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    The EU Clinical Trials Register currently displays   43973   clinical trials with a EudraCT protocol, of which   7311   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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    Clinical Trial Results:
    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

    Summary
    EudraCT number
    2012-002203-18
    Trial protocol
    Outside EU/EEA   HU   GR   ES   PL   BG  
    Global end of trial date
    14 Apr 2014

    Results information
    Results version number
    v1(current)
    This version publication date
    09 Aug 2018
    First version publication date
    09 Aug 2018
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    P903-31
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    -
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Cerexa, Inc (a subsidiary of Allergan, plc)
    Sponsor organisation address
    185 Hudson Street, Plaza 5, New Jersey, United States, NJ 07302-3908
    Public contact
    Clinical Trial Registry Team, Cerexa, Inc (a subsidiary of Allergan, plc), +1 877-277-8566, CTRegistration@allergan.com
    Scientific contact
    Clinical Trial Registry Team, Cerexa, Inc (a subsidiary of Allergan, plc), +1 877-277-8566, CTRegistration@allergan.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?
    No
    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
    17 Oct 2014
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    14 Apr 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main 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.
    Protection of trial subjects
    This study was conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki and that are consistent with good clinical practices and applicable regulatory requirements. Written informed consent from parent or legally acceptable representative and verbal informed assent from subject (if age appropriate and according to local requirements) were obtained before initiating study-related assessments or procedures.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    01 Nov 2012
    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
    Poland: 23
    Country: Number of subjects enrolled
    Spain: 5
    Country: Number of subjects enrolled
    Bulgaria: 13
    Country: Number of subjects enrolled
    Greece: 14
    Country: Number of subjects enrolled
    Hungary: 65
    Country: Number of subjects enrolled
    Ukraine: 20
    Country: Number of subjects enrolled
    United States: 12
    Country: Number of subjects enrolled
    Georgia: 9
    Worldwide total number of subjects
    161
    EEA total number of subjects
    120
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    30
    Children (2-11 years)
    121
    Adolescents (12-17 years)
    10
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    -

    Pre-assignment
    Screening details
    A total of 161 paediatric subjects between the ages of 2 months to < 18 years with Community-acquired Bacterial Pneumonia (CABP) were enrolled in the study.

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Randomised - controlled
    Blinding used
    Single blind
    Roles blinded
    Assessor [1]
    Blinding implementation details
    At each study centre, at least 1 blinded investigator (“Blinded Observer”) did not know the subject’s treatment assignment and conducted clinical assessments (including efficacy and safety).

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Ceftaroline fosamil
    Arm description
    122 subjects were randomised (ITT) to receive a minimum of 7 IV doses of ceftaroline fosamil (a minimum of 3 days of IV therapy). A switch to open-label oral study drug (amoxicillin clavulanate) was allowed on or after Study Day 4 if a subject met the protocol-specified criteria. A recommended total daily dose of up to 90 mg/kg/day amoxicillin clavulanate was to be divided equally every 12 hours. The total duration of study drug therapy was 5 to 14 days, inclusive.
    Arm type
    Experimental

    Investigational medicinal product name
    Ceftaroline fosamil
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    IV ceftaroline fosamil was infused over 60 (± 10) minutes every 8 hours (q8h [± 1 hour]) as follows: - Children ≥ 6 months: ceftaroline fosamil 12 mg/kg for subjects weighing ≤ 33 kg or 400 mg for subjects weighing > 33 kg - Children < 6 months: ceftaroline fosamil 8 mg

    Arm title
    Comparator
    Arm description
    39 subjects were randomised (ITT) to receive ceftriaxone for a minimum of 3 days of IV therapy. A switch to oral open-label study drug (amoxicillin clavulanate) was allowed on or after Study Day 4 if a subject met the protocol specified criteria. A recommended total daily dose of up to 90 mg/kg/day amoxicillin clavulanate was to be divided equally every 12h. The total duration of study drug therapy was 5 to 14 days, inclusive.
    Arm type
    Active comparator

    Investigational medicinal product name
    Ceftriaxone
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    IV ceftriaxone at a total daily dose of 75 mg/kg/day up to a maximum of 4 g/day, was given in equally divided doses, each infused over 30 (± 10) minutes every 12 hours (q12h [± 2 hours]).

