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    Summary
    EudraCT Number:2015-002340-14
    Sponsor's Protocol Code Number:REMAP-CAP
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2020-02-24
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2015-002340-14
    A.3Full title of the trial
    Randomized, Embedded, Multifactorial, Adaptive Platform trial for Community-Acquired Pneumonia (REMAP-CAP)
    Ensayo aleatorizado, integrado, multifactorial, plataforma adaptativa para la neumonía adquirida en la comunidad (REMAP-CAP)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Adaptive trial in severe pneumonia (REMAP-CAP)
    Ensayo adaptativo en neumonía severa (REMAP-CAP)
    A.3.2Name or abbreviated title of the trial where available
    REMAP-CAP
    A.4.1Sponsor's protocol code numberREMAP-CAP
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02735707
    A.5.3WHO Universal Trial Reference Number (UTRN)U1111-1189-1653
    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 SponsorUniversity Medical Center Utrecht
    B.1.3.4CountryNetherlands
    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 supportFP7-HEALTH-2013-INNOVATION-1
    B.4.2CountryEuropean Union
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity Medical Center Utrecht, Julius Centrum UMCU
    B.5.2Functional name of contact pointW.W. van Bentum-Puijk
    B.5.3 Address:
    B.5.3.1Street AddressUniversiteitsweg 100
    B.5.3.2Town/ cityUtrecht
    B.5.3.3Post code3584
    B.5.3.4CountryNetherlands
    B.5.4Telephone number+31(0)8875 55196
    B.5.6E-mailw.w.puijk-2@umcutrecht.nl
    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.2.1.2Country which granted the Marketing AuthorisationSpain
    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 nameLEVOFLOXACIN
    D.3.4Pharmaceutical form
    D.3.4.1Specific paediatric formulation No
    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 INNLEVOFLOXACIN
    D.3.9.1CAS number CAS 138199-7
    D.3.9.4EV Substance CodeSUB21640
    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 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.2.1.2Country which granted the Marketing AuthorisationSpain
    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 nameHYDROCORTISONE
    D.3.4Pharmaceutical form
    D.3.4.1Specific paediatric formulation No
    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 INNHYDROCORTISONE
    D.3.9.1CAS number 50-23-7
    D.3.9.4EV Substance CodeSUB08065MIG
    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) Yes
    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: 3
    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.2.1.2Country which granted the Marketing AuthorisationSpain
    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 nameCEFTRIAXONE
    D.3.4Pharmaceutical form
    D.3.4.1Specific paediatric formulation No
    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 INNCEFTRIAXONE
    D.3.9.1CAS number 73384-59-5
    D.3.9.4EV Substance CodeSUB07431MIG
    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) Yes
    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: 4
    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.2.1.2Country which granted the Marketing AuthorisationSpain
    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 nameAZITHROMYCIN
    D.3.4Pharmaceutical form
    D.3.4.1Specific paediatric formulation No
    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 INNAZITHROMYCIN
    D.3.9.1CAS number 83905-01-5
    D.3.9.4EV Substance CodeSUB05660MIG
    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: 5
    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.2.1.2Country which granted the Marketing AuthorisationSpain
    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 nameCLARITHROMYCIN
    D.3.4Pharmaceutical form
    D.3.4.1Specific paediatric formulation No
    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 INNCLARITHROMYCIN
    D.3.9.1CAS number 81103-11-9
    D.3.9.3Other descriptive nameCLARITHROMYCIN LACTOBIONATE
    D.3.9.4EV Substance CodeSUB20333
    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: 6
    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.2.1.2Country which granted the Marketing AuthorisationSpain
    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 nameERYTHROMYCIN
    D.3.4Pharmaceutical form
    D.3.4.1Specific paediatric formulation No
    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 INNERYTHROMYCIN
    D.3.9.1CAS number 3847-29-8
    D.3.9.4EV Substance CodeSUB01944MIG
    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: 7
    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.2.1.2Country which granted the Marketing AuthorisationSpain
    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-CLAVULANTE
    D.3.4Pharmaceutical form
    D.3.4.1Specific paediatric formulation No
    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 INNAMOXICILLIN
    D.3.9.1CAS number 34642-77-8
    D.3.9.4EV Substance CodeSUB00503MIG
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPOTASSIUM CLAVULANATE
    D.3.9.1CAS number 61177-45-5
    D.3.9.4EV Substance CodeSUB12232MIG
    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) Yes
    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: 8
    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.2.1.2Country which granted the Marketing AuthorisationSpain
    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 nameMOXIFLOXACIN
