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The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
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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).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
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    Summary
    EudraCT Number:2018-004880-29
    Sponsor's Protocol Code Number:HUB-INF-RADICAP
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2019-06-11
    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 number2018-004880-29
    A.3Full title of the trial
    Phase IV randomized, controlled, open and multicentre clinical trial with two parallel groups, to assess the impact of integral molecular tests in the antimicrobial use in community-acquired pneumonia (RADI-CAP) "
    ENSAYO CLÍNICO DE FASE IV, CON ASIGNACIÓN ALEATORIA, CONTROLADO, ABIERTO Y MULTICÉNTRICO, CON DOS GRUPOS PARALELOS, PARA EVALUAR EL IMPACTO DE LA EFICACIA DE LAS PRUEBAS MOLECULARES INTEGRALES EN EL USO DE ANTIBIOTERAPIA EN LA NEUMONIA ADQUIRIDA EN LA COMUNIDAD (RADI-CAP)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Impact of a molecular microbiology test for the diagnosis of pneumonia's cause in the use of antimicrobials
    Impacto de una prueba molecular de microbiología para el diagnóstico de la causa de la neumonía en el uso de antibióticos
    A.4.1Sponsor's protocol code numberHUB-INF-RADICAP
    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 SponsorDr. Jordi Carratalà Fernández (Servicio de Enfermedades Infecciosas) del Hospital Universitario de Bellvitge
    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 supportFundació Marató de TV3
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationDr. Gabriela Abelenda Alonso (Servicio de Enfermedades Infecciosas) Hospital Universitario de Bellvitge
    B.5.2Functional name of contact pointDr. Gabriela Abelenda Alonso
    B.5.3 Address:
    B.5.3.1Street AddressCalle Feixa Llarga, s/n
    B.5.3.2Town/ cityL'Hospitalet de Llobregat (Barcelona)
    B.5.3.3Post code08907
    B.5.3.4CountrySpain
    B.5.6E-mailgabi.abelenda.alonso@gmail.com
    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.3.4Pharmaceutical form Infusion
    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
    Community-acquired pneumonia (CAP)
    Neumonía adquirida en la comunidad (NAC)
    E.1.1.1Medical condition in easily understood language
    Patients hospitalized for community acquired pneumonia
    Pacientes hospitalizados por una Neumonía adquirida en la comunidad (NAC)
    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 PT
    E.1.2Classification code 10035664
    E.1.2Term Pneumonia
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the use of antimicrobials measured on days of antibiotic therapy (DOT) per 1000 stays in patients diagnosed with community acquired pneumonia.
    Evaluar el uso de antibioterapia medido en días de terapia antibiótica (DOT) por 1000 estancias en los pacientes con diagnóstico de NAC.
    E.2.2Secondary objectives of the trial
    Effectiveness:
    ·patients achieve clinical stability.
    ·days until clinical stability.
    ·Quantify time of intravenous antibiotic treatment until passage to the oral route.
    ·Quantify total days of antibiotic treatment.
    ·Evaluate de-escalation of antibiotic treatment to another treatment of smaller spectrum.
    ·days of oxygen therapy.
    ·days in invasive and non-invasive ventilation.
    ·need for admission to the ICU.
    ·days of hospital admission.
    ·incidence of Clostridium difficile infection during the study.
    ·incidence of phlebitis derived from the use of intravenous antimicrobials.
    ·Estimate incidence of mortality.
    ·Evaluate incidence of readmission after hospital discharge.
    ·Evaluate costs derived from the use of microbiological tests used, the antibiotics used and the hospital admission.
    Safety:
    ·Number of adverse events related to the collection of the sample or with the integral molecular test.
    ·Number of adverse events related to the CAP up to 30±5 days after discharge.
    Eficacia:
    -Cuántos pacientes consiguen una estabilidad clínica.
    -días hasta estabilidad clínica.
    -Cuantificar el tiempo de tratamiento antibiótico intravenoso hasta el paso a vía oral.
    -Cuantificar el total de días de tratamiento antibiótico.
    -Evaluar la desescalada de tratamiento antibiótico a otro tratamiento de menor espectro.
    -Días de oxigenoterapia.
    -Evaluar los días en ventilación invasiva y no invasiva.
    -Necesidad de ingreso en UCI.
    -Días de ingreso hospitalario.
    -Incidencia de nuevos casos de infección por Clostridium difficile durante el estudio.
    -Incidencia de casos de flebitis derivados del uso de antimicrobianos intravenoso.
    -Estimar la incidencia de mortalidad.
    -Evaluar la incidencia de reingreso tras el alta hospitalaria.

