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    Summary
    EudraCT Number:2015-001588-37
    Sponsor's Protocol Code Number:ACHN-490-009
    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:2015-09-11
    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 number2015-001588-37
    A.3Full title of the trial
    A Phase 3, Randomized, Multicenter, Double-Blind Study to Evaluate the Efficacy and Safety of Plazomicin Compared with Meropenem followed by Optional Oral Therapy for the Treatment of Complicated Urinary Tract Infection (cUTI), including Acute Pyelonephritis (AP), in Adults
    Estudio de Fase III aleatorizado, multicéntrico y doble ciego para evaluar la eficacia y seguridad de Plazomicina comparada con Meropenem seguidos de terapia oral opcional para el tratamiento en adultos de la Infección Complicada del Tracto Urinario (ITUc), incluida la Pielonefritis Aguda (PA)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study of Plazomicin Compared with Meropenem followed by Optional Oral Therapy for the Treatment of Complicated Urinary Tract Infection (cUTI), including Acute Pyelonephritis (AP)
    Un Estudio de Plazomicina comparada con Meropenem seguidos de terapia oral opcional para el tratamiento en adultos de la Infección Complicada del Tracto Urinario (ITUc), incluida la Pielonefritis Aguda (PA)
    A.4.1Sponsor's protocol code numberACHN-490-009
    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.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 number34911459110
    B.5.5Fax number34914342773
    B.5.6E-mailregulatory.spain@pharm-olam.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 for solution for infusion
    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 INNTo be determined
    D.3.9.1CAS number 1380078-95-4
    D.3.9.2Current sponsor codeACHN-490
    D.3.9.3Other descriptive nameACHN-490
    D.3.9.4EV Substance CodeSUB131046
    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 Meronem IV
    D.2.1.1.2Name of the Marketing Authorisation holderAstraZeneca UK Ltd
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 solution for injection/infusion
    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 trihydrate
    D.3.9.1CAS number 96036-03-2
    D.3.9.3Other descriptive nameMEROPENEM
    D.3.9.4EV Substance CodeSUB08778MIG
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for infusion
    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
    Complicated Urinary Tract Infection (cUTI)
    Acute Pyelonephritis (AP)
    Infección Complicada del Tracto Urinario (ITUc)
    Pielonefritis Aguda (PA)
    E.1.1.1Medical condition in easily understood language
    Complicated Urinary Tract Infection (cUTI)
    Acute Pyelonephritis (AP)
    Infección Complicada del Tracto Urinario (ITUc)
    Pielonefritis Aguda (PA)
    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 18.0
    E.1.2Level PT
    E.1.2Classification code 10054088
    E.1.2Term Urinary tract infection bacterial
    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 this study is to demonstrate the non-inferiority of plazomicin compared with meropenem based on the difference in composite microbiological eradication and clinical cure rate at both the Day 5 and test-of-cure (TOC) visits
    El objetivo principal de este estudio es demostrar la no inferioridad de plazomicina en comparación con meropenem según la diferencia de la tasa combinada de erradicación microbiológica y curación clínica tanto en la visita del Día 5 como en la visita de comprobación de curación (CDC).
    E.2.2Secondary objectives of the trial
    The secondary objectives of this study are to:
    - Summarize the composite microbiological eradication and clinical cure rates of plazomicin compared with meropenem at the Day 5 and TOC visits
    - Evaluate the safety of plazomicin in patients with cUTI including AP
    Los objetivos secundarios de este estudio son los siguientes:
    - Resumir las tasas combinadas de erradicación microbiológica y curación clínica de plazomicina en comparación con meropenem en la población microbiológicamente evaluable (ME) en las visitas del Día 5 y CDC.
