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Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
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  • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).


    The EU Clinical Trials Register currently displays   44334   clinical trials with a EudraCT protocol, of which   7366   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 on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
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    Summary
    EudraCT Number:2014-005281-30
    Sponsor's Protocol Code Number:DUR001-306
    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:2016-10-10
    Trial results View 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 number2014-005281-30
    A.3Full title of the trial
    A Phase 3, Multicenter, Open-Label, Randomized, Comparator Controlled Trial of the Safety and Efficacy of Dalbavancin versus Active Comparator in Pediatric Subjects with Acute Bacterial Skin and Skin Structure Infections
    Estudio Fase 3, multicéntrico, abierto, aleatorizado, controlado con
    comparador, para comprobar la seguridad y eficacia de la dalbavancina frente a un comparador activo en pacientes pediátricos con infecciones bacterianas agudas de la piel y tejidos blandos
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase 3, Multicenter, Open-Label, Randomized, Comparator Controlled Trial of the Safety and Efficacy of Dalbavancin versus Active Comparator in Pediatric Subjects with Acute Bacterial Skin and Skin Structure Infections
    Estudio Fase 3, multicéntrico, abierto, aleatorizado, controlado con
    comparador, para comprobar la seguridad y eficacia de la dalbavancina frente a un comparador activo en pacientes pediátricos con infecciones bacterianas agudas de la piel y tejidos blandos
    A.4.1Sponsor's protocol code numberDUR001-306
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02814916
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/056/2016
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorDurata Therapeutic International B.V. (an Allergan Affiliate)
    B.1.3.4CountryNetherlands
    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 supportDurata Therapeutic International B.V.
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationDurata Therapeutics International B.V.
    B.5.2Functional name of contact pointDirector Clinical & Medical Affairs
    B.5.3 Address:
    B.5.3.1Street AddressHarborside Financial Center, Plaza V
    B.5.3.2Town/ cityNew Jersey
    B.5.3.3Post codeNJ 07311
    B.5.3.4CountryUnited States
    B.5.4Telephone number+12014278864
    B.5.6E-mailurania.rappo@allergan.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 Xydalba
    D.2.1.1.2Name of the Marketing Authorisation holderDurata Therapeutics International B.V.
    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.3.4Pharmaceutical form Powder for concentrate 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 INNDalbavancin hydrochloride
    D.3.9.1CAS number 171500-79-1
    D.3.9.3Other descriptive nameDALBAVANCIN HYDROCHLORIDE
    D.3.9.4EV Substance CodeSUB130539
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number500
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) 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 RoleComparator
    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 Oxacillin for Injection USP
    D.2.1.1.2Name of the Marketing Authorisation holderOxacillin IV
    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 nameOxacillin
    D.3.4Pharmaceutical form Powder 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 INNOXACILLIN
    D.3.9.1CAS number 66-79-5
    D.3.9.4EV Substance CodeSUB09484MIG
    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.IMP: 3
    D.1.2 and D.1.3IMP RoleComparator
    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 Vancomycin Hydrochloride, USP
    D.2.1.1.2Name of the Marketing Authorisation holderVancomycin HCL
    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 nameVancomycin
    D.3.4Pharmaceutical form Powder 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 INNVancomycin
    D.3.9.1CAS number 1404-90-6
    D.3.9.3Other descriptive nameVANCOMYCIN HYDROCHLORIDE
    D.3.9.4EV Substance CodeSUB05077MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number500
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) 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: 4
    D.1.2 and D.1.3IMP RoleComparator
    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 Flucloxacillin 1g Powder for Solution for Injection or Infusion
    D.2.1.1.2Name of the Marketing Authorisation holderFloucloxacillin
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 nameFlucloxacillin
    D.3.4Pharmaceutical form Powder 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 INNFLUCLOXACILLIN
    D.3.9.1CAS number 5250-39-5
    D.3.9.4EV Substance CodeSUB07673MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number500
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) 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: 5
    D.1.2 and D.1.3IMP RoleComparator
    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 Cleocin
    D.2.1.1.2Name of the Marketing Authorisation holderClindamycin HCL
    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 nameClindamycin
