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    The EU Clinical Trials Register currently displays   43865   clinical trials with a EudraCT protocol, of which   7286   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).

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    Summary
    EudraCT Number:2013-001997-18
    Sponsor's Protocol Code Number:ACHN-490-007
    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:2013-12-05
    Trial results View 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 number2013-001997-18
    A.3Full title of the trial
    A Phase 3, Multicenter, Randomized, Open-Label Study to Evaluate the Efficacy and Safety of Plazomicin Compared with Colistin in Patients with Infection due to Carbapenem-Resistant Enterobacteriaceae (CRE)
    Estudio de fase 3, multicéntrico, aleatorizado y abierto para evaluar la
    eficacia y la seguridad de plazomicina en comparación con colistina en
    pacientes con infección causada por enterobacterias resistentes a los
    carbapenémicos (CRE)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study of Plazomicin Compared with Colistin when combined with a second antibiotic (either meropenem or tigcycline) in the treatment of Patients with blood stream Infection (BSI) or nosocomial pneumonia due to Carbapenem-Resistant Enterobacteriaceae (CRE). Therapeutic Drug Managment (TDM) will be used to ensure that Plazomicin exposures lie within an acceptable range of the target mean steady-state area the curve (AUC).
    Estudio de plazomicina en comparación con colistina cuando se combina con un segundo antibiótico (ya sea meropenem o tigcycline) en el tratamiento de pacientes con infecciones de la circulación sanguínea (ICS) o neumonías nosocomiales causadas por enterobacterias resistentes a los carbapenémicos. El control terapéutico de fármacos (CTF) se utilizará para asegurar que las exposiciones a la plazomicina se encuentren dentro de un intervalo aceptable del AUC en estado de equilibrio media objetivo.
    A.4.1Sponsor's protocol code numberACHN-490-007
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01970371
    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 SponsorAchaogen, Inc.
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportAchaogen, Inc.
    B.4.2CountryUnited States
    B.4.1Name of organisation providing supportUS Department of Health and Human Services, Biomedical Advanced Research and Development Authority (BARDA)
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAchaogen, Inc.
    B.5.2Functional name of contact pointClinical Trials Registration Group
    B.5.3 Address:
    B.5.3.1Street Address7000 Shoreline Court, Suite 371
    B.5.3.2Town/ citySouth San Francisco, CA
    B.5.3.3Post code94080
    B.5.3.4CountryUnited States
    B.5.4Telephone number+1650800-3636
    B.5.5Fax number+1650434-3765
    B.5.6E-mailclinical-trials@achaogen.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 No
    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 namePlazomicin
    D.3.2Product code ACHN-490
    D.3.4Pharmaceutical form Concentrate and solvent for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous drip use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTo be determined
    D.3.9.1CAS number 1380078-95-4
    D.3.9.2Current sponsor codeACHN-490
    D.3.9.3Other descriptive nameNO ACTIVE SUBSTANCE
    D.3.9.4EV Substance CodeSUB49728
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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 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 Colistimethate for Injection
    D.2.1.1.2Name of the Marketing Authorisation holderX-Gen Pharmaceuticals
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    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 nameColistimethate sodium
    D.3.4Pharmaceutical form Powder for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous drip use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCOLISTIMETHATE SODIUM
    D.3.9.1CAS number 8068-28-8
    D.3.9.4EV Substance CodeSUB06801MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/kg milligram(s)/kilogram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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
    Bloodstream infections (BSI) and nosocomial pneumonia due to carbapenem-resistant Enterobacteriaceae (CRE)
    Infecciones de la circulación sanguínea (ICS) y neumonías nosocomiales causadas por enterobacterias resistentes a los carbapenémicos (CRE)
    E.1.1.1Medical condition in easily understood language
    Infection due to Carbapenem Resistant Enterobacteriaceae (CRE)
    Infección causada por enterobacterias resistentes a los carbapenémicos (CRE)
    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 16.1
    E.1.2Level LLT
    E.1.2Classification code 10018657
    E.1.2Term Gram-negative bacterial infection NOS
    E.1.2System Organ Class 100000004862
    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 this study is to demonstrate the superiority, in terms of all-cause mortality at 28 days, of a plazomicin-based regimen compared with a colistin-based regimen in the treatment of BSI or nosocomial pneumonia due to CRE.
    El objetivo principal de este estudio consiste en demostrar la
    superioridad, en cuanto a mortalidad por cualquier causa a los 28 días, de un régimen a base de plazomicina con respecto a otro a base de colistina en el tratamiento de ICS o neumonías nosocomiales causadas por CRE.
