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    The EU Clinical Trials Register currently displays   44237   clinical trials with a EudraCT protocol, of which   7338   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:2006-000874-56
    Sponsor's Protocol Code Number:BAY12-8039/11976
    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:2006-06-06
    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 number2006-000874-56
    A.3Full title of the trial
    Estudio prospectivo, aleatorizado, de doble simulación, doble ciego y multicéntrico para comparar la seguridad y la eficacia de una dosis diaria de moxifloxacino 400 mg IV QD 24h frente a ertapenem 1.0g IV QD 24 h con una duración del tratamiento de 5 a 14 días en sujetos con infecciones intraabdominales complicadas. (Estudio PROMISE)
    A.3.2Name or abbreviated title of the trial where available
    PROMISE
    A.4.1Sponsor's protocol code numberBAY12-8039/11976
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorBayer HealthCare AG
    B.1.3.4CountryGermany
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 AVALOX
    D.2.1.1.2Name of the Marketing Authorisation holderBAYER VITAL 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.3.1Product nameMoxifloxacin
    D.3.2Product code BAY 12-8039
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INNmoxifloxacin
    D.3.9.2Current sponsor codeBAY 12-8039
    D.3.10 Strength
    D.3.10.1Concentration unit mg/l milligram(s)/litre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1.6
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    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 Yes
    D.3.11.13.1Other medicinal product typeantibióticos
    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 INVANZ
    D.2.1.1.2Name of the Marketing Authorisation holderMERCK SHARP & DOHME LIMITED
    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.3.1Product nameErtapenem
    D.3.4Pharmaceutical form Powder for solution for infusion
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INNertapenem
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    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 Yes
    D.3.11.13.1Other medicinal product typeantibióticos
    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
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboPowder for solution 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
    Infecciones Intraabdominales complicadas
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 8.1
    E.1.2Level LLT
    E.1.2Classification code 10056570
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Los objetivos del presente estudio son comparar la seguridad y la eficacia de una dosis diaria de 400 mg de moxifloxacino i.v. con una dosis diaria de 1 g de ertapenem i.v. en sujetos adultos con cIAI que requieran una intervención quirúrgica y un tratamiento antibiótico parenteral.

    La variable principal de eficacia en este estudio es la respuesta clínica al cabo de 21-28 días tras el fin del tratamiento con el medicamento del estudio (visita de test de cura).
    E.2.2Secondary objectives of the trial
    • Respuesta clínica y bacteriológica el día 5 ± 1 del tratamiento.
    • Respuesta clínica y bacteriológica al final del tratamiento (FDT).
    • Respuesta bacteriológica durante la visita de TdC (21-28 días tras el FDT).
    • Respuesta clínica durante la visita de TdC en sujetos con infección intraabdominal documentada bacteriológicamente.
    • Mortalidad atribuible a infecciones intraabdominales durante la visita de TdC (21-28 días tras el FDT).
    • Duración de la hospitalización (días en total).
    • Duración de la hospitalización tras la intervención (días).
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    Los sujetos deberán cumplir todos los criterios de inclusión que figuran a continuación:
    1. Hombres o mujeres hospitalizados  18 años de edad.
    2. Duración prevista del tratamiento con antibióticos intravenosos  5 días y ≤ 14 días.
    3. Capacidad para firmar un consentimiento informado.
    4. Infección intraabdominal confirmada o supuesta, definida de la siguiente manera:
    . En el caso de la infección intraabdominal confirmada, deberá haberse realizado una intervención quirúrgica (laparotomía o laparoscopia) durante las 24 horas anteriores a la inclusión que revele al menos uno de los siguientes trastornos:
    • Inflamación peritoneal importante con exudados purulentos (esto es, peritonitis).
    • Abscesos intraabdominales.
    • Perforación intestinal macroscópica con peritonitis localizada o difusa.
    . Los sujetos incluidos por una supuesta infección intraabdominal deberán presentar:
    1. Pruebas radiológicas [radiografías abdominales simples, tomografía axial computerizada (TAC), resonancia magnética (RM) o ultrasonidos] de perforación gastrointestinal o de absceso intraabdominal
    y
    2. Los siguientes signos y síntomas:
    • Síntomas relativos a la cavidad abdominal (p.ej., anorexia, náuseas, vómitos o dolor) que se manifiesten durante al menos 24 horas.
    • Dolor con la palpación (con o sin descompresión), contractura abdominal, ausencia o disminución de borborigmos, rigidez de la pared abdominal.
    • Al menos dos de los siguientes criterios SIRS (23):
    . Temperatura rectal o de la membrana timpánica > 38,0C o temperatura rectal o timpánica < 36,0°C.
    . Ritmo cardíaco > 90/min.
    . Ritmo respiratorio > 20/min.
    . Cifra de leucocitos > 12.000 células/mm3 o < 4.000 células/mm3.
    y
    3. Deberá programarse una intervención quirúrgica del sujeto (laparotomía o laparoscopia) dentro de las 24 horas siguientes a su inclusión en el estudio.
    E.4Principal exclusion criteria
    1) Hipersensibilidad conocida a las quinolonas y/o carbapenémicos y/o cualquier tipo de betalactámico (p.ej., penicilinas o cefalosporinas) o a cualquiera de sus excipientes.
    2) Mujeres embarazadas, en fase de lactancia o en las que no se pueda descartar un embarazo (Nota: todas las mujeres en edad fértil deberán someterse a una prueba de embarazo en orina antes de poder ser incluidas en el estudio).
