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    The EU Clinical Trials Register currently displays   43850   clinical trials with a EudraCT protocol, of which   7282   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2022-001297-63
    Sponsor's Protocol Code Number:ML-ORI-201
    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:2023-03-24
    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 number2022-001297-63
    A.3Full title of the trial
    A Multicenter, Open-Label, Evaluator-Blinded, Randomized Study to Evaluate the Safety and Tolerability of Single-Dose IV Oritavancin Versus Standard of Care for the Treatment of Pediatric Subjects with Acute Bacterial Skin And Skin Structure Infections
    Estudio multicéntrico, abierto, ciego para el evaluador y aleatorizado para evaluar la seguridad y la tolerabilidad de una dosis intravenosa única de oritavancina frente al tratamiento habitual de sujetos pediátricos con infecciones bacterianas agudas de la piel y de la estructura de la piel
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Multicenter, Open-Label, Evaluator-Blinded, Randomized Study to Evaluate the Safety and Tolerability of Single-Dose IV Oritavancin Versus Standard of Care for the Treatment of Pediatric Subjects with Acute Bacterial Skin And Skin Structure Infections
    Estudio multicéntrico, abierto, ciego para el evaluador y aleatorizado para evaluar la seguridad y la tolerabilidad de una dosis intravenosa única de oritavancina frente al tratamiento habitual de sujetos pediátricos con infecciones bacterianas agudas de la piel y de la estructura de la piel
    A.4.1Sponsor's protocol code numberML-ORI-201
    A.5.4Other Identifiers
    Name:INDNumber:051292
    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 SponsorMelinta Therapeutics, LLC
    B.1.3.4CountryUnited States
    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 supportMelinta Therapeutics, LLC
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMelinta Therapeutics, LLC
    B.5.2Functional name of contact pointDouglas Girgenti
    B.5.3 Address:
    B.5.3.1Street Address300 Tri-State International, Suite 272
    B.5.3.2Town/ cityLincolnshire
    B.5.3.3Post codeIL 60069
    B.5.3.4CountryUnited States
    B.5.4Telephone number+34900834223
    B.5.6E-mailRegistroEspanolDeEstudiosClinicos@druginfo.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 Yes
    D.2.1.1.1Trade name ORBACTIV®
    D.2.1.1.2Name of the Marketing Authorisation holderMelinta Therapeutics, LLC
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    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 nameORBACTIV®
    D.3.4Pharmaceutical form Lyophilisate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNOritavancin
    D.3.9.1CAS number 171099-57-3
    D.3.9.4EV Substance CodeSUB28422
    D.3.10 Strength
    D.3.10.1Concentration unit mg/kg milligram(s)/kilogram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number15
    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 KIMYRSA (TM)
    D.2.1.1.2Name of the Marketing Authorisation holderMelinta Therapeutics, LLC
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    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 nameKIMYRSA (TM)
    D.3.4Pharmaceutical form Lyophilisate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNOritavancin
    D.3.9.1CAS number 171099-57-3
    D.3.9.4EV Substance CodeSUB28422
    D.3.10 Strength
    D.3.10.1Concentration unit mg/kg milligram(s)/kilogram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number15
    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
    Acute Bacterial Skin and Skin Structure Infections
    Infecciones bacterianas agudas de la piel y de la estructura de la piel
    E.1.1.1Medical condition in easily understood language
    Bacterial infection of the skin and associated tissues.
    Infecciones bacterianas de la piel y tejidos asociados
    E.1.1.2Therapeutic area Diseases [C] - Skin and Connective Tissue Diseases [C17]
    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 safety and tolerability of single-dose IV oritavancin (ORBACTIV and KIMYRSA) relative to Standard of Care (SoC) treatments in pediatric subjects with Acute ABSSSI.
