Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register allows you to search for protocol and results information on:
  • interventional clinical trials that are conducted in the European Union (EU) and the European Economic Area (EEA);
  • clinical trials conducted outside the EU / EEA that are linked to European paediatric-medicine development.
  • Learn   more about the EU Clinical Trials Register   including the source of the information and the legal basis.


    The EU Clinical Trials Register currently displays   35419   clinical trials with a EudraCT protocol, of which   5814   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).
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Download PDF

    Clinical Trial Results:
    Open-label, Multicentre Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of Ceftaroline in Neonates and Young Infants with Late-Onset Sepsis

    Summary
    EudraCT number
    2014-003243-34
    Trial protocol
    HU   ES   IT   LT  
    Global end of trial date
    30 Dec 2017

    Results information
    Results version number
    v2(current)
    This version publication date
    01 Sep 2018
    First version publication date
    07 Jul 2018
    Other versions
    v1
    Version creation reason

    Trial information

    Close Top of page
    Trial identification
    Sponsor protocol code
    C2661002
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    -
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Pfizer Inc.
    Sponsor organisation address
    235 E 42nd Street, New York, United States, NY 10017
    Public contact
    Pfizer ClinicalTrials.gov Call Center, Pfizer Inc., 001 1-800-718-1021, ClinicalTrials.gov_Inquiries@pfizer.com
    Scientific contact
    Pfizer ClinicalTrials.gov Call Center, Pfizer Inc., 001 1-800-718-1021, ClinicalTrials.gov_Inquiries@pfizer.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    Yes
    EMA paediatric investigation plan number(s)
    EMEA-000769-PIP01-09
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    Yes
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    23 Mar 2018
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    30 Dec 2017
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    To evaluate the safety, tolerability, pharmacokinetics, and efficacy of Ceftaroline in neonates and young infants with late-onset sepsis.
    Protection of trial subjects
    The study was in compliance with the ethical principles derived from the Declaration of Helsinki and in compliance with all International Council for Harmonization (ICH) Good Clinical Practice (GCP) Guidelines. All the local regulatory requirements pertinent to safety of trial subjects were followed.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    04 Aug 2015
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United States: 4
    Country: Number of subjects enrolled
    Hungary: 7
    Worldwide total number of subjects
    11
    EEA total number of subjects
    7
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    7
    Infants and toddlers (28 days-23 months)
    4
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

    Close Top of page
    Recruitment
    Recruitment details
    -

    Pre-assignment
    Screening details
    The study was conducted in the United States and Hungary from 04 August 2015 to 26 December 2017. A total of 11 subjects were enrolled.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Non-randomised - controlled
    Blinding used
    Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Ceftaroline Fosamil: Young Infants
    Arm description
    Young infants aged greater than (>) 28 days to less than (<) 60 days, received ceftaroline fosamil infusion, intravenously (IV) at a dose of 4 milligrams per kilogram (mg/kg) or 6 mg/kg over 60 minutes every 8 hours in combination with ampicillin IV as per local standard of care, for a minimum of 48 hours and up to a maximum duration of 14 days. Along with this, subjects received an aminoglycoside which was optional and could be started and stopped at any time during the study at the discretion of investigator.
    Arm type
    Experimental

    Investigational medicinal product name
    Ceftaroline fosamil
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Subjects received Ceftaroline fosamil 4 mg/kg or 6 mg/kg over 60 minutes every 8 hours for 48 hours to 14 days plus ampicillin IV for 48 hours minimum and optional aminoglycoside per local standard of care therapy.

    Investigational medicinal product name
    Ampicillin
    Investigational medicinal product code
    Other name
    ampicillin
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Ampicillin IV is mandatory for 48 hours if the presence of an organism that requires treatment with ampicillin cannot be excluded. Given per standard of care.

    Investigational medicinal product name
    Aminoglycoside
    Investigational medicinal product code
    Other name
    aminoglycoside
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Aminoglycoside, given as standard of care therapy, is optional during the study as the discretion of the Investigator.

