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    The EU Clinical Trials Register currently displays   43977   clinical trials with a EudraCT protocol, of which   7312   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:2020-001324-33
    Sponsor's Protocol Code Number:APHP200392
    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:2020-03-29
    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 number2020-001324-33
    A.3Full title of the trial
    Use of a respiratory multiplex PCR and procalcitonin to reduce antibiotic exposure in patients with severe confirmed COVID-19 pneumonia : a multicenter, parallel-group, open-label, randomized controlled trial
    Utilisation d’une PCR MULTIplex respiratoire et de la procalcitonine pour réduire l’exposition aux antibiotiques au cours de la pneumonie grave à COVID-19 : un essai contrôlé randomisé, en ouvert, en groupes parallèles, multicentrique
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Use of a respiratory multiplex PCR and procalcitonin to reduce antibiotic exposure in patients with severe confirmed COVID-19 pneumonia
    Utilisation d’une PCR MULTIplex respiratoire et de la procalcitonine pour réduire l’exposition aux antibiotiques au cours de la pneumonie grave confirmée à COVID-19
    A.3.2Name or abbreviated title of the trial where available
    MULTI-COV
    A.4.1Sponsor's protocol code numberAPHP200392
    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 (APHP)
    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 supportAP-HP
    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 (AP-HP)
    B.5.2Functional name of contact pointPôle Promotion - DRCI
    B.5.3 Address:
    B.5.3.1Street AddressHôpital St Louis, 1 av Claude Vellefaux
    B.5.3.2Town/ cityPARIS
    B.5.3.3Post code75010
    B.5.3.4CountryFrance
    B.5.4Telephone number+33144841764
    B.5.5Fax number+33144841701
    B.5.6E-mailaurelie.zindjirdjian@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 Antimicrobial therapy (antibiotics)
    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
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    Oral use
    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
    Severe confirmed COVID-19 pneumonia
    Pneumonie sévère confirmée à COVID-19
    E.1.1.1Medical condition in easily understood language
    Severe confirmed COVID-19 pneumonia
    Pneumonie sévère confirmée à COVID-19
    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 20.0
    E.1.2Level LLT
    E.1.2Classification code 10051905
    E.1.2Term Coronavirus infection
    E.1.2System Organ Class 100000004862
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the efficacy of a management strategy combining a broad panel respiratory mPCR and an algorithm of early antibiotic de-escalation and discontinuation based on both the mPCR results and the procalcitonin, on antibiotics exposure, as compared with a conventional strategy, in severe confirmed COVID-19 pneumonia.
    Evaluer l’efficacité d’une stratégie combinant une PCR multiplex respiratoire FA-PPP et un algorithme de désescalade et d’interruption précoces de l’antibiothérapie basée sur le résultat de la mPCR et sur le dosage de la procalcitonine, sur la durée d’exposition aux antibiotiques, en comparaison à une stratégie conventionnelle au cours de la pneumonie sévère COVID-19.
    E.2.2Secondary objectives of the trial
    Mortality rates at 28 (D28) and 90 days (D90);
    - Overall antibiotics use, including broad- and narrow-spectrum antibiotics;
    - Total exposure to antibiotics at D28;
    - Number of organ-failure free days at D28;
    - Incidence rates of bacterial super-infections and colonization/infection with resistant pathogens at D28;
    - ICU and hospital lengths of stay;
    - Quality of life at D90.
    Comparer l’efficacité et la sécurité de la stratégie interventionnelle et de la stratégie contrôle, en terme de :
    - Mortalité à 28 et 90 jours;
    - Utilisation des Antibiotiques, incluant les antibiotiques à spectre étroit et large;
    - Exposition totale aux antibiotiques à 28 jours;
    - Défaillances d’organes à 28 jours;
    -Incidence des surinfections bactériennes et des colonisations/infections à bactéries multi/hautement résistantes à 28 jours;
    - Durée de séjour en réanimation et à l’hôpital;
    - Qualité de vie à 90 jours.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Adults (>= 18 years) admitted to the ICU;
    - Severe confirmed COVID-19 pneumonia, defined by i) a newly-appeared pulmonary parenchymal infiltrate; and ii) a positive RT-PCR (either upper or lower respiratory tract) for COVID-19 (SARS-CoV-2); iii) and admission to the ICU or intermediate care unit;
    - Informed consent or emergency procedure.