    Evaluar la seguridad y la tolerabilidad de una dosis única de oritavancina IV (ORBACTIV y KIMYRSA) en comparación con los tratamientos habituales (TH) en sujetos pediátricos con IBAPSE aguda
    E.2.2Secondary objectives of the trial
    To evaluate the Clinical Response of single-dose IV oritavancin (ORBACTIV and KIMYRSA) relative to SoC treatments in pediatric subjects with ABSSSI
    To evaluate the pharmacokinetic (PK) profile of single-dose IV oritavancin (ORBACTIV and KIMYRSA) in pediatric subjects with ABSSSI
    - Evaluar la respuesta clínica a una sola administración de oritavancina IV (ORBACTIV y KIMYRSA) en comparación con el TH en sujetos pediátricos con IBAPSE
    - Evaluar el perfil farmacocinético (FC) de una dosis única de oritavancina IV (ORBACTIV y KIMYRSA) en sujetos pediátricos con IBAPSE
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male or female, 3 months to <18 years of age at screening
    2. Diagnosis of at least one of the following ABSSSI infections (known or suspected to be caused by a gram-positive pathogen):
    a. Wound infection: that is either traumatic or surgical in origin, defined as an infection characterized by purulent drainage from a wound with surrounding erythema, edema, and/or induration
    b. Cellulitis/erysipelas: a diffuse skin infection characterized by spreading areas of erythema, edema, and/or induration
    c. Major cutaneous abscess: an infection characterized by a collection of pus within the dermis or subcutaneous tissue that is accompanied by surrounding erythema, edema, and/or induration
    3. ABSSSI must present with at least two of the following signs and symptoms:
    a. Purulent drainage or discharge
    b. Erythema (>1 cm beyond edge of wound or abscess)
    c. Fluctuance
    d. Heat or localized warmth
    e. Edema/induration
    f. Pain or tenderness to palpation
    AND
    at least one of the following signs of systemic inflammation:
    a. Proximal lymph node swelling and tenderness
    b. Increased temperature (>38.0°C [>100.4°F])
    c. Decreased temperature (<36.0°C [<96.8°F])
    d. Decreased white blood count (WBC) (<4000/mm3) or increased WBC (>12,000mm3)
    e. Bandemia >10%
    f. C-reactive protein (CRP) >upper limit of normal (ULN)
    4. Written informed consent obtained from parent(s) or legal guardian(s), with written or documented verbal assent of the child obtained, when appropriate, before initiation of any assessments conducted solely for study purposes.
    1. Sujetos de ambos sexos, entre los 3 meses y <18 años de edad en el momento de la aleatorización
    2. Diagnóstico de al menos una de las siguientes IBAPSE (que se sabe o se sospecha que ha sido causada por un microorganismo patógeno grampositivo):
    a. Infección de herida: que es de origen traumático o quirúrgico, definida como una infección que se caracteriza por drenaje purulento de una herida con eritema, edema y/o induración circundante
    b. Celulitis o erisipela: infección difusa de la piel que se caracteriza por amplias zonas de eritema, edema o induración
    c. Absceso cutáneo importante: infección que se caracteriza por una acumulación de pus dentro de la dermis o del tejido subcutáneo que se acompaña de eritema, edema o induración circundantes
    3. La IBAPSE debe presentar al menos dos de los siguientes signos y síntomas:
    a. Drenaje o secreción purulenta
    b. Eritema (>1 cm por fuera del borde de la herida o del absceso)
    c. Fluctuación
    d. Calor localizado de intensidad variable
    e. Edema o induración
    f. Dolor o sensibilidad a la palpación
    Y
    al menos uno de los siguientes signos de inflamación sistémica:
    a. Inflamación y dolor a la palpación de los ganglios linfáticos proximales
    b. Aumento de la temperatura (>38,0 °C)
    c. Disminución de la temperatura (<36,0 °C)
    d. Disminución del recuento de glóbulos blancos (GB) (<4000/mm3) o aumento de dicho recuento de GB (>12 000/mm3)
    e. Desviación a la izquierda >10 %
    f. Proteína C reactiva (PCR) por encima del límite superior de la normalidad (LSN)
    4. Consentimiento informado por escrito obtenido de los padres o tutores legales, con consentimiento verbal escrito o documentado del niño, cuando corresponda, antes del inicio de cualquier evaluación que se lleve a cabo únicamente con fines de estudio.
    E.4Principal exclusion criteria
    1. Subjects who have received more than 72 hours of effective antibacterial drug therapy for treatment of the current episode of ABSSSI
    2. Subjects who have received a glycopeptide antibiotic (e.g., vancomycin, telavancin, teicoplanin) within 24 hours of randomization
    3. Subjects who have received dalbavancin within 45 days prior to randomization
    4. Subjects who have been treated with oritavancin within the last 50 days
    5. Subjects with infection suspected to be associated with a device or implant
    6. Subjects with septic shock or hemodynamic instability
    7. Subjects with ABSSSI due to, or associated with any of the following:
    a. Infection suspected or documented to be caused solely by gramnegative pathogens (e.g., human or animal bite, injury contaminated with fresh or saltwater, external malignant otitis), fungi, or viruses
    b. Wound infection (surgical or traumatic) or abscess with only gram-negative pathogens
    c. Concomitant infection at another site, not including a secondary ABSSSI lesion (e.g., septic arthritis, endocarditis, osteomyelitis).