    - Evaluar la seguridad de plazomicina en pacientes con ITUc, incluida la PA.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Pyuria
    - Have a pretreatment baseline urine culture obtained within 36 hours before the start of administration of the first dose of study drug
    - Clinical signs and/or symptoms of acute pyelonephritis or complicated urinary tract infection
    - Normal renal function or mild renal impairment
    - Piuria
    - Disponer de un urocultivo basal pretratamiento, obtenido en las 36 horas anteriores al inicio de la administración de la primera dosis del fármaco del estudio
    - Signos y/o síntomas clínicos de PA o de ITUc
    - Función renal normal o insuficiencia renal leve
    E.4Principal exclusion criteria
    - Confirmed fungal urinary tract infection at the time of randomization
    - Known urinary tract infection or colonization with Gram-positive pathogens
    - Current cUTI or AP is known to be caused by a pathogen resistant to meropenem
    - Female patients of childbearing potential if they are known to be pregnant or have a positive pregnancy test at screening, breastfeeding, or unable or unwilling to use a highly effective method of birth control during the study and for at least 30 days following the last dose of study medication
    - Any rapidly progressing disease or immediately life-threatening illness
    - Documented presence of immunodeficiency or an immunocompromised condition
    - Documented or known history of otologic surgery or disease including use of hearing aid, head injury, Ménière's disease, tumor of the head, neck, or auditory system, perilymphatic fistula, autoimmune disease of the inner ear
    - Infección urinaria por hongos confirmada en el momento de la aleatorización
    - Infección urinaria conocida o colonización en el momento de la aleatorización con microorganismos patógenos grampositivos
    - ITUc o la PA actual está provocada por un microorganismo patógeno resistente a meropenem
    - Mujeres con posibilidad de quedar embarazadas si se sabe que están embarazadas o tienen resultados positivos en una prueba de embarazo en la selección, mujeres en periodo de lactancia o aquellas que no pueden o no desean utilizar un método anticonceptivo muy eficaz durante el estudio y, al menos, los 30 días posteriores a la administración de la última dosis del fármaco del estudio
    - Cualquier enfermedad de evolución rápida o enfermedades potencialmente mortales de forma inminente
    - Presencia documentada de inmunodeficiencia o de un estado inmunodeprimido
    - Antecedentes documentados o conocidos de enfermedad o intervención otológica, entre los que se incluyen el uso de prótesis auditivas, traumatismo craneal, síndrome de Ménière, tumor en la cabeza, cuello o el sistema auditivo, fístula perilinfática, enfermedad autoinmunitaria del oído interno
    E.5 End points
    E.5.1Primary end point(s)
    Composite microbiological eradication and clinical cure rate in the microbiological modified intent-to-treat population
    Tasa combinada de erradicación microbiológica y curación clínica en la población por intención de tratar modificada microbiológica
    E.5.1.1Timepoint(s) of evaluation of this end point
    Days 5 and 17 (+/- 2 days) after study drug start
    Días 5 y 17 (+/- 2 días) después del inicio de la medicacación en estudio.
    E.5.2Secondary end point(s)
    (1) Composite microbiological eradication and clinical cure rate in the microbiologically evaluable population
    (2) Overall incidence of adverse events
    (1) Tasa combinada de erradicación microbiológica y curación clínica en la población evaluable
    (2) Incidencia Global de acontecimientos adversos
    E.5.2.1Timepoint(s) of evaluation of this end point
    (1) Days 5 and 17 (+/- 2 days) after study drug start
    (2) 32 Days
    (1) Días 5 y 17 (+/- 2 días) después del inicio de la medicacación en estudio.
    (2) 32 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 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) 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 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) 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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA43
    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
    Argentina
    Brazil
    Bulgaria
    Chile
    Colombia
    Czech Republic
    Estonia
    Georgia
    Germany
    Latvia
    Mexico
    Poland
    Russian Federation
    Serbia
    Spain
    Ukraine
    United Kingdom
    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
    LVLS
    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 months16
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months23
    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: 371
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 159
    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 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 state15
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 289
    F.4.2.2In the whole clinical trial 530
    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)
    The study treatments (plazomicin [test drug], meropenem [comparator], and levofloxacin [optional oral therapy]) 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.
    Los tratamientos del estudio (plazomicina [fármaco en investigación], meropenem [comparador], y levofloxacinao [terapia oral opcional]) están destinadas para el tratamiento a corto plazo de la infección bacteriana. Si el tratamiento fracasa, se espera que los investigadores utilicen un tratamiento adecuado de cuidado estándar alternativo.
    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 Decision2015-11-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-10-29
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-09-22
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