    3) Antecedentes de trastornos/enfermedad tendinosa relacionados con el tratamiento con quinolona.
    4) Prolongación QT adquirida documentada o congénita; hipocalemia sin corregir; bradicardia clínicamente relevante, insuficiencia cardíaca clínicamente relevante con fracción de eyección ventricular izquierda reducida; antecedentes de arritmias sintomáticas.
    5) Uso concomitante de cualquiera de los siguientes medicamentos, que se ha observado que aumentan el intervalo QT: antiarrítmicos de clase IA (p.ej. quinidina, hidroquinina, disopiramida) o antiarrítmicos de clase III (p.ej. amiodarona, sotalol, dofetilida, ibutilida), neurolépticos (p.ej. fenotiacinas, pimozida, sertindol, haloperidol, sultoprida), agentes antidepresivos tricíclicos, determinados antimicrobianos (esparfloxacino, eritromicina i.v., pentamidina, antimaláricos, particularmente halofantrina), determinados antihistamínicos (terfenadina, astemizol, mizolastina) y otros (cisaprida, vincamina i.v., bepridilo, difemanilo).
    6) Enfermedad hepática terminal grave conocida (Child Pugh Clase C, véase el apéndice 10.2).
    7) Aclaramiento de creatinina  30 ml/min/1,73 m2 (la fórmula de Cockroft-Gault para calcular el aclaramiento de creatinina puede consultarse en el apéndice 10.5).
    8) Tratamiento antibacteriano sistémico administrado durante más de 24 horas dentro de los 7 días siguientes a la inclusión en el estudio.
    9) Necesidad de un tratamiento antibacteriano sistémico con un agente que no sea ninguno de los indicados en el protocolo del estudio (Nota: se aceptará un tratamiento antimicótico profiláctico).
    10) Sonda peritoneal permanente.
    11) Ascitis preexistente o supuesta peritonitis bacteriana espontánea.
    12) Perforación del estómago o del duodeno, si la duración de la perforación es inferior a 24 horas o si se ha intervenido durante las 24 horas siguientes a la perforación.
    13) Perforación del intestino delgado (excluyendo el duodeno) o del colon, si la duración de la perforación es inferior a 12 horas o si se ha intervenido durante las 12 horas siguientes a la perforación.
    14) Todos los procesos pancreáticos, incluyendo sepsis pancreática, sepsis peripancreática o infección intraabdominal secundaria a pancreatitis.
    15) Absceso hepático y esplénico.
    16) Necrosis o isquemia intestinal transmural sin perforación, absceso o peritonitis confirmados.
    17) Colecistitis aguda y gangrenosa sin perforación.
    18) Colangitis aguda.
    19) Apendicitis precoz aguda, supurativa o gangrenosa sin perforación.
    20) Sujetos que requieran irrigación de antibióticos en la cavidad abdominal o en la herida de la intervención.
    21) Tratamiento con “abdomen abierto” o marsupialización, o previsión de varias laparotomías.
    22) Infecciones originadas en el aparato genital femenino.
    23) Infecciones perinefríticas.
    24) Signos de sepsis con choque que requiera la administración de vasopresores durante más de 4 horas consecutivas.
    25) Enfermedad rápidamente mortal subyacente conocida (muerte esperada en un plazo de 6 meses).
    26) Neutropenia (cifra de neutrófilos < 1.000/l) causada por un tratamiento inmunosupresor o por una neoplasia maligna.
    27) Pacientes que estén recibiendo un tratamiento crónico con un inmunosupresor conocido (incluyendo un tratamiento crónico con > 15 mg/día de prednisona sistémica o equivalente).
    28) Sujetos que se sepa que padecen SIDA (cifra CD4 <200/µl) o VIH seropositivos que estén recibiendo un HAART (Nota: podrá incluirse a sujetos con VIH+. No se requerirá una prueba del VIH para este protocolo de estudio).
    29) Sujetos con una neoplasia o preneoplasia hematológica, incluyendo enfermedad de Hodgkin y linfoma no Hodgkin (podrá incluirse en este estudio a sujetos con tumor sólido).
    30) Sujetos con un índice de masa corporal (IMC)  45 kg/m2.
    31) Sujetos que ya hayan sido incluidos previamente en este estudio.
    32) Sujetos que hayan participado en cualquier estudio de investigación clínica sobre un medicamento durante las 4 semanas anteriores.
    E.5 End points
    E.5.1Primary end point(s)
    La variable principal de eficacia en este estudio es la respuesta clínica al cabo de 21-28 días tras el fin del tratamiento con el medicamento del estudio (visita de test de cura).
    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 No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Information not present in EudraCT
    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 No
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    de doble simulación ("double-dummy")
    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.8.3 The trial involves single site in the Member State concerned Information not present in EudraCT
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.5The trial involves multiple Member States Yes
    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 Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    E.8.7Trial has a data monitoring committee Information not present in EudraCT
    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
    El final del estudio se define como 'Base de datos Limpia'
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2006-06-06. Yes
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    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 state72
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 378
    F.4.2.2In the whole clinical trial 845
    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)
    Dado que la medicación del estudio es un antibiótico, la enfermedad (infección intraabdominal) se supone curada después de que el tratamiento con el medicamento del estudio se haya completado. Sin embargo, si procede, después de la participación en el estudio, los pacientes recibirán el tratamiento estándar.
    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 Decision2006-07-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-06-06
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2009-03-25
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