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    Summary
    EudraCT Number:2011-005805-66
    Sponsor's Protocol Code Number:DEXCAR-0212
    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:2012-06-12
    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 number2011-005805-66
    A.3Full title of the trial
    Dexametasona administration in first febrile urinary tract infection episode as renal damage
    prevention strategy.
    Administración de dexametasona en primer episodio de infección
    del tracto urinario febril, como prevención de daño renal.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Renal scarring prevention by corticoid treatment in children with renal infection
    Prevención de la formación de cicatriz renal en niños con infección renal mediante tratamiento con un corticoide.
    A.3.2Name or abbreviated title of the trial where available
    DEXCAR
    DEXCAR
    A.4.1Sponsor's protocol code numberDEXCAR-0212
    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 SponsorUnitat de Recerca en Pediatria Nutrició i Desenvolupament Humà
    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 supportUnitat de recerca en Pediatria Nutrició i Desenvolupament Humà
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUnitat de Recerca en Pediatria Nutrició i Desenvolupament Humà
    B.5.2Functional name of contact pointUnitat de Recerca en Pediatria Nutr
    B.5.3 Address:
    B.5.3.1Street AddressSant Llorenç 21
    B.5.3.2Town/ cityReus
    B.5.3.3Post code43201
    B.5.3.4CountrySpain
    B.5.4Telephone number34977759364
    B.5.5Fax number34977759322
    B.5.6E-mailnatalia.ferre@urv.cat
    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.2.1.1.1Trade name FORTECORTIN 4 MG SOLUCION INYECTABLE
    D.2.1.1.2Name of the Marketing Authorisation holderMERK S. L.
    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 nameFORTECORTIN 4 MG SOLUCION INYECTABLE
    D.3.4Pharmaceutical form Solution for 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 INNDEXAMETHASONE SODIUM PHOSPHATE
    D.3.9.1CAS number 2392-39-4
    D.3.9.4EV Substance CodeSUB01615MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    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.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection
    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
    Acute pyelonephritis
    Pielonefritis aguda
    E.1.1.1Medical condition in easily understood language
    Upper tract urinary infection
    Infección urinaria de tracto alto
    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 evaluate the reduction in percentage of renal scarring presence between control group (conventional therapy) and intervention group (conventional therapy + dexametasona) after 6 months of infectious episode diagnosis
    Evaluar el porcentaje de reducción de cicatriz renal entre el grupo control (terapia convencional) y el grupo de intervención (terapia convencional+ dexametasona) a partir de los 6 meses post episodio infeccioso
    E.2.2Secondary objectives of the trial
    To evaluate diferences in:
    - clinical variables (hospitalization time, fever hours, recurrence % within 6 months after diagnosis)
    - inflamatory variables (urinary IL6 and IL8, serum procalcitonin and CRP at admision)
    - radiologic variables (determined by DMSA after 6 months of diagnosis)

    between control and intervention group.

    - To determine predictive factors for permanent renal damage.
    - To evaluate the intervention effect on high riks subgroups (i.e. vesiculouretral reflux).
    Evaluar las diferencias :
    - clínicas (tiempo de hospitalización, horas de fiebre, % de recurrencia en 6 meses tras el diagnóstico).
    - inflamatorias (IL6 y IL8 en orina, procalcitonina y PCR en suero al ingreso)
    - radiológicas (mediante DSMA a los 6 meses del primer episodio de ITU febril)

    entre el grupo de control y de intervención

    - Determinar factores predictivos de daño renal permanente.
    ? Valorar el efecto de la intervención sobre subgrupos de riesgo elevado (reflujo vesicoureteral).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Children with suspected acute pyelonephritis (aged between 2 months abd 14 years) confirmed by acute phase DMSA who meet the criteria for hospitalization defined in the Clinical Practice Guidances for urinary tract infection in pediatric population (Plan de Calidad para el Sistema Nacional de Salud del Ministerio de Sanidad, Política Social e Igualdad. Instituto Aragonés de Ciencias de la Salud; 2011).

    In brief:
    a) age less than 3 months,
    b) General condition afectation, toxic appearance,
    c) Vomiting, oral intolerance,
    d) Deshidratation, bad peripheral perfusion,
    e) Intermedium risk situations as:
    - High fever (more than 38.5ºC) in 3-6 month infabts and fever persistence after 48h of treatment,
    - Inusual germ risk factors (recent antibiotherapy or hospitalization, cateterism),
    - Family history of vesiculouretral reflux, repetitive febrile urinary infections,
    - Significant elevation of acute phase reactants that could require endovenous treatment.
    Niños de entre 2 meses y 14 años con sospecha de pielonefritis aguda confirmada mediante DMSA en fase aguda y que cumplan los criterios de hospitalización definidos en la Guía de Practica Clínica sobre Infección del Tracto Urinario en la Población Pediátrica (Plan de Calidad para el Sistema Nacional de Salud del Ministerio de Sanidad,
    Política Social e Igualdad. Instituto Aragonés de Ciencias de la Salud; 2011).

    Brevemente:

    a) Edad menor de 3 meses,
    b) Afectación del estado general, aspecto toxico,
    c) Vómitos o intolerancia a la vía oral,
    d) Deshidratación, mala perfusión periférica,
    e) Situaciones de riesgo intermedio como:
    ? Fiebre elevada (? 38,5 ºC) en niños o niñas de 3 a 6 meses de edad y persistencia de la fiebre tras 48 horas de tratamiento,
    ? Factores de riesgo de germen no habitual (antibioterapia reciente, hospitalización reciente, cateterismo),
    ? Historia familiar de reflujo vesiculoureteral, infecciones urinarias febriles de repetición,
    ? Elevación importante de los reactantes de fase aguda que podrían requerir también tratamiento endovenoso.
    E.4Principal exclusion criteria
    a) Children with acute pyelonephritis between 2 months and 14 years who do not meet the criteria for hospitalization,
    b) Patients with procalcitonine < 0.05 ng/ml,
    c) Patients with previous renal scarring or previous uropathy,
    d) Patients with previous acute pyelonephritis if there is no confirmation by DMSA that renal sacrring is absent,
    e) Patinets with dexametasona alergy,
    f) Endocrinologis diseases (suprarenal insuficiency, bad controled DM),
    g) Previous history of cancer,
    h) Patients with severe disease,
    i) Patients with immunosupresor treatment,
    j) Previous oral or parenteral corticoid treatment within the last 2 monts,
    k) Those patients that have been vaccinated with live vaccine during the two weeks before the start of the trial intervention,
    l) Those patients included in the study who develope a second urinary tract infection within the 6 monts of follow up will be excluded.
    m) Acute renal damage absence in the ealry DMSA.
    a) Niños con pielonefritis aguda de entre 2 meses y 14 años que no cumplan criterios de hospitalización,
    b) Pacientes con una procalcitonina < 0.05 ng/ml,
    c) Pacientes con cicatriz renal previa y/o uropatía previa,
    d) Pacientes con pielonefritis aguda previa si no se ha confirmado mediante DMSA tardío que nNO existe cicatriz renal,
    e) Pacientes alérgicos a la dexametasona,
    f) Enfermedad endocrinológica (insuficiencia suprarrenal, diabetes mellitus mal controlada),
    g) Antecedentes de cáncer,
    h) Pacientes con alguna enfermedad grave,
    i) Paciente en tratamiento inmunosupresor,
    j) Toma previa de corticoides orales o parenterales de forma continuada en los últimos 2 meses,
    k) Pacientes que hayan sido vacunaos con vacuna viva durante las 2 semanas anteriores al inicio de la intervención del ensayo,
    l) El paciente incluido en el ensayo y que realice un segundo episodio de pielonefritis aguda antes de 6 meses, será excluido del mismo.
    m) Ausencia de lesión renal aguda en el DMSA precoz.
    E.5 End points
    E.5.1Primary end point(s)
    Percentatge reduction inthe risk of renal scarring after an acute pyelonephritis episode by dexamethasone treatment added to the conventional therapy.
    Porcentage de reducción del riesgo de cicatriz renal tras episodio de pielonefritis aguda mediante el tratamiento con dexametasona añanido a la terapia convencional
    E.5.1.1Timepoint(s) of evaluation of this end point
    Six months after acute pyelonephritis diagnosis
    Seis meses despúes del diagnostico de la pielonefritis aguda
    E.5.2Secondary end point(s)
    Diferences between control group and intervention group in:
    - days of hospitalizacion,
    - fever hours,
    - urine IL6 and IL8 concentration,
    - blood PCT and PCR confentration at admision.
    Diferencias entre el grupo control y el grupo de intervención en:
    - días de hospitalización,
    - horas de fiebre,
    - concentarción de IL6 y IL8 en orina,
    - concentracion de PCT y PCR en sangre al ingreso.
    E.5.2.1Timepoint(s) of evaluation of this end point
    During hospitalization.
    Durante la hospitalización
    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 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 concerned7
    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 trial will finish with the last renal scarring presence evaluation (by DMSA) in the last included patient (6 months after the urinary infection diagnosis).
    El ensayo terminará con la última valoración de presencia de cicatriz renal mediante DMSA en el ultimo paciente incluido (6 meses después del diagnóstico de la infección urinaria).
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months12
    E.8.9.1In the Member State concerned days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 180
    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) Yes
    F.1.1.4.1Number of subjects for this age range: 180
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 180
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 180
    F.1.2Adults (18-64 years) No
    F.1.3Elderly (>=65 years) No
    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 Yes
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Included patients have between 2 months and 14 years. Parental consent is needed.
    Los pacientes incluidos tienen entre 2 meses y 14 años de edad. Es necesario el consetimeinto de los porgenitores.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state180
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 180
    F.4.2.2In the whole clinical trial 180
    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)
    Apart form the treatment with fortecortin or placebo during hospitalization, patients will recive the habitual follow-up and evaluation that is protocolized in a pediatric nefrology unit after a acute pyelonephritis episode.
    A parte del tratamiento con frortecortin o placebo durante el ingreso, los apcientes recibirán el seguimiento y evaluacones habituales protocolizados en una Unidad de nefrología pediatrica para aquesllos pacientes que han padecido una pielonefritis aguda.
    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 Decision2012-09-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-02-14
    P. End of Trial
    P.End of Trial StatusOngoing
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