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    Summary
    EudraCT Number:2021-002197-78
    Sponsor's Protocol Code Number:APHP200011
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2022-01-18
    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 number2021-002197-78
    A.3Full title of the trial
    Antimicrobial Stewardship For Ventilator Associated Pneumonia in Intensive Care
    Acronym: ASPIC
    Optimisation de l'antibiothérapie pour les pneumonies précoces survenant chez les patients ventilés en réanimation
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Antimicrobial Stewardship For Ventilator Associated Pneumonia in Intensive Care
    Optimisation de l'antibiothérapie pour les pneumonies précoces survenant chez les patients ventilés en réanimation
    A.3.2Name or abbreviated title of the trial where available
    ASPIC
    A.4.1Sponsor's protocol code numberAPHP200011
    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 SponsorAssistance Publique - Hôpitaux de Paris
    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.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAssistance Publique - Hôpitaux de Paris
    B.5.2Functional name of contact pointDRCI
    B.5.3 Address:
    B.5.3.1Street Address Hôpital Saint-Louis, 1av. C. Vellefaux
    B.5.3.2Town/ cityParis
    B.5.3.3Post code75010
    B.5.3.4CountryFrance
    B.5.4Telephone number0033144841732
    B.5.5Fax number003314484171
    B.5.6E-maillaura.blanchet@aphp.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 ciprofloxacine Kabi Axepim Istopen Piperacilline amikacine ceftazidime claventin céfotaxime getamicine tavanic tazocilline tienam Augmentin clamoxyl meronem
    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.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMP
    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.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    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 ciprofloxacine Kabi Axepim Istopen Piperacilline amikacine ceftazidime claventin céfotaxime getamicine tavanic tazocilline tienam Augmentin clamoxyl meronem
    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.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMP
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    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
    ventilator associated neumonia in intensive care
    pneumonie survenant chez les patients ventilés en réanimation
    E.1.1.1Medical condition in easily understood language
    ventilator associated neumonia in intensive care
    pneumonie survenant chez les patients ventilés en réanimation
    E.1.1.2Therapeutic area Diseases [C] - Symptoms and general pathology [C23]
    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
    The aim of this study is to investigate whether an antimicrobial stewardship for VAP based on daily assessment of clinical cure and antimicrobial discontinuation, if it is obtained, would be non-inferior in terms of all-cause mortality, treatment failure or occurrence of new episode of pneumonia.
    L’objectif principal de cette étude est de déterminer si une gestion des antibiotiques pour les patients traités pour une pneumonie acquise sous ventilation (VAP) basée sur une évaluation quotidienne de la guérison clinique, avec arrêt des antibiotiques, si elle est obtenue, serait non inférieure en termes de mortalité toutes causes, d'échec du traitement ou d'apparition d'un nouvel épisode de pneumonie
    E.2.2Secondary objectives of the trial
    To investigate if an antimicrobial stewardship for VAP based on daily assessment of clinical cure, if it is obtained, would be non-inferior in term of all-cause mortality and of occurrence of treatment failure, of occurrence of occurrence of new episode of pneumonia, increase the number of antibiotic free-alive days, from initiation of VAP antibiotic therapy to day 28, reduce at day 28, of VAP antibiotic therapy the global DOOR score and RADAR, reduce at day 28, the duration of invasive mechanical ventilation, reduce at day 28 after inclusion the length of stay in intensive care unit,reduce at day 28, the rate of VAP recurrence, reduce at day 28 the rate of complications of antibiotic therapy, symptoms, acute kidney injury, skin reactions and other drug-specific adverse12, reduce at day 28: the rate of acquisition of carriage of MDR bacteria,The rate of subsequent infection.