    D.3.4Pharmaceutical form
    D.3.4.1Specific paediatric formulation No
    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 INNMOXIFLOXACIN
    D.3.9.1CAS number 186826-86-8
    D.3.9.3Other descriptive nameMOXIFLOXACIN HYDROCHLORIDE
    D.3.9.4EV Substance CodeSUB03342MIG
    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: 9
    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 Oseltamivir
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Registration GmbH Emil-Barell-Strasse 1 79639 Grenzach-Wyhlen Germany
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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 nameoseltamivir phosphate
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPEnteral use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNOSELTAMIVIR
    D.3.9.1CAS number 204255-11-8
    D.3.9.3Other descriptive nameOSELTAMIVIR PHOSPHATE
    D.3.9.4EV Substance CodeSUB12544MIG
    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 Community Acquired Pneumonia
    Neumonía severa adquirida en la comunidad
    E.1.1.1Medical condition in easily understood language
    Severe Pneumonia
    Neumonía severa
    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 20.1
    E.1.2Level LLT
    E.1.2Classification code 10010120
    E.1.2Term Community acquired pneumonia
    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
    The primary objective of this REMAP is, for adult patients with severe CAP who are admitted to an ICU, to identify the effect of a range of interventions to improve outcome as defined by the occurrence of death during the index hospital admission censored 90 days from the date of enrolment.
    El objetivo principal de este estudio para los pacientes adultos con neumonía severa adquirida en la comunidad que ingresan en una UCI, es identificar el efecto de una variedad de intervenciones para mejorar el resultado según lo definido por la ocurrencia de muerte durante el índice de ingreso hospitalario medido a los 90 días de la fecha de reclutamiento.
    E.2.2Secondary objectives of the trial
    The secondary objectives are to determine, for adult patients with severe CAP who are admitted to an ICU, the effect of interventions on ICU mortality, ICU length of stay (LOS), hospital LOS, ventilator free days (VFDs) censored at 28 days, organ failure free days (OFFDs) censored at 28 days, other endpoints as indicated for specific domains, and, where feasible or specified in a DSA, survival at 6 months, health related quality of life (HRQoL) assessed after 6 months using the EQ5D and disability assessed after 6 months using the World Health Organization Disability Assessment Schedule (WHODAS).
    Los objetivos secundarios son determinar, para los pacientes adultos con neumonía severa adquirida en la comunidad que ingresan en una UCI, el efecto de las intervenciones sobre la mortalidad en la UCI, la duración de la estancia en la UCI (LOS), la LOS hospitalaria, los días sin ventilación (VFD) medido a los 28 días, días libres de fallo orgánico (OFFD) medido a los 28 días, otras variables indicadas para dominios específicos y, cuando sea factible o especificado en un DSA, la supervivencia a los 6 meses, la calidad de vida relacionada con la salud (CVRS) evaluada después de 6 meses con el EQ5D y discapacidad evaluada después de 6 meses usando el Programa de Evaluación de Discapacidad de la Organización Mundial de la Salud (WHODAS).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    General REMAP-CAP Inclusion Criteria:
    1. Adult patient admitted to an ICU for acute severe CAP within 48 hours of hospital admission with
    a. symptoms or signs or both that are consistent with lower respiratory tract infection (for example, acute onset of dyspnea, cough, pleuritic chest pain) AND
    b. Radiological evidence of new onset infiltrate of infective origin (in patients with pre-existing radiological changes, evidence of new infiltrate)
    2. Up to 48 hours after ICU admission, receiving organ support with one or more of:
    a. Non-invasive or invasive ventilatory support;
    b. Receiving infusion of vasopressor or inotropes or both
    Criterios generales de inclusión REMAP-CAP:
    1. Paciente adulto ingresado en una UCI por NAC severa aguda dentro de las 48 horas posteriores al ingreso hospitalario con
    a. síntomas o signos o ambos que son consistentes con infección del tracto respiratorio inferior (por ejemplo, inicio agudo de disnea, tos, dolor torácico pleurítico) Y
    b. Evidencia radiológica de nuevo infiltrado de origen infeccioso (en pacientes con cambios radiológicos preexistentes, evidencia de nuevo infiltrado)
    2. Hasta 48 horas después de la admisión a la UCI, recibiendo apoyo de órganos con uno o más de:
    a. Soporte ventilatorio no invasivo o invasivo;
    si. Recibiendo infusión de vasopresores o inotrópicos o ambos
    E.4Principal exclusion criteria
    General REMAP-CAP Exclusion Criteria:
    1. Healthcare-associated pneumonia:
    a. Prior to this illness, is known to have been an inpatient in any healthcare facility within the last 30 days
    b. Resident of a nursing home or long-term care facility.
    2. Death is deemed to be imminent and inevitable during the next 24 hours AND one or more of the patient, substitute decision maker or attending physician are not committed to full active treatment.
    3. Previous participation in this REMAP within the last 90 days

