ou prélèvement distal par cathéter protégé (PDP)

    Critères de non inclusion:
    1- Refus du proche pour la participation du patient au protocole
    2- Délai entre la réalisation du prélèvement respiratoire diagnostique initial (LBA ou PDP) et la 1ère dose d'imipénème supérieur à 24 heures.
    3- Femme enceinte.
    4- Altération sévère de la fonction rénale (clairance de la créatinine < 10ml/min ou épuration extra rénale).
    5- Allergie connue à l'imipénème ou à l'amikacine.
    6- Traitement en cours par amikacine ou imipénème
    7- Décès du patient attendu dans les 48 heures suivant le diagnostic de la PAVM
    8- Non affiliation à un régime de sécurité sociale (bénéficiaire ou ayant droit).
    9- Myasthénie
    10- Administration simultanée avec d'autres aminosides
    11- Association avec les polymixines par voie parenthérale
    12- Association avec la toxine botulique

    E.5 End points
    E.5.1Primary end point(s)
    Variation de la numération (exprimée en colonies formant unité, cfu par ml) des bacilles à Gram négatif (BGN) isolés en quantité significative sur le prélèvement respiratoire diagnostique (LBA ou PDP), entre l'aspiration endotrachéale quantitative (AEQ) réalisée à l'initiation du traitement (H0) et l'AEQ réalisée 48 heures après l'initiation du traitement antibiotique (H48).
    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 No
    E.6.5Efficacy No
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised Information not present in EudraCT
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    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) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    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 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 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 years1
    E.8.9.1In the Member State concerned months7
    E.8.9.1In the Member State concerned days0
    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 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
    patients sous ventilation mécanique
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state60
    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 Decision2008-08-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-09-10
    P. End of Trial
    P.End of Trial StatusOngoing
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