    Arm title
    Ceftaroline Fosamil: Term Neonates
    Arm description
    Term Neonates (defined as gestational age greater than or equal to [>=] 37 weeks) aged 7 to less than equal to (<=28) days received ceftaroline fosamil infusion, IV at a dose of 4 mg/kg or 6 mg/kg over 60 minutes every 8 hours in combination with ampicillin IV as per local standard of care, for a minimum of 48 hours and up to a maximum duration of 14 days. Along with this, subjects received an aminoglycoside which was optional and could be started and stopped at any time during the study at the discretion of investigator.
    Arm type
    Experimental

    Investigational medicinal product name
    Ceftaroline fosamil
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Subjects received Ceftaroline fosamil 6 mg/kg over 60 minutes every 8 hours for 48 hours to 14 days plus ampicillin IV for 48 hours minimum and optional aminoglycoside per local standard of care therapy.

    Investigational medicinal product name
    Ampicillin
    Investigational medicinal product code
    Other name
    ampicillin
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Ampicillin IV is mandatory for 48 hours if the presence of an organism that requires treatment with ampicillin cannot be excluded. Given per standard of care.

    Investigational medicinal product name
    Aminoglycoside
    Investigational medicinal product code
    Other name
    aminoglycoside
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Aminoglycoside, given as standard of care therapy, is optional during the study as the discretion of the Investigator.

    Arm title
    Ceftaroline Fosamil: Preterm Neonates
    Arm description
    Preterm neonates (defined as gestational age >=34 weeks to <37 weeks) aged 7 to <=28 days received ceftaroline fosamil infusion, IV at a dose of 4 mg/kg or 6 mg/kg over 60 minutes every 8 hours in combination with ampicillin IV as per local standard of care, for a minimum of 48 hours and up to a maximum duration of 14 days. Along with this, subjects received an aminoglycoside which was optional and could be started and stopped at any time during the study at the discretion of investigator.
    Arm type
    Experimental

    Investigational medicinal product name
    Ceftaroline fosamil
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Subjects received Ceftaroline fosamil 6 mg/kg over 60 minutes every 8 hours for 48 hours to 14 days plus ampicillin IV for 48 hours minimum and optional aminoglycoside per local standard of care therapy.

    Investigational medicinal product name
    Ampicillin
    Investigational medicinal product code
    Other name
    ampicillin
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Ampicillin IV is mandatory for 48 hours if the presence of an organism that requires treatment with ampicillin cannot be excluded. Given per standard of care.

    Investigational medicinal product name
    Aminoglycoside
    Investigational medicinal product code
    Other name
    aminoglycoside
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Aminoglycoside, given as standard of care therapy, is optional during the study as the discretion of the Investigator.

    Number of subjects in period 1
    Ceftaroline Fosamil: Young Infants Ceftaroline Fosamil: Term Neonates Ceftaroline Fosamil: Preterm Neonates
    Started
    4
    5
    2
    Completed
    2
    3
    2
    Not completed
    2
    2
    0
         Treatment stopped to be discharged home
             2
             2
             -

    Baseline characteristics

    Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    Ceftaroline Fosamil: Young Infants
    Reporting group description
    Young infants aged greater than (>) 28 days to less than (<) 60 days, received ceftaroline fosamil infusion, intravenously (IV) at a dose of 4 milligrams per kilogram (mg/kg) or 6 mg/kg over 60 minutes every 8 hours in combination with ampicillin IV as per local standard of care, for a minimum of 48 hours and up to a maximum duration of 14 days. Along with this, subjects received an aminoglycoside which was optional and could be started and stopped at any time during the study at the discretion of investigator.

    Reporting group title
    Ceftaroline Fosamil: Term Neonates
    Reporting group description
    Term Neonates (defined as gestational age greater than or equal to [>=] 37 weeks) aged 7 to less than equal to (<=28) days received ceftaroline fosamil infusion, IV at a dose of 4 mg/kg or 6 mg/kg over 60 minutes every 8 hours in combination with ampicillin IV as per local standard of care, for a minimum of 48 hours and up to a maximum duration of 14 days. Along with this, subjects received an aminoglycoside which was optional and could be started and stopped at any time during the study at the discretion of investigator.