    AB Domain Specific Exclusion Criteria

    Received more than 48 hours of IV antibiotic treatment for this index illness
    • More than 24 hours has elapsed since ICU admission
    • Known hypersensitivity to all of the study drugs in the site randomization schedule
    • A specific antibiotic choice is indicated, for example:
    o Suspected or proven concomitant infection such as meningitis
    o Suspected or proven infection with resistant bacteria where agents being trialed would not be expected to be active. This includes cystic fibrosis, bronchiectasis or other chronic suppurative lung disease where infection with Pseudomonas may be suspected but does not include patients with suspected methicillin-resistant Staphylococcus aureus (MRSA) infection (see MRSA below).
    o Febrile neutropenia or significant immunosuppression (including organ or bone marrow transplantation, human immunodeficiency virus (HIV) Infection with CD4 cell count <200 cells/μL, systemic immunosuppressive, systemic corticosteroids comprising prednisolone, or equivalent, ≥20mg/day for > 4 preceding weeks).
    o Suspected melioidosis (tropical sites during melioidosis season – see melioidosis below)
    o There is sufficient microbiological information to guide specific antibacterial therapy
    • The treating clinician believes that participation in the domain would not be in the best interests of the patient

    AB Specific Intervention Exclusion Criteria
    1. Known non-serious hypersensitivity to penicillins will result in exclusion from receiving interventions that include piperacillin and amoxicillin
    2. Known non-serious hypersensitivity to cephalosporins will result in exclusion from receiving interventions that include ceftriaxone and ceftaroline
    3. Known serious hypersensitivity to beta-lactams, including penicillins or cephalosporins, will result in exclusion from interventions that include piperacillin, amoxicillin, ceftriaxone, and ceftaroline.
    4. Known hypersensitivity to moxifloxacin or levofloxacin will result in exclusion from moxifloxacin or levofloxacin intervention
    5. Known serious hypersensitivity to the macrolide will result in exclusion from interventions that include piperacillin, amoxicillin, ceftriaxone, and ceftaroline.
    6. Known or suspected pregnancy will result in exclusion from moxifloxacin or levofloxacin and ceftaroline interventions.

    Corticosteroid domain Specific Exclusion Criteria
    • Known hypersensitivity to hydrocortisone
    • Intention to prescribe systemic corticosteroids for a reason that is unrelated to the current episode of CAP (or direct complications of CAP), such as chronic corticosteroid use before admission, acute severe asthma, or suspected or proven Pneumocystis jiroveci pneumonia
    • More than 24 hours have elapsed since ICU admission
    • The treating clinician believes that participation in the domain would not be in the best interests of the patient

    Corticosteroïde domain Intervention-Specific Exclusions Criteria: not applicable

    Macrolide duration domain Specific Exclusion Criteria
    Agreement to participate in this domain has been declined or has not been requested before the end of study day 5
    • There is microbiological confirmation or the clinician strongly suspects Legionella or any other form of atypical pneumonia
    • Macrolide antibiotics have already been discontinued for more than 36 hours
    • The treating clinician believes that participation in the domain would not be in the best interests of the patient
    Macrolide Duration Intervention-Specific Exclusions Criteria: not applicable

    Antiviral Domain specific exclusion criteria
    More than 24 hours has elapsed since Intensive Care Unit (ICU) admission
    • Known hypersensitivity to oseltamivir
    • Patient has already received two or more doses of oseltamivir or other neuraminidase inhibitors
    • Intention to commence or continue, if already commenced, an antiviral active against influenza other than oseltamivir
    • The treating clinician believes that participation in the domain would not be in the best interests of the patient

    Antiviral domain Intervention-Specific Exclusions Criteria: not applicable
    Criterios generales de exclusión de REMAP-CAP:
    1. Neumonía asociada a la asistencia sanitaria:
    a. Antes de esta enfermedad, se sabe que ha estado internado en cualquier centro de salud en los últimos 30 días.
    b. Residente de un hogar de ancianos o centro de atención a largo plazo.
    2. La muerte se considera inminente e inevitable durante las próximas 24 horas Y uno o más de los pacientes, el tomador de decisiones sustituto o el médico tratante no están comprometidos con el tratamiento activo completo.
    3. Participación previa en este REMAP dentro de los últimos 90 días.