    1. Examiner si une gestion des antibiotiques pour la VAP basée sur une évaluation quotidienne de la guérison clinique et de l'arrêt des antibiotiquesserit non-inferieure en tere de oratlite et d'échec de traitement, en terme de nouvel épisode de pneumonie, augmenterait le nombre de jours sans antibiotique entre le début de l’antibiothérapie et le J28, réduirait à J28 après l’initiation de l’antibiothérapie les scores DOOR et RADAR), réduirait à J28 la durée de la ventilation mécanique, réduirait à J28 la durée Du séjour en soins intensifs, réduirait à J28 le taux de récurrence de la VAP, réduirait à J28 le taux de complications liées à l’antibiothérapie, réduirait à J28 après inclusion :
    - le taux d'acquisition du portage des bactéries MDR
    - Le taux d'infection subséquente due à des entérobactéries résistantes aux carbapénèmes,
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Adult patient is ≥18 and
    - Patient under MV
    - Diagnosis of microbiologically confirmed of first episode of VAP
    - Initial adequate empiric antibiotic therapy
    -Written informed consent from the patient or a legal representative if appropriate. If absence of a legal representative the patient may be included in emergency procedure
    Patient adulte âgé de 18 ans ou plus
    - Patient sous MV
    - Diagnostic de confirmation microbiologique du premier épisode de PAV
    - Traitement antibiotique empirique adéquat initial
    - -Consentement éclairé écrit du patient ou d'un représentant légal le cas échéant. En cas d'absence d'un représentant légal, le patient peut être inclus dans la procédure d'urgence
    E.4Principal exclusion criteria
    Patient under selective decontamination of the digestive tract
    - Concomitant extra-respiratory infection requiring antibiotic therapy at the moment of inclusion
    - Inclusion in another interventional study concerning antimicrobial strategies
    - Moribund (IGS II>80)
    - Thoracic trauma with Abbreviated Injury Scale (AIS) thorax  3
    - Severely immunocompromised patients (such as congenital immunodeficiency , neutropenia (<1leucocyte/ml or <0.5 neutrophil/ml) or acute hematologic malignancy or stem cell transplant, HIV infection with CD4 count below 200/mm3
    - VAP due to: Pseudomonas aeruginosa, Carbapenem-resistant Acinetobacter spp, Carbapenem-resistant Enterobacteriaceae
    - Bacterial VAP in a context of COVID-19 or other confirmed viral pneumonia
    - No health insurance coverage
    Patient sous décontamination sélective du tube digestif
    - Infection extra-respiratoire concomitante nécessitant un traitement antimicrobien au moment de l'inclusion
    - Inclusion dans une autre étude interventionnelle concernant les stratégies antimicrobiennes
    - Moribond (IGS II> 80)
    - Traumatisme thoracique avec thorax à échelle de blessure abrégée (AIS)  3
    - Patients gravement immunodéprimés (tels que déficit immunitaire congénital, neutropénie (<1 leucocyte / ml ou <0,5 neutrophile / ml) ou hémopathie maligne aiguë ou greffe de cellules souches, infection par le VIH avec un taux de CD4 inférieur à 200 / mm3
    - VAP due à: Pseudomonas aeruginosa, Acinetobacter spp résistant aux carbapénèmes, Enterobacteriaceae résistantes aux carbapénèmes
    - VAP bactérienne dans un contexte de COVID-19 ou autre pneumonie virale confirmée
    - Non bénéficiaire ou ayant droit de l'assurance maladie
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is a composite endpoint with non-inferiority criteria including:
    1. all-cause mortality (ACM) measured at day 28 after initiation of antibiotic therapy OR
    2. Treatment failure defined by signs of pneumonia within 72 hours after the end antibiotic therapy at the test of cure visit OR
    3. New episode of microbiologically confirmed VAP from 72 hours after the end antibiotic treatment to day 28 after initiation of VAP antibiotic treatment
    Le critère d'évaluation principal, mesuré au jour 28, est un critère d'évaluation hiérarchique comprenant par ordre de priorité:
    1. mortalité toutes causes à J28
    2. échec du traitement définit par des signes de pneumonie dans les 72 heures après la fin du traitement
    3. taux de rechute ou de récidive de pneumonie
    E.5.1.1Timepoint(s) of evaluation of this end point
    day 28
    jour 28
    E.5.2Secondary end point(s)
    1) Rate of all-cause mortality
    2) Rate of treatment failure
    3) Rate of new episode of VAP
    4) Number of antibiotic free alive-days from initiation of VAP antibiotic therapy to day 28
    5) Global score constructed with the DOOR and RADAR. Overall clinical outcome at day 28, from most to least desirable are:
    1. Survival, clinical cure, no adverse events
    2. Survival, clinical cure, antibiotic related side effects
    3.Survival, clinical cure, subsequent extrapulmonary infection
    4. Survival, clinical cure, subsequent new episode of VAP
    5. Death
    6) Duration of invasive MV, at day 28 after inclusion, defined as total of days under MV
    7) Length of ICU stay at day 28 after inclusion, defined by the number of days between inclusion and ICU discharge or in-ICU death.
