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    Summary
    EudraCT Number:2017-003829-15
    Sponsor's Protocol Code Number:AID-ICU
    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:2019-12-02
    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 number2017-003829-15
    A.3Full title of the trial
    Agents Intervening against Delirium in the Intensive Care Unit (AID-ICU)
    Agentes que intervienen contra el delirium en las unidades de cuidados intensivos (AID-ICU)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Pharmacological treatment of organic psychosis in critically ill adults
    Agentes que intervienen contra el delirium en las unidades de cuidados intensivos (AID-ICU)
    A.3.2Name or abbreviated title of the trial where available
    AID-ICU
    A.4.1Sponsor's protocol code numberAID-ICU
    A.5.4Other Identifiers
    Name:ClinicalTrials.govNumber:NCT03392376
    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 SponsorZealand University Hospital
    B.1.3.4CountryDenmark
    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 supportInnovations Fund Denmark
    B.4.2CountryDenmark
    B.4.1Name of organisation providing supportZealand University Hospital
    B.4.2CountryDenmark
    B.4.1Name of organisation providing supportThe Regions medicine foundation
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationInstitut de Recerca Biomèdica de Lleida (IRBLleida)
    B.5.2Functional name of contact pointCristina Casas Pi
    B.5.3 Address:
    B.5.3.1Street AddressAlcalde Rovire Roure, 80
    B.5.3.2Town/ cityLleida
    B.5.3.3Post code25198
    B.5.3.4CountrySpain
    B.5.4Telephone number+34973705236
    B.5.6E-mailccasas@irblleida.cat
    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 Haloperidol
    D.2.1.1.2Name of the Marketing Authorisation holderJanssen-Cilag A/S
    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.3.4Pharmaceutical form Injection
    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 INNHaloperidol/Serenase
    D.3.9.1CAS number 52-86-8
    D.3.9.3Other descriptive nameHALOPERIDOL
    D.3.9.4EV Substance CodeSUB08005MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboInjection
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Treatment of delirium in critically ill adult patients in intensive care unit.
    Tratamiento del Delirium para pacientes críticos de la Unidad de Cuidados Intensivos
    E.1.1.1Medical condition in easily understood language
    Treatment of psychosis related to critical illness in adult patients admitted to intensive care unit
    Tratamiento de la psicosis relacionada con enfermedades críticas en pacientes adultos ingresados en la unidad de cuidados intensivos
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10000702
    E.1.2Term Acute delirium
    E.1.2System Organ Class 100000004873
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10013758
    E.1.2Term Drug-induced delirium
    E.1.2System Organ Class 100000004873
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10042275
    E.1.2Term Subacute delirium
    E.1.2System Organ Class 100000004873
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level LLT
    E.1.2Classification code 10012220
    E.1.2Term Delirium due to a general medical condition
    E.1.2System Organ Class 100000004873
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level LLT
    E.1.2Classification code 10012226
    E.1.2Term Delirium, cause unknown
    E.1.2System Organ Class 100000004873
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10050233
    E.1.2Term Delirium on emergence
    E.1.2System Organ Class 100000004863
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level LLT
    E.1.2Classification code 10071313
    E.1.2Term Hypoactive delirium
    E.1.2System Organ Class 100000004873
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level LLT
    E.1.2Classification code 10071314
    E.1.2Term Hyperactive delirium
    E.1.2System Organ Class 100000004873
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level LLT
    E.1.2Classification code 10071315
    E.1.2Term Mixed delirium
    E.1.2System Organ Class 100000004873
    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 benefits and harms of haloperidol in adult, critically ill patients with delirium in the ICU. The primary objective is to determine, if haloperidol treatment in ICU patients with delirium will increase the number of days alive out of the hospital within 90 days. This primary objective includes 90 days mortality and length of hospital stay within 90 days after randomisation.
    Evaluar los beneficios y los daños del haloperidol en pacientes adultos con enfermedades graves con delirio en la UCI. El objetivo principal es determinar si el tratamiento con haloperidol en pacientes de la UCI con delirio aumentará el número de días vivos fuera del hospital dentro de los 90 días. Este objetivo primario incluye 90 días de mortalidad y la duración de la estancia hospitalaria dentro de los 90 días posteriores a la asignación al azar.
    E.2.2Secondary objectives of the trial
    To investigate if haloperidol as compared with placebo in ICU patients with delirium will change the:
    - Number of days alive without delirium or coma in the ICU
    - Number of patients with one or more adverse reactions and/or the total number of adverse reactions to haloperidol compared with placebo.
    - Number of patients needing one or more doses of escape medicine and or the dosages of escape medicine per patient in the haloperidol Group compared with the placebo group
    - Number of days alive without mechanical ventilation in the 90-day trial period
    - One-year mortality after inclusion
    - Measurement of cognitive function one year after inclusion on selected trial sites.
    - A health economic analysis will be performed.
    Para investigar si el haloperidol en comparación con el placebo en pacientes de UCI con delirio cambiará:
    - Número de días de vida sin delirio o coma en la UCI
    - Número de pacientes con una o más reacciones adversas y / o el número total de reacciones adversas al haloperidol en comparación con placebo.
    - Número de pacientes que necesitan una o más dosis de medicamento de escape y / o las dosis de medicamento de escape por paciente en el grupo de haloperidol en comparación con el grupo de placebo
    - Número de días de vida sin ventilación mecánica en el período de prueba de 90 días.
    - Mortalidad a un año después de la inclusión.
    - Medición de la función cognitiva un año después de la inclusión en sitios de prueba seleccionados.