    Criterios de exclusión específicos del dominio AB

    Recibió más de 48 horas de tratamiento antibiótico IV para esta enfermedad índice
    • Han transcurrido más de 24 horas desde la admisión en la UCI
    • Hipersensibilidad conocida a todos los medicamentos del estudio en el programa de aleatorización del sitio.
    • Se indica una elección antibiótica específica, por ejemplo:
    o Infección concomitante sospechada o comprobada, como meningitis
    o Infección sospechada o comprobada con bacterias resistentes donde no se espera que los agentes que se prueban sean activos. Esto incluye fibrosis quística, bronquiectasias u otra enfermedad pulmonar supurativa crónica en la que se puede sospechar infección con Pseudomonas, pero no se incluyen pacientes con sospecha de infección por Staphylococcus aureus resistente a meticilina (MRSA) (ver MRSA a continuación).
    o Neutropenia febril o inmunosupresión significativa (incluido el trasplante de órganos o médula ósea, infección por el virus de la inmunodeficiencia humana (VIH) con recuento de células CD4 <200 células / μL, inmunosupresores sistémicos, corticosteroides sistémicos que comprenden prednisolona o equivalente, ≥20 mg / día durante> 4 precedentes semanas).
    o Sospecha de melioidosis (sitios tropicales durante la temporada de melioidosis - ver melioidosis a continuación)
    o Existe suficiente información microbiológica para guiar la terapia antibacteriana específica.
    • El clínico tratante cree que la participación en el dominio no sería lo mejor para el paciente.

    Criterios de exclusión de intervención específica AB
    1. La hipersensibilidad no grave conocida a las penicilinas dará como resultado la exclusión de recibir intervenciones que incluyen piperacilina y amoxicilina
    2. La hipersensibilidad no grave conocida a las cefalosporinas dará como resultado la exclusión de recibir intervenciones que incluyen ceftriaxona y ceftarolina
    3. La hipersensibilidad grave conocida a los betalactámicos, incluidas las penicilinas o las cefalosporinas, dará como resultado la exclusión de intervenciones que incluyen piperacilina, amoxicilina, ceftriaxona y ceftarolina.
    4. La hipersensibilidad conocida a moxifloxacina o levofloxacina resultará en la exclusión de la intervención de moxifloxacina o levofloxacina
    5. La hipersensibilidad grave conocida al macrólido dará como resultado la exclusión de intervenciones que incluyen piperacilina, amoxicilina, ceftriaxona y ceftarolina.
    6. El embarazo conocido o sospechado dará como resultado la exclusión de las intervenciones de moxifloxacina o levofloxacina y ceftarolina.

    Criterios de exclusión específicos del dominio de corticosteroides
    • Hipersensibilidad conocida a la hidrocortisona.
    • Intención de prescribir corticosteroides sistémicos por una razón que no está relacionada con el episodio actual de CAP (o complicaciones directas de CAP), como el uso crónico de corticosteroides antes del ingreso, asma grave aguda o neumonía por Pneumocystis jiroveci sospechada o comprobada.
    • Han transcurrido más de 24 horas desde la admisión a la UCI
    • El clínico tratante cree que la participación en el dominio no sería lo mejor para el paciente.

    Dominio de corticosteroides Criterios de exclusiones específicas de intervención: no aplicable

    Dominio de duración de macrólidos Criterios de exclusión específicos
    El acuerdo para participar en este dominio se ha rechazado o no se ha solicitado antes del final del día de estudio 5
    • Hay confirmación microbiológica o el clínico sospecha fuertemente de Legionella o cualquier otra forma de neumonía atípica.
    • Los antibióticos macrólidos ya han sido descontinuados por más de 36 horas.
    • El clínico tratante cree que la participación en el dominio no sería lo mejor para el paciente.

    Duración de macrólidos Criterios de exclusión específicos de intervención: no aplicable

    Criterios de exclusión específicos del dominio antiviral
    Han transcurrido más de 24 horas desde la admisión en la Unidad de Cuidados Intensivos (UCI)
    • Hipersensibilidad conocida al oseltamivir.
    • El paciente ya recibió dos o más dosis de oseltamivir u otros inhibidores de la neuraminidasa.
    • Intención de comenzar o continuar, si ya comenzó, un antiviral activo contra la influenza que no sea oseltamivir
    • El clínico tratante cree que la participación en el dominio no sería lo mejor para el paciente.

