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    Summary
    EudraCT Number:2021-004469-11
    Sponsor's Protocol Code Number:PP-SA-001
    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:2022-05-06
    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 number2021-004469-11
    A.3Full title of the trial
    A Pilot, Multicenter, Randomized, Non Comparative, Double-Blind Study of Phage Therapy in Patients with Hip or Knee Prosthetic Joint Infection due to Staphylococcus aureus Treated with DAIR and Antibiotic Therapy
    Un estudio piloto , multicéntrico, aleatorizado, no comparativo y de doble ciego de la terapia fágica en pacientes con infección de la articulación protésica de cadera o rodilla debida a Staphylococcus aureus tratados con DAIR y antibióticos.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    New multicenter study on the use of bacteria-killing viruses to treat patients with hip or knee prosthesis infection caused by a bacterium called "Staphylococcus aureus"
    Nuevo estudio multicéntrico sobre el uso de virus que eliminan las bacterias para tratar a pacientes con infección de prótesis de cadera o rodilla causada por una bacteria llamada "Staphylococcus aureus"
    A.3.2Name or abbreviated title of the trial where available
    PhagoDAIR I
    PhagoDAIR I
    A.4.1Sponsor's protocol code numberPP-SA-001
    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 SponsorPHERECYDES PHARMA
    B.1.3.4CountryFrance
    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 supportPHERECYDES PHARMA
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationEurofins Optimed
    B.5.2Functional name of contact pointSophie Moulin
    B.5.3 Address:
    B.5.3.1Street Address1 rue des Essarts
    B.5.3.2Town/ cityGières
    B.5.3.3Post code38610
    B.5.3.4CountryFrance
    B.5.4Telephone number+330438374758
    B.5.6E-mailAecOptimed@eurofins.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.3.1Product nameAnti-Staphylococcus aureus Bacteriophages- PP1493
    D.3.4Pharmaceutical form Suspension for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSolution for injection (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNAnti-Staphylococcus aureus Bacteriophages- PP1493
    D.3.9.3Other descriptive nameAnti-Staphylococcus aureus Bacteriophages- PP1493
    D.3.9.4EV Substance CodeSUB266771
    D.3.10 Strength
    D.3.10.1Concentration unit PFU/ml plaque forming unit(s)/millilitre
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number1000000000 to 100000000000
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 Yes
    D.3.11.13.1Other medicinal product typeBacteriophages
    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 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.3.1Product nameAnti-Staphylococcus aureus Bacteriophages- PP1815
    D.3.4Pharmaceutical form Suspension for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSolution for injection (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNAnti-Staphylococcus aureus Bacteriophages- PP1815
    D.3.9.3Other descriptive nameAnti-Staphylococcus aureus Bacteriophages- PP1815
    D.3.9.4EV Substance CodeSUB266772
    D.3.10 Strength
    D.3.10.1Concentration unit PFU/ml plaque forming unit(s)/millilitre
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number1000000000 to 100000000000
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 Yes
    D.3.11.13.1Other medicinal product typeBacteriophages
    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 injection
    D.8.4Route of administration of the placeboInjection (Noncurrent)
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    knee or hip prosthetic joint infection (PJI) due to Staphylococcus aureus, with the indication of DAIR and Suppressive Antibiotics Therapy (SAT)
    infección de la articulación protésica de la rodilla o de la cadera debida a Staphylococcus aureus, con DAIR y terapia antibiótica supresiva (TAS)
    E.1.1.1Medical condition in easily understood language
    Hip or Knee Prosthetic Infection.
    Infección de protesis de cadera o rodilla
    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 20.0
    E.1.2Level LLT
    E.1.2Classification code 10023216
    E.1.2Term Joint infection
    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
    The overall objective of this pilot study is to generate data which will allow to optimize the design of future comparative studies.
    The Primary Objective is:
    To estimate the rate of clinical control of infection due to Staphylococcus aureus at Week 12+/-2 of two different therapeutic regimens: DAIR + curative antibiotics therapy combined with bacteriophages or solution of NaCl 0,9%, which will allow to calculate the sample size for future comparative studies.
