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    Summary
    EudraCT Number:2014-000914-76
    Sponsor's Protocol Code Number:1409R2121
    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:2014-10-16
    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 number2014-000914-76
    A.3Full title of the trial
    A Multicenter, Double-blind, Randomized, Clinical Study to Assess the Efficacy and Safety of Intravenous S-649266 in Complicated Urinary Tract Infections with or without Pyelonephritis or Acute Uncomplicated Pyelonephritis Caused by Gram-Negative Pathogens in Hospitalized Adults in Comparison with Intravenous Imipenem/Cilastatin
    Estudio multicéntrico, doble ciego y randomizado para evaluar la eficacia y la seguridad de S-649266 administrado por vía intravenosa en el tratamiento de las infecciones complicadas de las vías urinarias, acompañadas o no de pielonefritis o pielonefritis aguda no sobreañadida, causadas por bacterias gramnegativas en pacientes adultos hospitalizados, en comparación con el tratamiento intravenoso con imipenem/cilastatina
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A randomized study in hospitalised patients with complicated urinary tract infections caused by Gram-negative bacteria to compare the efficacy and safety of S-649266 to Imipenem/Cilastin, both administered by intravenous infusion
    Estudio randomizado en pacientes hospitalizados con infecciones complicadas de las vías urinarias causadas por bacterias gramnegativas para comparar la eficacia y seguridad de S-649266 con imipenem/cilastatina ambos administrads por infusion intravenosa.
    A.4.1Sponsor's protocol code number1409R2121
    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 SponsorShionogi 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 supportShionogi Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMedpace Spain S.L
    B.5.2Functional name of contact pointCountry Manager - Monica Bermejo
    B.5.3 Address:
    B.5.3.1Street AddressC/ Antonio Maura 16, 5º Izq.
    B.5.3.2Town/ cityMadrid
    B.5.3.3Post code28014
    B.5.3.4CountrySpain
    B.5.4Telephone number+34918534105
    B.5.5Fax number900981853
    B.5.6E-mailm.bermejo@medpace.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.3.2Product code S-649266
    D.3.4Pharmaceutical form Powder 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 INNNA
    D.3.9.3Other descriptive nameS-649266
    D.3.9.4EV Substance CodeSUB131099
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number500
    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 Zienam
    D.2.1.1.2Name of the Marketing Authorisation holderMSD SHARP & DOHME GMBH
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    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
    Complicated Urinary Tract Infections with or without Pyelonephritis or Acute Uncomplicated Pyelonephritis caused by Gram-negative Pathogens
    infecciones causadas por organismos patógenos gramnegativos multirresistentes (MR) a partir de una infección complicada de las vías urinarias (ICVU), en presencia o no de pielonefritis o pielonefritis aguda no sobreañadida
    E.1.1.1Medical condition in easily understood language
    Complicated Urinary Tract Infections caused by Gram-negative pathogens
    infecciones complicadas de las vías urinarias causadas por bacterias gramnegativas
    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 HLT
    E.1.2Classification code 10046577
    E.1.2Term Urinary tract infections
    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
    To compare the clinical and microbiologic responses of S-649266 with those of imipenem/cilastatin (IMP/CS) in a patient population at risk for multidrug resistant (MDR) Gram-negative pathogens originating from complicated urinary tract infection (cUTI) with or without pyelonephritis or acute uncomplicated pyelonephritis. The primary efficacy assessment will be performed at the test of cure (TOC) (approximately 7 days following the end of treatment (EOT)).
    ? Comparar las respuestas clínicas y microbiológicas de S-649266 y imipenem/cilastatina (IMP/CS) en una población de pacientes con riesgo de padecer infecciones causadas por organismos patógenos gramnegativos multirresistentes (MR) a partir de una infección complicada de las vías urinarias (ICVU), en presencia o no de pielonefritis o pielonefritis aguda no sobreañadida. La evaluación principal de la eficacia se llevará a cabo en la prueba de curación (PC) (a los 7 días de haber finalizado el tratamiento [FT]).
    E.2.2Secondary objectives of the trial
    ? To assess the safety of S-649266 in a patient population with the potential to have MDR bacterial infections.
    ? To compare the clinical and microbiologic response of S-649266 with IMP/CS in a patient population at risk for MDR Gram-negative pathogens originating from cUTI at Early Assessment (EA), EOT, and at follow-up (FUP) as defined in the table of Acceptable Time Windows
    ? To assess microbiologic response per pathogen at EA, EOT, TOC, and FUP
    ? To assess microbiologic response per patient at EA, EOT, TOC, and FUP
    ? To assess clinical response per pathogen at EA, EOT, TOC, and FUP
    ? To assess clinical response per patient at EA, EOT, TOC, and FUP
    ? To determine plasma and urine drug concentrations at specified times post dose in a population of patients with acute infection.
    ?Evaluar la seguridad de S-649266 en una población de pacientes que estén en riesgo de padecer infecciones bacterianas causadas por agentes patógenos MR.
    ?Comparar la respuesta clínica y microbiológica de S-649266 y la de IMP/CS en una población de pacientes que estén en riesgo de padecer infecciones causadas por agentes patógenos gramnegativos MR a partir de una ICVU, en las visitas de Evaluación inicial (EI), FT y seguimiento, tal como se define en la tabla de Márgenes de tiempo aceptables (Tabla 7-2).
    ?Evaluar la respuesta microbiológica según el agente patógeno en las visitas de EI, FT, PC y seguimiento.
    ?Evaluar la respuesta microbiológica según el paciente en las visitas de EI, FT, PC y seguimiento.
    ?Evaluar la respuesta clínica según el agente patógeno en las visitas de EI, FT, PC y seguimiento.
    ?Evaluar la respuesta clínica según el paciente en las visitas de EI, FT, PC y seguimiento.
    ?Determinar las concentraciones plasmáticas y en orina del fármaco
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Hospitalized patients who have a clinical diagnosis of either cUTI with or without pyelonephritis or acute uncomplicated pyelonephritis, and who have provided written informed consent or informed consent provided by legal guardian. (Note: Country specific rules and local Ethics Committee approval for legal guardian informed consent will determine whether or not a patient unable to comprehend or sign the informed consent is allowed to be enrolled in the study).
    The specific clinical diagnosis will include:

    cUTI with a history of at least one of the following:
    ?Indwelling urinary catheter
    ?Urinary retention (at least 100 mL of residual urine after voiding)
    ?Neurogenic bladder
    ?Obstructive uropathy
    ?Azotemia (BUN and creatinine values greater than normal laboratory values)
    OR
    Pyelonephritis and normal urinary tract anatomy, ie, acute uncomplicated pyelonephritis

    AND
    All patients must have at least two of the following signs or symptoms:
    ?Chills or rigors or warmth associated with fever (temperature greater than or equal to 38 degrees Celsius)
    ?Flank pain (pyelonephritis) or suprapubic/pelvic pain (cUTI)
    ?Nausea or vomiting
    ?Dysuria, urinary frequency, or urinary urgency
    ?Costo-vertebral angle tenderness on physical examination

    AND
    Urinalysis evidence of pyuria demonstrated by:
    ?Dipstick analysis positive for leukocyte esterase
    ?Or ?10 WBCs per ?L in unspun urine, or ?10 WBCs per high power field in spun urine)
    2. Has a positive urine culture obtained within 48 hours prior to randomization containing ? 100000CFU/mL of a Gram-negative uropathogen likely to be susceptible to imipenem (Note: patients may be enrolled prior to the results of the urine culture being available)
    3. Patients, who have been treated previously with an empiric antibiotic other than the study medications, but failed treatment, both clinically and microbiologically, are eligible for the study if they have an identified uropathogen which is non-susceptible to the empiric treatment and is a Gram-negative uropathogen likely to be susceptible to imipenem.
    4. Female patients can participate if they are surgically sterile or have completed menopause, or if they are capable of having children, are not pregnant or nursing, they agree not to attempt pregnancy while receiving intravenous study drug therapy and for a period of 7 days thereafter
    1. Pacientes hospitalizados que tengan un diagnóstico clínico de ICVU, con o sin pielonefritis, o pielonefritis aguda no sobreañadida, que hayan otorgado (o su tutor legal haya otorgado) su consentimiento informado por escrito. (Nota: Las normas específicas nacionales y la autorización de los Comités Éticos locales del consentimiento informado otorgado por los tutores legales determinarán si se permite a un paciente que no pueda comprender o firmar el documento de consentimiento informado entrar en el estudio).
    El diagnóstico clínico específico incluirá lo siguiente:

    ICVU con antecedentes de al menos una de los siguientes casos:
    ? Sonda vesical permanente.
    ? Retención urinaria (un volumen de residuo urinario de 100 ml como mínimo tras la micción).
    ? Vejiga neurógena.
    ? Uropatía obstructiva.
    ? Azoemia (concentraciones de NUS y creatinina superiores a los valores analíticos normalizados).
    O
    Pielonefritis y estructura anatómica normal de las vías urinarias, es decir, pielonefritis aguda no sobreañadida.

    Y
    Todos los pacientes deben presentar al menos dos de los signos o síntomas siguientes:
    ? Escalofríos o temblores acompañados de sensación de calor con fiebre (una temperatura de 38 °C en adelante).
    ? Dolor en la fosa lumbar (pielonefritis) o dolor suprapúbico o pélvico (ICVU).
    ? Náuseas o vómitos.
    ? Disuria, polaquiuria o tenesmo vesical.
    ? Dolor en la fosa lumbar a la palpación.

