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    Summary
    EudraCT Number:2007-001863-31
    Sponsor's Protocol Code Number:LR-07
    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:2008-10-22
    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 number2007-001863-31
    A.3Full title of the trial
    Estudio Comparativo de la Eficacia de Pautas “Cortas” y “Largas” de la Combinación Rifampicina-Levofloxacino en la Infección Estafilocócica Postquirúrgica Precoz y Hematógena de Prótesis Articular

    o bien

    Comparative Study of the Efficacy of “Short” and “Long” duration Levofloxacin-Rifampicin combination therapy in the treatment of Early Postoperative and Haematogenous Staphylococcal Prosthetic Joint Infection
    A.4.1Sponsor's protocol code numberLR-07
    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 SponsorHospital Universitario de Bellvitge
    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 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 TAVANIC
    D.2.1.1.2Name of the Marketing Authorisation holderSanofi Aventis SA
    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.3.1Product nameLEVOFLOXACIN
    D.3.2Product code LEVOFLOXACIN
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNLEVOFLOXACIN
    D.3.9.1CAS number 100986-85-4
    D.3.9.2Current sponsor codeLEVOFLOXACINO
    D.3.9.3Other descriptive nameLEVOFLOXACINO
    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) 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 No
    D.3.11.8Extractive medicinal product No
    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 No
    D.IMP: 2
    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 RIFALDIN
    D.2.1.1.2Name of the Marketing Authorisation holderMARION MERRELL, S.A.
    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.3.1Product nameRIFAMPICIN
    D.3.2Product code RIFAMPICIN
    D.3.4Pharmaceutical form Capsule*
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNRIFAMPICIN
    D.3.9.1CAS number 13292-46-1
    D.3.9.2Current sponsor codeRIFAMPICINA
    D.3.9.3Other descriptive nameRIFAMPICINA
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number300
    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 No
    D.3.11.8Extractive medicinal product No
    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 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
    El tratamiento de elección de la infección precoz postquirúrgica y hematógena de prótesis articular con implante estable es el desbridamiento precoz con retención del material y un tratamiento antibiótico posterior. En los casos de etiología estafilocócica el tratamiento con rifampicina y quinolonas durante un período prolongado de 3-6 meses se considera el más indicado; sin embargo esta duración prolongada se ha establecido de una forma empírica, sin criterios de evidencia suficientes.
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10021795
    E.1.2Term Infection and inflammatory reaction due to internal joint prosthesis
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10065011
    E.1.2Term Prosthesis related infection
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Evaluar la eficacia del tratamiento con desbridamiento precoz y antibioterapia con una combinación de rifampicina y levofloxacino por vía oral durante 8 semanas (Grupo A) (pauta corta a estudio) frente a una pauta de 3 meses (prótesis de cadera) ó 6 meses (prótesis de rodilla) (Grupo B) (pautas largas estándar), en la infección protésica postquirúrgica precoz y en la infección hematógena de etiología estafilocócica (S. aureus y Estafilococo Coagulasa Negativo).
    E.2.2Secondary objectives of the trial
    a) Comparar los resultados obtenidos en prótesis de rodilla y de cadera
    b) Analizar el valor de la PCR seriada como predictor de la evolución clínica
    c) Comparar la tolerancia y efectos adversos en ambos grupos de antibioterapia.
    d) Documentar el posible desarrollo de resistencia de las cepas responsables de la infección a rifampicina y/o a fluoroquinolonas en ambos grupos terapéuticos.
    e) Comparar el desarrollo de aflojamiento protésico en ambos grupos terapéuticos.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Se incluirán consecutivamente todos los pacientes con infección protésica de cadera o rodilla postquirúrgca precoz o hematógena, etiología estafilocócica e implante estable, (síntomas que no excedan las tres semanas en el momento de la cirugía) tratadas con desbridamiento y retención de la prótesis, atendidos en los centros participantes durante el período de estudio (2 años).

     Diagnóstico de infección protésica: fiebre, dolor local, signos inflamatorios o supuración de la herida y/o visualización de pus macroscópico en el acto quirúrgico. La infección protésica se catalogará de IPP si se presenta durante los primeros 30 días posteriores a la implantación de la prótesis. La infección protésica se catalogará de IH cuando el cuadro clínico sea de presentación brusca, o se desarrolle concomitantemente a la presencia de bacteriemia u otra infección localizada como foco original de la misma.