    D.3.4Pharmaceutical form Capsule
    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 INNCLINDAMYCIN
    D.3.9.3Other descriptive nameCLINDAMYCIN HYDROCHLORIDE
    D.3.9.4EV Substance CodeSUB01342MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number300
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) 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: 6
    D.1.2 and D.1.3IMP RoleComparator
    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 Clindamycin Hydrochoride Capsules, USP
    D.2.1.1.2Name of the Marketing Authorisation holderClindamycin HCL
    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 nameClindamycin
    D.3.4Pharmaceutical form Capsule
    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 INNCLINDAMYCIN
    D.3.9.3Other descriptive nameCLINDAMYCIN HYDROCHLORIDE
    D.3.9.4EV Substance CodeSUB01342MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    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: 7
    D.1.2 and D.1.3IMP RoleComparator
    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 Clindamycin Palmitate Hydrochloride for Oral Solution, USP
    D.2.1.1.2Name of the Marketing Authorisation holderClindamycin
    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 nameClindamycin
    D.3.4Pharmaceutical form Concentrate for oral solution
    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 INNCLINDAMYCIN
    D.3.9.3Other descriptive nameCLINDAMYCIN HYDROCHLORIDE
    D.3.9.4EV Substance CodeSUB01342MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    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: 8
    D.1.2 and D.1.3IMP RoleComparator
    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 Cefadroxil for Oral Suspension USP
    D.2.1.1.2Name of the Marketing Authorisation holderCefadroxil
    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 nameCefadroxil
    D.3.4Pharmaceutical form Concentrate for oral suspension
    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 INNCEFADROXIL
    D.3.9.3Other descriptive nameCEFADROXIL
    D.3.9.4EV Substance CodeSUB06164MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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: 9
    D.1.2 and D.1.3IMP RoleComparator
    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 Cefadroxil Capsules
    D.2.1.1.2Name of the Marketing Authorisation holderCefadroxil
    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 nameCefadroxil
    D.3.4Pharmaceutical form Capsule
    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 INNCEFADROXIL
    D.3.9.3Other descriptive nameCEFADROXIL
    D.3.9.4EV Substance CodeSUB06164MIG
    D.3.10 Strength
    D.3.10.1Concentration unit millilitre(s)/gram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number500
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) 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 infection
    infecciones bacterianas agudas de la piel y tejidos blandos
    E.1.1.1Medical condition in easily understood language
    Skin infection
    infeccion de la piel
    E.1.1.2Therapeutic area Body processes [G] - Microbiological Phenomena [G06]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level LLT
    E.1.2Classification code 10066412
    E.1.2Term Staphylococcus aureus skin infection
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level LLT
    E.1.2Classification code 10037633
    E.1.2Term Pyoderma (skin infection)
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level LLT
    E.1.2Classification code 10040873
    E.1.2Term Skin infection aggravated
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level PT
    E.1.2Classification code 10040872
    E.1.2Term Skin infection
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level LLT
    E.1.2Classification code 10040875
    E.1.2Term Skin infection pyogenic
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level LLT
    E.1.2Classification code 10040874
    E.1.2Term Skin infection NOS
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level PT
    E.1.2Classification code 10066409
    E.1.2Term Staphylococcal skin 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 the safety and descriptive efficacy of dalbavancin for the treatment of acute bacterial skin and skin structure infections in children, aged 3 months to 17 years, known or suspected to be caused by susceptible Gram-positive organisms, including methicillin-resistant strains of Staphylococcus aureus
    Determinar la seguridad y eficacia descrita de dalbavancina para el tratamiento de infecciones bacterianas agudas de la piel y tejidos blandos en niños, entre 3 meses y 17 años de edad, que se sabe o se sospecha han sido causadas por organismos grampositivos susceptibles, que incluyen cepas de Staphylococcus aureus resistentes a la meticilina.
    E.2.2Secondary objectives of the trial
    To assess clinical response at 48-72 h post randomization (≥ 20% reduction in lesion size compared to baseline) measured in patients who did not receive rescue therapy and are alive, and clinical response based on the global clinical assessment by the investigator at end of treatment (14 ± 2 days after start of therapy), at test of cure visit (28 ± 2 days after start of therapy), and at last follow-up visit (54 ± 7 days after start of therapy).
