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    Summary
    EudraCT Number:2011-003812-22
    Sponsor's Protocol Code Number:P903-23
    National Competent Authority:Lithuania - SMCA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2012-05-25
    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 ConcernedLithuania - SMCA
    A.2EudraCT number2011-003812-22
    A.3Full title of the trial
    A Multicenter, Randomized, Observer-Blinded, Active-Controlled Study to Evaluate the Safety, Tolerability, Efficacy, and Pharmacokinetics of Ceftaroline Versus Comparator in Pediatric Subjects With Acute Bacterial
    Skin and Skin Structure Infections
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Safety and Efficacy Study of Ceftaroline Versus a Comparator in Pediatric Subjects with Complicated Skin Infections
    A.4.1Sponsor's protocol code numberP903-23
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01400867
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/158/2010
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorCerexa, Inc. (subsidary of Forest Laboratories)
    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 supportCerexa, Inc. (subsidary of Forest Laboratories)
    B.4.2CountryUnited States
    B.4.1Name of organisation providing supportAstraZeneca AB
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCerexa, Inc. (subsidary of Forest Laboratories)
    B.5.2Functional name of contact pointExecutive Director, Reg Affairs
    B.5.3 Address:
    B.5.3.1Street Address2100 Franklin St Suite 900
    B.5.3.2Town/ cityOakland
    B.5.3.3Post code94612
    B.5.3.4CountryUnited States
    B.5.4Telephone number+1510285-9228
    B.5.5Fax number+1510859 482
    B.5.6E-mailkhaeckl@cerexa.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 Teflaro™
    D.2.1.1.2Name of the Marketing Authorisation holderForest Research Institute
    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 nameCeftaroline fosamil
    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 INNCeftaroline fosamil
    D.3.9.1CAS number 229016-73-3
    D.3.9.3Other descriptive namePPI-0903, TAK-599, ceftaroline acetate
    D.3.9.4EV Substance CodeSUB31648
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number400
    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 Azactam 1 g powder for solution for injection
    D.2.1.1.2Name of the Marketing Authorisation holderBristol-Myers Squibb kft.
    D.2.1.2Country which granted the Marketing AuthorisationHungary
    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 solution for injection/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 INNAZTREONAM
    D.3.9.1CAS number 78110-38-0
    D.3.9.4EV Substance CodeSUB05664MIG
    D.3.10 Strength
    D.3.10.1Concentration unit g gram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    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, 1000 mg, powder for solution for infusion
    D.2.1.1.2Name of the Marketing Authorisation holderSandoz Limited
    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.3.4Pharmaceutical 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.3.9.4EV Substance CodeSUB05076MIG
    D.3.10 Strength
    D.3.10.1Concentration unit g gram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    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 Cefazolin Sandoz 1 g powder for solution for injection or infusion
    D.2.1.1.2Name of the Marketing Authorisation holderSandoz GmbH
    D.2.1.2Country which granted the Marketing AuthorisationAustria
    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 solution for injection/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 INNCEFAZOLIN
    D.3.9.1CAS number 25953-19-9
    D.3.9.4EV Substance CodeSUB07379MIG
    D.3.10 Strength
    D.3.10.1Concentration unit g gram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    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 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 Zinforo
    D.2.1.1.2Name of the Marketing Authorisation holderAstraZeneca AB
    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 nameCeftaroline fosamil
    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 INNCeftaroline fosamil
    D.3.9.1CAS number 229016-73-3
    D.3.9.3Other descriptive namePPI-0903, TAK-599, ceftaroline acetate
    D.3.9.4EV Substance CodeSUB31648
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number600
    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
    E.1.1.1Medical condition in easily understood language
    Skin and skin structure infections
    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 14.1
    E.1.2Level PT
    E.1.2Classification code 10040872
    E.1.2Term Skin infection
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Evaluate the safety and tolerability of ceftaroline versus comparator in pediatric subjects ages 2 months to < 18 years with acute bacterial skin and skin structure infections (ABSSSI)
    E.2.2Secondary objectives of the trial
    • Evaluate the efficacy of ceftaroline versus comparator in pediatric subjects ages 2 months to < 18 years with ABSSSI
    • Evaluate the pharmacokinetics of ceftaroline in pediatric subjects ages 2 months to < 18 years with ABSSSI
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Informed consent in writing from parent(s) or legally acceptable representative(s) and informed assent from subject (if age appropriate according to local requirements)
    2. Male or female, 2 months to < 18 years old
    3. Presence of ABSSSI warranting 3 days of initial hospitalization and a minimum of 3 days of IV antibacterial therapy, but no more than 14 days of total therapy (IV and PO combined)
    4. Presence of ABSSSI with measurable margins of erythema (cellulitis), that includes deeper and/or extensive soft tissue involvement* (eg, deep and extensive cellulitis, erysipelas, or major abscess), or requires significant therapeutic surgical intervention** (eg, major abscess or an infected wound
    [postoperative surgical or traumatic]), defined as:
    • Abscess: presence of a loculated fluid collection with erythema (ie, cellulitis) extending from the abscess margin and onset within 7 days before randomization. A “major abscess” either extends to deeper soft tissue or requires significant surgical intervention. Incision and drainage should be conducted within 24 hours after first dose of IV study drug. A minimum area of surrounding erythema (cellulitis) around the abscess is required for a subject to be enrolled in the study; refer to Appendix I for calculation and minimum size requirement.