    Notes
    [1] - The roles blinded appear inconsistent with a simple blinded trial.
    Justification: Blinding of subject IV dosing regimens was not necessary because treatment was administered by unblinded study centre staff not involved in assessments of clinical response
    Number of subjects in period 1
    Ceftaroline fosamil Comparator
    Started
    122
    39
    Completed
    116
    38
    Not completed
    6
    1
         Consent withdrawn by subject
    2
    -
         Other reasons
    3
    -
         Lost to follow-up
    1
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall trial
    Reporting group description
    -

    Reporting group values
    Overall trial Total
    Number of subjects
    161 161
    Age categorical
    Units: Subjects
        In utero
    0 0
        Preterm newborn infants (gestational age < 37 wks)
    0 0
        Newborns (0-27 days)
    0 0
        Infants and toddlers (28 days-23 months)
    30 30
        Children (2-11 years)
    121 121
        Adolescents (12-17 years)
    10 10
        Adults (18-64 years)
    0 0
        From 65-84 years
    0 0
        85 years and over
    0 0
    Gender categorical
    Units: Subjects
        Female
    76 76
        Male
    85 85
    Subject analysis sets

    Subject analysis set title
    Ceftaroline - Safety Set
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    The safety set consists of all patients who received any amount of IV study drug.

    Subject analysis set title
    Comparator - Safety Set
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    The safety set consists of all patients who received any amount of IV study drug.

    Subject analysis set title
    Ceftaroline - MITT Set
    Subject analysis set type
    Modified intention-to-treat
    Subject analysis set description
    The MITT population consists of all randomized subjects who received any amount of IV study drug and who had a confirmed diagnosis of CABP.

    Subject analysis set title
    Comparator - MITT Set
    Subject analysis set type
    Modified intention-to-treat
    Subject analysis set description
    The MITT population consists of all randomized subjects who received any amount of IV study drug and who had a confirmed diagnosis of CABP.

    Subject analysis set title
    Ceftaroline - mMITT Set
    Subject analysis set type
    Modified intention-to-treat
    Subject analysis set description
    The mMITT Population includes subjects for whom at least 1 typical bacterial pathogen has been isolated from an adequate microbiological specimen at baseline.

    Subject analysis set title
    Comparator - mMITT Set
    Subject analysis set type
    Modified intention-to-treat
    Subject analysis set description
    The mMITT Population includes subjects for whom at least 1 typical bacterial pathogen has been isolated from an adequate microbiological specimen at baseline.

    Subject analysis set title
    Ceftaroline - Clinically Evaluable Set
    Subject analysis set type
    Per protocol
    Subject analysis set description
    The Clinically Evaluable (CE) population consists of all patients in the ITT population who also meet the minimal CABP disease criteria and all evaluability criteria.

    Subject analysis set title
    Comparator - Clinically Evaluable Set
    Subject analysis set type
    Per protocol
    Subject analysis set description
    The Clinically Evaluable (CE) population consists of all patients in the ITT population who also meet the minimal CABP disease criteria and all evaluability criteria.

    Subject analysis sets values
    Ceftaroline - Safety Set Comparator - Safety Set Ceftaroline - MITT Set Comparator - MITT Set Ceftaroline - mMITT Set Comparator - mMITT Set Ceftaroline - Clinically Evaluable Set Comparator - Clinically Evaluable Set
    Number of subjects
    121
    39
    107
    36
    24
    9
    98
    36
    Age categorical
    Units: Subjects
        In utero
    0
    0
    0
    0
    0
    0
    0
    0
        Preterm newborn infants (gestational age < 37 wks)
    0
    0
    0
    0
    0
    0
    0
    0
        Newborns (0-27 days)
    0
    0
    0
    0
    0
    0
    0
    0
        Infants and toddlers (28 days-23 months)
    23
    7
    23
    6
    4
    2
    23
    6
        Children (2-11 years)
    90
    30
    77
    28
    19
    7
    69
    28
        Adolescents (12-17 years)
    8
    2
    7
    2
    1
    0
    6
    2
        Adults (18-64 years)
    0
    0
    0
    0
    0
    0
    0
    0
        From 65-84 years
    0
    0
    0
    0
    0
    0
    0
    0
        85 years and over
    0
    0
    0
    0
    0
    0
    0
    0
    Age continuous
    Units:
        
    ±
    ±
    ±
    ±
    ±
    ±
    ±
    ±
    Gender categorical
    Units: Subjects
        Female
        Male

    End points

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    End points reporting groups
    Reporting group title
    Ceftaroline fosamil
    Reporting group description
    122 subjects were randomised (ITT) to receive a minimum of 7 IV doses of ceftaroline fosamil (a minimum of 3 days of IV therapy). A switch to open-label oral study drug (amoxicillin clavulanate) was allowed on or after Study Day 4 if a subject met the protocol-specified criteria. A recommended total daily dose of up to 90 mg/kg/day amoxicillin clavulanate was to be divided equally every 12 hours. The total duration of study drug therapy was 5 to 14 days, inclusive.