    To assess clinical response by baseline pathogen at 48-72 h post randomization ( ≥ 20% reduction in lesion size compared to baseline), and clinical response by baseline pathogen based on the global clinical assessment by the investigator at end of treatment (14 ± 2 days after start of therapy), at test of cure visit (28 ± 2 days after start of therapy), and at last follow-up visit (54 ± 7 days after start of therapy).
    To evaluate the pharmacokinetics of dalbavancin in pediatric patients aged 3 months to 17 years of age.
    • Evaluar la resp clínica a las 48-72h de la aleatorización (reducción ≥ 20% del tamaño de la lesión en comparación a la referencia) en pacientes que no recibieron terapia de rescate y están vivos;resp clínica en base a la evaluación clínica general del investigador al finalizar el tto (14±2 días de iniciada la terapia), en la visita de prueba de cura (28±2 de iniciada la terapia) y en la última visita de sgto (54 ± 7 días luego de iniciada la terapia).
    • Evaluar la resp clínica por patógeno de referencia a las 48-72h de la aleatorización (reducción ≥ 20% en el tamaño de la lesión en comparación a la ref); y la respuesta clínica en base al patógeno de ref según la evaluación clínica general del investigador al finalizar el tto (14±2 días de iniciada la terapia), en la visita de prueba de cura (28±2 de iniciada la terapia) y en la última visita de seguimiento (54±7 días luego de iniciada la terapia).
    • Evaluar la FC de dalbavancina en pacientes pediátricos de entre 3 meses y 17 años.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Male or female patients 3 months -17 years of age
    - A clinical picture compatible with an ABSSSI suspected or confirmed to be caused by Gram-positive bacteria, including MRSA.
    - In addition to local signs of ABSSSI, the patient has at least one of the following:
    • Fever, defined as body temperature ≥ 38.4°C (101.2°F) taken orally, ≥ 38.7°C (101.6°F) tympanically, or ≥ 39°C (102.2°F) rectally (core temperature)
    • Leukocytosis (WBC > 10,000 mm3) or leukopenia (WBC < 2,000 mm3) or left shift of >10% band neutrophils
    - Infection either involving deeper soft tissue or requiring significant surgical intervention:
    (a) Major cutaneous abscess characterized as a collection of pus within the dermis or deeper that is accompanied by erythema, edema and/or induration which:
    i. requires surgical incision and drainage, and
    ii. is associated with cellulitis such that the total affected area involves at least 35 cm2 of erythema, or total affected area of erythema is at least BSA (m2) x 43.0 (cm2/m2), OR
    iii. alternatively, involves the central face and is associated with an area of erythema of at least 15 cm2
    (b) Surgical site or traumatic wound infection characterized by purulent drainage with surrounding erythema, edema and/or induration which occurred within 30 days after the trauma or surgery and is associated with cellulitis such that
    i. the total affected area involves at least 35 cm2 of erythema, or total affected area of erythema is at least BSA (m2) x 43.0 (cm2/m2), OR
    ii. alternatively, involves the central face and is associated with an affected area of at least 15 cm2
    (c) Cellulitis, defined as a diffuse skin infection characterized by spreading areas of erythema, edema and/or induration and
    i. is associated with erythema that involves at least 35 cm2 of surface area, or surface area of erythema is at least BSA (m2) x 43.0 (cm2/m2), OR
    ii. alternatively, cellulitis of the central face that is associated with an affected area of at least 15 cm2
    - In addition to the requirement for erythema, all patients are required to have at least two (2) of the following signs of ABSSSI:
    (a) Purulent drainage/discharge
    (b) Fluctuance
    (c) Heat/localized warmth
    (d) Tenderness to palpation
    (e) Swelling/induration
    - Patients must be expected to survive with appropriate antibiotic therapy and appropriate supportive care throughout the study.
    1. Pacientes varones o mujeres de 3 meses a 17 años de edad.
    2. Un cuadro clínico compatible con una ABSSSI que se sospecha o se sabe fue causado por una bacteria grampositiva, que incluye SARM.
