Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register allows you to search for protocol and results information on:
  • interventional clinical trials that are conducted in the European Union (EU) and the European Economic Area (EEA);
  • clinical trials conducted outside the EU / EEA that are linked to European paediatric-medicine development.
  • Learn   more about the EU Clinical Trials Register   including the source of the information and the legal basis.


    The EU Clinical Trials Register currently displays   42336   clinical trials with a EudraCT protocol, of which   6971   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).


    Phase 1 trials conducted solely in adults and that are not part of an agreed PIP are not public in the EU CTR (refer to European Guidance 2008/C 168/02   Art. 3 par. 2 and   Commission Guideline 2012/C 302/03,   Art. 5) .

    Clinical Trials marked as "Trial now transitioned" were transitioned to the Clinical Trial Regulation 536/2014 and can be further followed in the Clinical Trial Information System  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2018-002465-18
    Sponsor's Protocol Code Number:PROTEDI
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2019-08-09
    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 number2018-002465-18
    A.3Full title of the trial
    Efficacy and tolerance of 4 weeks of tedizolid in prosthetic joint infections treated with implant removal
    Eficacia y tolerancia de 4 semanas de tedizolid en infecciones articulares protésicas tratadas previamente con recambio del implante
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Efficacy and tolerance of 4 weeks of tedizolid in prosthetic joint infections treated with implant removal
    Eficacia y tolerancia de 4 semanas de tedizolid en infecciones articulares protésicas tratadas previamente con recambio del implante
    A.3.2Name or abbreviated title of the trial where available
    PROTEDI
    PROTEDI
    A.4.1Sponsor's protocol code numberPROTEDI
    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 SponsorFundació Clínic per a la Recerca Biomèdica
    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 supportBristol-Myers Squid
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationClinical Trials Unit (CTU)
    B.5.2Functional name of contact pointAnna Cruceta
    B.5.3 Address:
    B.5.3.1Street AddressCalle Rosselló 138
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08036
    B.5.3.4CountrySpain
    B.5.4Telephone number0034932279838
    B.5.6E-mailacruceta@clinic.cat
    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 SIVEXTRO
    D.2.1.1.2Name of the Marketing Authorisation holderMerck Sharp & Dohme de España, 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.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    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 INNTEDIZOLID
    D.3.9.1CAS number 856867-55-5
    D.3.9.2Current sponsor codeMK-1986
    D.3.9.3Other descriptive nameTEDIZOLID PHOSPHATE
    D.3.9.4EV Substance CodeSUB35385
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    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
    prosthetic joint infections treated with implant removal.
    infecciones de prótesis articulares tratadas con recambio de implante.
    E.1.1.1Medical condition in easily understood language
    Prosthetic joint infections treated with implant removal.
    Infecciones de prótesis articulares tratadas con recambio de implante.
    E.1.1.2Therapeutic area Diseases [C] - Bacterial Infections and Mycoses [C01]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    to evaluate the efficacy of 4 weeks of 200 mg/24h of tedizolid for prosthetic join infections caused by tedizolid susceptible microorganisms treated with implant removal in one or two stages at 6 months of follow-up after stopping tedizolid treatment.
    evaluar la eficacia de 4 semanas de 200 mg / 24 h de tedizolid para las infecciones protéiscas causadas por microorganismos susceptibles a tedizolid tratadas previamente con recambio del implante en una o dos etapas a los 6 meses de seguimiento después de suspender el tratamiento con tedizolid.
    E.2.2Secondary objectives of the trial
    - Evaluate the efficacy of tedizolid at 12 months of follow-up
    - evaluate the rate of gastrointestinal adverse events with tedizolid
    - determine the rate of haematological abnormalities during tedizolid treatment
    - in case of two-stage exchange, the rate of positive cultures during reimplantation.
    - Evaluar la eficacia de tedizolid a los 12 meses de seguimiento;
    - evaluar la tasa de eventos adversos gastrointestinales con tedizolid;
    - determinar la tasa de anormalidades hematológicas durante el tratamiento con tedizolid
    - en caso de intercambio en dos etapas, la tasa de cultivos positivos durante el reimplante.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male or female older than 18 years who accept and sign the informed consent.
    2. Infection signs onset more than 3 months after index arthroplasty.
    3. Diagnostic of chronic (≥3 weeks of clinical symptoms) hip or knee prosthetic joint infection according to MSIS criteria *(Parvizi J, Gherke T. Definition of peri-prosthetic joint infection. J Arthroplasty 2014; 29: 1331)
    4. Infection due to a tedizolid susceptible microorganism.
    5. Surgical approach: one or two – stage exchange of all implant components.
    6. Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
    1. Hombres o mujeres mayores de 18 años que acepten y firmen el consentimiento informado.
    2. Inicio de los signos de infección más de 3 meses después de la artroplastia índice.
    3. Diagnóstico de infecciones crónicas (≥3 semanas de síntomas clínicos) de artroplastia de cadera o rodilla según los criterios del MSIS * (Parvizi J, Gherke T. Definición de infección articular peri-protésica, J Arthroplasty 2014; 29: 1331)
    4. Infección debido a un microorganismo sensible a tedizolid.
    5. Enfoque quirúrgico: intercambio de una o dos etapas de todos los componentes del implante.
    6. Dispuesto y capaz de cumplir con las visitas programadas, el plan de tratamiento, las pruebas de laboratorio y otros procedimientos de estudio.
    E.4Principal exclusion criteria
    1. Patients with a prosthetic joint infection with negative cultures.
    2. Patients who undergo debridement without removing the prosthesis or only partially removed
    3. ≥15 days of other antibiotic treatment before starting tedizolid
    4. Life expeancy ≤ 1 year.
    5. Previous enrollment in this protocol.
    6. Hypersensitivity to tedizolid or any formulation excipients.
    7. Concurrent use of another investigational medication within 30 days of study entry.
    8. Women who are pregnant or breast-feeding
    1. Pacientes con una infección articular protésica con cultivos negativos.
    2. Pacientes que se someten a desbridamiento sin extirpar la prótesis o solo parcialmente extirpada.
    3. ≥15 días de otro tratamiento con antibióticos antes de comenzar el tedizolid.
    4. Esperanza de vida ≤ 1 año.
    5. Inscripción previa en este protocolo.
    6. Hipersensibilidad a tedizolid o cualquier excipiente de formulación.
    7. Uso concurrente de otro medicamento en investigación dentro de los 30 días posteriores al ingreso al estudio.
    8. Mujeres que están embarazadas o amamantando.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint will be the investigator-assessed clinical outcome (surgical wound closed and absence of local signs of infection) at the 9th visit (6 months after finishing tedizolid treatment).
    El punto final primario será el resultado clínico evaluado por el investigador (herida quirúrgica cerrada y ausencia de signos locales de infección) en la novena visita (6 meses después de terminar el tratamiento con tedizolid).
    E.5.1.1Timepoint(s) of evaluation of this end point
    The 9th visit (6 months after finishing tedizolid treatment).
    La novena visita (6 meses después de finalizar el tratamiento con tedizolid).
    E.5.2Secondary end point(s)
    Secondary Efficacy endpoints:
    1. Investigator-assessed clinical outcomes (surgical wound closed and absence of local signs of infection) at the 10th visit (12 months after finishing tedizolid treatment).
    2. The rate of positive cultures during reimplantation on the two stage exchange cases.