    • Wound infection: presence of either purulent/seropurulent discharge from the surgical/traumatic wound with erythema (ie, cellulitis) surrounding the wound margin. Onset must have occurred within 7 days before randomization and within 30 days following the trauma or surgical procedure. A minimum size of wound infection is required for a subject to be enrolled in the
    study;
    • Cellulitis/erysipelas: presence of advancing erythema, induration/edema, and heat with onset within 7 days before randomization. A minimum size of cellulitis/erysipelas is required for a subject to be enrolled in the study;
    * Deeper soft tissue: subdermal tissue, including subcutaneous fat
    ** Significant surgical intervention: a major invasive therapeutic procedure (not including commonly performed minor procedures such as suture removal, superficial debridement of devitalized tissue, or routine wound care)
    5. In addition to erythema (cellulitis), presence of at least 1 of the following local signs and symptoms of acute infection (present for < 10 days):
    • Purulent or seropurulent drainage or discharge
    • Induration/edema
    • Fluctuance
    • Heat or localized warmth
    AND the presence of at least 1 of the following systemic signs:
    • Fever (> 38°C [100.4°F]) or hypothermia (< 35°C [95.0°F]). Temperature should not be measured by the axillary method.
    • WBC count > 12,000/mm3
    • > 10% immature neutrophils (bands) regardless of total peripheral WBC
    6. Female subjects who have reached menarche must have a negative urine pregnancy test
    7. Female subjects who have reached menarche and are sexually active must be willing to practice sexual abstinence or dual methods of birth control (eg, condom or diaphragm with spermicidal foam or gel)
    during treatment and for at least 28 days after the last dose of any study drug (IV or PO)
    8. Sufficient IV access to receive medication
    E.4Principal exclusion criteria
    1. Documented history of any hypersensitivity or allergic reaction to vancomycin, aztreonam, or any β-lactam antimicrobial
    2. Uncomplicated skin and soft tissue infections such as simple abscess, impetiginous lesions, superficial or small size cellulitis, furunculosis, carbunculosis, or folliculitis.
    3. Skin and skin structure infections with a high cure rate after surgical incision alone or after aggressive local skin care.
    4. Skin and soft tissue infections with any of the following characteristics:
    ○ Known or suspected anaerobic pathogens, Pseudomonas, Proteus, or ESBL-producing organisms
    ○ Known or suspected fungal, parasitic, or viral pathogens as the cause for the ABSSSI
    ○ Decubitus ulcer or diabetic foot infection
    ○ Complicated by osteomyelitis, septic arthritis, or endocarditis
    ○ Burn wound
    ○ Underlying inflammatory skin disease that may obscure determination of response, such as atopic dermatitis
    ○ Human or animal bite
    ○ Rapidly necrotizing process such as necrotizing fasciitis
    ○ Gangrene
    ○ Presence of prosthetic materials
    ○ Need for amputation
    5. More than 24 hours of any systemic antibacterial therapy within 96 hours before randomization.
    EXCEPTIONS:
    a. Microbiological or clinical treatment failure with a nonstudy
    antibacterial therapy that was administered for at least 72 hours.