    El objetivo general de este estudio piloto es generar datos que permitan optimizar el diseño de futuros estudios comparativos.
    El objetivo principal es:
    Estimar la tasa de control clínico de la infección por Staphylococcus aureus en la semana 12 +/-2 de dos regímenes terapéuticos diferentes: DAIR + terapia antibiótica curativa combinada con bacteriófagos o solución de NaCl 0,9%, lo que permitirá calcular el tamaño de la muestra para futuros estudios comparativos.
    E.2.2Secondary objectives of the trial
    1. Assess the safety of two different therapeutic regimens (DAIR + curative antibiotics therapy combined with bacteriophages or Solution of NaCl 0,9%) during the whole study;
    2. describe initial activity of phages on patients’ Staphylococcus aureus strain and the clinical outcome (infection control or relapse) of patients at Week 12;
    3. describe superinfected patients (other species found in per operative sample) in terms of clinical control of the infection at Week 12;
    4. describe the profile of the Staphylococcus aureus strain in case of failure before Week 12;
    5. describe the Staphylococcus Aureus quantification in blood and in serum at D0, D0-T2H, D2, D4, D14, D28 and Week 12; and in case of rescue treatment
    6. describe the immunological response in serum at D0, D14, D28 and Week 12, and in joint fluid at D0 and D14 only for patients with a Total Knee Arthroplasty (TKA); and in case of rescue treatment
    1. Evaluar la seguridad de dos pautas de tratamiento diferentes (DAIR+tratamiento antibiótico curativo en combinación con bacteriófagos o solución de NaCl al 0,9 %) durante todo el estudio
    2. Describir la actividad inicial de los fagos en la cepa de Staphylococcus aureus de los pacientes y el resultado clínico (control de la infección o recaída) de los pacientes en la semana 12
    3. Describir los pacientes sobreinfectados (se han encontrado otras especies en la muestra perioperatoria) en términos de control clínico de la infección en la semana 12
    4. Describir el perfil de la cepa de Staphylococcus aureus en caso de fracaso antes de la semana 12
    5. Describir la cuantificación de Staphylococcus aureus en sangre y en suero en el D0, D0-T2H, D2, D4, D14, D28 y en la semana 12
    6. Describir la respuesta inmunológica en suero en el D0, D14, D28 y en la semana 12 y en el líquido articular en el D0 y el D14 solo de los pacientes con artroplastia total de rodilla (ATR)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Male or female > or = 18 years
    2.Staphylococcus aureus monomicrobial knee or hip PJI > 3 months after prosthesis implantation with clinical signs of infection and with indication of DAIR with direct closure and Suppressive Antibiotics Therapy (SAT)
    3. Staphylococcus aureus only in joint fluid within 6 months before the randomization or in case of relapse of infection under antibiotics therapy after a DAIR performed within 6 months prior to pre-inclusion visit
    4.Without preoperative diagnosis of superinfection due to another pathogen
    5.Phagogram displaying the susceptibility of the strain to at least one of the phages.
    6.Patient with a life expectancy of 2 years and more as determined by the principal investigator
    7.Females of childbearing potential/Sexually active males with partner of childbearing potential: commitment to consistently and correctly use an acceptable method of birth control (oral, transdermal, systemic or implant contraception birth control, intrauterine devices, diaphragm or condoms) for 1 month after the last study drug administration
    8.Females of non-childbearing potential: either surgically sterilized or at least 1 year postmenopausal (amenorrhea duration at least 12 months)
    9.Negative pregnancy test for women with childbearing potential
    10.Signing a written informed consent before any study related procedyres including phagogramprior to the phagogram
    11.Affiliated to a national social security system and / or private health insuranceCovered by Health Insurance System and / or in compliance with the recommendations of National Law in force relating to biomedical research.
    1. Hombre o mujer > o = 18 años.
    2. IAP monomicrobiana de rodilla o cadera por Staphylococcus aureus ˃3 meses después de la implantación de la prótesis con signos clínicos de infección y con indicación de DAIR con cierre directo y tratamiento antibiótico supresor (TAS).
