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    The EU Clinical Trials Register currently displays   43974   clinical trials with a EudraCT protocol, of which   7312   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:2012-002203-18
    Sponsor's Protocol Code Number:P903-31
    National Competent Authority:Bulgarian Drug Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2013-09-13
    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 ConcernedBulgarian Drug Agency
    A.2EudraCT number2012-002203-18
    A.3Full title of the trial
    A Multicenter, Randomized, Observer-Blinded, Active Controlled Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of Ceftaroline Versus Ceftriaxone in Pediatric Subjects With Community-acquired Bacterial Pneumonia Requiring Hospitalization
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Blind (treatment to be received is not known to the observer), Controlled (a chance to receive any of the treatments to be given) Study to Assess How Safe and Acceptable Ceftaroline and Ceftriaxone are and Whether both can be Used to treat Young Children who have Pneumonia and Need to be Hospitalized.
    A.4.1Sponsor's protocol code numberP903-31
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/072/2012
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorCerexa, Inc.
    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.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCerexa, Inc.
    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 codeCA 94612
    B.5.3.4CountryUnited States
    B.5.4Telephone number0015102859228
    B.5.5Fax number0015102859482
    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 No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product 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 nameceftaroline accetate,PPI-0903, TAK-599
    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 Ceftriaxone
    D.2.1.1.2Name of the Marketing Authorisation holderCristers
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    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 nameCeftriaxone
    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 INNCeftriaxone Sodium
    D.3.9.1CAS number 74578-69-1
    D.3.9.3Other descriptive nameCEFTRIAXONE SODIUM
    D.3.9.4EV Substance CodeSUB01138MIG
    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 Augmentin
    D.2.1.1.2Name of the Marketing Authorisation holderBeecham Group Plc
    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 nameAmoxicillin Clavulanate
    D.3.4Pharmaceutical form Film-coated tablet
    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 INNAMOXICILLIN
    D.3.9.1CAS number 26787-78-0
    D.3.9.4EV Substance CodeSUB05481MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number875
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCLAVULANIC ACID
    D.3.9.1CAS number 58001-44-8
    D.3.9.4EV Substance CodeSUB06642MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number125
    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 Augmentin®-Duo 400/57
    D.2.1.1.2Name of the Marketing Authorisation holderBeecham Group Plc
    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 nameAmoxicillin Clavulanate
    D.3.2Product code J01CR02
    D.3.4Pharmaceutical form Powder 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 INNAMOXICILLIN
    D.3.9.1CAS number 26787-78-0
    D.3.9.4EV Substance CodeSUB05481MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number400
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCLAVULANIC ACID
    D.3.9.1CAS number 58001-44-8
    D.3.9.4EV Substance CodeSUB06642MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number57
    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 Augmentin® 125/31 SF Suspension
    D.2.1.1.2Name of the Marketing Authorisation holderBeecham Group plc
    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 nameAmoxicillin Clavulanate
    D.3.2Product code J01CR02
    D.3.4Pharmaceutical form Powder 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 INNAMOXICILLIN
    D.3.9.1CAS number 26787-78-0
    D.3.9.4EV Substance CodeSUB05481MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number125
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCLAVULANIC ACID
    D.3.9.1CAS number 58001-44-8
    D.3.9.4EV Substance CodeSUB06642MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number31.25
    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
    Community-acquired Bacterial Pneumonia
    E.1.1.1Medical condition in easily understood language
    Pneumonia
    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 16.0
    E.1.2Level PT
    E.1.2Classification code 10035664
    E.1.2Term Pneumonia
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.0
    E.1.2Level LLT
    E.1.2Classification code 10004051
    E.1.2Term Bacterial pneumonia, unspecified
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.0
    E.1.2Level PT
    E.1.2Classification code 10060946
    E.1.2Term Pneumonia bacterial
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.0
    E.1.2Level LLT
    E.1.2Classification code 10010120
    E.1.2Term Community acquired pneumonia
    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
    The primary objective is to evaluate the safety and tolerability of ceftaroline versus ceftriaxone in pediatric subjects ages 2 months to < 18 years with CABP requiring hospitalization.