    Reporting group title
    Comparator
    Reporting group description
    39 subjects were randomised (ITT) to receive ceftriaxone for a minimum of 3 days of IV therapy. A switch to oral open-label study drug (amoxicillin clavulanate) was allowed on or after Study Day 4 if a subject met the protocol specified criteria. A recommended total daily dose of up to 90 mg/kg/day amoxicillin clavulanate was to be divided equally every 12h. The total duration of study drug therapy was 5 to 14 days, inclusive.

    Subject analysis set title
    Ceftaroline - Safety Set
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    The safety set consists of all patients who received any amount of IV study drug.

    Subject analysis set title
    Comparator - Safety Set
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    The safety set consists of all patients who received any amount of IV study drug.

    Subject analysis set title
    Ceftaroline - MITT Set
    Subject analysis set type
    Modified intention-to-treat
    Subject analysis set description
    The MITT population consists of all randomized subjects who received any amount of IV study drug and who had a confirmed diagnosis of CABP.

    Subject analysis set title
    Comparator - MITT Set
    Subject analysis set type
    Modified intention-to-treat
    Subject analysis set description
    The MITT population consists of all randomized subjects who received any amount of IV study drug and who had a confirmed diagnosis of CABP.

    Subject analysis set title
    Ceftaroline - mMITT Set
    Subject analysis set type
    Modified intention-to-treat
    Subject analysis set description
    The mMITT Population includes subjects for whom at least 1 typical bacterial pathogen has been isolated from an adequate microbiological specimen at baseline.

    Subject analysis set title
    Comparator - mMITT Set
    Subject analysis set type
    Modified intention-to-treat
    Subject analysis set description
    The mMITT Population includes subjects for whom at least 1 typical bacterial pathogen has been isolated from an adequate microbiological specimen at baseline.

    Subject analysis set title
    Ceftaroline - Clinically Evaluable Set
    Subject analysis set type
    Per protocol
    Subject analysis set description
    The Clinically Evaluable (CE) population consists of all patients in the ITT population who also meet the minimal CABP disease criteria and all evaluability criteria.

    Subject analysis set title
    Comparator - Clinically Evaluable Set
    Subject analysis set type
    Per protocol
    Subject analysis set description
    The Clinically Evaluable (CE) population consists of all patients in the ITT population who also meet the minimal CABP disease criteria and all evaluability criteria.

    Primary: Extent of exposure - Safety Set

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    End point title
    Extent of exposure - Safety Set [1]
    End point description
    Extent of exposure is defined as calendar days of exposure to study drug during the IV and oral treatment periods.
    End point type
    Primary
    End point timeframe
    Extent of exposure has been evaluated from date of the first dose of study drug to date of the last dose of study drug + 1 day.
    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: The primary objective of this study is to evaluate the safety and tolerability of ceftaroline in children and it is not powered for inferential statistical analysis.
    End point values
    Ceftaroline - Safety Set Comparator - Safety Set
    Number of subjects analysed
    121
    39
    Units: Number of patients
        < 3 days
    2
    0
        3 - 5 days
    7
    1
        6 - 8 days
    36
    8
        9 - 15 days
    74
    30
        > 15 days
    2
    0
    No statistical analyses for this end point