    Reporting group title
    Ceftaroline Fosamil: Preterm Neonates
    Reporting group description
    Preterm neonates (defined as gestational age >=34 weeks to <37 weeks) aged 7 to <=28 days received ceftaroline fosamil infusion, IV at a dose of 4 mg/kg or 6 mg/kg over 60 minutes every 8 hours in combination with ampicillin IV as per local standard of care, for a minimum of 48 hours and up to a maximum duration of 14 days. Along with this, subjects received an aminoglycoside which was optional and could be started and stopped at any time during the study at the discretion of investigator.

    Reporting group values
    Ceftaroline Fosamil: Young Infants Ceftaroline Fosamil: Term Neonates Ceftaroline Fosamil: Preterm Neonates Total
    Number of subjects
    4 5 2 11
    Age categorical
    Units: Subjects
        Young infants aged >28 days to <60 days
    4 0 0 4
        Term neonates aged 7 to <=28 days
    0 5 0 5
        Pre-term neonate aged 7 to <=28 days
    0 0 2 2
    Age Continuous
    Units: days
        arithmetic mean (standard deviation)
    48.0 ± 4.69 22.0 ± 3.81 15.5 ± 4.95 -
    Sex: Female, Male
    Units: Subjects
        Female
    3 1 1 5
        Male
    1 4 1 6
    Race (NIH/OMB)
    Units: Subjects
        Asian
    1 0 0 1
        White
    3 5 2 10
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    0 1 0 1
        Not Hispanic or Latino
    4 4 2 10

    End points

    Close Top of page
    End points reporting groups
    Reporting group title
    Ceftaroline Fosamil: Young Infants
    Reporting group description
    Young infants aged greater than (>) 28 days to less than (<) 60 days, received ceftaroline fosamil infusion, intravenously (IV) at a dose of 4 milligrams per kilogram (mg/kg) or 6 mg/kg over 60 minutes every 8 hours in combination with ampicillin IV as per local standard of care, for a minimum of 48 hours and up to a maximum duration of 14 days. Along with this, subjects received an aminoglycoside which was optional and could be started and stopped at any time during the study at the discretion of investigator.

    Reporting group title
    Ceftaroline Fosamil: Term Neonates
    Reporting group description
    Term Neonates (defined as gestational age greater than or equal to [>=] 37 weeks) aged 7 to less than equal to (<=28) days received ceftaroline fosamil infusion, IV at a dose of 4 mg/kg or 6 mg/kg over 60 minutes every 8 hours in combination with ampicillin IV as per local standard of care, for a minimum of 48 hours and up to a maximum duration of 14 days. Along with this, subjects received an aminoglycoside which was optional and could be started and stopped at any time during the study at the discretion of investigator.

    Reporting group title
    Ceftaroline Fosamil: Preterm Neonates
    Reporting group description
    Preterm neonates (defined as gestational age >=34 weeks to <37 weeks) aged 7 to <=28 days received ceftaroline fosamil infusion, IV at a dose of 4 mg/kg or 6 mg/kg over 60 minutes every 8 hours in combination with ampicillin IV as per local standard of care, for a minimum of 48 hours and up to a maximum duration of 14 days. Along with this, subjects received an aminoglycoside which was optional and could be started and stopped at any time during the study at the discretion of investigator.

    Subject analysis set title
    Ceftaroline Fosamil: All Subjects
    Subject analysis set type
    Sub-group analysis
    Subject analysis set description
    Subjects received ceftaroline fosamil infusion, IV at a dose of 4 mg/kg or 6 mg/kg over 60 minutes every 8 hours in combination with ampicillin IV as per local standard of care, for a minimum of 48 hours and up to a maximum duration of 14 days. Along with this, subjects received an aminoglycoside as per local standard of care, which was optional and could be started and stopped at any time during the study at the discretion of investigator.‌

    Primary: Number of Subjects With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Discontinuations Due to Adverse Events (AEs)