    Seguridad:
    -Número de acontecimientos adversos relacionados con la recogida de la muestra o con la prueba molecular integral.
    -Número de acontecimientos adversos relacionados con la antibioterapia hasta los 30±5 días tras el alta.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Adult patients (18 years of age or older), of both sexes, hospitalized with a diagnosis of CAP during first 24 hours since emergency department arrival.
    • Patient or his legal representative gives the informed consent
    • Pacientes adultos (18 años o más), de ambos sexos, hospitalizados con diagnóstico de NAC durante las primeras 24 horas desde su llegada al centro.
    • El sujeto o su representante legal o su familiar más cercano (en caso de incapacidad del sujeto por gravedad de la situación clínica) otorguen el consentimiento informado.
    E.4Principal exclusion criteria
    • Pregnancy and / or nursing.
    • Severe immunocompromised patients (eg, chemotherapy or radiotherapy in the previous 90 days, use of immunosuppressive drugs, chronic use of corticosteroids at a minimum dose of 15 mg / day in the last two weeks, transplantation of hematopoietic progenitors, solid organ transplant, HIV patients with CD4 ≤ 200 cells / mm3)
    • Imminent death (life expectancy ≤ 24h)
    • Congestive heart failure (NYHA class 3 or 4).
    • Participation in another clinical trial of pharmacological treatment.
    • En mujeres: embarazo y/o lactancia.
    • Inmunodeprimidos graves (ej. quimioterapia o radioterapia en los 90 días previos, uso de fármacos inmunosupresores, uso crónico de corticoides a la dosis mínima de 15 mg/día en las últimas dos semanas, trasplante de progenitores hematopoyéticos, trasplante de órgano sólido, pacientes HIV con CD4 inferiores a 200 céls/mm3).
    • Muerte inminente (expectativa de vida ≤ a 24h).
    • Insuficiencia cardíaca congestiva (clase 3 o 4 de la NYHA).
    • Participación en otro ensayo clínico de tratamiento.
    E.5 End points
    E.5.1Primary end point(s)
    To evaluate the absolute number of DOT-1000 stays in admitted patients diagnosed with CAP.
    Evaluar el número absoluto de DOT-1000 estancias en pacientes ingresados con diagnóstico de NAC.
    E.5.1.1Timepoint(s) of evaluation of this end point
    The main variable (DOT / 1000 stays) will be collected in the End of Study visit (30±5 days after discharge).
    La variable principal (DOT/1000 estancias) se recogerá el día de la Visita de Fin de estudio (30±5 días después del alta hospitalaria)
    E.5.2Secondary end point(s)
    Secondary over the main variable (DOT):
    · Days of intravenous antibiotic treatment.
    · Days until de-escalation of antibiotic treatment to another of lower spectrum.
    · Days until antibiotic monotherapy.
    · Days until detection of the causal agent.
    Clinical secondary related to CAP :
    · Days of oxygen treatment
    · Days of invasive or non-invasive ventilation
    · Days of hospital admission.
    · Patients who are readmitted before 30±5 after hospital discharge.

    Secondary adverse events:
    · Patients with complications related to CAP until the end of the clinical trial.
    · Patients with medical complications not directly related to CAP until the end of the clinical trial.
    · Number of adverse events related to antibiotic therapy.
    · Number of adverse events related to antibiotic therapy.
    · Patients diagnosed with Clostridium difficile infection during the clinical trial.
    · Patients with phlebitis resulting from the use of intravenous antimicrobials.

    Mortality:
    · Patients deceased 5 days after the randomization (early mortality).
    · Patients deceased 30 days after randomization (mortality ≥ 30 days).
    · Deceased patients, related to CAP during the clinical trial ( ≥30±5 days after hospital discharge).
    · Patients who died from any cause during the clinical trial (days admitted ≥ 30±5 days after hospital discharge).
    Secundarios sobre la variable principal (DOT):
    • Número de días de tratamiento antibiótico intravenoso.
    • Número de días hasta desescalada de tratamiento antibiótico a otro de menor espectro.
    • Número de días hasta la monoterapia.
    • Número de días hasta la detección del agente causal.

    Secundarios clínicos relacionados con la propia NAC:
    • Número de días de tratamiento con oxígeno.
    • Número de días de ventilación invasiva o no invasiva.
    • Número de días de ingreso hospitalario.
    • Número de pacientes que reingresan antes de los 30±5 tras el alta hospitalaria.

    Secundarios acontecimientos adversos:
    • Número de pacientes con complicaciones relacionados con la recogida de la muestra o con la prueba molecular integral.
    • Número de pacientes con complicaciones relacionadas con la NAC hasta fin del ensayo clínico.
    • Número de pacientes con complicaciones médicas no directamente relacionadas con la NAC hasta fin del ensayo clínico.
    • Número de acontecimientos adversos relacionados con la antibioterapia.
    • Número de pacientes que se les diagnostique infección por Clostridium difficile durante el ensayo clínico.
    • Número de pacientes que se les diagnostica una flebitis consecuencia derivados del uso de antimicrobianos intravenoso.
    • Número de pacientes que reingresan por NAC.

    Mortalidad:
    • Número de pacientes fallecidos a los 5 días de la asignación aleatoria (mortalidad precoz).
    • Número de pacientes fallecidos a los 30 días de la asignación aleatoria (mortalidad a los 30 días).
    • Número de pacientes fallecidos, relacionados con la NAC durante el ensayo clínico (días ingreso más 30±5 días tras el alta hospitalaria).
    • Número de pacientes fallecidos por cualquier causa durante el ensayo clínico (días ingreso más 30±5 días tras el alta hospitalaria).
    E.5.2.1Timepoint(s) of evaluation of this end point
    During the treatment period of each patient in the study (up to 30 ± 5 days after discharge).
    Periodo tratamiento del paciente.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Yes
    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 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) Yes
    E.8.2.2Placebo No
    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 concerned2
    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
    The study will end with the completion of the follow-up monitoring and data collection of the last patient included (last patient-last visit).
    El estudio finalizará cuando finalice la evaluación (visita fin de estudio) del último paciente incluido (“Last Patient-Last Visit”).
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months36
    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: 146
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 294
    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 2019-06-11. 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 No
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    In patients unable to provide consent due to medical condition (patients hospitalized in the ICU, intubation, delirium), surrogate consent can be obtained from the legal representative.
    En caso de que el paciente no pueda otorgar su consentimiento informado debido a su estado médico (ingreso en la UCI, intubación, síndrome confusional agudo), se podrá obtener el consentimiento de un representate legal.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state440
    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)
    Patients at the end of trial treatment will continue treatment according to usual clinical practice.
    Los pacientes al finalizar el tratamiento del ensayo continuaran tratamiento según práctica clínica habitual.
    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 Decision2019-10-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-09-19
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2022-11-28
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