    - Se realizará un análisis económico de salud.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Acute admission to the ICU AND
    - Age ≥ 18 years AND
    - Diagnosed delirium with a validated screening tool as either CAM-ICU or ICDSC.
    - Ingresados Agudos en la UCI (Unidad de Cuidados Intensivos)
    - Edad ≥ 18 años
    - Delirium diagnosticado con una escala validada como CAM-ICU o ICDSC.
    E.4Principal exclusion criteria
    - Contraindications to haloperidol
    - Habitual treatment with any antipsychotic medication
    - Permanently incompetent (e.g. dementia, mental retardation)
    - Delirium assessment non-applicable (coma or language barriers)
    - Withdrawal from active therapy or brain death
    - Fertile women (women < 50 years) with positive urine human chorionic gonadotropin (hCG) or plasma-hCG
    - Consent according to national regulations not obtainable
    - Patients under coercive measures by regulatory authorities
    - Patients with alcohol-induced delirium (delirium tremens)
    - Contraindicaciones de Haloperidol
    - Tratamiento habitual con cualquier mediación antipsicótica
    - Incompetencia permanente (demencia, retraso mental)
    - Evaluación del delirio no aplicable (coma o barreras del idioma)
    - Retirada por terapia activa o muerte cerebral
    - Mujeres fértiles (mujeres <50 años) con gonadotropina coriónica humana (hCG) o plasma-hCG en orina positivas.
    - No obtención del Consentimiento de acuerdo con la normativa nacional
    - Pacientes bajo medidas coercitivas por autoridades reguladoras
    - Pacientes con delirio inducido por alcohol (delirium tremens)
    E.5 End points
    E.5.1Primary end point(s)
    Days alive out of the hospital within 90 days post-randomisation
    Días vivos fuera del hospital dentro de los 90 días posteriores a la aleatorización
    E.5.1.1Timepoint(s) of evaluation of this end point
    90 days post-randomisation
    90 días después de randomización
    E.5.2Secondary end point(s)
    1. Number of days alive without delirium and coma in the ICU
    2. Number of patients with one or more serious adverse reactions to haloperidol and total number of serious adverse reactions to haloperidol
    3. Usage of escape medicine and dosage of escape medicine per patient
    4. Number of days alive without mechanical ventilation in the 90-day period
    5. 1-year mortality post-randomisation
    6. EQ-5D-5L and EQ-VAS one year after randomisation. Patients who have died will be assigned the lowest possible EQ-5D-5L and EQ-VAS score.
    7. Cognitive function 1-year after randomisation as assessed using RBANS score at selected sites.
    8. A health economic analysis will be performed. The analytic details will be based on the result of the trial and specified (cost-effectiveness vs. cost-minimisation analyses). Outcomes will be one-year mortality and Quality adjusted Life Years (QALYs). The latter will be conducted on the basis of Eq-5D-5L. The inclusion of QALYs generates a cost-utility analysis.
    1. Número de días de vida sin delirio y coma en la UCI
    2. Número de pacientes con una o más reacciones adversas graves al haloperidol y número total de reacciones adversas graves al haloperidol
    3. Uso de medicamento de escape y dosis de medicamento de escape por paciente
    4. Número de días vivos sin ventilación mecánica en el período de 90 días.
    5. Mortalidad al año después de la aleatorización
    6. EQ-5D-5L y EQ-VAS un año después de la asignación al azar. A los pacientes que hayan fallecido se les asignará el puntaje EQ-5D-5L y EQ-VAS más bajo posible.
    7. Función cognitiva 1 año después de la asignación al azar, evaluada mediante la puntuación RBANS en los sitios seleccionados.
    8. Se realizará un análisis económico de salud. Los detalles analíticos se basarán en el resultado del ensayo y se especificarán (análisis de costo-efectividad versus análisis de minimización de costos). Los resultados serán la mortalidad a un año y los años de vida ajustados por calidad (AVAC). Este último se llevará a cabo sobre la base de Eq-5D-5L. La inclusión de AVAC genera un análisis de costo-utilidad.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Endpoint number 1-4: 90 days post-randomisation
    Endpoint number 5-8: 1 year post-randomisation
    Punto final número 1-4: 90 días después de la aleatorización
    Punto final número 5-8: 1 año después de la asignación al azar
    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 Yes
    E.6.5Efficacy Yes
    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 No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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 Yes
    E.8.2.3Other No
    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 Yes
    E.8.5.1Number of sites anticipated in the EEA30
    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
    Denmark
    Finland
    France
    Italy
    Norway
    Spain
    Sweden
    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
    1 year post-randomisation of the last included patient in the trial
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years3
    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: 200
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 800
    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 2019-12-02. Yes
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    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
    Patients (ICU patients) with delirium are temporarily incompetent (it is the hallmark of delirium), to investigate the treatment of this condition we need to enroll patients without consent. Consent will be obtained according to national law.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state200
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 850
    F.4.2.2In the whole clinical trial 1000
    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
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation Scandinavian Critical Care Trials Group
    G.4.3.4Network Country Denmark
    G.4 Investigator Network to be involved in the Trial: 2
    G.4.1Name of Organisation Copenhagen Trial Unit
    G.4.3.4Network Country Denmark
    G.4 Investigator Network to be involved in the Trial: 3
    G.4.1Name of Organisation Centre for Research in Intensive Care (CRIC)
    G.4.3.4Network Country Denmark
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2020-02-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-02-24
    P. End of Trial
    P.End of Trial StatusOngoing
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