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    Summary
    EudraCT Number:2022-000144-30
    Sponsor's Protocol Code Number:SePkLin
    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:2022-03-17
    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 number2022-000144-30
    A.3Full title of the trial
    SePkLin Study: Pragmatic, Multicenter, Randomized, Controlled Clinical Trial in Patients with Sepsis to Evaluate the Safety and Efficacy of Personalized Pk/Pd Dosing Versus Standard Dosing of LINezolid
    Estudio SePkLin: Ensayo clínico pragmático, multicéntrico, aleatorizado y controlado en pacientes con Sepsis para evaluar la seguridad y eficacia de la dosificación personalizada Pk/Pd versus dosificación estándar de LINezolid
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Clinical trial in patients with Sepsis to evaluate the safety and efficacy of personalized dosing of Linezolid
    Ensayo clínico en pacientes con Sepsis para evaluar la seguridad y eficacia de la dosificación personalizada de Linezolid
    A.3.2Name or abbreviated title of the trial where available
    SePkLin Study
    Estudio SePkLin
    A.4.1Sponsor's protocol code numberSePkLin
    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 Instituto de Investigación Sanitaria de Santiago de Compostela
    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 supportInstituto de Salud Carlos III
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationFundación Instituto de Investigación Sanitaria de Santiago de Compostela
    B.5.2Functional name of contact pointAnxo Fernández Ferreiro
    B.5.3 Address:
    B.5.3.1Street AddressTravesía da Choupana s/n
    B.5.3.2Town/ citySantiago de Compostela
    B.5.3.3Post code15706
    B.5.3.4CountrySpain
    B.5.6E-mailanxordes@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.2.1.1.1Trade name Linezolid - ORAL
    D.2.1.1.2Name of the Marketing Authorisation holderSandoz Farmacéutica, 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 nameLinezolid
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNLINEZOLID
    D.3.9.1CAS number 165800-03-3
    D.3.9.4EV Substance CodeSUB08520MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1200
    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 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 Linezolid - INFUSION
    D.2.1.1.2Name of the Marketing Authorisation holderFresenius Kabi España, S.A.U.
    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 nameLinezolid
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSolution for infusion (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNLINEZOLID
    D.3.9.1CAS number 165800-03-3
    D.3.9.4EV Substance CodeSUB08520MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1200
    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
    Sepsis
    Sepsis
    E.1.1.1Medical condition in easily understood language
    Sepsis
    Sepsis
    E.1.1.2Therapeutic area Diseases [C] - Bacterial Infections and Mycoses [C01]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10040047
    E.1.2Term Sepsis
    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
    The primary objective of the study is to demonstrate the superiority of personalized linezolid dosing based on PK/PD by evaluating the incidence of thrombocytopenia in both treatment groups.
    El objetivo primario del estudio es demostrar la superioridad de la dosificación personalizada de linezolid en base a PK/PD evaluando la incidencia de trombopenia en ambos grupos de tratamiento.
    E.2.2Secondary objectives of the trial
    • To demonstrate greater efficacy of personalized dosing by analyzing the survival rate, clinical and microbiological cure rate, length of stay and days free of supportive therapies (vasopressor agents, renal replacement therapy, extracorporeal oxygenation) vs. conventional dosage.
    • To analyze safety by evaluating the severity of haematological toxicity episodes (thrombocytopenia and anemia) and the need for transfusions of platelets and packed red blood cells.
    • To study the cost-utility of personalized dosage by analyzing the quality of life of patients through validated questionnaires.
    • To analyze the percentage of patients who reach the target pharmacokinetic and pharmacodynamic parameters for concentration, AUC0-24h/MIC ratio and %T>MIC.
    • To validate pharmacogenetic biomarkers that may be associated with drug exposure, efficacy, safety and response to treatment.
    • Demostrar una mayor eficacia de la dosificación personalizada analizando la tasa de supervivencia, la tasa de curación clínica y microbiológica, la duración del ingreso y los días libres de terapias de soporte (agentes vasopresores, terapias de reemplazo renal, oxigenación extracorpórea) frente a la dosificación convencional.
    • Analizar la seguridad evaluando la gravedad de los episodios de toxicidad hematológica (trombopenia y anemia) y la necesidad de transfusiones de plaquetas y concentrados de hematíes.
    • Estudiar el coste-utilidad de la dosificación personalizada mediante análisis de calidad de vida de pacientes a través de cuestionarios validados.
    • Analizar porcentaje de pacientes que alcanza los parámetros farmacocinéticos y farmacodinámicos objetivo de concentración, cociente AUC0-24h/CMI y %T>CMI.
    • Validar biomarcadores farmacogenéticos que puedan estar asociados con la exposición al fármaco, su eficacia, seguridad y respuesta al tratamiento.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Adult patients (18 years and older) receiving linezolid.
    2. Diagnosis of sepsis (SOFA scale ≥ 2 points or in the case of chronic organ dysfunction, increase of 2 points compared to the baseline score).
    3. Patients have started antibiotic treatment with linezolid according to usual clinical practice.
    1. Pacientes adultos (18 años o más) a tratamiento con linezolid.
    2. Diagnóstico de sepsis (escala SOFA ≥ 2 puntos o en caso de disfunción orgánica crónica, aumento de 2 puntos respecto a la puntuación basal).