    - Adults (>= 18 years) admitted to the ICU;
    - Severe confirmed COVID-19 pneumonia, defined by i) a newly-appeared pulmonary parenchymal infiltrate; and ii) a positive RT-PCR (either upper or lower respiratory tract) for COVID-19 (SARS-CoV-2); iii) and admission to the ICU or intermediate care unit;
    - Informed consent or emergency procedure.
    E.4Principal exclusion criteria
    - Pregnancy and breastfeeding women ;
    - Congenital immunodeficiency;
    - HIV infection with CD4 count below 200/mm3 or unknown in the last year;
    - High-grade hematological malignancy;
    - Neutropenia (<1 leucocyte/mL or < 0.5 neutrophil/mL);
    - Immunosuppressive drugs within the previous 30 days, including anti-cancer cytotoxic chemotherapy and anti-rejection drugs for organ/bone marrow transplant;
    - Moribund patient or death expected from underlying disease during the current admission;
    - Patient deprived of liberty or under legal protection measure.
    Femmes enceintes ou allaitantes ;
    - Immunodépression congénitale ;
    - Infection par le VIH avec un taux de CD4 inférieur à 200 / mm3 ou inconnu au cours de la dernière année;
    - Hémopathie maligne de haut grade évolutive ;
    - Neutropénie (<1 leucocyte/mL or < 0.5 neutrophil/mL);
    - Traitement immunosuppresseur au cours des 30 jours précédents, incluant la chimiothérapie anticancéreuse cytotoxique et les médicaments anti-rejet chez le greffé d'organe solide ou de moelle ;
    - Patient moribond ou décès imminent lié à une maladie préalable ;
    - Personne privée de liberté ou sous protection juridique.
    E.5 End points
    E.5.1Primary end point(s)
    The primary assessment criterion is the number of antibiotic free days at D28, which corresponds to the number of days alive without any antibiotic at Day 28. The D28 time point is usual in studies assessing antibiotic use in ICU patients.
    Nombre de jours vivant sans antibiotique à J28.
    E.5.1.1Timepoint(s) of evaluation of this end point
    D28
    J28
    E.5.2Secondary end point(s)
    The secondary assessment criteria are:
    - Mortality rates at D28 and D90;
    - Number of defined daily dose (DDD) per 100 patient-days of broad- and narrow-spectrum antibiotics;
    - Antibiotics duration at D28;
    - Number of organ-failure free days (based on SOFA) at D28;
    - Incidence rates of bacterial super-infections at D28;
    Incidence rates of colonization/infection with multidrug resistant bacteria and Clostridium difficile infections at D28;
    - ICU and hospital lengths of stay;
    - Quality of life at D90, assessed using a quality of life questionnaire (EQ5D5L).
    - Taux de mortalité à 28 et 90 jours;
    - Nombre de defined daily dose (DDD) pour 100 patients-jours pour les antibiotiques à spectres étroit et large;
    - Nombre de jours d’exposition aux antibiotiques à 28 jours ;
    - Nombre de jours sans défaillance d’organe (basé sur SOFA)
    à 28 jours;
    - Incidence des surinfections bactériennes à 28 jours;
    -Incidence des colonisations/infections à bactéries multi/hautement résistantes et à C. difficile à 28 jours ;
    - Durée de séjour en réanimation et à l’hôpital
    - Qualité de vie à J90, évaluée à l'aide d'un questionnaire sur la qualité de vie (EQ5D5L).
    E.5.2.1Timepoint(s) of evaluation of this end point
    D28 and D90
    J28 et J90
    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 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) No
    E.7.4Therapeutic use (Phase IV) Yes
    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
    Stratégie conventionnelle
    Conventional strategy
    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 concerned20
    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
    Dernière visite de suivi du dernier patient
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months6
    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.1.2.1Number of subjects for this age range: 97
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 97
    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 Yes
    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
    The next-of-kin gives his consent if the patient is unable to express his will (USC).
    In his absence, inclusion with the emergency procedure: the next-of-kin and the patient give their consent as soon as possible.
    La personne de confiance donne son consentement si le patient n'est pas en état de consentir (patient en réanimation).
    En son absence, procédure d'inclusion en urgence: la personne de confiance donnera son consentement dès que possible.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state194
    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 Decision2020-04-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-04-09
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2021-02-02
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