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    Clinical Trial Results:
    A Phase III, Multicentre, Randomised, Double-Blind, Comparative Study to Evaluate the Efficacy and Safety of Ceftaroline Fosamil (600 mg every 8 hours) Versus Vancomycin Plus Aztreonam in the Treatment of Patients With Complicated Bacterial Skin and Soft Tissue Infections With Evidence of Systemic Inflammatory Response or Underlying Comorbidities

    Summary
    EudraCT number
    		 2011-004013-16
    Trial protocol
    		 GR   BE   CZ   BG   DE   AT   PL   ES   GB   SK   IT  
    Global end of trial date
    30 Apr 2015

    Results information
    Results version number
    		 v1(current)
    This version publication date
    01 Feb 2017
    First version publication date
    19 Jul 2015
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    D3720C00001
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    AstraZeneca AB
    Sponsor organisation address
    151 85 Södertälje, Södertälje, Sweden,
    Public contact
    Jesus Gonzalez, AstraZeneca, UK +44 (0)7557 541 031 , Jesus.Gonzalez@astrazeneca.com
    Scientific contact
    Matthew Dryden, Royal Hampshire County Hospital, Department of Microbiology, UK +44 (0)1962 824451, Matthew.Dryden@hhft.nhs.uk
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    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
    05 Mar 2015
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    26 Jun 2014
    Global end of trial reached?
    Yes
    Global end of trial date
    30 Apr 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of the study was to assess whether ceftaroline fosamil was non inferior to vancomycin plus aztreonam in the clinical cure rate at the TOC visit in both the MITT and CE analysis sets of adult patients with cSSTI.
    Protection of trial subjects
    The study will be performed in accordance with the ethical principles that have their origin in the Declaration of Helsinki and are consistent with the International Conference on Harmonisation (ICH) harmonised tripartite guideline E6(R1): Good Clinical Practice, applicable regulatory requirements and the AstraZeneca policy on Bioethics and Human Biological Samples.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    17 May 2012
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Argentina: 10
    Country: Number of subjects enrolled
    Australia: 1
    Country: Number of subjects enrolled
    Belgium: 1
    Country: Number of subjects enrolled
    Brazil: 16
    Country: Number of subjects enrolled
    Bulgaria: 83
    Country: Number of subjects enrolled
    Chile: 3
    Country: Number of subjects enrolled
    China: 151
    Country: Number of subjects enrolled
    Croatia: 46
    Country: Number of subjects enrolled
    Czech Republic: 4
    Country: Number of subjects enrolled
    France: 1
    Country: Number of subjects enrolled
    Germany: 10
    Country: Number of subjects enrolled
    Greece: 4
    Country: Number of subjects enrolled
    Hong Kong: 6
    Country: Number of subjects enrolled
    Israel: 16
    Country: Number of subjects enrolled
    Italy: 2
    Country: Number of subjects enrolled
    Mexico: 11
    Country: Number of subjects enrolled
    Peru: 35
    Country: Number of subjects enrolled
    Philippines: 5
    Country: Number of subjects enrolled
    Poland: 3
    Country: Number of subjects enrolled
    Romania: 21
    Country: Number of subjects enrolled
    Russian Federation: 115
    Country: Number of subjects enrolled
    South Africa: 22
    Country: Number of subjects enrolled
    Korea, Democratic People's Republic of: 18
    Country: Number of subjects enrolled
    Spain: 13
    Country: Number of subjects enrolled
    Taiwan: 12
    Country: Number of subjects enrolled
    Turkey: 14
    Country: Number of subjects enrolled
    Ukraine: 29
    Country: Number of subjects enrolled
    United States: 120
    Worldwide total number of subjects
    772
    EEA total number of subjects
    188
    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)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    578
    From 65 to 84 years
    178
    85 years and over
    16

    Subject disposition

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    Recruitment
    Recruitment details
    		 Overall, 802 patients were enrolled from 111 centres in 6 regions in this study. The first patient was enrolled on 17 May 2012 and the last patient last visit was on 26 June 2014.

    Pre-assignment
    Screening details
    		 None

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst, Carer, Assessor
    Blinding implementation details
    Individual treatment codes, indicating the treatment randomisation for each randomised patient, will be available to the investigators from the IVRS/IWRS. Routines for this will be described in the IVRS/IWRS user manual that will be provided to each centre.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Ceftaroline fosamil at 600 mg every 8 hours (q8h)
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ceftaroline fosamil
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder and solvent for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Sterile crystalline powder in a single-dose, clear glass 20-mL vial,

    Arm title
    		 Vancomycin Plus Aztreonam
    Arm description
    		 -
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Vancomycin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder and solvent for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Lyophilized powder, intravenous, dose strength (based on patient’s

    Investigational medicinal product name
    Aztreonam
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Sterile powder containing approximately 1 gram of aztreonam per

    Number of subjects in period 1 [1]
    		Ceftaroline fosamil at 600 mg every 8 hours (q8h) Vancomycin Plus Aztreonam
    Started
    506
    255
    Completed
    459
    223
    Not completed
    47
    32
         Adverse event, serious fatal
    3
    2
         Consent withdrawn by subject
    16
    6
         Lack of therapeutic response
    5
    6
         Adverse event, non-fatal
    3
    6
         Other
    3
    1
         Lost to follow-up
    15
    8
         Protocol deviation
    2
    3
    Notes
    [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: Overall 802 patients were recruited, 772 patients were randomized, but only 761 patients had data for the study.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Ceftaroline fosamil at 600 mg every 8 hours (q8h)
    Reporting group description
    		 -

    Reporting group title
    Vancomycin Plus Aztreonam
    Reporting group description
    		 -

    Reporting group values
    		 Ceftaroline fosamil at 600 mg every 8 hours (q8h) Vancomycin Plus Aztreonam Total
    Number of subjects
    		 506 255 761
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 387 183 570
        From 65-84 years
    		 111 64 175
        85 years and over
    		 8 8 16
    Age Continuous |
    Units: Years
        arithmetic mean (standard deviation)
    		 52.6 ( 16.51 ) 53.6 ( 16.25 ) -
    Gender, Male/Female
    Units: Participants
        Female
    		 196 107 303
        Male
    		 310 148 458

    End points

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    End points reporting groups
    Reporting group title
    Ceftaroline fosamil at 600 mg every 8 hours (q8h)
    Reporting group description
    		 -

    Reporting group title
    Vancomycin Plus Aztreonam
    Reporting group description
    		 -

    Primary: Clinical response at Test of Cure in MITT

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    End point title
    		 Clinical response at Test of Cure in MITT
    End point description
    The observed difference in the clinical cure rates at TOC (ceftaroline group minus vancomycin plus aztreonam group) in MITT
    End point type
    Primary
    End point timeframe
    7 to 20 days after the last dose of study drug
    End point values
    		 Ceftaroline fosamil at 600 mg every 8 hours (q8h) Vancomycin Plus Aztreonam
    Number of subjects analysed
    506
    255
    Units: Participants
        Clinical cure
    396
    202
        Clinical failure
    58
    34
        Indeterminate
    52
    19
    Statistical analysis title
    		 Difference in clinical cure rates at TOC in MITT
    Statistical analysis description
    Difference in clinical cure rates (Ceftaroline minus Vancomycin/Aztreonam). CI was calculated by unstratified Miettinen and Nurminen CI.
    Comparison groups
    Ceftaroline fosamil at 600 mg every 8 hours (q8h) v Vancomycin Plus Aztreonam
    Number of subjects included in analysis
    761
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Risk difference (RD)
    Point estimate
    -0.95
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -6.9
         upper limit
    		 5.41

    Primary: Clinical response at Test-of cure in CE

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    End point title
    		 Clinical response at Test-of cure in CE
    End point description
    The observed difference in the clinical cure rates at TOC (ceftaroline group minus vancomycin plus aztreonam group) in CE
    End point type
    Primary
    End point timeframe
    7 to 20 days after the last dose of study drug
    End point values
    		 Ceftaroline fosamil at 600 mg every 8 hours (q8h) Vancomycin Plus Aztreonam
    Number of subjects analysed
    395
    211
    Units: Participants
        Clinical cure
    342
    211
        Clinical failure
    53
    31
    Statistical analysis title
    		 Difference in clinical cure rates at TOC in CE
    Statistical analysis description
    Difference in clinical cure rates (Ceftaroline minus Vancomycin/Aztreonam). CI was calculated by unstratified Miettinen and Nurminen CI.
    Comparison groups
    Ceftaroline fosamil at 600 mg every 8 hours (q8h) v Vancomycin Plus Aztreonam
    Number of subjects included in analysis
    606
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Risk difference (RD)
    Point estimate
    1.27
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.32
         upper limit
    		 7.48

    Secondary: Per patient microbiological response at TOC in mMITT

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    End point title
    		 Per patient microbiological response at TOC in mMITT
    End point description
    Difference in microbiological favorable response rate at TOC in mMITT
    End point type
    Secondary
    End point timeframe
    7 to 20 days after the last dose of study drug
    End point values
    		 Ceftaroline fosamil at 600 mg every 8 hours (q8h) Vancomycin Plus Aztreonam
    Number of subjects analysed
    248
    136
    Units: Participants
        Favorable
    203
    109
        Unfavorable
    17
    17
        Indeterminate
    28
    10
    Statistical analysis title
    		 Difference in favorable rates at TOC in mMITT
    Statistical analysis description
    Difference in favorable rates (Ceftaroline minus Vancomycin/Aztreonam). CI was calculated by unstratified Miettinen and Nurminen CI.
    Comparison groups
    Ceftaroline fosamil at 600 mg every 8 hours (q8h) v Vancomycin Plus Aztreonam
    Number of subjects included in analysis
    384
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Risk difference (RD)
    Point estimate
    1.71
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -6.21
         upper limit
    		 10.39

    Secondary: Per-patient micro response at TOC for ME

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    End point title
    		 Per-patient micro response at TOC for ME
    End point description
    Difference in microbiological favorable response rate at TOC in ME
    End point type
    Secondary
    End point timeframe
    7 to 20 days after the last dose of study drug
    End point values
    		 Ceftaroline fosamil at 600 mg every 8 hours (q8h) Vancomycin Plus Aztreonam
    Number of subjects analysed
    181
    112
    Units: Participants
        Favorable
    167
    98
        Unfavorable
    14
    14
    Statistical analysis title
    		 Difference in favorable rates at TOC in ME
    Statistical analysis description
    Difference in favorable rates (Ceftaroline minus Vancomycin/Aztreonam).CI was calculated by unstratified Miettinen and Nurminen CI.
    Comparison groups
    Ceftaroline fosamil at 600 mg every 8 hours (q8h) v Vancomycin Plus Aztreonam
    Number of subjects included in analysis
    293
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Risk difference (RD)
    Point estimate
    4.77
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.11
         upper limit
    		 12.86

    Secondary: Clinical response at EOT in MITT

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    End point title
    		 Clinical response at EOT in MITT
    End point description
    The observed difference in the clinical cure rates at EOT (ceftaroline group minus vancomycin plus aztreonam group) in MITT
    End point type
    Secondary
    End point timeframe
    On day of last dose of study drug (or + 1 day)
    End point values
    		 Ceftaroline fosamil at 600 mg every 8 hours (q8h) Vancomycin Plus Aztreonam
    Number of subjects analysed
    506
    255
    Units: Participants
        Clinical cure
    429
    213
        Clinical fialure
    44
    29
        Indeterminate
    31
    11
        Missing
    2
    2
    Statistical analysis title
    		 Difference in cure rates at EOT in MITT
    Statistical analysis description
    Difference in cure rates (Ceftaroline minus Vancomycin/Aztreonam). CI was calculated by unstratified Miettinen and Nurminen CI.
    Comparison groups
    Ceftaroline fosamil at 600 mg every 8 hours (q8h) v Vancomycin Plus Aztreonam
    Number of subjects included in analysis
    761
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Risk difference (RD)
    Point estimate
    1.25
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.05
         upper limit
    		 7.06

    Secondary: Clinical response at EOT in CE

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    End point title
    		 Clinical response at EOT in CE
    End point description
    The observed difference in the clinical cure rates at EOT (ceftaroline group minus vancomycin plus aztreonam group) in CE
    End point type
    Secondary
    End point timeframe
    On day of last dose of study drug (or +1 day)
    End point values
    		 Ceftaroline fosamil at 600 mg every 8 hours (q8h) Vancomycin Plus Aztreonam
    Number of subjects analysed
    395
    211
    Units: Participants
        Clinical cure
    356
    184
        Clinical failure
    39
    27
    Statistical analysis title
    		 Difference in cure rates at EOT in CE
    Statistical analysis description
    Difference in cure rates (Ceftaroline minus Vancomycin/Aztreonam). CI was calculated by unstratified Miettinen and Nurminen CI.
    Comparison groups
    Ceftaroline fosamil at 600 mg every 8 hours (q8h) v Vancomycin Plus Aztreonam
    Number of subjects included in analysis
    606
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Risk difference (RD)
    Point estimate
    2.92
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.19
         upper limit
    		 8.73

    Secondary: clinical relapse rates at LFU in CE (patients with clinical cure at TOC)

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    End point title
    		 clinical relapse rates at LFU in CE (patients with clinical cure at TOC)
    End point description
    The observed difference in the clinical relapse rates at LFU (ceftaroline group minus vancomycin plus aztreonam group) in CE
    End point type
    Secondary
    End point timeframe
    21 to 42 days after the last dose of study drug
    End point values
    		 Ceftaroline fosamil at 600 mg every 8 hours (q8h) Vancomycin Plus Aztreonam
    Number of subjects analysed
    342
    180
    Units: Participants
        Relapse
    3
    3
        No relapse
    335
    174
        Indeterminate
    3
    3
        Missing
    1
    0
    Statistical analysis title
    		 Difference in relapse rates at LFU in CE
    Statistical analysis description
    Difference in relapse rates (Ceftaroline minus Vancomycin/Aztreonam). CI was calculated by unstratified Miettinen and Nurminen CI.
    Comparison groups
    Ceftaroline fosamil at 600 mg every 8 hours (q8h) v Vancomycin Plus Aztreonam
    Number of subjects included in analysis
    522
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Risk difference (RD)
    Point estimate
    -0.79
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.98
         upper limit
    		 1.18

    Secondary: Early response at 48 to 72 hours of treatment in MITT

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    End point title
    		 Early response at 48 to 72 hours of treatment in MITT
    End point description
    The observed difference in the early success rates at 48 to 72 hours of treatment (ceftaroline group minus vancomycin plus aztreonam group) in MITT
    End point type
    Secondary
    End point timeframe
    48 to 72 hours after first dose of study drug
    End point values
    		 Ceftaroline fosamil at 600 mg every 8 hours (q8h) Vancomycin Plus Aztreonam
    Number of subjects analysed
    506
    255
    Units: Participants
        Success
    445
    229
        Failure
    28
    11
        Indeterminate
    33
    15
    Statistical analysis title
    		 Difference in success rates at 48-72 hours in MITT
    Statistical analysis description
    Difference in success rates (Ceftaroline minus Vancomycin/Aztreonam). CI was calculated by unstratified Miettinen and Nurminen CI.
    Comparison groups
    Ceftaroline fosamil at 600 mg every 8 hours (q8h) v Vancomycin Plus Aztreonam
    Number of subjects included in analysis
    761
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Risk difference (RD)
    Point estimate
    -1.86
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -6.34
         upper limit
    		 3.15

    Secondary: Per-pathogen microbiological response at TOC by baseline pathogen from site of skin infection in ME

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    End point title
    		 Per-pathogen microbiological response at TOC by baseline pathogen from site of skin infection in ME
    End point description
    Per-pathogen microbiological response at TOC by baseline pathogen from site of skin infection in ME analysis set
    End point type
    Secondary
    End point timeframe
    7 to 20 days after the last dose of study drug
    End point values
    		 Ceftaroline fosamil at 600 mg every 8 hours (q8h) Vancomycin Plus Aztreonam
    Number of subjects analysed
    181
    112
    Units: Participants
        MSSA - Patients reported
    94
    57
        MSSA - Favorable
    91
    49
        MSSA - Unfavorable
    3
    8
        MRSA - Patients reported
    25
    15
        MRSA - Favorable
    22
    12
        MRSA - Unfavorable
    3
    3
        Streptococcus pyogenes - Patients reported
    15
    7
        Streptococcus pyogenes - Favorable
    14
    7
        Streptococcus pyogenes - Unfavorable
    1
    0
        Streptococcus agalactiae - Patients reported
    6
    9
        Streptococcus agalactiae - