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    Summary
    EudraCT Number:2010-023310-31
    Sponsor's Protocol Code Number:MagicBullet/COLMER
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2010-11-22
    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 number2010-023310-31
    A.3Full title of the trial
    Ensayo clínico en fase IV aleatorizado, abierto, multicéntrico y de no inferioridad para comparar la seguridad y la eficacia de colistina iv. con meropenem iv. en el tratamiento de la neumonía asociada a ventilación mecánica
    A.4.1Sponsor's protocol code numberMagicBullet/COLMER
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorConsorcio de apoyo a la Investigación Biomédica en Red (CAIBER)
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 COLISTIMETATO DE SODIO GES 1 MUI polvo para solución inyectable/para inhalación por nebulizador
    D.2.1.1.2Name of the Marketing Authorisation holderG.E.S. GENERICOS ESPAÑOLES LABORATORIO, S.A.
    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 nameColistimetato de sodio
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INNCOLISTINA MESILATO SODIO
    D.3.9.3Other descriptive nameCOLISTIN MESILATE SODIUM
    D.3.10 Strength
    D.3.10.1Concentration unit IU international unit(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number3000000
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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.2.1.1.1Trade name MERONEM I.V. 1000 mg polvo para solución inyectable o para perfusión
    D.2.1.1.2Name of the Marketing Authorisation holderASTRAZENECA FARMACEUTICA SPAIN, S.A.
    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 Powder for injection*
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INNMEROPENEM TRIHIDRATO
    D.3.9.3Other descriptive nameMEROPENEM TRIHIDRATO
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1000
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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
    Neumonía asociada a ventilación mecánica
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 13
    E.1.2Level LLT
    E.1.2Classification code 10052596
    E.1.2Term Neumonia nosocomial
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    - Demostrar que colistina iv. no es inferior a meropenen en en el tratamiento empirico de las NAVM con respecto al punto final de eficacia primaria: mortalidad a los 28 días.
    E.2.2Secondary objectives of the trial
    1. Demostrar que colistina no es inferior a meropenen en el tratamiento empirico de las NAVM con respecto a la eficacia: curación clínica por intención de tratar y en pacientes evaluables clínicamente.
    2. Comparar la eficacia microbiológica del tratamiento con colistina frente a meropenen en la NAVM.
    3. Comparar la seguridad del tratamiento con colistina frente a meropenen en la NAVM. Incluido el desarrollo de resistencias.
    4. Describir la farmacocinética de colistina en los pacientes con NAVM.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Edad 18 años
    - Cada paciente para ser incluido debe cumplir los siguientes criterios:
    1. Criterios clínicos y radiológicos de NAVM.
    2. Desarrollo de la NAVM después de al menos cuatro días de ingreso en hospital.
    3. Sospecha de bacilo gram-negativo multi-resistente como causante de la NAVM.
    4. Clinical Pulmonary Infection Store (CPIS) > 6.
    5. Muestra de secreciones respiratorias obtenidas del tracto respiratorio bajo mediante broncoscopio con lavado broncoalveolar o aspirado bronquial procesados ambos cuantitativamente. obtenida en las 24 h. previas al inicio del tratamiento antimicrobiano del estudio.
    - Las mujeres en edad fértil (no sometidas a esterilización quirúrgica y que se encuentren en el periodo comprendido entre la menarquia y 1 año después de la menopausia) deberán tener una prueba negativa de embarazo en orina en el momento del reclutamiento.
    - El paciente o su representante legal deben firmar un documento de consentimiento informado aprobado por el Comité Ético de Ensayos Clínicos
    E.4Principal exclusion criteria
    - Hipersensibilidad a cualquiera de los dos antimicrobianos del estudio (colistina/meropenem).
    - Insuficiencia renal en tratamiento sustitutivo.
    - Peso corporal <40 kg o >150 kg.
    - Pacientes previamente incluidos en otro ensayo clínico.
    - Shock refractario u otra enfermedad que, en opinión del investigador, presente una expectativa de vida inferior a 48 horas, después del reclutamiento.
    E.5 End points
    E.5.1Primary end point(s)
    Variable primaria: mortalidad a los 28 días.
    Variables secundarias:
    - Evaluación de la eficacia clínica: la respuesta clínica será clasificada por el investigador como curación, fracaso o indeterminada al final del tratamiento. La curación se define como la resolución completa de todos los signos y síntomas de neumonía. El fracaso como la persistencia o la progresión de los mismos. La recurrencia, la recurrencia de los signos, síntomas y/o nuevas evidencias radiográficas de neumonía tras el final del tratamiento. (Se aporta CRD con las variables a recoger en cada visita del ensayo, anexo).
    - Valoración de la eficacia microbiológica: la respuesta microbiológica se clasifica como curación, fracaso o indeterminada por el investigador al final del tratamiento. La recaída se define como la recurrencia de los signos, síntomas o nuevas evidencias radiográficas de neumonía presentes en la última evaluación junto con el aislamiento del patógeno inicial.
    - La evaluación de seguridad se llevará a cabo mediante la recogida de los acontecimientos adversos ocurridos durante el ensayo. Se llevará a cabo el registro de todos los acontecimientos adversos que cumplan los criterios de RAGI (reacción grave adversa inesperada) y se realizará su notificación expeditiva a las autoridades reguladoras y comités éticos implicados en el ensayo.
    - Los parámetros farmacocinéticos incluirán (AUC, Cmáx, Tmáx, Cmáx/AUC). (Protocolo farmacocinética en anexo I).
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    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 Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    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.8.3 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 concerned9
    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 Information not present in EudraCT
    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
    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 months6
    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 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    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 No
    F.3.3.1Women of childbearing potential not using contraception Information not present in EudraCT
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    F.3.3.3Pregnant women Information not present in EudraCT
    F.3.3.4Nursing women Information not present in EudraCT
    F.3.3.5Emergency situation Information not present in EudraCT
    F.3.3.6Subjects incapable of giving consent personally Information not present in EudraCT
    F.3.3.7Others Information not present in EudraCT
    F.4 Planned number of subjects to be included
    F.4.1In the member state400
    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 Decision2011-02-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-01-31
    P. End of Trial
    P.End of Trial StatusCompleted
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