    3. Además de los signos locales de ABSSSI, el paciente debe tener al menos uno de los siguientes:
    • Fiebre, definida como temperatura corporal ≥ 38,4°C tomada con método oral, ≥ 38,7°C timpánico o ≥ 39°C rectal (temperatura interna)
    • Leucocitosis (LEU > 10,000 mm3) o leucopenia (LEU < 2,000 mm3) o cambio izquierdo de >10% de neutrófilos de banda
    4. Una infección que involucre tejidos blandos profundos o que necesite de intervención quirúrgica significativa:
    (a) Abscesos cutáneos grandes caracterizados como un conjunto de pus dentro de la dermis o en mayor profundidad acompañados por eritema, edema y/o induración que:
    i. requiera de incisión quirúrgica y drenaje; y
    ii. está asociado con celulitis de forma tal que el área afectada total sea, al menos, 35 cm2 o eritema, o que el área afectada total de eritema sea de al menos ASC (m2) x 43,0 (cm2/m2), O
    iii. alternativamente, involucre la cara central y se asocie con un área de eritema de al menos 15 cm2
    (b) Infección en el sitio de la cirugía o en una herida traumática caracterizada por drenaje purulento con eritema, edema y/o induración circundante que ocurrió dentro de los 30días luego del trauma o la cirugía y que está asociado con celulitis de forma
    i. que el área afectada total sea, al menos, 35 cm2 o eritema, o que el área afectada
    total de eritema sea de al menos ASC (m2) x 43,0 (cm2/m2), O
    ii. alternativamente, involucre la cara central y se asocie con un área afectada de al menos 15 cm2
    (c) Celulitis, definida como una infección cutánea difusa caracterizada por áreas de eritema, edema y/o induración que se propaga y
    i. que está asociada con un eritema que afecta, al menos, 35 cm2 del área de superficie o que el área afectada de eritema sea de, al menos, ASC (m2) x 43,0 (cm2/m2), O
    ii. alternativamente, celulitis de la cara central que se asocie con un área afectada de al menos 15 cm2
    5. Además de los requisitos de eritema, todos los pacientes deben tener al menos dos (2) de los siguientes signos de ABSSSI:
    (a) Drenaje/descarga purulenta
    (b) Fluctuación
    (c) Calor/ardor localizado
    (d) Sensibilidad al tacto
    (e) Hinchazón/induración
    8. Se debe esperar que los pacientes sobrevivan con la terapia antibiótica y los cuidados de apoyo adecuados a lo largo del studio.
    E.4Principal exclusion criteria
    - Clinically significant renal impairment, defined as calculated creatinine clearance < 30 mL/min.
    - Clinically significant hepatic impairment, defined as serum bilirubin or alkaline phosphatase >2X ULN for age, and/or serum AST or ALT >3X ULN for age.
    - Patients with sustained shock defined as systolic blood pressure < 90 mm Hg in children ≥ 10 years old, < 70 mm Hg + [2 x age in years] in children 1 to <10 years, or < 70 mmHg in infants 3 to <12 months old for more than 2 hours despite adequate fluid resuscitation, with evidence of hypoperfusion or need for sympathomimetic agents to maintain blood pressure.
    - Receipt of a systemically or topically administered antibiotic with a Gram-positive spectrum that achieves therapeutic concentrations in the serum or at the site of the skin infection within 14 days prior to randomization. An exception is allowed for patients receiving a single dose of a short-acting (half-life ≤ 12 hours) antibacterial drug prior to randomization
    - Patients with necrotizing fasciitis, or deep-seated infections that would require > 2 weeks of antibiotics (e.g., endocarditis, osteomyelitis or septic arthritis).
    - Infections caused exclusively by Gram-negative bacteria (without Gram-positive bacteria present) and infections caused by fungi, whether alone or in combination with a bacterial pathogen.
    - Venous catheter entry site infection.
    - Infections involving diabetic foot ulceration, perirectal abscess or a decubitus ulcer.
    - Patient with an infected device, even if the device is removed. Examples include infection of: prosthetic cardiac valve, vascular graft, a pacemaker battery pack, joint prosthesis, implantable pacemaker or defibrillator, intra-aortic balloon pump, left ventricular assist device, or a neurosurgical device such as a ventricular peritoneal shunt, intra-cranial pressure monitor, or epidural catheter.