    E.2.2Secondary objectives of the trial
    • Evaluate the efficacy of ceftaroline versus ceftriaxone in pediatric
    subjects with CABP requiring hospitalization.

    • Evaluate the pharmacokinetics of ceftaroline in pediatric subjects ages
    2 months to < 18 years with CABP requiring hospitalization.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Informed consent in writing from parent(s) or other 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 of age.
    3. Presence of CABP requiring hospitalization and IV antibacterial therapy.
    4. Presence of CABP meeting each of the following criteria:
    I. Fever (temperature > 38.0°C) or hypothermia (temperature <35.0°C).
    Note that temperature should not be measured by the axillary method.
    II. New infiltrate(s) compatible with bacterial pneumonia, including a new alveolar/lobar infiltrate or consolidation (based on imaging results or diagnostic testing)
    III. Acute onset or worsening within the previous 5 days before randomization of at least 2 of the following clinical signs or symptoms:
    - Cough
    - Tachypnea, defined as (World Health Organization, 2011):
    - 2 months to < 12 months: ≥ 50 breaths/min
    - 12 months to < 5 years: ≥ 40 breaths/min
    - ≥ 5 years: ≥ 20 breaths/min
    - Dyspnea
    - Grunting
    - Sputum production
    - Chest pain
    - Cyanosis
    - Evidence of pneumonia with parenchymal consolidation (eg. dullness on percussion, diminished breath sounds, egophony, bronchial breath sounds, rales or crackles)
    - Increased work of breathing (eg. nasal flaring, chest wall retractions)
    IV. Presence of at least 1 of the following:
    - Organism consistent with a typical respiratory pathogen identified or isolated from a respiratory or blood culture
    - Leukocytosis (> 15,000 white blood cells [WBC]/mm^3)
    - >15% immature neutrophils (bands) regardless of total peripheral WBC
    - Leukopenia (< 4500 WBC/mm^3) likely due to the bacterial infection
    - Hypoxemia (oxygen saturation < 92% on room air)
    5. Female subjects who have reached menarche must have a negative urine pregnancy test.
    6. 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).
    7. Sufficient IV access to receive medication.
    E.4Principal exclusion criteria
    1. Documented history of any hypersensitivity or allergic reaction to any β-lactam antimicrobial.
    2. Confirmed or suspected infection with a pathogen known to be resistant to ceftriaxone (eg, Pseudomonas aeruginosa, methicillinresistant Staphylococcus aureus [MRSA]) or known infection at baseline with a sole atypical organism (eg, Mycoplasma pneumoniae, Chlamydophila pneumoniae, Chlamydia trachomatis, Legionella pneumophila). Epidemiological clues to potential MRSA infection include
    necrotizing pneumonia, existence of an ongoing local MRSA infection outbreak, known skin colonization with MRSA, recent invasive MRSA infection, and recent influenza. Subjects with risk factors for MRSA infection who have predominance of gram-positive cocci in clusters on sputum Gram stain should also be excluded.
    3. Confirmed or suspected respiratory tract infection attributable to sources other than community-acquired bacterial pathogens (eg, ventilator-associated pneumonia; hospital-acquired pneumonia [occurring 48 hours or more after admission, which was not incubating at the time of admission (Niederman, 1996; Tablan et al, 2004)]; visible/gross aspiration pneumonia; suspected sole viral [eg, respiratory syncytial virus], fungal, Mycobacterium tuberculosis infection of the lung); chronic lung disease or neurologic disease preventing normal clearance of secretions.
    4. Non-infectious causes of pulmonary infiltrates (eg, cystic fibrosis, chemical pneumonitis from aspiration, hypersensitivity pneumonia) on chest radiography.