    8) Rate of VAP recurrence by the intensivist at day 28
    9) Rate of antibiotic related side effects
    10) Rate of acquisition of MDR bacteria at day 28 defined as the identification of a MDR bacteria carriage not present at admission
    11) Rate of death at days 28 and 90 at day 28
    12) Rate of non-interruption of antibiotic therapy despite a positive clinical cure in the intervention group only at day 28 after inclusion.
    13) Total cumulative costs of antibiotics at day 28 and incremental cost effectiveness ratio
    1) Taux de mortalité toutes causes
    2) Taux d'échec du traitement
    3) Taux de nouvel épisode de VAP
    4) Nombre de jours vivants sans antibiotique entre le début de l'antibiothérapie et le 28e jour
    5) Score global construit avec le DOOR et le RADAR. Les résultats cliniques globaux au jour 28, du plus au moins souhaitable sont:
    a) Survie, guérison clinique, aucun événement indésirable
    b) Survie, guérison clinique, effets secondaires liés aux antibiotiques
    c) survie, guérison clinique, infection extrapulmonaire ultérieure
    d) Survie, guérison clinique, nouvel épisode ultérieur de PAV
    e) Décès
    6) Durée de la MV invasive, au jour 28 après l'inclusion, définie comme le total des jours sous MV
    7) Durée du séjour en soins intensifs au jour 28 après l'inclusion, définie par le nombre de jours entre l'inclusion et la sortie des soins intensifs ou le décès en soins intensifs.
    8) Taux de récidive de la VAP au jour 28
    9) Taux d'effets secondaires liés aux antibiotiques
    10) Taux d'acquisition de bactéries MDR au jour 28 défini comme l'identification d'un portage de bactéries MDR non présent à l'admission
    11) Taux de mortalité aux jours 28 et 90
    12) Taux de non-interruption de l'antibiothérapie malgré une guérison clinique positive dans le groupe d'intervention au jour 28 après l'inclusion.
    13) Coûts cumulatifs totaux des antibiotiques au jour 28 et rapport coût-efficacité
    E.5.2.1Timepoint(s) of evaluation of this end point
    day 90
    jour 90
    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 No
    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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    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 Yes
    E.8.2.3.1Comparator description
    compararaison deux stratégies de prise en charge du traitement de la pneumonie
    comparing two management strategies of treatment of pneumonia
    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 concerned24
    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
    last visite last patient
    dernière visite dernier patient
    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 months3
    E.8.9.1In the Member State concerned days15
    E.8.9.2In all countries concerned by the trial months3
    E.8.9.2In all countries concerned by the trial days15
    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: 590
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 590
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2022-01-18. Yes
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women Yes
    F.3.3.4Nursing women Yes
    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
    The study take place in intensive care. if the patient is unable to give the consent. The legal representative swill be infored and his consent will be asked. In absence of a legal rerentative, the pateint may be included in emergency procedure
    l'étude est réanimation. si un patient est incapble de donner son consentent, nous deanderons le consentement du proche. en son absence le pateint sera inclus selon la procédure d'urgence.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state590
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 590
    F.4.2.2In the whole clinical trial 590
    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)
    standard care
    soin standard
    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 Decision2021-08-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-04-27
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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