    - Gram-negative bacteremia, even in the presence of Gram-positive infection or Gram-positive bacteremia. Note: If a Gram-negative bacteremia develops during the study, or is subsequently found to have been present at Baseline, the patient should be removed from study treatment and receive appropriate antibiotic(s) to treat the Gram-negative bacteremia.
    - Patients whose skin infection is the result of having sustained full or partial thickness burns.
    - Patients with uncomplicated skin infections such as superficial/simple cellulitis/erysipelas, impetiginous lesion, furuncle, or simple abscess that only requires surgical drainage for cure.
    - Concomitant condition requiring any antibiotic therapy that would interfere with the assessment of study drug for the condition under study.
    - Sickle cell anemia
    - Cystic fibrosis
    - Anticipated need of antibiotic therapy for longer than 14 days.
    - Patients who are placed in a hyperbaric chamber as adjunctive therapy for the ABSSSI.
    - More than 2 surgical interventions (defined as procedures conducted under sterile technique and typically unable to be performed at the bedside) for the skin infection, or patients who are expected to require more than 2 such interventions.
    - Medical conditions in which chronic inflammation may preclude assessment of clinical response to therapy even after successful treatment (e.g., chronic stasis dermatitis of the lower extremity).
    - Immunosuppression/immune deficiency, including hematologic malignancy, recent bone marrow transplant (in post-transplant hospital stay), absolute neutrophil count < 500 cells/mm3, receiving immunosuppressant drugs after organ transplantation, receiving oral steroids ≥ 20 mg prednisolone per day (or equivalent) for > 14 days prior to enrollment, and known or suspected human immunodeficiency virus (HIV) infected patients with a CD4 cell count < 200 cells/mm3 or with a past or current acquired immunodeficiency syndrome (AIDS)-defining condition and unknown CD4 count.
    - Patients with a rapidly fatal illness, who are not expected to survive for 3 months.
    1. Disfunción renal clínicamente significativa, definida como depuración de creatinina calculada < 30 mL/min.
    2. Disfunción hepática clínicamente significativa, definida como bilirrubina sérica o fosfatasa alcalina >2X ULN para la edad y/o AST o ALT sérico >3X ULN para la edad.
    4. Pacientes con shock sostenido definido como una presión arterial sistólica < 90 mm Hg en niños de ≥ 10 años, < 70 mm Hg + [2 x edad en años] en niños entre 1 y <10años o < 70 mm Hg en infantes entre 3 y <12 meses durante más de dos horas a pesar de una reanimación de fluidos adecuada, con evidencia de hipoperfusión o necesidad
    de agentes simpaticomiméticos para mantener la presión arterial.
    5. Recepción de un antibiótico administrado en forma sistémica o tópica de espectro grampositivo que logra concentraciones terapéuticas en suero o en el lugar de la infección cutánea dentro de los 14 días previos a la aleatorización. Se permite una excepción para pacientes que reciban una dosis única de un fármaco antibacteriano de corta duración (vida media ≤ 12 horas) previo a la aleatorización. 7. Pacientes con fascitis necrotizante o infecciones profundas que necesiten de > 2 semanas de antibióticos (por ej., endocarditis, osteomielitis o artritis séptica).
    8. Infecciones causadas exclusivamente por bacterias gramnegativas (sin la presencia de bacterias grampositivas) e infecciones causadas por hongos, ya sea solas o en combinación con un patógeno bacteriano.
    9. Infección en el punto de entrada del catéter venoso.
    10. Infecciones que involucran úlceras del pie diabético, abscesos perirectales o una úlcera del decúbito.
    11. Paciente con un dispositivo infectado, incluso si el dispositivo es retirado. Los ejemplos incluyen infecciones de válvula cardíaca, injerto vascular, batería de marcapasos, prótesis articular, marcapasos implantable o desfibrilador, balón
    intraaórtico de contrapulsación, dispositivo de asistencia ventricular izquierda, o un dispositivo neuroquirúrgico como una derivación ventriculoperitoneal, un monitor de presión intracraneal o catéter epidural.