    Primary: Adverse Events - Safety Set

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    End point title
    Adverse Events - Safety Set [2]
    End point description
    The safety assessment includes monitoring of adverse events (AEs), serious adverse events, deaths, and discontinuations due to AEs, including cephalosporin class effects and additional AEs.
    End point type
    Primary
    End point timeframe
    Adverse events have been reported from signing the ICF through the late-follow up visit (21 to 35 days after the last dose of any study drug [IV or oral]) or until 30 days after last dose of study drug, whichever occurred later.
    Notes
    [2] - 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: The primary objective of this study is to evaluate the safety and tolerability of ceftaroline in children and it is not powered for inferential statistical analysis.
    End point values
    Ceftaroline - Safety Set Comparator - Safety Set
    Number of subjects analysed
    121
    39
    Units: Number of patients
        Subjects with any TEAE
    55
    18
        Subjects with any study drug-related TEAEs
    12
    3
        Subjects with any SAEs
    6
    1
        Subjects with any study drug-related SAEs
    0
    0
        Discontinuations due to any study drug due to AE
    3
    0
        Discontinuations of IV study drug due to AE
    2
    0
        Deaths
    0
    0
    No statistical analyses for this end point

    Secondary: Clinical Response at Study Day 4 - MITT Set

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    End point title
    Clinical Response at Study Day 4 - MITT Set
    End point description
    Clinical response at Study Day 4 is defined as improvement in at least 2 out of 7 symptoms (cough, dyspnoea, chest pain, sputum production, chills, feeling of warmth/feverish and exercise intolerance or lethargy) and have worsening in none.
    End point type
    Secondary
    End point timeframe
    Clinical response at Study Day 4 has been evaluated from Study Day 1 (the first day of IV study drug administration) to Study Day 4.
    End point values
    Ceftaroline - MITT Set Comparator - MITT Set
    Number of subjects analysed
    107
    36
    Units: Number of patients
        Responder
    74
    24
        Non-responder
    24
    11
        Incomplete data
    9
    1
    No statistical analyses for this end point

    Secondary: Clinical Stability at Study Day 4 - MITT Set

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    End point title
    Clinical Stability at Study Day 4 - MITT Set
    End point description
    Clinical stability at Study Day 4 is defined as meeting all of the following criteria: Afebrile (temperature ≤ 38.0°C); age-appropriate normal pulse and respiratory rates; oxygen saturation ≥ 92% on room air; worsening of none of the following symptoms relative to baseline: cough, dyspnoea, chest pain, sputum production, chills or rigors, feeling feverish, and exercise intolerance or lethargy.
    End point type
    Secondary
    End point timeframe
    Clinical stability at Study Day 4 has been evaluated from Study Day 1 (the first day of IV study drug administration) to Study Day 4.
    End point values
    Ceftaroline - MITT Set Comparator - MITT Set
    Number of subjects analysed
    107
    36
    Units: Number of patients
        Stability
    37
    13
        No stability
    60
    23
        Incomplete data
    10
    0
    No statistical analyses for this end point

    Secondary: Clinical Response at Study Day 4 - mMITT Set

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    End point title
    Clinical Response at Study Day 4 - mMITT Set
    End point description
    Clinical response at Study Day 4 is defined as improvement in at least 2 out of 7 symptoms (cough, dyspnoea, chest pain, sputum production, chills, feeling of warmth/feverish and exercise intolerance or lethargy) and have worsening in none.
    End point type
    Secondary
    End point timeframe
    Clinical Response at Study Day 4 has been evaluated from Study Day 1 (the first day of IV study drug administration) to Study Day 4.
    End point values
    Ceftaroline - mMITT Set Comparator - mMITT Set
    Number of subjects analysed
    24
    9
    Units: Number of patients
        Responder
    14
    7
        Non-responder
    7
    1
        Incomplete data
    3
    1
    No statistical analyses for this end point

    Secondary: Clinical Stability at Study Day 4 - mMITT Set

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    End point title
    Clinical Stability at Study Day 4 - mMITT Set
    End point description
    Clinical stability at Study Day 4 is defined as meeting all of the following criteria: Afebrile (temperature ≤ 38.0°C); age-appropriate normal pulse and respiratory rates; oxygen saturation ≥ 92% on room air; worsening of none of the following symptoms relative to baseline: cough, dyspnoea, chest pain, sputum production, chills or rigors, feeling feverish, and exercise intolerance or lethargy.
    End point type
    Secondary
    End point timeframe
    Clinical Stability at Study Day 4 has been evaluated from Study Day 1 (the first day of IV study drug administration) to Study Day 4.
    End point values
    Ceftaroline - mMITT Set Comparator - mMITT Set
    Number of subjects analysed
    24
    9
    Units: Number of patients
        Stability
    5
    1
        No stability
    15
    8
        Incomplete data
    4
    0
    No statistical analyses for this end point