    d. Infected burn
    e. Primary infection superimposed on a pre-existing skin disease with associated inflammatory changes, e.g., atopic dermatitis, eczema
    f. Any evolving necrotizing process (e.g., necrotizing fasciitis), gangrene, or infection suspected or proven to be caused by clostridioides species (e.g., crepitance on examination of the ABSSSI site and/or surrounding tissue(s), radiographic evidence of subcutaneous gas in proximity to the infection)
    g. Clinically significant viral infection (e.g., influenza, COVID-19) which, in the Investigator’s judgement, will impact the study clinical outcome assessments (e.g., subject is febrile due to the viral infection)
    8. Subjects currently receiving chronic systemic immunosuppressive therapy
    9. Subjects with neutropenia, defined as ab-solute neutrophil count (ANC) <500 cells/mm3
    10. Subjects with severe renal impairment as an eGFR
    < 30 ml/min/1.73m2 when using the updated bedside Schwartz formula. For subjects under 1 year of age, severe renal impairment is
    defined as serum creatinine ≥ 2 times the 97.5th percentile creatinine for age, converted to mg/dL, from Table 10 OR requirement for dialysis. If you have a subject under 1 year of age with renal impairment, please consult with the Medical Monitor before enrollment (see Appendix 3).
    11. Menstruating females with a positive result for the urine or serum human chorionic gonadotropin (HCG) test administered at screening
    12. Females of childbearing potential (and males with female partners of childbearing potential) unwilling to practice abstinence or use at least two methods of contraception (e.g., oral contraceptives, barrier methods, approved contraceptive implants) during the entire study period
    13. Subjects with a history of infusion-related immunoglobulin E (IgE)- mediated allergic reaction or hypersensitivity reaction to glycopeptides (e.g., vancomycin, telavancin, dalbavancin, oritavancin, teicoplanin) or any of their excipients
    14. Subjects who are taking heparin (other than heparin flush for line patency) or warfarin, and/or require anticoagulant monitoring [activated partial thromboplastin time (aPTT), prothrombin time (PT), international normalized ratio (INR)]
    15. Subjects receiving treatment with investigational medicinal product or investigational device within 3 months before enrollment or during the study
    16. Subjects whom the investigator considers unlikely to adhere to the protocol, comply with Study Drug administration, or complete the clinical study (e.g., unlikely to survive 28 days from initiation of Study Drug)
    17. Subjects with alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >3x ULN or total bilirubin ≥2x ULN.
    1. Sujetos que hayan recibido terapia farmacológica antibacteriana eficaz para el tratamiento del episodio actual de la IBAPSE durante más de 72 horas
    2. Sujetos que hayan recibido un antibiótico glucopéptido (p. ej., vancomicina, telavancina, teicoplanina) en las 24 horas posteriores a la aleatorización
    3. Sujetos que hayan recibido dalbavancina en los 45 días anteriores a la aleatorización
    4. Sujetos que hayan recibido tratamiento con oritavancina en los últimos 50 días
    5. Sujetos con sospecha de infección asociada a un dispositivo o implante
    6. Sujetos con shock séptico o inestabilidad hemodinámica
    7.Sujetos con IBAPSE debida o asociada a cualquiera de los siguientes motivos:
    a. Sospecha de infección o infección documentada causada únicamente por microorganismos patógenos gramnegativos (p. ej., mordedura humana o animal, lesión contaminada con agua dulce o salada, otitis maligna externa), hongos o virus
    b. Infección de herida (quirúrgica o traumática) o absceso causado solo por microorganismos patógenos gramnegativos
    c. Infección concomitante en otro sitio que no sea una IBAPSE secundaria (p. ej., artritis séptica, endocarditis, osteomielitis).
    d. Quemadura infectada
    e. Infección primaria superpuesta a una enfermedad cutánea preexistente con cambios inflamatorios asociados, por ejemplo, dermatitis atópica, eccema
    f. Cualquier proceso necrosante en evolución (p. ej., fascitis necrosante), gangrena o infección que se sospeche o se demuestre que se debe a especies de clostridioides (p. ej., crepitación en la exploración de la zona de la IBAPSE y/o del (de los) tejido(s) circundante(s), evidencia radiográfica de gas subcutáneo en los alrededores de la infección)
    g. Infección viral clínicamente significativa (p. ej., gripe, COVID-19) que, a juicio del investigador, afectará las evaluaciones de los resultados clínicos del estudio (p. ej., el sujeto tiene fiebre debido a la infección viral)
    8. Sujetos que actualmente reciben terapia inmunosupresora sistémica crónica
    9. Sujetos con neutropenia, definida como recuento absoluto de neutrófilos (RAN) <500 células/mm3
    10. Sujetos con insuficiencia renal grave, como TFGe <30 ml/min/1,73 m2 al utilizar la fórmula de Schwartz actualizada para uso a pie de cama. Para sujetos menores de 1 año, la insuficiencia renal grave se define como creatinina sérica 2 veces superior o igual al percentil97,5de creatinina para la edad, convertido a mg/dl, de la tabla 10 O necesidad de diálisis. Si tiene un sujeto menor de 1 año con insuficiencia renal, consulte con el monitor médico antes de inscribirlo (véase el apéndice 3).
    11. Pacientes femeninas que menstrúan y que tengan un resultado positivo en la prueba de gonadotropina coriónica humana (HCG) en orina o suero efectuada en la selección
    12. Pacientes femeninas con capacidad reproductiva (y pacientes masculinos con parejas femeninas con capacidad reproductiva) que no deseen practicar la abstinencia ni usar al menos dos métodos anticonceptivos (p. ej., anticonceptivos orales, métodos de barrera, implantes anticonceptivos aprobados) durante todo el periodo de estudio
    13. Sujetos con antecedentes de reacción alérgica mediada por inmunoglobulina E (IgE) relacionada con la infusión o reacción de hipersensibilidad a los glucopéptidos (p. ej., vancomicina, telavancina, dalbavancina, oritavancina, teicoplanina) o cualquiera de sus excipientes
    14. Sujetos que están recibiendo heparina (aparte del lavado de la vía con heparina) o warfarina, y/o que requieren control anticoagulante [tiempo de tromboplastina parcial activada (TTPa), tiempo de protrombina (TP), índice internacional normalizado (INR)]
    15. Sujetos que han recibido tratamiento con un producto en investigación o un dispositivo en investigación en los 3 meses anteriores a la inscripción o durante el estudio
    16. Sujetos que el investigador considere poco probable que cumplan con el protocolo o con la administración del fármaco del estudio o que completen el estudio clínico (p. ej., es poco probable que sobrevivan 28 días desde el inicio de la administración del fármaco del estudio)
    17.Sujetos con alanina aminotransferasa (ALT) o aspartato aminotransferasa (AST) >3 × LSN o bilirrubina total ≥2 × LSN.
    E.5 End points
    E.5.1Primary end point(s)
    Safety assessment of ORBACTIV and KIMYRSA in pediatric populations.
    Evaluación de la seguridad de ORBACTIV y KIMYRSA en poblaciones pediátricas
    E.5.1.1Timepoint(s) of evaluation of this end point
    Data will be analyzed by treatment group using the following parameters: laboratory results, vital signs, adverse events (AEs), physical examinations, and concomitant medication use.
    Los datos se analizarán por grupo de tratamiento por medio de los siguientes parámetros: resultados de laboratorio, constantes vitales, acontecimientos adversos (AA), exploraciones físicas y uso de medicamentos concomitantes.
    E.5.2Secondary end point(s)
    All-cause mortality assessed at the Time of Cure (ToC) visit
    Mortalidad por todas las causas evaluada en la visita de EdC
    E.5.2.1Timepoint(s) of evaluation of this end point
    o Clinical Response of Cure, Failure, or Unknown at EoT Visit
    o Clinical Response of Cure, Failure, or Unknown at ToC Visit
    - Respuesta clínica de curación ,fracaso , o desconocida en la visita de FdT
    - Respuesta clínica de curación, fracaso, o desconocida en la visita de EdC
    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 Yes
    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 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 Yes
    E.8.2.3.1Comparator description
    Tratamiento habitual
    Standard of Care
    E.8.2.4Number of treatment arms in the trial3
    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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA27
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    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 States
    Belgium
    Bulgaria
    Greece
    Latvia
    Lithuania
    Poland
    Portugal
    Romania
    Spain
    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 years3
    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 years3
    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 Yes
    F.1.1Number of subjects for this age range: 200
    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) Yes
    F.1.1.4.1Number of subjects for this age range: 20
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 90
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 90
    F.1.2Adults (18-64 years) No
    F.1.3Elderly (>=65 years) No
    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
    Subjects between 2 and 17 years old will give assent
    Asentimiento para sujetos entre 2 y 17 años de edad
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 161
    F.4.2.2In the whole clinical trial 200
    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)
    There are no plans for post-study treatment
    No hay planes de tratamiento posterior al 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 Decision2023-04-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2023-04-05
    P. End of Trial
    P.End of Trial StatusOngoing
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