    E.2.2Secondary objectives of the trial
    The secondary objectives of this study are:
    - to compare additional efficacy outcomes and safety of a plazomicin-based regimen with a colistin-based regimen in the treatment of BSI or nosocomial pneumonia due to CRE
    - to evaluate the PK of intravenous (IV) plazomicin in patients with CRE infection.
    - to evaluate the clinical utility of TDM for plazomicin dose adjustment
    Los objetivos secundarios de este estudio son:
    - Comparar otros criterios de valoración de la eficacia y la seguridad
    entre un régimen a base de plazomicina y otro a base de colistina en el tratamiento de ICS o neumonías nosocomiales causadas por CRE.
    - Evaluar la farmacocinética (FC) de plazomicina por vía intravenosa (IV) en pacientes con infección por CRE.
    - Evaluar la utilidad clínica del CTF (control terapéutico de fármacos) para ajustar la dosis de plazomicina.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Male and female patients age 18 to 85 years, inclusive
    - APACHE II score between 15 and 30, inclusive
    - Presumptive identification of a carbapenem resistant-member of the
    Enterobacteriaceae as defined by rapid testing methods from an appropriate culture specimen ≤ 72 hours prior to study OR definitive identification of a carbapenem resistant-member of the Enterobacteriaceae as defined by local lab identification and susceptibility testing from an appropriate culture specimen ≤ 72 hours prior to study entry
    - Diagnosis of BSI as defined by at least one positive blood culture meeting the above microbiological criteria associated with at least one of the following signs of infection: Fever or hypothermia; New onset arterial hypotension; Elevated total peripheral white blood cell (WBC) count > 10,000 cells/mm3, > 15% immature neutrophils (band forms) regardless of total peripheral WBC count, or leukopenia with total WBC count < 4500 cells/mm3
    - Or, diagnosis of nosocomial pneumonia in a patient on mechanical ventilation, as defined by lower respiratory tract or pleural fluid culture meeting the above defined microbiological criteria, and associated with the following clinical signs of pneumonia: A chest X-ray or computed tomography (CT) scan with findings consistent with a diagnosis of pneumonia; Worsening gas exchange; Purulent deep respiratory specimen; AND one of the following: Elevated total peripheral WBC count > 10,000 cells/mm3, > 15% immature neutrophils (band forms) regardless of total peripheral WBC count, or leukopenia with total WBC count < 4500 cells/mm3; Fever or hypothermia
    - Pacientes de uno u otro sexo y de 18 a 85 años de edad, ambos
    inclusive.
    - Puntuación APACHE II entre 15 y 30, ambos inclusive
    - La presunta identificación de un miembro de la familia de enterobacterias resistente a los carbapenémicos tal como se define por métodos de detección rápida de una muestra de cultivo apropiado ≤ 72 horas antes del estudio O la identificación definitiva de un miembro de la familia de enterobacterias resistente a los carbapenémicos tal como se define por la identificación del laboratorio local y las pruebas de sensibilidad a partir de una muestra de cultivo apropiado ≤ 72 horas antes de su inclusión en el estudio.
    - Diagnóstico de ICS definida por la presencia de al menos un
    hemocultivo positivo que cumpla los criterios microbiológicos anteriores y acompañado de al menos uno de los siguientes signos de infección: fiebre o hipotermia, hipotensión arterial de nueva aparición, recuento total de leucocitos periféricos > 10.000 células/mm3, > 15% de neutrófilos inmaduros (cayados) independientemente del recuento total de leucocitos periféricos o leucopenia con un recuento total de leucocitos < 4500 células/mm3.
    - O diagnóstico de neumonía nosocomial en un paciente sometido a
    ventilación mecánica, definida por la presencia de un cultivo de vías
    respiratorias inferiores o líquido pleural que cumpla los criterios
    microbiológicos definidos anteriormente y acompañado de los siguientes signos clínicos de neumonía: Radiografía o tomografía computarizada (TC) de tórax con hallazgos compatibles con un diagnóstico de neumonía, empeoramiento del intercambio de gases, muestra respiratoria profunda purulenta, Y una de las circunstancias siguientes: Recuento total de leucocitos periféricos > 10.000 células/mm3, > 15% de neutrófilos inmaduros (cayados) independientemente del recuento total de leucocitos periféricos o leucopenia con un recuento total de leucocitos < 4500 células/mm3, fiebre o hipotermia.