    5. More than 24 hours of any potentially effective systemic antibacterial therapy for CABP within 96 hours before randomization.
    EXCEPTIONS:
    a) Microbiological or clinical treatment failure with an antibiotic other than IV study drugs that was administered for at least 48 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. Requirement for more than 10 days of systemic corticosteroid therapy (any dose).
    8. History of seizures, excluding febrile seizure of childhood.
    9. Creatinine clearance < 50 mL/min/1.73 m^2 as calculated using the updated Schwartz "bedside" formula (Schwartz et al, 2009): CrCl (mL/min/1.73 m^2) = 0.413 × height (length) (cm)/serum creatinine (mg/dL).
    10. Clinical signs or suspicion of bacterial meningitis.
    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/mm^3)
    - Thrombocytopenia (< 60,000 platelets/mm^3)
    - If human immunodeficiency virus (HIV)-positive, has CD4 count < 250 cells/mm^3 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)
    12. Evidence of immediately life-threatening disease, progressively fatal disease, or life expectancy of 3 months or less.
    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 randomization or previously participated in the current study or in another study of ceftaroline fosamil (in which an active agent was taken or received).
    15. Unable or unwilling to adhere to the study-specified procedures and restrictions.
    16. Any condition (eg. septic shock, acute hemodynamic instability nonresponsive to pressor support) 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 objective is to evaluate the safety and tolerability of ceftaroline versus ceftriaxone in pediatric subjects ages 2 months to < 18 years with CABP requiring hospitalization.
    E.5.1.1Timepoint(s) of evaluation of this end point
    • Adverse events: AEs, SAEs, deaths, and discontinuations due to AEs will be evaluated. Cephalosporin class effects and additional AEs (including, but not limited to, seizures, Clostridium difficile-associated diarrhea, allergic reactions, hemolytic anemia, hepatic abnormalities, and changes in renal function) will be closely monitored at Treatment, EOIV, EOT, TOC, LFU.
    • Clinical: vital signs (pulse, blood pressure, respiratory rate, oxygen saturation, and temperature) at Treatment, EOIV, EOT, TOC, LFU
    • Laboratory: complete blood count with differential (at treatment day 7, EOIV, TOC), direct Coombs test (at TOC), and chemistry panel (at treatment day 2 and 3, EOIV)

    Refer to Schedule of Assessments and Procedures within the protocol
    E.5.2Secondary end point(s)
    1. Evaluate the efficacy of ceftaroline versus ceftriaxone in pediatric subjects with CABP requiring hospitalization.

    2. Evaluate the pharmacokinetics of ceftaroline in pediatric subjects ages 2 months to < 18 years with CABP requiring hospitalization.
    E.5.2.1Timepoint(s) of evaluation of this end point
    •Clinical response at Study Day4 by subject and by baseline pathogen in the Modified Intent-to-Treat and the Microbiological Modified Intent-to-Treat Populations
    •Clinical stability at Study Day4 by subject and by baseline pathogen in the MITT and mMITT Populations
    •Clinical outcome at End-of-Intravenous Study Drug, EOT, and TOC in the MITT and CE Populations
    •Clinical and microbiological outcomes by subject and by baseline pathogen at TOC in the mMITT and Microbiologically Evaluable Populations
    •Clinical relapse at Late FU in the MITT Population
    •Emergent infections in the mMITT Population
    •Concentrations of ceftaroline fosamil, ceftaroline, and ceftaroline M1 in plasma
    •If available, concentrations of ceftaroline fosamil, ceftaroline, and ceftaroline M1 in cerebrospinal fluid
    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) 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 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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA29
    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
    Bulgaria
    Georgia
    Greece
    Hungary
    Poland
    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
    Last Subject last Visit
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months3
    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: 160
    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: 40
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 80
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 40
    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
    Study to include children of age starting at 2 months until < 18 years of age.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state15
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 50
    F.4.2.2In the whole clinical trial 160
    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 Decision2013-09-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-10-16
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2014-04-10
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