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    Summary
    EudraCT Number:2022-000602-10
    Sponsor's Protocol Code Number:PID13859
    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:2022-04-18
    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 number2022-000602-10
    A.3Full title of the trial
    Short or Long Antibiotic Regimes in Orthopaedics (SOLARIO):
    A Randomised Open Label Multi-Centre Clinical Trial
    Regímenes antibióticos cortos o largos en ortopedia (SOLARIO): Un ensayo clínico multicéntrico aleatorio y abierto
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study comparing the administration of short and long antibiotic treatment in patients with bone infections
    Un estudio que compara la administración de tratamiento antibiótico corto y largo en pacientes con infecciones óseas
    A.3.2Name or abbreviated title of the trial where available
    SOLARIO
    A.4.1Sponsor's protocol code numberPID13859
    A.5.4Other Identifiers
    Name:SOLARIONumber:SOLARIO
    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 SponsorOxford University Hospitals NHS Foundation Trust
    B.1.3.4CountryUnited Kingdom
    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 supportEuropean Bone and Joint Infection Society (EBJIS)
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationxford University Hospitals NHS Foundation Trust
    B.5.2Functional name of contact pointDr. Matthew Scarborough
    B.5.3 Address:
    B.5.3.1Street AddressHeadley Way, Headington
    B.5.3.2Town/ cityOxford
    B.5.3.3Post code9DU
    B.5.3.4CountryUnited Kingdom
    B.5.6E-mailMatthew.Scarborough@ouh.nhs.uk
    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 Gentamicina B. Braun 1 mg/ml EFG
    D.2.1.1.2Name of the Marketing Authorisation holderBRAUN
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameGENTAMYCIN
    D.3.4Pharmaceutical form Powder and solution for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSolution for infusion (Noncurrent)
    Concentrate for solution for infusion (Noncurrent)
    Implantation
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNGentamicin
    D.3.9.1CAS number 1403-66-3
    D.3.9.4EV Substance CodeSUB02326MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/l milligram(s)/litre
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number1 to 3
    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 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 Vancomicina Normon 1000 mg polvo para concentrado para solución para perfusión EFG
    D.2.1.1.2Name of the Marketing Authorisation holderNORMON
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameVANCOMYCIN
    D.3.4Pharmaceutical form Powder and solution for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPConcentrate for solution for infusion (Noncurrent)
    Intravenous use
    Implantation
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNVancomycin
    D.3.9.1CAS number 1404-90-6
    D.3.9.4EV Substance CodeSUB05076MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1000
    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
    Orthopaedic infections, including chronic osteomyelitis and prosthetic joint infection) needing prolonged courses of antibiotics (6 weeks or more)and also surgical treatment
    Infecciones osteoarticulares, incluida la osteomielitis crónica y la infección de prótesis articular) que requieren ciclos prolongados de antibióticos (6 semanas o más) y también tratamiento quirúrgico
    E.1.1.1Medical condition in easily understood language
    Adult patients presenting bone infections that need to be treated with antibiotics and surgery
    Pacientes adultos que presentan infecciones óseas que deben ser tratadas con antibióticos y cirugía
    E.1.1.2Therapeutic area Body processes [G] - Bones and nerves physological processes [G11]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10031252
    E.1.2Term Osteomyelitis
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level HLT
    E.1.2Classification code 10005941
    E.1.2Term Bone and joint infections (excl arthritis)
    E.1.2System Organ Class 100000004859
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level HLT
    E.1.2Classification code 10005940
    E.1.2Term Bone and joint infections
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10076011
    E.1.2Term Application site joint infection
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10076118
    E.1.2Term Medical device site joint infection
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level PT
    E.1.2Classification code 10060803
    E.1.2Term Diabetic foot infection
    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
    To determine if local antibiotics combined with short course systemic antibiotics (<=7 days) are non-inferior to local antibiotics plus prolonged course systemic antibiotics (>=4 weeks) in the management of acute or chronic bone and joint infection, as judged by the proportion of patients experiencing treatment failure at 1 year follow-up.
    Determinar si los antibióticos locales combinados con antibióticos sistémicos de corta duración (<=7 días) no son inferiores a los antibióticos locales más antibióticos sistémicos de duración prolongada (>=4 semanas) en el tratamiento de la infección ósea y articular aguda o crónica, según la proporción de pacientes que experimentan un fracaso del tratamiento en el seguimiento de 1 año
    E.2.2Secondary objectives of the trial
    To compare:
    1) Possible or probable treatment failure
    2) Incidence of serious adverse events (including death),
    3) Antibiotic-related side effects
    4) Resource allocation (length of inpatient hospital stay, frequency of outpatient visits, antibiotic prescribing)
    5) Patient reported outcome measures
    6) Deviation from allocated treatment strategy
    Comparar:
    1) El posible o probable fracaso del tratamiento
    2) Incidencia de acontecimientos adversos graves (incluida la muerte),
    3) Efectos secundarios relacionados con los antibióticos
    4) Asignación de recursos (duración de la estancia hospitalaria, frecuencia de las visitas ambulatorias, prescripción de antibióticos)
    5) Medidas de resultados comunicadas por los pacientes
    6) Desviación de la estrategia de tratamiento asignada
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1) Provision of informed consent
    2) Aged 18 years or over
    3) Presenting with an orthopaedic infection, defined by one or more of the following criteria:
    a) localised pain, OR
    b) localised erythema, OR
    c) temperature ≥ 38.0ºC, OR
    d) a discharging sinus or wound
    4) Undergoing surgical treatment for the infection
    5) Locally administered antibiotics in a HTA-approved product or in a carrier CE marked for antibiotic delivery
    6) Has received <= 7 days of systemic antimicrobial therapy after surgery
    7) Would ordinarily be managed with a prolonged course (>= 4 weeks) of systemic antibiotic(s)
    8) Specimens for microbiological analysis taken at index surgery
    1) Prestación de consentimiento informado
    2) Tener 18 años o más
    3) Que presenten una infección ortopédica, definida por uno o más de los siguientes criterios
    a) dolor localizado, O
    b) eritema localizado, O
    c) temperatura ≥ 38,0ºC, O
    d) un seno o una herida que descargue.
    4) Sometido a tratamiento quirúrgico por la infección
    5) Antibióticos administrados localmente en un producto aprobado por la HTA o en un soporte con marcado CE para la administración de antibióticos
    6) Ha recibido <= 7 días de terapia antimicrobiana sistémica después de la cirugía
    7) Se trataría normalmente con un tratamiento prolongado (>= 4 semanas) de antibióticos sistémicos
    8) Muestras para el análisis microbiológico tomadas en la cirugía inicial
    E.4Principal exclusion criteria
    Surgical exclusion criteria
    1) The index operation was not a definitive procedure with the aim of eradicating infection:
    a) Primary closure has not been achieved, or
    b) Re-look surgery is planned
    2) The index operation involved implant retention (e.g. DAIR)
    Microbiological exclusion criteria
    3) Any identified micro-organisms from operative specimens from the site of incident infection are fully resistant to the local antibiotic(s) administered at the site of infection
    Medical exclusion criteria
    4) Other infection necessitating additional systemic antibiotic treatment beyond 7 days after surgery, such as Staphylococcus aureus bacteraemia, psoas abscess, discitis or bacterial endocarditis.
    5) If the patient is in a clinical trial involving an Investigational Medicinal Product (IMP) related to infection
    Criterios de exclusión quirúrgica

    1) La operación índice no fue un procedimiento definitivo con el objetivo de erradicar la infección:
    a) No se ha logrado el cierre primario, o
    b) Se ha planificado una cirugía de revisión

    2) La operación índice implicaba la retención de un implante (por ejemplo, DAIR)

    Criterios de exclusión microbiológica

    3) Todos los microorganismos identificados en las muestras operatorias del lugar de la infección incidental son totalmente resistentes a los antibióticos locales administrados en el lugar de la infección

    Criterios de exclusión médica

    4) Otra infección que requiera un tratamiento antibiótico sistémico adicional más allá de 7 días después de la cirugía, como bacteriemia por Staphylococcus aureus, absceso del psoas, discitis o endocarditis bacteriana.

    5) Si el paciente participa en un ensayo clínico con un medicamento en investigación relacionado con la infección
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint will be definitive treatment failure within 12 months of surgery, as determined by a blinded endpoint committee using redacted information from the patient record. Definite treatment failure is defined by one or more of the following:
    1) The isolation by culture of micro-organisms from 2 or more samples of bone/peri-prosthetic tissue from the site of incident infection at re-operation, where the micro-organisms are phenotypically indistinguishable*.
    2) A pathogenic organism (e.g. Staphylococcus aureus but not Staphylococcus epidermidis) on a single, closed, biopsy or aspirate from the site of incident infection.
    3) Histology diagnostic of infection from bone/peri-prosthetic tissue obtained at re-operation at the site of incident infection.
    4) Formation of a sinus tract arising from the bone/prosthesis/orthopaedic device identified at clinical review or re-operation.
    5) Recurrence of frank pus adjacent to bone/prosthesis/orthopaedic device identified at re-operation or aspiration
    6) Elevated synovial fluid White Cell Count or neutrophil percentage, or ++ change on leucocyte esterase strip, from prosthetic joint site affected by incident infection, at re-operation or aspiration.
    7) Death resulting from orthopaedic infection at the incident anatomic site.
    * indistinguishable refers to the results of routine laboratory work, including bacterial genus/species and the results of routine antibiotic susceptibility testing. We will not require any additional bacterial typing in the laboratory beyond local routine practice.
    El criterio de valoración primario será el fracaso definitivo del tratamiento dentro de los 12 meses siguientes a la intervención quirúrgica, determinado por un comité de criterios de valoración ciego que utilizará información redactada del expediente del paciente. El fracaso definitivo del tratamiento se define por uno o más de los siguientes factores
    1) El aislamiento mediante cultivo de microorganismos a partir de 2 o más muestras de tejido óseo/periprotésico del lugar de la infección incidente en la reintervención, donde los microorganismos son fenotípicamente indistinguibles*.
    2) Un organismo patógeno (por ejemplo, Staphylococcus aureus pero no Staphylococcus epidermidis) en una única biopsia o aspirado cerrado del lugar de la infección.
    3) Histología diagnóstica de la infección en el tejido óseo/peri-protésico obtenida en una reintervención en el lugar de la infección.
    4) Formación de un tracto sinusal procedente del hueso/prótesis/dispositivo ortopédico identificado en la revisión clínica o en la reintervención.
    5) Reaparición de pus franco adyacente al hueso/prótesis/dispositivo ortopédico identificado en la reintervención o la aspiración.
    6) Elevación del recuento de glóbulos blancos o del porcentaje de neutrófilos en el líquido sinovial, o cambio de ++ en la tira de esterasa leucocitaria, en la zona de la articulación protésica afectada por la infección incidente, en la reintervención o la aspiración.
    7) Muerte resultante de la infección ortopédica en el sitio anatómico incidente.
    * indistinguible se refiere a los resultados del trabajo de laboratorio de rutina, incluyendo el género/especie bacteriana y los resultados de las pruebas de susceptibilidad a los antibióticos de rutina. No exigiremos ninguna tipificación bacteriana adicional en el laboratorio más allá de la práctica rutinaria local.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Within 12 months of surgery
    En los 12 meses siguientes a la intervención quirúrgica
    E.5.2Secondary end point(s)
    Secondary endpoints will be:
    1) Probable treatment failure and possible treatment failure
    2) Serious Adverse Events (SAEs), including death (i.e. all-cause mortality)
    3) Antibiotic side effects
    4) Resource allocation using (a) length of inpatient hospital stay, (b) frequency of outpatient visits, (c) antibiotic prescribing costs, In-hospital treatment cost.
    5) Quality of life as evaluated by the patient reported outcome measures on the EQ-5D-5L questionnaire, at baseline and 1 year follow-up
    6) Deviation from allocated treatment strategy, (including early termination of systemic antibiotics) because of adverse events, patient preference or any other reason
    Los criterios de valoración secundarios serán:
    1) Probable fracaso del tratamiento y posible fracaso del tratamiento
    2) Efectos adversos graves (EAS), incluida la muerte (es decir, la mortalidad por todas las causas)
    3) Efectos secundarios de los antibióticos
    4) Asignación de recursos mediante (a) la duración de la estancia hospitalaria, (b) la frecuencia de las visitas ambulatorias, (c) los costes de la prescripción de antibióticos, el coste del tratamiento en el hospital.
    5) Calidad de vida evaluada por las medidas de resultado informadas por el paciente en el cuestionario EQ-5D-5L, al inicio y al año de seguimiento
    6) Desviación de la estrategia de tratamiento asignada, (incluyendo la terminación temprana de los antibióticos sistémicos) debido a eventos adversos, preferencia del paciente o cualquier otra razón
    E.5.2.1Timepoint(s) of evaluation of this end point
    Within 12 months of surgery
    En los 12 meses siguientes a la intervención quirúrgica
    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 No
    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 No
    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 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 concerned1
    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 Yes
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    United Kingdom
    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
    The end of the study is defined as the date of the last follow-up assessment of the last participant recruited.
    El final del estudio se define como la fecha de la última evaluación de seguimiento del último participante reclutado.
    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 months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years3
    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: 400
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 100
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 500
    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
    Ninguno
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation European Bone and Joint Infection Society
    G.4.3.4Network Country Switzerland
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2022-07-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-06-22
    P. End of Trial
    P.End of Trial StatusOngoing
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