    Safety endpoints:
    3. The rate of gastrointestinal adverse events notified during the follow-up time (from the 3th until de 10th and last visit).
    4. The rate of hematological abnormalities (anemia,thrombocytopenia and leucopenia) evidenced by laboratory values during the treatment (3rd, 4th, 5th and 6th visits).
    Los endpoints de eficacia secundarios:
    1. Resultados clínicos evaluados por el investigador (herida quirúrgica cerrada y ausencia de signos locales de infección) en la 10ª visita (12 meses después de finalizar el tratamiento con tedizolid).
    2. La tasa de cultivos positivos durante el reimplante en los casos de intercambio de dos etapas.

    Endpoints secundarios de seguridad:
    3. La tasa de eventos adversos gastrointestinales notificados durante el tiempo de seguimiento (del 3 al 10 y última visita).
    4. La tasa de anomalías hematológicas (anemia, trombocitopenia y leucopenia) evidenciadas por valores de laboratorio durante el tratamiento (3ª, 4ª, 5ª y 6ª visitas).
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. The 10th visit (12 months after finishing tedizolid treatment).
    2. during reimplantation
    3. during the follow-up time (from the 3th until de 10th and last visit).
    4. during the treatment (3rd, 4th, 5th and 6th visits).
    1. La 10a visita (12 meses después de terminar el tratamiento con tedizolid).
    2. durante el reimplante
    3. durante el tiempo de seguimiento (del 3 al 10 y última visita).
    4. durante el tratamiento (3ª, 4ª, 5ª y 6ª visitas).
    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 No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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
    un grupo
    one group
    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
    cohortes historicas
    historical cohorts
    E.8.2.4Number of treatment arms in the trial1
    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 concerned6
    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 No
    E.8.7Trial has a data monitoring committee No
    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
    ÚLTIMO PACIENTE ÚLTIMA VISITA
    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 months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    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: 15
    F.1.3Elderly (>=65 years) No
    F.1.3.1Number of subjects for this age range: 5
    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 state20
    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
    Ninguna
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2019-12-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-12-12
    P. End of Trial
    P.End of Trial StatusOngoing
    For support, visit the EMA Service Desk , log in using your EMA account and open a ticket specifying "EU CTR" in your request.
    If you do not have an account, please visit the EMA Account management page page click on "Create an EMA account" and follow the instructions.
    The status of studies in GB is no longer updated from 1.1.2021
    For the UK, as from 1.1.2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
    European Medicines Agency © 1995-2022 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    Legal notice
    EMA HMA