    Criterios de exclusiones específicas de intervención del dominio antiviral: no aplicable
    E.5 End points
    E.5.1Primary end point(s)
    The primary objective of this REMAP is, for adult patients with severe CAP who are admitted to an ICU, to identify the effect of a range of interventions to improve outcome as defined by all-cause mortality at 90 days.
    El objetivo principal de este estudio es, para los pacientes adultos con NAC severa que ingresan en una UCI, identificar el efecto de una variedad de intervenciones para mejorar el resultado según lo definido por la mortalidad por todas las causas a los 90 días.
    E.5.1.1Timepoint(s) of evaluation of this end point
    90 Days from the date of enrolment.
    90 días a partir de la fecha de reclutamiento.
    E.5.2Secondary end point(s)
    The secondary objectives are to determine, for adult patients with severe CAP who are admitted to an ICU, the effect of interventions on ICU mortality, ICU length of stay (LOS), hospital LOS, ventilator free days (VFDs) censored at 28 days, organ failure free days (OFFDs) censored at 28 days, other endpoints as indicated for specific domains, and, where feasible or specified in a DSA, survival at 6 months, health related quality of life (HRQoL) assessed after 6 months using the EQ5D and disability assessed after 6 months using the World Health Organization Disability Assessment Schedule (WHODAS).
    Los objetivos secundarios son determinar, para los pacientes adultos con NAC severa que ingresan en una UCI, el efecto de las intervenciones sobre la mortalidad en la UCI, la duración de la estancia en la UCI (LOS), la LOS hospitalaria, los días sin ventilación (VFD) medidos a los 28 días, días libres de fallo orgánica (OFFD) medidos a los 28 días, otras variables indicadas para dominios específicos y, cuando sea factible o especificado en un DSA, la supervivencia a los 6 meses, la calidad de vida relacionada con la salud (CVRS) evaluada después de 6 meses con el EQ5D y discapacidad evaluada después de 6 meses usando el Programa de Evaluación de Discapacidad de la Organización Mundial de la Salud (WHODAS).
    E.5.2.1Timepoint(s) of evaluation of this end point
    The secondary objectives are to determine, for adult patients with severe CAP who are admitted to an ICU, the effect of interventions on ICU mortality, ICU length of stay (LOS), hospital LOS, ventilator free days (VFDs) censored at 28 days, organ failure free days (OFFDs) censored at 28 days, other endpoints as indicated for specific domains, and, where feasible or specified in a DSA, survival at 6 months, health related quality of life (HRQoL) assessed after 6 months using the EQ5D and disability assessed after 6 months using the World Health Organization Disability Assessment Schedule (WHODAS).
    Los objetivos secundarios son determinar, para los pacientes adultos con NAC severaque ingresan en una UCI, el efecto de las intervenciones sobre la mortalidad en la UCI, la duración de la estancia en la UCI (LOS), la LOS hospitalaria, los días sin ventilación (VFD) medidos a los 28 días, días libres de fallo orgánico (OFFD) medido a los 28 días, otras variables indicadas para dominios específicos y, cuando sea factible o especificado en un DSA, la supervivencia a los 6 meses, la calidad de vida relacionada con la salud (CVRS) evaluada después de 6 meses con el EQ5D y discapacidad evaluada después de 6 meses usando el Programa de Evaluación de Discapacidad de la Organización Mundial de la Salud (WHODAS).
    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) 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 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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial20
    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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA100
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Australia
    Belgium
    Croatia
    Czech Republic
    Denmark
    Germany
    Greece
    Hungary
    Ireland
    Netherlands
    New Zealand
    Portugal
    Romania
    Spain
    United Kingdom
    E.8.7Trial has a data monitoring committee Yes
    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 visit of the last subject undergoing the trial
    Última visita del último sujeto del estudio
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months2
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years5
    E.8.9.2In all countries concerned by the trial months4
    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: 2000
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 2000
    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 2020-02-24. Yes
    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
    Patients with severe CAP and medically unable to give consent.
    Pacientes con neumonía severa adquirida en la comunidad y médicamente incapaces de dar su consentimiento.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state60
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 4000
    F.4.2.2In the whole clinical trial 4000
    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
    Ninguno.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation COMBACTE
    G.4.3.4Network Country Netherlands
    G.4 Investigator Network to be involved in the Trial: 2
    G.4.1Name of Organisation Imperial College/ICNARC
    G.4.3.4Network Country United Kingdom
    G.4 Investigator Network to be involved in the Trial: 3
    G.4.1Name of Organisation JENA university
    G.4.3.4Network Country Germany
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2020-02-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-01-31
    P. End of Trial
    P.End of Trial StatusOngoing
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