     Diagnóstico de etiología estafilocócica a partir de muestras fiables: hemocultivos, cultivo de pus obtenido por artrocentesis o cultivos operatorios.

     Se aceptarán los casos de etiología polimicrobiana, siempre que no sea necesario añadir otro antibiótico con actividad antiestafilocócica a la pauta de levofloxacino y rifampicina.
    E.4Principal exclusion criteria
     Edad inferior a 18 años.
     Embarazo o lactancia.
     Expectativa de vida inferior a 6 meses.
     Negativa del paciente a participar y/o firmar el consentimiento informado.
     Negativa a abandonar el uso de lentes de contacto durante el tratamiento antibiótico.
     Dudas sobre el cumplimiento terapéutico.
     Alergia o intolerancia a quinolonas o rifampicina que hayan obligado a la suspensión del antibiótico.
     Resistencia del microorganismo aislado a quinolonas o rifampicina.
     Administración de antibióticos con actividad antiestafilocócica, distintos de la rifampicina y del levofloxacino durante más de 7 días, durante el período de tratamiento o el de seguimiento posterior.
     Retraso del desbridamiento más allá de 3 semanas desde el inicio de la clínica.
     Signos de aflojamiento protésico en la radiografía simple.
     Retirada del material protésico.
    E.5 End points
    E.5.1Primary end point(s)
    Criterios de evaluación de la respuesta:

    I. Curación: ausencia de fiebre, signos flogóticos o fístula y ausencia de aflojamiento radiológico en los controles sucesivos hasta los 12 meses.

    II. Fracaso:
    Por persistencia de la infección:
    -Durante el tratamiento: persistencia de la sintomatología que obliga a la retirada de la prótesis.
    - Al final del tratamiento: clínica sugestiva de infección con aislamiento del mismo microorganismo en muestras quirúrgicas o no quirúrgicas, siempre que el clínico las haya considerado valorables. La observación de un valor elevado de PCR al finalizar la pauta terapéutica asignada no se considera un criterio de fracaso por sí sola, sin la presencia concomitante de datos clínicos sugestivos de infección persistente.
     Por recaída: remisión inicial de los síntomas pero posterior reaparición de la clínica y aislamiento del mismo microorganismo, ya sea en muestras quirúrgicas o no quirúrgicas, siempre que el clínico las haya considerado valorables, una vez finalizado el tratamiento.

     Por reinfección: remisión inicial de los síntomas pero posterior reaparición de la clínica con aislamiento de un microorganismo distinto en muestras valorables.

    Se evaluará la posible aparición de resistencia a rifampicina y/o levofloxacino en las cepas de estafilococos aisladas al final del tratamiento o posteriormente en los casos de persistencia de la infección o recaída.

    III. Aflojamiento aséptico: presencia de aflojamiento protésico en el curso del seguimiento, pero sin evidencia de infección y con negatividad microbiológica.

    IV. Efectos adversos: Se recogerán los acontecimientos adversos y se evaluará la posible relación de causalidad con los tratamientos del estudio. Se notificaran los acontecimientos adversos a las autoridades competentes según lo establecido en el real Decreto 223/04. Se recogerán de manera especial los efectos adversos siguientes:

     Gastrointestinales (molestias gástricas, vómitos, diarrea etc)
     Elevación de transaminasas.
     Síntomas compatibles con síndrome flu-like inducido por rifampicina (fiebre, escalofríos, cefalea, artromialgias etc).
     Síndrome lupus-like inducido por rifampicina.
     Miopatía o tendinitis por quinolonas.
    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 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
    Mismos medicamentos con diferente duración del tratamiento
    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 concerned11
    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 Information not present in EudraCT
    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
    Se establece como final del ensayo clínico la última visita protocolizada del último paciente incluido en el ensayo clínico.
    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 months
    E.8.9.1In the Member State concerned days
    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 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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    El protocolo no excluye a los paciente incapaces de dar consetimiento informado por ellos mismos, pero sí permite que otra persona responsable del paciente lo conceda.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state195
    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)
    El seguimiento de los pacientes cuando su participación ha terminado en el ensayo no será diferente a los demás pacientes atendidos con este tipo de infección en los centros implicados en el estudio.
    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 Decision2009-03-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-01-08
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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