    E.4Principal exclusion criteria
    - Patient has received more than 72 hours of empirical therapy
    - Infection with CRE isolate with reduced susceptibilty to colistin
    - Presence of refractory septic shock
    - Objective clinical evidence for any of the following clinical syndromes that necessitates antimicrobial therapy for greater than 14 days: endovascular infection including endocarditis, osteomyelitis, prosthetic joint infection, meningitis and/or other central nervous system infections
    -Objective clinical evidence of infectious involvement of intravascular material not intended to be removed within 4 calendar days of initial positive culture
    - Pulmonary disease that precludes evaluation of therapeutic response including known bronchial obstruction or a history of post-obstructive pneumonia, tracheobronchitis, primary lung cancer or malignancies metastatic to the lung, bronchiectasis, known or suspected active tuberculosis
    - Patients with severe liver disease (Child-Pugh score of Class C)
    - Patients in acute renal failure or on intermittent hemodialysis (IHD) at the time of screening
    - Patients with a history of seizure disorder and who are receiving anti-convulsive therapy
    - Diagnosis of myasthenia gravis or any other neuromuscular disorder
    - El paciente ha recibido tratamiento empírico durante más de 72 horas
    - Infección por una cepa de CRE con sensibilidad reducida a colistina
    - Presencia de shock séptico refractario
    - Datos clínicos objetivos de alguno de los síndromes clínicos siguientes con necesidad de tratamiento antibiótico durante más de 14 días: infección endovascular, incluida endocarditis, osteomielitis, infección de prótesis articular, meningitis u otra infección del sistema nervioso central.
    - Datos clínicos objetivos de afectación infecciosa de material
    intravascular sin previsión de extracción en los 4 días siguientes al
    cultivo positivo inicial.
    - Enfermedad pulmonar que excluye la evaluación de la respuesta
    terapéutica incluyendo obstrucción bronquial conocida o antecedentes de neumonía postobstructiva, traqueobronquitis, cáncer de pulmón primario o neoplasias malignas metastásicas en el pulmón,bronquiectasias, tuberculosis activa confirmada o presunta.
    - Pacientes con hepatopatía grave (puntuación de Child Pugh de clase C).
    - Pacientes con insuficiencia renal aguda o en hemodiálisis intermitente (HDI) en el momento de selección.
    - Pacientes con antecedentes de trastorno convulsivo y que estén
    recibiendo tratamiento para el trastorno anticonvulsivo.
    - Diagnóstico de miastenia grave u otro trastorno neuromuscular.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint is all-cause mortality
    El criterio de valoración principal de la eficacia será la mortalidad por cualquier causa
    E.5.1.1Timepoint(s) of evaluation of this end point
    28 days
    28 días
    E.5.2Secondary end point(s)
    Secondary efficacy parameters include time to death through Day 28; all cause mortality at 14 days after randomization; assessment of clinical response (as determined by the adjudication committee) at end of treatment, test of cure, and end of study; overall incidence of adverse events; plazomicin PK parameters; and frequency with which the use of TDM leads to a dose adjustment of plazomicin.
    Los criterios de valoración secundarios de la eficacia serán el tiempo
    transcurrido hasta la muerte durante 28 días, la mortalidad por cualquier causa a los 14 días de la aleatorización, la evaluación de la respuesta clínica (según lo determinado por el comité de adjudicación) al final del tratamiento, comprobación de la curación y final del estudio; incidencia global de acontecimientos adversos; parámetros PK de plazomicina, y frecuencia con la que el uso del CTF lleva a un ajuste de la dosis de plazomicina.
    E.5.2.1Timepoint(s) of evaluation of this end point
    14 and 28 days
    14 y 28 días
    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 Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic Yes
    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) Yes
    E.7.4Therapeutic use (Phase IV) No
    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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA41
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    France
    Greece
    Italy
    Argentina
    Brazil
    Colombia
    Germany
    Korea, Republic of
    Spain
    Israel
    Mexico
    Poland
    Taiwan
    Turkey
    Ukraine
    United States
    E.8.7Trial has a data monitoring committee Yes
    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
    Last follow-up call for the last patient
    Última llamada de seguimiento para el último paciente
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial 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: 179
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 179
    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 Yes
    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
    Critically ill in an intensive care unit with a subset sedated and/or on mechanical ventilation
    Pacientes en estado crítico en una unidad de cuidados intensivos con
    un subgrupo sedado o con ventilación mecánica
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state33
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 200
    F.4.2.2In the whole clinical trial 358
    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)
    Both of the study treatments (trial drug, plazomicin and comparator, colistin) are intended for the short term treatment of bacterial infection. If the treatment fails, the investigators are expected to use an appropriate alternative standard of care treatment.
    Ambos tratamientos del estudio (el fármaco del ensayo, plazomicina y
    el comparador, colistina) están destinados para el tratamiento a corto
    plazo de la infección bacteriana. Si el tratamiento fracasa, se espera
    que los investigadores utilicen un tratamiento estándar alternativo
    adecuado.
    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 Decision2014-01-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-01-09
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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