    3. Que hayan iniciado tratamiento antibiótico con linezolid según práctica clínica habitual.
    E.4Principal exclusion criteria
    1. Interruption of treatment before the first blood sample.
    2. Pregnant or nursing women.
    3. Known allergy or hypersensitivity to linezolid.
    4. Patients will be excluded if they are already in any other intervention trials.
    1. Interrupción del tratamiento antes de la primera muestra de sangre.
    2. Mujeres embarazadas o en periodo de lactancia.
    3. Alergia o hipersensibilidad conocida a linezolid.
    4. Los pacientes serán excluidos si ya están en cualquier otro ensayo de intervención.
    E.5 End points
    E.5.1Primary end point(s)
    Incidence of thrombocytopenia. Thrombopenia will be considered to be a platelet count below 75% of the patient's baseline value, at any time during the follow-up period.
    Incidencia de trombopenia. Se considerará trombopenia a un recuento de plaquetas por debajo del 75% del valor basal del paciente, en cualquier momento del período de seguimiento.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Thrombocytopenia will be evaluated on the days on which blood tests are performed as established in the protocol.
    La trombopenia se evaluará los días en los que se realiza la analítica sanguínea según lo establecido en el protocolo.
    E.5.2Secondary end point(s)
    Other efficacy variables:
    • Recurrence rate (relapses and reinfections) up to day 28: Recurrence is defined as the reappearance of symptoms of infection together with a positive culture for the same microorganism isolated in the initial culture in a patient with clinical cure at the cure visit. Reinfection is defined in a similar way, but with isolation of a different strain from the initial one.
    • Mortality: mortality from all causes will be evaluated at 14 and 28 days.
    • Changes in the SOFA scale: evolution of the daily values ​​in the SOFA scale.
    • Duration of admission to the critical care unit: number of days from admission to the critical care unit until being discharged from the unit.
    • Duration of hospital admission: number of days from hospital admission to discharge.
    • Days free from treatment with vasopressor agents: number of days that the patient avoided receiving vasopressor agents.
    • Days free from mechanical ventilation: number of days that the patient avoided mechanical ventilation.
    • Renal Replacement Therapy Free Days: Number of days the patient avoided renal replacement therapy.
    • Days free of extracorporeal therapy: number of days that the patient avoided the use of extracorporeal membrane oxygenation.
    Other PK/PD-gene variables
    Pharmacokinetics/pharmacodynamics: it will be evaluated every 3±1 days according to the sample extraction schedule.
    • Percentage of patients in therapeutic range: the percentage of patients in therapeutic range will be evaluated, 2-7 mg/L
    • Percentage of patients achieving the target PK/PD parameter: the percentage of patients achieving the target PK/PD parameter of AUC0 →24h/MIC ≥100 and %T>MIC will be evaluated. When microbiological culture and its corresponding MIC are not available, the ECOFF value defined by EUCAST will be used.
    Otras variables de eficacia:
    • Tasa de recurrencia (recidivas y reinfecciones) hasta el día 28: Se define como recidiva la reaparición de síntomas de infección junto con cultivo positivo para el mismo microorganismo aislado en el cultivo inicial en un paciente con curación clínica en la visita de curación. La reinfección se define de manera similar, pero con aislamiento de una cepa distinta de la inicial.
    • Mortalidad: se evaluará la mortalidad por todas las causas a los 14 y 28 días.
    • Cambios en la escala SOFA: evolución de los valores diarios en la escala SOFA.
    • Duración del ingreso en unidad de críticos: número de días desde el ingreso en unidad de críticos hasta ser dado de alta de la unidad.
    • Duración del ingreso hospitalario: número de días desde el ingreso hospitalario hasta el alta.
    • Días libres de tratamiento con agentes vasopresores: número de días que el paciente evitó recibir agentes vasopresores.
    • Días libres de ventilación mecánica: número de días que el paciente evitó ventilación mecánica.
    • Días libres de terapias de reemplazo renal: número de días que el paciente evitó terapias de reemplazo renal.
    • Días libres de terapias extracorpóreas: número de días que el paciente evitó uso de membrana de oxigenación extracorpórea.
    Otras variables PK/PD-gen
    Farmacocinéticas/farmacodinámicas: se evaluará cada 3±1 días según cronograma de extracción de muestras.
    • Porcentaje de pacientes en rango terapéutico: se evaluará el porcentaje de pacientes en rango terapéutico, 2-7 mg/L
    • Porcentaje de pacientes que alcanzan el parámetro PK/PD objetivo: se evaluará el porcentaje de pacientes que alcanzan el parámetro PK/PD objetivo de AUC0 →24h/CMI ≥100 y %T>CMI. Cuando no se disponga de cultivo microbiológico y su correspondiente CMI se utilizará el valor de ECOFF definido por la EUCAST.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Visits 1 to 8, see Protocol Table 3
    Visitas 1 a 8, ver Tabla 3 del protocolo
    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 No
    E.6.4Safety No
    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 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) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Mismo fármaco con dosis convencional
    Same drug with conventional dose
    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
    LVLP
    Última visita del último paciente
    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 months
    E.8.9.1In the Member State concerned days60
    E.8.9.2In all countries concerned by the trial days60
    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: 346
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 346
    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 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 No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state692
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 692
    F.4.2.2In the whole clinical trial 692
    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)
    Expected normal treatment of the condition under investigation
    Tratamiento habitual para la patología en investigación
    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 Decision2022-06-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-06-02
    P. End of Trial
    P.End of Trial StatusOngoing
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