    Close Top of page
    End point title
    Number of Subjects With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Discontinuations Due to Adverse Events (AEs) [1]
    End point description
    An AE was any untoward medical occurrence in a subject who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following endpoints or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to study follow-up (SFU) visit (28 to 35 days after last dose of study treatment) that were absent before treatment or that worsened relative to pretreatment state. AEs included both SAEs and non-SAEs. Safety analysis set consisted of all enrolled subjects for whom informed consent form was signed and received any amount of ceftaroline fosamil.
    End point type
    Primary
    End point timeframe
    Baseline up to SFU visit (up to a maximum study duration of 49 days)
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Statistical analysis was not planned for this endpoint
    End point values
    Ceftaroline Fosamil: Young Infants Ceftaroline Fosamil: Term Neonates Ceftaroline Fosamil: Preterm Neonates
    Number of subjects analysed
    4
    5
    2
    Units: subjects
        AEs
    1
    3
    1
        SAEs
    0
    0
    1
        Discontinuations Due to AEs
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Plasma Concentration of Ceftaroline Fosamil

    Close Top of page
    End point title
    Plasma Concentration of Ceftaroline Fosamil
    End point description
    Data was not summarized and provided for individual subjects only and reported in this end point for only those subjects who had concentrations above limit of quantification (LOQ). LOQ was 50 nanogram per milliliter (ng/mL). Pharmacokinetic (PK) analysis set included all subjects who received a known amount of ceftaroline fosamil, were randomized to a PK sample collection schedule, and had at least 1 PK sample collected.
    End point type
    Secondary
    End point timeframe
    At the end of infusion (EOI)
    End point values
    Ceftaroline Fosamil: All Subjects
    Number of subjects analysed
    11
    Units: ng/mL
    number (not applicable)
        Subject 1
    67.7
        Subject 2
    63.7
        Subject 3
    74.5
    No statistical analyses for this end point

    Secondary: Plasma Concentration of Ceftaroline

    Close Top of page
    End point title
    Plasma Concentration of Ceftaroline
    End point description
    Ceftaroline fosamil was the prodrug of ceftaroline. Data was not summarized and provided for individual subjects only and reported in this end point for only those subjects who had concentrations above LOQ at any specific time-point. LOQ was 50 ng/mL. The PK analysis set included all subjects who received a known amount of ceftaroline fosamil, were randomized to a PK sample collection schedule, and had at least 1 PK sample collected.
    End point type
    Secondary
    End point timeframe
    At EOI, 15 minutes to 2 hours, 3 to 4 hours and 5 to 7 hours after EOI
    End point values
    Ceftaroline Fosamil: All Subjects
    Number of subjects analysed
    11
    Units: ng/mL
        Subject 1: 3 to 4 hrs EOI
    3420
        Subject 2: At EOI
    12400
        Subject 2: At 3 to 4 Hours after EOI
    4280
        Subject 3: At EOI
    7890
        Subject 3: At 3 to 4 Hours after EOI
    1760
        Subject 4: At 15 minutes to 2 hours after EOI
    9440
        Subject 4: At 5 to 7 hours after EOI
    1800
        Subject 5: At EOI
    9410
        Subject 6: At 15 minutes to 2 hours after EOI
    4370
        Subject 7: At 15 minutes to 2 hours after EOI
    5550
        Subject 7: At 5 to 7 hours after EOI
    1870
        Subject 8: At 15 minutes to 2 hours after EOI
    2240
        Subject 8: At 5 to 7 hours after EOI
    4770
        Subject 9: At 15 minutes to 2 hours after EOI
    4750
        Subject 9: At 5 to 7 hours after EOI
    1700
        Subject 10: At EOI
    9700
        Subject 10: At 3 to 4 hours after EOI
    3550
        Subject 11: At 15 minutes to 2 hours after EOI
    4760
        Subject 11: At 5 to 7 hours after EOI
    2440
    No statistical analyses for this end point

    Secondary: Plasma Concentration of Ceftaroline M-1

    Close Top of page
    End point title
    Plasma Concentration of Ceftaroline M-1
    End point description
    Ceftaroline M-1 was the inactive metabolite of ceftaroline. Data was not summarized and provided for individual subjects only and reported in this end point for only those subjects who had concentrations above LOQ at any specific time-point. LOQ was 50 ng/mL The PK analysis set will include all subjects who received a known amount of ceftaroline fosamil, were randomized to a PK sample collection schedule, and had at least 1 PK sample collected.
    End point type
    Secondary
    End point timeframe
    At EOI, 15 minutes to 2 hours, 3 to 4 hours and 5 to 7 hours after EOI
    End point values
    Ceftaroline Fosamil: All Subjects
    Number of subjects analysed
    11
    Units: ng/mL
        Subject 1: At 3 to 4 hours after EOI
    729
        Subject 2: At EOI
    678
        Subject 2: At 3 to 4 hours after EOI
    749
        Subject 3: At EOI
    950
        Subject 3: At 3 to 4 hours after EOI
    559
        Subject 4: At 15 minutes to 2 hours after EOI
    970
        Subject 4: At 5 to 7 hours after EOI
    642
        Subject 5: At EOI
    850
        Subject 6: At 15 minutes to 2 hours after EOI
    832
        Subject 7: At 15 minutes to 2 hours after EOI
    728
        Subject 7: At 5 to 7 hours after EOI
    634
        Subject 8: At 15 minutes to 2 hours after EOI
    630
        Subject 8: At 5 to 7 hours after EOI
    785
        Subject 9: At 15 minutes to 2 hours after EOI
    592
        Subject 9: At 5 to 7 hours after EOI
    461
        Subject 10: At EOI
    575
        Subject 10: At 3 to 4 hours after EOI
    648
        Subject 11: At 15 minutes to 2 hours after EOI
    671
        Subject 11: At 5 to 7 hours after EOI
    646
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With Favorable Clinical Response

    Close Top of page
    End point title
    Percentage of Subjects With Favorable Clinical Response
    End point description
    Clinical response was assessed by the investigator as Cure, Failure or Indeterminate at End of treatment (EOT) and Test of Cure (TOC). Favorable clinical response was defined as clinical response of Cure, defined as resolution of all acute signs and symptoms of Late-onset sepsis (LOS) or improvement to such an extent that no further antibacterial therapy is required. Eradication defined as absence of the original baseline pathogen from the source specimen; presumed eradication was defined when source specimen was not available to culture and the subject was assessed as a clinical cure (resolution of all acute signs and symptoms of LOS or improvement to such an extent that no further antibacterial therapy was required) EOT visit occurred within 24 hours after the end of last infusion. Modified ITT analysis set: subjects who received ceftaroline fosamil and met minimal disease criteria of late-onset sepsis.
    End point type
    Secondary
    End point timeframe
    EOT visit (within 24 hours after the end of infusion), TOC visit (8 to 15 days after last dose of study drug)
    End point values
    Ceftaroline Fosamil: Young Infants Ceftaroline Fosamil: Term Neonates Ceftaroline Fosamil: Preterm Neonates
    Number of subjects analysed
    4
    3
    1
    Units: percentage of subjects
    number (confidence interval 95%)
        At EOT visit
    50.0 (12.3 to 87.7)
    33.3 (3.9 to 82.3)
    100 (14.7 to 100)
        At TOC visit
    50.0 (12.3 to 87.7)
    33.3 (3.9 to 82.3)
    100 (14.7 to 100)
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With Favorable Microbiological Response

    Close Top of page
    End point title
    Percentage of Subjects With Favorable Microbiological Response
    End point description
    Microbiological response was determining programmatically and assessed at the subject level at EOT and TOC. Microbiological response was defined as Favorable (Eradication or Presumed Eradication), Unfavorable (Persistence or Presumed Persistence) or Indeterminate (subject's clinical response is Indeterminate and no microbiological culture data is available). Eradication defined as absence of the original baseline pathogen from the source specimen; presumed eradication was defined when source specimen was not available to culture and the subject was assessed as a clinical cure (resolution of all acute signs and symptoms of LOS or improvement to such an extent that no further antibacterial therapy was required) EOT visit occurred within 24 hours after the end of last infusion. TOC visit occurred within 8 to 15 days after last dose of study drug. Analyzed in the mITT set.
    End point type
    Secondary
    End point timeframe
    EOT visit (within 24 hours after the end of infusion), TOC visit (8 to 15 days after last dose of study drug)
    End point values
    Ceftaroline Fosamil: Young Infants Ceftaroline Fosamil: Term Neonates Ceftaroline Fosamil: Preterm Neonates
    Number of subjects analysed
    4
    3
    1
    Units: percentage of subjects
    number (confidence interval 95%)
        At EOT visit
    50.0 (12.3 to 87.7)
    66.7 (17.7 to 96.1)
    100 (14.7 to 100)
        At TOC visit
    25.0 (2.8 to 71.6)
    33.3 (3.9 to 82.3)
    100 (14.7 to 100)
    No statistical analyses for this end point

    Adverse events

    Close Top of page
    Adverse events information
    Timeframe for reporting adverse events
    Baseline up to SFU visit (up to a maximum study duration of 49 days)
    Adverse event reporting additional description
    Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another, or a subject may have experienced both a serious and non-serious event.
    Assessment type
    Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    20.0
    Reporting groups
    Reporting group title
    Ceftaroline Fosamil: Young Infants
    Reporting group description
    Young infants aged > 28 days to <60 days, received ceftaroline fosamil infusion, IV at a dose of 4 mg/kg or 6 mg/kg over 60 minutes every 8 hours in combination with ampicillin IV as per local standard of care, for a minimum of 48 hours and up to a maximum duration of 14 days. Along with this, subjects received an aminoglycoside which was optional and could be started and stopped at any time during the study at the discretion of investigator.

    Reporting group title
    Ceftaroline Fosamil: Term Neonates
    Reporting group description
    Term neonates (defined as gestational age >= 37 weeks) aged 7 to <=28 days received ceftaroline fosamil infusion, IV at a dose of 4 mg/kg or 6 mg/kg over 60 minutes every 8 hours in combination with ampicillin IV as per local standard of care, for a minimum of 48 hours and up to a maximum duration of 14 days. Along with this, subjects received an aminoglycoside which was optional and could be started and stopped at any time during the study at the discretion of investigator.

    Reporting group title
    Ceftaroline Fosamil: Preterm Neonates
    Reporting group description
    Preterm neonates (defined as gestational age >=34 weeks to <37 weeks) aged 7 to <=28 days received ceftaroline fosamil infusion, IV at a dose of 4 mg/kg or 6 mg/kg over 60 minutes every 8 hours in combination with ampicillin IV as per local standard of care, for a minimum of 48 hours and up to a maximum duration of 14 days. Along with this, subjects received an aminoglycoside which was optional and could be started and stopped at any time during the study at the discretion of investigator.

    Serious adverse events
    Ceftaroline Fosamil: Young Infants Ceftaroline Fosamil: Term Neonates Ceftaroline Fosamil: Preterm Neonates
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    1 / 2 (50.00%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Infections and infestations
    Salmonellosis
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    1 / 2 (50.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    Ceftaroline Fosamil: Young Infants Ceftaroline Fosamil: Term Neonates Ceftaroline Fosamil: Preterm Neonates
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    1 / 4 (25.00%)
    3 / 5 (60.00%)
    1 / 2 (50.00%)
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    1 / 2 (50.00%)
         occurrences all number
    0
    0
    1
    Nervous system disorders
    Cerebral cyst
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 5 (20.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    1
    0
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    1 / 4 (25.00%)
    1 / 5 (20.00%)
    0 / 2 (0.00%)
         occurrences all number
    1
    1
    0
    Renal and urinary disorders
    Pyelocaliectasis
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    1
    1
    0
    Rhinitis
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    1 / 2 (50.00%)
         occurrences all number
    0
    0
    1
    Skin and subcutaneous tissue disorders
    Dermatitis
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 5 (20.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    1
    0
    Infections and infestations
    Oral candidiasis
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 5 (20.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    1
    0
    Otitis externa
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    1 / 2 (50.00%)
         occurrences all number
    0
    0
    1

    More information

    Close Top of page

    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    16 Dec 2015
    The dose of ceftaroline fosamil to be given was increased to 6 mg/kg.
    25 Aug 2016
    Inclusion criterion was revised so that subjects must only meet at least 1 of the listed laboratory criteria, rather than 2.
    25 May 2017
    Safety follow-up visit window changed to 28 - 35 days.

    Interruptions (globally)

    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    30 Dec 2017
    Based on the decision of PDCO and FDA, the study was terminated prematurely.
    -

    Limitations and caveats

    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
    European Medicines Agency © 1995-2019 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    Legal notice
    EMA HMA