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    Summary
    EudraCT Number:2016-002796-10
    Sponsor's Protocol Code Number:PROMELUNG
    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:2016-12-27
    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 number2016-002796-10
    A.3Full title of the trial
    Assessment of intrapulmonary concentrations of meropenem administered by continuous infusion in postoperative pneumonia.
    Evaluación de las concentraciones intrapulmonares de meropenem tras perfusión continua en neumonía postoperatoria.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Assessment of meropenem concentrations in lungs in patients with postoperative pneumonia.
    Evaluación de las concentraciones del antibiótico meropenem en el pulmón en pacientes con neumonía postoperatoria.
    A.4.1Sponsor's protocol code numberPROMELUNG
    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 SponsorConsorci Mar Parc de Salut de Barcelona (Parc de Salut MAR)
    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 supportNone
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationHospital del Mar
    B.5.2Functional name of contact pointServicio de Anestesiología
    B.5.3 Address:
    B.5.3.1Street AddressPasseig Marítim, 25-29
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08003
    B.5.3.4CountrySpain
    B.5.4Telephone number0034932483350
    B.5.5Fax number0034932483617
    B.5.6E-mail60543@parcdesalutmar.cat
    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 Meropenem Accordpharma®
    D.2.1.1.2Name of the Marketing Authorisation holderAccord Healthcare, S.L.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.3.4Pharmaceutical form Powder and solvent for 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 INNMeropenem
    D.3.9.1CAS number 119478-56-7
    D.3.9.3Other descriptive nameMEROPENEM TRIHYDRATE
    D.3.9.4EV Substance CodeSUB21617
    D.3.10 Strength
    D.3.10.1Concentration unit g gram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    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
    Post-operative pneumonia
    Neumonía postoperatoria
    E.1.1.1Medical condition in easily understood language
    Pneumonia
    Neumonía
    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 demonstrate whether the administration of 1 g meropenem by continuous infusion (1 g every 8 hours in 8 hours infusion) can achieve optimous PK / PD intrapulmonary concentrations compared with intrapulmonary concentrations of 2 g meropenem by continuous infusion (2 g every 8 hours in 8 hours infusion).
    Demostrar que en pacientes con neumonía postoperatoria, la administración de 1 g meropenem en perfusión continua (1 g cada 8 horas en perfusión de 8 horas) permite alcanzar concentraciones intrapulmonares óptimas según objetivo PK/PD (farmacocinético/farmacodinámico), comparado con las concentraciones intrapulmonares alcanzadas con la dosis de 2 g meropenem en perfusión continua (2 g cada 8 en perfusión de 8 horas).
    E.2.2Secondary objectives of the trial
    a) To describe the variability of meropenem pharmacokinetics in plasma concentrations trough a model design population.
    b) To realize a cabo Monte Carlo simulation to assess the probability to achieve the PK / PD for the different doses of the drug.
    c) To assess whether or not there is a relationship between the value of the index of pulmonary vascular permeability (IPVP) and intrapulmonary drug concentrations.
    a) describir la variabilidad farmacocinética de las concentraciones de meropenem en plasma mediante el diseño de un modelo poblacional.
    b) llevar a cabo una simulación de Monte Carlo para valorar la probabilidad de alcanzar el objetivo PK/PD para las distintas dosis del fármaco.
    c) valorar si existe relación entre los valores del índice de permeabilidad vascular pulmonar (IPVP) y las concentraciones intrapulmonares del fármaco.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Patients of both genres aged older than 18 years old at the screening visit.
    • Diagnosis of pneumonia in FRGMR post-operative patients . The diagnosis of pneumonia is based on clínical criteria and / or scores on the Clinical Infectious Pulmonary Score (PIACSS) ≥ 6 points.
    • Admission at theIntensive Care postoperative Unit (ICUPQ): The patient've been admited to ICUPQ after a surgical intervention and been developed a pneumonia during this insgress.
    • Patients who have signed inform consent indicating that they have been informed regarding all the clinical trial aspects, or in the event that the subjects of the trial are incapacitated, signature of consent by the family member or legally designated representative.
    •Pacientes de ambos sexos mayores de 18 años de edad en el momento de la visita.
    •Diagnóstico de neumonía postoperatoria en pacientes con FRGMR. El diagnóstico de neumonía estará basado en criterios clínicos y/o puntuación en el Clinical Pulmonary Infectious Score (CPIS) ≥ 6 puntos.
    •Ingreso en Unidad de Críticos Postquirúrgicos (UCIPQ): El paciente deberá haber sido admitido en UCIPQ tras una intervención quirúrgica y haber desarrollado una neumonía durante dicho ingreso.
    •Pacientes que firmen el consentimiento informado indicando que han sido informados de todos los aspectos pertinentes sobre el ensayo.
    E.4Principal exclusion criteria
    • Allergy or hypersensitivity to β-lactamic antibiotics or any of the excipients of the drug clinical trial.
    • Administration of carbapenemics antibiotics in the previous 15 days to inclusion of the study.
    •Glomerular filtration <50 ml / min (GFR) (calculed by MDRD-4 formula (four-variable Modification of Diet in Renal Disease formula) or acute renal failure with renal indications of renal replacement.
    • Severe disruption of the function, liver cirrhosis, defined as Class C según the classification of Child-Pugh.
    • Obesity (BMI> 30).
    • Known colonization with pathogens with resistance to meropenem.
    • Life expectancy <3 days.
    • Pregnant women or breast feeding.
    • Participation in a clinical research dentro de los 3 months prior to administration of the drug.
    •Alergia o hipersensibilidad a antibióticos β-lactámicos o a alguno de los excipientes de los fármacos del ensayo clínico.
    •Administración de antibióticos carbapenémicos en los 15 días previos a la inclusión en el estudio.
    •Tasa de filtración glomerular < 50 ml/min (TFG) (calculada según la formula MDRD-4 (four-variable Modification of Diet in Renal Disease formula) o insuficiencia renal aguda con indicación de técnicas de reemplazo renal.
    •Afectación severa de la función hepática, definida como Cirrosis Clase C según la clasificación de Child-Pugh.
    •Obesidad (IMC > 30).
    •Colonización con patógenos con resistencia conocida a meropenem.
    •Esperanza de vida < 3 días.
    •Mujeres embarazadas o en periodo de lactancia.
    •Participación en alguna investigación clínica dentro de los 3 meses anteriores a la administración del fármaco.
    E.5 End points
    E.5.1Primary end point(s)
    - Meropenem concentration in epithelial lining fluid (ELF): Samples of pick trough lavado bronchoalveolar (BAL) using fibrobroncoscópica technique (at the end of perfusion 8h).
    -Concentración de fármaco en líquido de revestimiento epitelial (ELF): recogida de muestras mediante lavado broncoalveolar (BAL) usando técnica fibrobroncoscópica (al final de la perfusión de 8h).
    E.5.1.1Timepoint(s) of evaluation of this end point
    AT the end of 8 hours infusion on the 3th day.
    Al final de la perfusión de 8 horas el tercer día desde el inicio del tratamiento.
    E.5.2Secondary end point(s)
    -Demografic data: age, sex, weight, BMI
    Clinical data: APACHE II, serum creatinine, at the initiation of treatment, GFR (MDRD-4 formula) at initianion of treatment, serum albumin, PVPI, diagnosis of sepsis or septic shock, presence of edemas.
    -Crude 30 day mortality.
    -Microbiological test results.
    Blood sample variables:
    -Trough concentration (Cmin): sample collected before administration of the drug dose (0h).
    - Blood sample at 90 minutes after initiation of administration of the drug (1.5h).
    - Blood sample at 3 hours after initiation of administration of the drug (3h).
    -Blood sample at 6 hours after initiation of administration of the drug (6h).
    - Concentration at the end of 8 hour infusion (Css): sample collected at 8 hours after initiation of administration of the drug in both groups (8h).
    -Datos demográficos: edad, sexo, peso, índice de masa corporal (IMC).
    -Datos clínicos: APACHE II, creatinina sérica al inicio del tratamiento, tasa de filtración glomerular (formula 4-MDRD) al inicio del tratamiento, albúmina sérica, urea sérica, Índice de Permeabilidad Vascular Pulmonar (IPVP), diagnóstico de sepsis o shock séptico, presencia de edemas.
    -Mortalidad cruda a los 30 días.
    -Resultados microbiológicos.
    -Variables de muestras sanguíneas:
    -Concentración valle (Cmin): recogida de muestra antes de la administración de la dosis del fármaco (0h).
    -Concentración a los 90 minutos (C1,5h): recogida de muestra de sangre a los 90 minutos tras el inicio de la administración del fármaco
    -Concentración a las 3 horas (C3h): recogida de muestra de sangre a las 3 horas tras el inicio de la administración del fármaco
    -Concentración a las 6 horas (C6h): recogida de muestra de sangre a las 6 horas tras el inicio de la administración del fármaco
    -Concentración al final de la perfusión de 8h (Css): recogida de muestra a las 8 horas tras el inicio de la administración del fármaco en ambos grupos (8h).
    E.5.2.1Timepoint(s) of evaluation of this end point
    At the screening visit (day0), at day 1, day 3, and day 30.
    A visita de selección (día 0 ), día 1, día 3 y día 30.
    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 No
    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
    Ambos grupos reciben la misma medicación a dos dosis diferentes
    The same medication is given to both groups, but in two regimens of doses
    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 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 finalise at day 30, after the inclusion of the last patient.
    El ensayo finalizará cuando acabe el seguimento del último paciente reclutado que será a los 30 días desde la inclusión.
    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 days0
    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: 5
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 25
    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
    Patients in mechanical ventilation (orotracheal intubation and requiring sedation).
    The legal representative or family member will be in charge of signing the inform consent.
    Pacientes en ventilación mecánica (intubación orotraqueal y que requieran sedación).
    El representante legal o familiar será el encargado de firmar el consentimiento.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state30
    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 will receive adequate treatment by their physician.
    Los pacientes recibirán el tratamiento que su médico considere oportuno.
    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 Decision2017-02-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-02-01
    P. End of Trial
    P.End of Trial StatusOngoing
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