    12. Bacteria gramnegativa, incluso en la presencia de una infección grampositiva o bacteremia grampositiva. Nota: Si se desarrolla una bacteremia gramnegativa durante el estudio o se descubre posteriormente que estaba presente en el Inicio, el paciente
    debería ser retirado del tratamiento del estudio y recibir los antibióticos adecuados para tratar bacteremia gramnegativa.
    13. Pacientes cuyas infecciones cutáneas sean el resultado de quemaduras completas o de espesor parcial.
    14. Pacientes con infecciones cutáneas no complicadas como celulitis/erisipelas superficiales/simples, lesiones impetiginizadas o abscesos simples que solo necesitan de drenaje quirúrgico para ser curadas.
    15. Condición concomitante que necesita de cualquiera terapia antibiótica que interfiera con la evaluación del fármaco del estudio para la condición en estudio.
    16. Anemia de células falciformes
    17. Fibrosis quística
    18. Necesidad anticipada de terapia con antibióticos durante más de 14 días.
    19. Pacientes que son colocados en una cámara hiperbárica como terapia adyuvante para
    la ABSSSI.
    20. Más de dos intervenciones quirúrgicas (definidas como procedimientos realizados bajo técnicas estériles y que generalmente no se pueden realizar en la cabecera de la cama) para la infección cutánea, o pacientes que se espera necesiten más de dos
    intervenciones de este tipo.
    21. Condiciones médicas donde una inflamación crónica pueda impedir la evaluación de la respuesta clínica a la terapia, incluso luego de un tratamiento exitoso (por ej., dermatitis por estasis crónica de las extremidades inferiores).
    22. Inmunosupresión/deficiencia inmune, incluida malignidad hematológica, trasplante de médula ósea reciente (en la hospitalización posterior al trasplante), conteo absoluto de neutrófilos < 500 células/mm3, con suministro de fármacos
    inmunosupresivos, esteroides orales ≥ 20 mg prednisolona por día (o equivalente) durante > 14 días antes de la inscripción, y pacientes que se sabe o sospecha están infectados con el virus de inmunodeficiencia humana (VIH) con conteo celular CD4 < 200 células/mm3 o con condición pasada o actual relacionada al síndrome de
    inmunodeficiencia adquirida (SIDA) y conteo de CD4 desconocido.
    24. Pacientes con una enfermedad terminal de progresión rápida que no se espera sobrevivan tres meses.
    E.5 End points
    E.5.1Primary end point(s)
    Primary Endpoint includes all safety parameters:
    - Safety will be assessed by means of physical examination and vital signs, collection of
    adverse events and clinical laboratory tests.
    - Audiologic testing will be conducted in at least 30 children < 12 years old (in selected
    centers), of which 50% (~15 children) will be <2 years old. At least 20 of the 30 children
    should have received dalbavancin.
    - The impact of dalbavancin on the bowel flora will be determined in patients 3 months to < 2
    years, by performing PCR for Clostridium difficile (C. diff) and culture for vancomycinresistant
    enterococci (VRE) on a stool specimen or rectal swab.
    Análisis primario (seguridad)
    -Se evaluará la seguridad a través de evaluaciones físicas y signos vitales, la recopilación de eventos adversos y pruebas clínicas de laboratorio.
    -Se realizarán pruebas audiológicas en, al menos, 30 niños de < 12 años (en centros seleccionados), de los cuales el 50% (~15 niños) tendrán < 2 años. Al menos 20 de los 30 niños deberían haber recibido dalbavancina.
    -El impacto de la dalbavancina en la flora intestinal se determinará en pacientes de entre 3 meses y < 2 años, mediante un PCR para Clostridium difficile (C. diff) y un cultivo para enterococos resistentes a la vancomicina (VRE) sobre una muestra de heces o un hisopado
    rectal
    E.5.1.1Timepoint(s) of evaluation of this end point
    - Physical examination: Baseline
    - Vital signs: Baseline, and at Day 1, 48-72 hours post randomization, Day 8 (± 1 day), Day 14 (± 2 days), Day 28 (± 2 days), Day 54 (± 7 days), or at premature discontinuation
    - Adverse events: every visit,
    - Clinical laboratory tests: Baseline and at Day 14 (± 2 days), or at premature discontinuation.