    Failure must be confirmed by either a microbiological laboratory
    report or documented worsening clinical signs or symptoms.
    b. Low-dose tetracycline derivative for acne (eg, doxycycline 50 mg
    q12h)
    6. Requirement for any potentially effective concomitant systemic antibacterial therapy.
    7. History of seizures, excluding well-documented febrile seizure of childhood.
    8. Creatinine clearance < 50 mL/min/1.73 m2 as calculated using the updated Schwartz “bedside” formula (Schwartz et al, 2009):
    0.413 × Height (length) (cm) CrCl (mL/min/1.73 m2) =
    Serum creatinine (mg/dL)
    9. Clinical signs or suspicion of meningitis
    10. Current septic shock or acute hemodynamic instability including a requirement for pressor support.
    11. Evidence of significant hepatic, hematologic, or immunocompromising condition (any of the following):
    ○ Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 3 times the upper limit of normal (× ULN) or total bilirubin level > 2 × ULN
    ○ Known acute viral hepatitis
    ○ Neutropenia (< 500 neutrophils/mm3)
    ○ Thrombocytopenia (< 60,000 platelets/mm3)
    ○ If HIV positive, has CD4 count < 250 cells/mm3 at the last measurement or history of AIDS-defining illness
    ○ Bone marrow ablative therapy, including bone marrow transplantation, within the last 12 months
    ○ Bone marrow or solid organ recipients who have had an episode of graft versus host disease or acute rejection episode, respectively, within the last 6 months
    ○ Severe combined immunodeficiency disorder (SCID)
    ○ Requirement for high-dose (eg, > 20 mg/day of prednisone or equivalent) or prolonged systemic corticosteroid therapy. Short courses of corticosteroids, such as those for currently worsening asthma, are permitted.
    12. Evidence of immediately life-threatening disease, progressively fatal disease, or life expectancy of ≤ 3 months
    13. Females who are currently pregnant or breastfeeding
    14. Participation in any study involving administration of an investigational agent or device within 30 days before the start of first dose of IV study drug or previously participated in the current study or in another study of ceftaroline fosamil (in which
    an active agent was received)
    15. Unable or unwilling to adhere to the study-specified procedures and restrictions
    16. Any condition (eg, cystic fibrosis) that would make the subject, in the opinion of the Investigator, unsuitable for the study (eg, would place a subject at risk or compromise the quality of the data)
    E.5 End points
    E.5.1Primary end point(s)
    The primary outcome measures are safety assessments and include:
    • Adverse events: AEs, SAEs, deaths, and discontinuations due to AEs; cephalosporin class effects and additional AEs
    • Clinical: vital signs (pulse, blood pressure, respiratory rate, temperature)
    • Laboratory: complete blood count (CBC) with differential, direct Coombs test, and chemistry panel
    E.5.1.1Timepoint(s) of evaluation of this end point
    AEs and SAEs are reported from signing of informed consent through LFU visit, or 30 days after last dose of study drug, whichever is later.
    Vital signs and pain scale assessments are collected at baseline, daily while on IV study drug (up to 14 days), and at the EOIV, EOT, TOC, and LFU visits.
    Clinical laboratory parameters are collected at the Baseline, EOIV, and TOC visits.
    E.5.2Secondary end point(s)
    Secondary efficacy end points will include the following (see protocol for more detailed definitions of responses and populations):
    • Clinical response at Study Day 3 in the Modified Intent-to-Treat (MITT) Population
    • Clinical outcome at EOIV, EOT, and TOC in the MITT and Clinically Evaluable (CE) Populations
    • Clinical and microbiological outcomes by subject and by pathogen at TOC in the Microbiological Modified Intent-to-Treat (mMITT) and Microbiologically Evaluable (ME) Populations
    • Clinical relapse at LFU in the MITT Population
    • Emergent infections in the mMITT Population

    Second secondary end points are Pharmacokinetic Outcome Measures:
    • Concentrations of ceftaroline fosamil, ceftaroline, and ceftaroline M-1 in plasma
    • If available, concentrations of ceftaroline fosamil, ceftaroline, and ceftaroline M-1 in CSF
    E.5.2.1Timepoint(s) of evaluation of this end point
    See section E.5.2 above for specific timepoints(s) of evaluation corresponding to each efficacy end point. Two blood samples for pharmacokinetic end points will be collected after the fourth infusion of ceftaroline fosamil and before oral switch or Study Day 5 (whichever is earlier).
    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 No
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Observer-Blinded
    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 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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA25
    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
    Brazil
    Chile
    Georgia
    Germany
    Latvia
    Lithuania
    Peru
    Poland
    Romania
    South Africa
    Spain
    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
    Last Visit Last Subject
    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 months6
    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: 270
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) Yes
    F.1.1.4.1Number of subjects for this age range: 67
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 135
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 68
    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
    Pediatric patients
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state14
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 100
    F.4.2.2In the whole clinical trial 270
    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)
    Standard of care
    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 Decision2012-09-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-07-20
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2014-05-13
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