    E
    Indicios de leucocituria en el análisis de orina, demostrados mediante:
    ? Resultado positivo en el análisis de estearasa leucocitaria obtenido mediante tiras reactivas.
    ? O FL ? 10 por ?l en orina no centrifugada o FL ? 10 por campo de gran aumento en orina centrifugada.
    2. Dar un resultado positivo en el cultivo de orina obtenido en las 48 horas previas a la randomización, que contenga ? 105 UFC (unidades formadoras de colonias)/ml de cepas uropatógenas gramnegativas que puedan ser susceptibles al imipenem (nota: los pacientes deberán haber entrado en el estudio antes de que se obtengan los resultados del cultivo de orina).
    3. Los pacientes que hayan sido tratados previamente con un antibiótico experimental distinto a los fármacos del estudio, pero que no hayan respondido al tratamiento, ni clínica ni microbiológicamente, son aptos para el estudio si se ha identificado una cepa uropatógena que no sea susceptible al tratamiento experimental y sea un gramnegativo que pueda ser susceptible a imipenem.
    4. Las mujeres pueden participar en el estudio si son estériles quirúrgicamente o han superado el período menopáusico o, en caso de estar en edad fértil, no estén embarazadas ni en el período de lactancia, acepten no quedarse embarazadas mientras estén recibiendo el tratamiento con el fármaco del estudio por vía intravenosa (i.v.) y en los 7 días posteriores a este.
    E.4Principal exclusion criteria
    1. Have a history of hypersensitivity reactions to carbapenems, cephalosporins, penicillins, or other ?-lactam antibiotics
    2. Patient's urine culture at study entry isolates more than 2 microorganisms, regardless of colony count, or patient has a confirmed fungal UTI.
    3. Patients with asymptomatic bacteriuria, the presence of ?100000CFU/mL of a uropathogen and pyuria but without local or systemic symptoms
    4. Patient is receiving hemodialysis or peritoneal dialysis. Impairment of renal function with an estimated CrCl ? 20 mL/min, requirement for peritoneal dialysis, hemodialysis or hemofiltration, or oliguria (< 20 mL/h urine output over 24 hours).
    1. Tener antecedentes de reacción de hipersensibilidad a los carbapenémicos, cefalosporinas, penicilinas u otros antibióticos betalactámicos.
    2. Pacientes que en el cultivo de orina realizado en la entrada al estudio se aíslen más de 2 microrganismos, independientemente del recuento de colonias, o pacientes que padezcan una infección urinaria confirmada.
    3. Pacientes con bacteriuria asintomática, presencia de ? 105 UFC/ml de una cepa uropatógena y leucocituria sin síntomas sistémicos o locales.
    4. Pacientes que estén siendo sometidos a hemodiálisis o diálisis peritoneal. Insuficiencia renal, con un CrCl calculado ? 20 ml/min, que precise diálisis peritoneal, hemodiálisis o hemofiltración u oliguria (volumen de orina de 24 horas < 20 ml/h).
    E.5 End points
    E.5.1Primary end point(s)
    Clinical and microbiologic response: Clinical cure in clinical outcomes (resolution of the signs and symptoms of cUTI or return to pre-infection baseline if known) and Eradication in microbiological outcomes (microbiological success) at the Test of Cure (TOC).
    La respuesta clínica y la respuesta microbiológica: La evaluación del criterio compuesto de valoración principal de la eficacia de erradicación microbiológica y respuesta clínica se llevará a cabo con la prueba de curación (PC)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Test of cure (TOC) - EOT + 7 days
    prueba de curación (PC) (unos 7 días después de la finalización del tratamiento [FT]; se define la FT como el último día de tratamiento con el fármaco del estudio).
    E.5.2Secondary end point(s)
    Microbiologic response per pathogen and patient at EA, EOT, TOC, and FUP
    Clinical response per patient and pathogen at EA, EOT, TOC, and FUP
    Pharmacokinetic and safety profile
    respuesta microbiológica por patógenos y paciente de EI, FT, PC y seguimiento
    respuesta clínica por paciente y el patógeno en EI, FT, PC y seguimiento Perfil farmacocinético y de seguridad
    E.5.2.1Timepoint(s) of evaluation of this end point
    Early assessment (EA) - Day 4
    End of treatment (EOT) - last day of study drug ie up to 14 days
    Test of cure (TOC) - EOT + 7 days
    Follow-up (FUP) - EOT + 14 days

    PK Day 3: plasma-prior to, just before the end and 2 hours post infusion; urine-2 and 6 hours post infusion
    La evaluación temprana (EI) - Día 4
    Final del tratamiento (FT) - último día del fármaco del estudio, es decir, hasta 14 días
    Prueba de cura (PC) - FT + 7 días
    Seguimiento - FT+ 14 días

    PK Día 3: plasma antes de, justo antes del final y 2 horas después de la infusión; orina-2 y 6 horas después de la infusión
    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 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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA55
    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
    Canada
    Croatia
    Czech Republic
    Germany
    Hungary
    Italy
    Japan
    Poland
    Romania
    Russian Federation
    Spain
    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 Visit Last Subject (LVLS)
    Ultima visita del ultimo paciente (LVLS)
    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 months0
    E.8.9.1In the Member State concerned days7
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months4
    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: 120
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 180
    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 state11
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 279
    F.4.2.2In the whole clinical trial 300
    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)
    None
    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 Decision2015-04-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-11-14
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-08-16
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