    - Audiologic testing : Baseline and repeated at Day 28 (± 2 days). If the audiologic
    assessment at Day 28 shows an abnormality : follow-up assessments will be
    performed at 3 months and 6 months post-dose, as needed or until returned to baseline.
    - The impact of dalbavancin on the bowel flora: Baseline and Day 28 (± 2days). The testing of bowel flora in this age group will be done in all study arms.
    Evaluaciones físicas se realizarán:inicio, se registrarán los signos vitals:inicio y D1, 48-72hde la aleatorización, Día 8 (±1 día), Día 14 (±2 días), D28 (±2días), el D54 (±7 días), o en disc prematura. Se recopilarán los EA en cada visita.
    Se obtendrán pruebas clínicas de lab en el Inicio y D14 (±2 días) o en la disc premature.
    Pruebas audiológicas se realizarán:Inicio,se repetirán el D28 (±2días).Si la evaluación audiológica del D28 indica anormalidad, se realizarán evaluaciones de segto a los 3 y 6 meses de la dosis, según sea necesario, o hasta volver al valor de Inicio.
    El impacto de la dalbavancina en la flora intestinal se determinará en el momento inicial y el Día 28 (±2 días). En este grupo etario se realizará análisis de la flora intestinal para todos los brazos de studio.
    E.5.2Secondary end point(s)
    Clinical response at 48-72 hours after randomization defined as ≥ 20% reduction in lesion size compared to baseline, in patients who did not receive rescue therapy and are alive.
    Microbiological outcome
    Pharmacokinetic outcome
    La respuesta clínica a las 48-72 horas luego de la aleatorización se define como la reducción del ≥ 20% en el tamaño de la lesión en comparación con el Inicio, medido en pacientes que no recibieron terapia de rescate y están vivos.
    resultados microbiológicos
    resultado farmacocinético
    E.5.2.1Timepoint(s) of evaluation of this end point
    Clinical response and microbiology outcome:
    Baseline, 48-72 hours post randomization, EOT visit (14 ± 2 days), TOC visit (28 ± 2 days) and follow up visit (54 ± 7 days)
    Plasma PK samples will be collected on all patients on dalbavancin (single dose arm and two-dose arm), at 30 minutes and at 2 hours (Day 1), at 48-72 hours (Day 3-4), at 168 ± 24 hours (Day 8 ± 1) before the Day 8 dalbavancin dose, and at 312 ± 48 hours (Day 14 ± 2) and at premature discontinuation.
    La respuesta clínica y microbiologica:

    visita inicial,48-72 horas luego de la aleatorización,en la visita de fin de estudio (FDT) (14 ± 2 días),PDC (28 ± 2 días) y en la visita de seguimiento (54 ± 7días).
    Las muestras de PK en plasma seran recogidas para todos los pacientes en Dalbavacina ( (Grupo de dosis única y dos grupo de dosis), a los 30 minutos y a las 2 horas (día 1), en 48-72 horas (día 3-4), en 168 ± 24 horas (día 8 ± 1) antes del día 8 dosis dalbavancina, y en 312 ± 48 horas (día 14 ± 2) ya la interrupción prematura.
    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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    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 Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    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 concerned12
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA48
    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
    Argentina
    Belarus
    Brazil
    Bulgaria
    Chile
    Colombia
    Ecuador
    Georgia
    Greece
    Guatemala
    Latvia
    Lithuania
    Mexico
    Panama
    Poland
    Romania
    Russian Federation
    South Africa
    Spain
    Ukraine
    United States
    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
    End of Study in all participating countries is defined as the last patient’s Final Visit
    ultima visita del ultimo paciente.Fin del estudio en todos los países participantes se define como la última visita del último paciente
    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 Yes
    F.1.1Number of subjects for this age range: 300
    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: 60
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 150
    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
    Informed consent forms will be provided for parents and Assent forms will be provided for 2-5, 6-11 and 12-17 years
    Formularios de consentimiento informado serán proporcionados para los padres y las formas asentimiento por 2-5, 6-11 y 12-17 años
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state12
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 103
    F.4.2.2In the whole clinical trial 300
    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
    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 Decision2017-02-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-01-04
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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