    Secondary: Clinical Outcome at TOC - MITT Set

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    End point title
    Clinical Outcome at TOC - MITT Set
    End point description
    Clinical Outcome at TOC is defined as assessment of clinical cure, clinical failure and indeterminate for the MITT population at Test-Of-Cure.
    End point type
    Secondary
    End point timeframe
    Clinical Outcome at Test-of-Cure (TOC) has been evaluated 8 to 15 days after administration of the last dose of any study drug [IV or PO].
    End point values
    Ceftaroline - MITT Set Comparator - MITT Set
    Number of subjects analysed
    107
    36
    Units: Number of patients
        Clinical cure
    94
    32
        Clinical failure
    8
    4
        Indeterminate
    5
    0
    No statistical analyses for this end point

    Secondary: Clinical Outcome at TOC - Clinically Evaluable Set

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    End point title
    Clinical Outcome at TOC - Clinically Evaluable Set
    End point description
    Clinical Outcome at TOC is defined as assessment of clinical cure, clinical failure and indeterminate for the CE population at Test-Of-Cure.
    End point type
    Secondary
    End point timeframe
    Clinical Outcome at Test-of-Cure (TOC) has been evaluated 8 to 15 days after administration of the last dose of any study drug [IV or PO].
    End point values
    Ceftaroline - Clinically Evaluable Set Comparator - Clinically Evaluable Set
    Number of subjects analysed
    98
    36
    Units: Number of patients
        Clinical cure
    90
    32
        Clinical failure
    8
    4
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From the start of first dose of study drug through the late follow-up visit or 30 days after the last dose of IV or oral study drug, whichever occurred later.
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    17.0
    Reporting groups
    Reporting group title
    Ceftaroline - Safety Population
    Reporting group description
    -

    Reporting group title
    Comparator - Safety Population
    Reporting group description
    -

    Serious adverse events
    Ceftaroline - Safety Population Comparator - Safety Population
    Total subjects affected by serious adverse events
         subjects affected / exposed
    6 / 121 (4.96%)
    1 / 39 (2.56%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Respiratory, thoracic and mediastinal disorders
    Pulmonary thrombosis
         subjects affected / exposed
    0 / 121 (0.00%)
    1 / 39 (2.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Gastroenteritis
         subjects affected / exposed
    2 / 121 (1.65%)
    0 / 39 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchitis
         subjects affected / exposed
    1 / 121 (0.83%)
    0 / 39 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infectious pleural effusion
         subjects affected / exposed
    1 / 121 (0.83%)
    0 / 39 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    1 / 121 (0.83%)
    0 / 39 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia respiratory syncytial viral
         subjects affected / exposed
    1 / 121 (0.83%)
    0 / 39 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Dehydration
         subjects affected / exposed
    1 / 121 (0.83%)
    0 / 39 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    Ceftaroline - Safety Population Comparator - Safety Population
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    20 / 121 (16.53%)
    12 / 39 (30.77%)
    Blood and lymphatic system disorders
    Thrombocytosis
         subjects affected / exposed
    2 / 121 (1.65%)
    3 / 39 (7.69%)
         occurrences all number
    2
    3
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    3 / 121 (2.48%)
    2 / 39 (5.13%)
         occurrences all number
    3
    2
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    10 / 121 (8.26%)
    2 / 39 (5.13%)
         occurrences all number
    10
    2
    Vomiting
         subjects affected / exposed
    4 / 121 (3.31%)
    2 / 39 (5.13%)
         occurrences all number
    4
    2
    Infections and infestations
    Otitis media
         subjects affected / exposed
    1 / 121 (0.83%)
    3 / 39 (7.69%)
         occurrences all number
    1
    3

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    11 Apr 2012
    The following changes were implemented with Amendment 1: Clarification of the efficacy outcome measures of clinical response, clinical stability, and clinical and microbiological outcomes in the Modified Intent-to-Treat (MITT) and the Microbiological Modified Intent-to-Treat (mMITT) populations; updates to the dosing language; updates to the clinical laboratory tests; addition of a symptom questionnaire to be performed by the Blinded Observer and other clarifications.
    26 Oct 2012
    The following changes were implemented with Amendment 2: Change of Study Phase designation; updates to dosing regimen; change in criteria for switching to outpatient parenteral antimicrobial therapy (OPAT) and other clarifications.

    Interruptions (globally)

    Were there any global interruptions to the trial? No

    Limitations and caveats

    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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