    3. Staphylococcus aureus solo en el líquido articular dentro de los 6 meses anteriores a la aleatorización o en caso de recaída bajo tratamiento antibiótico después de un DAIR realizado dentro de los 6 meses anteriores a la visita de preinclusión.
    4. Sin diagnóstico preoperatorio de sobreinfección por otro patógeno.
    5. Fagograma que muestra la susceptibilidad de la cepa a como mínimo uno de los fagos.
    6. Paciente con una esperanza de vida de 2 años o más, según determine el investigador principal.
    7. Mujeres en edad fértil y hombres sexualmente activos con pareja en edad fértil: compromiso de utilizar de forma constante y correcta un método anticonceptivo
    aceptable (anticonceptivo oral, transdérmico o sistémico, implante o dispositivos intrauterinos) durante 1 mes después de la última administración del fármaco del
    estudio.
    8. Mujeres no fértiles: esterilizadas quirúrgicamente o con menopausia de como mínimo 1 año (duración de la amenorrea de 12 meses como mínimo).
    9. Prueba de embarazo negativa.
    10. Firmar un consentimiento informado por escrito antes de realizar cualquier procedimiento relacionado con el estudio, incluido el fagograma.
    11. Estar afiliado a un sistema nacional de seguridad social y/o un seguro médico privado en cumplimiento de las recomendaciones de la legislación nacional vigente relativa a
    la investigación biomédica.
    E.4Principal exclusion criteria
    1. Early Staphylococcus aureus Prosthesis Joint infection ( >3months after the prosthesis implantation)
    2. Other germ found in culture of joint fluid sample
    3. Phagogram displaying no susceptibility of the strain to anti-Staphylococcus aureus bacteriophages
    4. Patients with ASA score > or = 4
    5. Severe sepsis or Septic shock or hemodynamic instability
    6. Patients with an indication to prosthesis replacement or amputation
    7. Immunosuppressed patients
    8. ALT or AST > 5 x ULN, creatinine > 1.53 mg/dl in men and > 1.24 mg/dl in women
    9. Known allergic reactions to components of phages products
    10. Medical history which in the opinion of the investigator would mean that the patient is unsuitable for participation in the study
    11. Patient who, in the judgment of the Investigator, is likely to be non-compliant or uncooperative during the study, or unable to cooperate because of a language problem, poor mental development
    12. Currently in exclusion period from a previous study
    13. Concomitant participation to another interventional clinical trial.
    14. Patients who are pregnant or breastfeeding. Patients should not be enrolled if they plan to become pregnant during the treatment period and 1 month after the last administration of study drug
    15. Women/Men refusing to use an effective contraception during 1 month after the last administration of study drug
    16. No possibility of contact in case of emergency.
    17. Minors, persons deprived of liberty by judicial or administrative decision, persons receiving psychiatric care and persons admitted to a health or social institution, to adult patient under legal protection or unable to express consent.
    1. Infección articular protésica temprana por Staphylococcus aureus (˂3 meses después de la implantación de la prótesis).
    2. Detección de otro germen en el cultivo de la muestra de líquido articular.
    3. Fagograma que muestra la no susceptibilidad de la cepa a los bacteriófagos contra el Staphylococcus aureus.
    4. Pacientes con puntuación ASA > o = 4.
    5. Sepsis grave, shock séptico o inestabilidad hemodinámica.
    6. Pacientes con indicación de sustitución de prótesis o amputación.
    7. Pacientes inmunodeprimidos.
    8. ALT o AST > 5 x LSN, creatinina > 1,53 mg/dl en hombres y > 1,24 mg/dl en mujeres.
    9. Reacciones alérgicas conocidas a componentes de productos fágicos.
    10. Antecedentes médicos que, en opinión del investigador, hagan que el paciente no sea apto para participar en el estudio.
    11. Paciente que, a juicio del investigador, es probable que no cumpla con las instrucciones o no coopere durante el estudio, o que no pueda cooperar debido a un problema del
    lenguaje o un desarrollo mental deficiente.
