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    The EU Clinical Trials Register currently displays   43871   clinical trials with a EudraCT protocol, of which   7290   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:2016-004056-29
    Sponsor's Protocol Code Number:FFIS/2016/01/NORM
    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:2017-10-20
    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 number2016-004056-29
    A.3Full title of the trial
    Clinical trial phase IV randomized controlled to study the influence of temperature control in patients with septic shock
    Ensayo clínico controlado aleatorizado en fase IV para estudiar el efecto en el control de la temperatura en pacientes con shock séptico.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    study of the influence of temperature control in patients with septic shock
    Ensayo clínico para estudiar el efecto en el control de la temperatura en pacientes con shock séptico.
    A.3.2Name or abbreviated title of the trial where available
    NORMOTERMIA
    A.4.1Sponsor's protocol code numberFFIS/2016/01/NORM
    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 SponsorFundación para la Formación e Investigación Sanitaria
    B.1.3.4CountrySpain
    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 supportFFIS
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationFundación para la Formación e Investigación
    B.5.2Functional name of contact pointSponsor
    B.5.3 Address:
    B.5.3.1Street AddressCalle Luis Fontes Pagán 9, 1 planta
    B.5.3.2Town/ cityMurcia
    B.5.3.3Post code30003
    B.5.3.4CountrySpain
    B.5.4Telephone number34968359763
    B.5.5Fax number34968359777/381289
    B.5.6E-maillola.serna@carm.es
    D. IMP Identification
    D.IMP: 1
    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.2.1.2Country 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 nameNA
    D.3.2Product code NA
    D.3.4Pharmaceutical form Solution for infusion
    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 INNPARACETAMOL
    D.3.9.1CAS number 103-90-2
    D.3.9.2Current sponsor codeN/A
    D.3.9.3Other descriptive namePARACETAMOL
    D.3.9.4EV Substance CodeSUB09611MIG
    D.3.10 Strength
    D.3.10.1Concentration unit g gram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number4
    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.2.1.2Country 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 Solution for infusion
    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 INNMETAMIZOLE
    D.3.9.1CAS number 50567-35-6
    D.3.9.2Current sponsor codeN/A
    D.3.9.4EV Substance CodeSUB03187MIG
    D.3.10 Strength
    D.3.10.1Concentration unit g gram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number6
    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
    septic shock
    shock séptico
    E.1.1.1Medical condition in easily understood language
    septic shock
    shock séptico
    E.1.1.2Therapeutic area Diseases [C] - Bacterial Infections and Mycoses [C01]
    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
    To study the effect of temperature control at 36º by external devices (medical device) on mortality in patients with septic shock
    Estudiar el efecto del control de la temperatura a 36º mediante dispositivos externos (producto sanitario) sobre la mortalidad en pacientes con shock séptico
    E.2.2Secondary objectives of the trial
    - Evaluate the effect of temperature control on the inflammatory response in septic shock, compared to the control by usual ICU methods.
    - Analyze the influence of temperature control on the incidence of multiorgan failure.
    - Evaluate biochemical, immunological and coagulation biomarkers, which allow us to predict clinical events and monitor the response to the two types of treatments.
    - Evaluar el efecto del control de la temperatura sobre la respuesta inflamatoria en el shock séptico, comparada con el control por métodos habituales en UCI.
    - Analizar la influencia del control de la temperatura sobre la incidencia de fallo multiorgánico.
    - Evaluar biomarcadores bioquímicos, inmunológicos y de coagulación, que nos permitan predecir eventos clínicos y monitorizar la respuesta a los dos tipos de tratamientos.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Patients older than 18 years who enter the ICU with a diagnosis of septic shock or develop it during their stay (first episode)
    - Possibility of inclusion in the study in the first 12 hours after the diagnosis of septic shock.
    - Provision of survival and stay in ICU > = of 48 hours.
    - Signature of informed consent by the patient or relatives
    - Pacientes mayores de 18 años que ingresen en UCI con diagnóstico de shock séptico o que lo desarrollen durante su estancia (primer episodio)
    - Posibilidad de inclusión en el estudio en las primeras 12 horas tras el diagnóstico de shock séptico.
    - Previsión de supervivencia y de estancia en UCI >= de 48 horas.
    - Firma del consentimiento informado por parte del paciente o familiares
    E.4Principal exclusion criteria
    - Patients younger than 18 years.
    - Patients with any of the following assumptions: pregnancy or breastfeeding, active bleeding, congenital coagulopathy, major surgery in the previous 24 hours or terminal illness (life expectancy <6 months).
    - Patient large burned, subjected to major surgery or any other assumption that prevents the placement of patches on the affected surface.
    - Patients immunosuppressed for any cause (treatment with corticosteroids, immunosuppression after transplantation, etc.) or with a known immunodeficiency.
    - Patients allergic to Paracetamol and / or Metamizole.
    - Absence of the signature of informed consent by the patient or relatives or refusal to participate in the study.
    - The patient is participating in another clinical trial.
    - Any other reason that the researcher considers.
    - Pacientes menores de 18 años.
    - Pacientes que presenten alguno de los siguientes supuestos: embarazo o lactancia, sangrado activo, coagulopatía congénita, cirugía mayor en las 24 horas previas o enfermedad terminal (expectativa de vida < 6 meses).
    - Paciente gran quemado, sometido a cirugía mayor amplia o cualquier otro supuesto que impida la colocación de los parches en la superficie afectada.
    - Pacientes inmunodeprimidos por cualquier causa (tratamiento con corticoides, inmunosupresión tras trasplante, etc.) o con una inmunodeficiencia conocida.
    - Pacientes alérgicos a Paracetamol y/o Metamizol.
    - Ausencia de la firma del consentimiento informado por parte del paciente o familiares o negativa a participar en el estudio.
    - Que el paciente esté participando en otro ensayo clínico.
    - Cualquier otro motivo que el investigador considere.
    E.5 End points
    E.5.1Primary end point(s)
    Short-term and long-term mortality in follow-up
    Mortalidad a corto y largo plazo en el seguimiento
    E.5.1.1Timepoint(s) of evaluation of this end point
    During hospital admission and at 6 months
    Durante el ingreso hospitalario y a los 6 meses
    E.5.2Secondary end point(s)
    Inflammatory response measured by different analytical data and the occurrence of organic failure
    Respuesta inflamatoria medida mediante diferentes datos analíticas y la aparición de fallo orgánico
    E.5.2.1Timepoint(s) of evaluation of this end point
    During the hospital admission
    Durante el ingreso hospitalario
    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 Yes
    E.6.13.1Other scope of the trial description
    Immune response
    Respuesta inmune
    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) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Producto Sanitario
    Medical Device
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    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 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
    LVLS
    Ultima visita del último sujeto reclutado
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days
    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: 86
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 15
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    For its clinical situation
    Debido a su sitación clínica
    F.3.3.7Others Information not present in EudraCT
    F.4 Planned number of subjects to be included
    F.4.1In the member state86
    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
    Ninguna
    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 Decision2017-12-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-11-27
    P. End of Trial
    P.End of Trial StatusOngoing
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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