    12. Pacientes actualmente en periodo de exclusión de un estudio anterior.
    13. Participación concomitante en otro ensayo clínico intervencionista.
    14. Pacientes embarazadas o en periodo de lactancia. Las pacientes no deben inscribirse si planean quedarse embarazadas durante el periodo de tratamiento y 1 mes después de
    la última administración del fármaco del estudio.
    15. Mujeres y hombres que se nieguen a usar un método anticonceptivo eficaz durante 1 mes después de la última administración del fármaco del estudio.
    16. No poder contactar en caso de emergencia.
    17. Los menores, las personas privadas de libertad por decisión judicial o administrativa, las personas que reciben atención psiquiátrica y las personas ingresadas en una
    institución sanitaria o social, y los pacientes adultos bajo protección legal o incapaces de expresar su consentimiento.
    E.5 End points
    E.5.1Primary end point(s)
    Clinical control of infection at week 12 +/-2 will be defined by:
    - no clinical signs of evolutive infection:
    - no fever (defined by a temperature less than 38°C) due to prosthesis infection
    - no recurrence, no worsening pain assessed with an Visual Analog Scale (VAS) and defined by an VAS at Week 12 below VAS prior to the DAIR
    - Peri articular Inflammatory and infectious Clinical signs will be collected :
    - No local post surgical recurrence or worsening of articular swelling
    - No unusual aspect of scar as erythema or abnormal flow or a fistula or inflammatory or local necrosis or no healing
    - and no new surgical procedure requested before Week 12+/-2 and no Staphylococcus aureus detected in joint fluid in case of aspiration for suspicion of relapse before Week 12+/-2.
    El control clínico de la infección en la semana 12 +/-2 se definirá por:
    - ausencia de signos clínicos de infección evolutiva:
    - ausencia de fiebre (definida por una temperatura inferior a 38°C) debida a la infección de la prótesis
    - ninguna recidiva, ningún empeoramiento del dolor evaluado con una escala visual analógica (EVA) y definido por una EVA en la semana 12 inferior a la EVA antes del DAIR
    - Se recogerán los signos clínicos inflamatorios e infecciosos peri articulares:
    - No hay recidiva local postquirúrgica ni empeoramiento de la inflamación articular
    - Ningún aspecto inusual de la cicatriz como eritema o flujo anormal o una fístula o necrosis inflamatoria o local o ausencia de cicatrización
    - y ninguna nueva intervención quirúrgica solicitada antes de la semana 12+/-2 y ningún Staphylococcus aureus detectado en el líquido articular en caso de aspiración por sospecha de recidiva antes de la semana 12+/-2.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 12 +/-2
    Semana 12 +/-2
    E.5.2Secondary end point(s)
    1. Safety parameters: adverse events, physical examination, biological tests as hematology and biochemistry during the whole study;
    2. Initial activity of phages: active bacteriophages (PP1493 and/or PP1815) according to phagogram results in regard of the clinical outcome (infection control or relapse) of patients at Week 12+/-2
    3. Clinical control of the infection (as described in primary endpoint) at Week 12+/-2 for superinfected patients (other species isolated during the surgical procedure)
    4. In case of failure before Week 12+/-2, aspiration of joint fluid at time of failure for microbiological test and identification of Staphylococcus aureus strain: antibiogram and phagogram
    5. Microbiology:
    - Blood: Staphylococcus aureus quantification (CFU) at D0, D0-T2H, D2, D4, D14+/-1, D28+/-2 and Week 12+/-2;
    - Serum: Staphylococcus aureus quantification (qPCR) at D0, D0-T2H, D2, D4, D14+/-1, D28+/-2 and Week 12+/-2
    6. Immunology:
    - Serum: anti S.aureus phage antibodies, at D0, D14±1, D28±2 and Week 12±2 and IL-6 at D0, D14+/-1 and W12+/-2
    - Joint fluid: anti S.aureus phage antibodies and IL-6 at D0 and at D14+/-1 only for patients with TKA
    7. Pharmacokinetics:
    - Serum: quantification of the phages by qPCR at D0, D0T2H, D2, D4, D14+/-1, D28+/-2 and Week 12+/-2
    - Blood: quantification of the phages by plaque assay at D0, D0T2H, D2, D4, D14+/-1, D28+/-2 and Week 12+/-2 for patients in sites (France) in Paris, Nantes and Lyon
    - Joint Fluid: quantification of the phage by qPCR and plaque assay at D0 and at D14+/-1 only for patients with TKA; the plaque assay will be performed only for patients in sites (France) in Paris, Nantes and Lyon;
    8. Bacteriological Infection Control at D14+/-1 in joint fluid (only patients with TKA): microbiological culture, quantification of S. aureus by qPCR, WBC count, C-Reactive Protein, IL6;
    9. Duration of hospitalization
    10. Questionnaire EQ-5D-5L for quality of life at each visit (except D14+/-1 and D28+/-2);
    11. Evaluation of joint function at D-1 or D0, Week 12+/-2, Month 6 +/-2 weeks, Month 12+/-1, Month 18+/-1 and Month 24+/-2 with:
    - Knee: KOOS 12-Knee Survey
    - Hip: HOOS 12-Hip Survey
    12. Clinical control of the infection (as described in primary endpoint) at Month 6+/-2 weeks, Month 12+/-1, Month 18+/-1 and Month 24+/-2;
    13. X Ray at D-1 or D0, Week 12+/-2, Month6 +/-2 weeks, Month 12+/-1, Month 18+/-1 and Month 24+/-2: to check potential appearance of abnormal loosening (border with shifting of the prosthesis), periprosthetic border;
    14. In case of rescue treatment: clinical infection control at week 12-RT+/-2 after the first ultra guided injection, safety parameters, pharmacokinetics, bacteriological and immunological tests.
    1. Parámetros de seguridad: eventos adversos, examen físico, pruebas biológicas como hematología y bioquímica durante todo el estudio;
    2. 2. Actividad inicial de los fagos: bacteriófagos activos (PP1493 y/o PP1815) según los resultados del fagograma en relación con el resultado clínico (control de la infección o recaída) de los pacientes en la semana 12+/-2
    3. Control clínico de la infección (como se describe en el criterio de valoración primario) en la semana 12+/-2 para los pacientes superinfectados (otras especies aisladas durante el procedimiento quirúrgico)
    4. En caso de fracaso antes de la Semana 12+/-2, aspiración del líquido articular en el momento del fracaso para el análisis microbiológico y la identificación de la cepa de Staphylococcus aureus: antibiograma y fagograma
    5. Microbiología:
    - Sangre: Cuantificación de Staphylococcus aureus (UFC) en D0, D0-T2H, D2, D4, D14+/-1, D28+/-2 y Semana 12+/-2;
    - Suero: Cuantificación de Staphylococcus aureus (qPCR) en D0, D0-T2H, D2, D4, D14+/-1, D28+/-2 y Semana 12+/-2.
    6. Inmunología:
    - Suero: anticuerpos anti fago de S.aureus, en D0, D14±1, D28±2 y Semana 12±2 e IL-6 en D0, D14+/-1 y W12+/-2
    - Líquido articular: anticuerpos anti fago de S.aureus e IL-6 en D0 y en D14+/-1 sólo para los pacientes con TKA
    7. Farmacocinética:
    - Suero: cuantificación de los fagos por qPCR en D0, D0T2H, D2, D4, D14+/-1, D28+/-2 y Semana 12+/-2
    - Sangre: cuantificación de los fagos por ensayo de placa en D0, D0T2H, D2, D4, D14+/-1, D28+/-2 y Semana 12+/-2 para los pacientes en los centros (Francia) de París, Nantes y Lyon
    - Líquido articular: cuantificación del fago por qPCR y ensayo de placa en D0 y en D14+/-1 sólo para los pacientes con TKA; el ensayo de placa se realizará sólo para los pacientes en los centros (Francia) de París, Nantes y Lyon;
    8. Control bacteriológico de la infección en D14+/-1 en el líquido articular (sólo en pacientes con TKA): cultivo microbiológico, cuantificación de S. aureus por qPCR, recuento de glóbulos blancos, proteína C reactiva, IL6;
    9. Duración de la hospitalización
    10. Cuestionario EQ-5D-5L de calidad de vida en cada visita (excepto D14+/-1 y D28+/-2);
    11. Evaluación de la función articular en D-1 o D0, Semana 12+/-2, Mes 6 +/-2 semanas, Mes 12+/-1, Mes 18+/-1 y Mes 24+/-2 con:
    - Rodilla: KOOS 12-Knee Survey
    - Cadera: HOOS 12-Hip Survey
    12. Control clínico de la infección (como se describe en el criterio de valoración primario) en el mes 6+/-2 semanas, mes 12+/-1, mes 18+/-1 y mes 24+/-2;
    13. Rayos X en D-1 o D0, Semana 12+/-2, Mes6+/-2 semanas, Mes 12+/-1, Mes 18+/-1 y Mes 24+/-2: para comprobar la posible aparición de aflojamiento anormal (borde con desplazamiento de la prótesis), borde periprotésico;
    14. En caso de tratamiento de rescate: control clínico de la infección en la semana 12-RT+/-2 tras la primera inyección ultraguiada, parámetros de seguridad, farmacocinética, pruebas bacteriológicas e inmunológicas.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1: end of study
    2: Week 12+/-2
    3:Week 12+/-2
    4: Week 12+/-2
    5:D0, D0-T2H, D2, D4, D14+/-1, D28+/-2 and Week 12+/-2
    6:Serum: D0, D14+/-1, D28+/-2 and Week 12+/-2; Joint fluid: D0 and at D14+/-1
    7: D0, D0T2H, D2, D4, D14+/-1, D28+/-2 and Week 12+/-2 for Serum; D0, D0T2H, D2, D4, D14+/-1, D28+/-2 and Week 12+/-2 for blood; D0 and at D14+/-1 for joint fluid
    8: D14+/-1
    9: end of study
    10: each visit (except D14+/-1 and D28+/-2);
    11: D-1 or D0, Week 12+/-2, Month 6 +/-2 weeks, Month 12+/-1, Month 18+/-1 and Month 24+/-2
    12: Month 6+/-2 weeks, Month 12+/-1, Month 18+/-1 and Month 24+/-2;
    13: t D-1 or D0, Week 12+/-2, Month6 +/-2 weeks, Month 12+/-1, Month 18+/-1 and Month 24
    14 :week 12-RT+/-2
    1: fin del estudio
    2: Semana 12+/-2
    3: Semana 12+/-2
    4: Semana 12+/-2
    5:D0, D0-T2H, D2, D4, D14+/-1, D28+/-2 y Semana 12+/-2
    6: Suero: D0, D14+/-1, D28+/-2 y Semana 12+/-2; Líquido articular: D0 y en D14+/-1
    7: D0, D0T2H, D2, D4, D14+/-1, D28+/-2 y Semana 12+/-2 para suero; D0, D0T2H, D2, D4, D14+/-1, D28+/-2 y Semana 12+/-2 para sangre; D0 y en D14+/-1 para líquido articular
    8: D14+/-1
    9: fin del estudio
    10: cada visita (excepto D14+/-1 y D28+/-2)
    11: D-1 o D0, semana 12+/-2, mes 6+/-2 semanas, mes 12+/-1, mes 18+/-1 y mes 24+/-2
    12: Mes 6+/-2 semanas, Mes 12+/-1, Mes 18+/-1 y Mes 24+/-2;
    13: t D-1 o D0, semana 12+/-2, mes6+/-2 semanas, mes 12+/-1, mes 18+/-1 y mes 24
    14: semana 12-RT+/-2
    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 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 No
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    piloto
    pilot
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA20
    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 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
    LVLS
    Última visita del último paciente
    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 months36
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months36
    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: 34
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 30
    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 state18
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 64
    F.4.2.2In the whole clinical trial 64
    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
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2022-06-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-06-17
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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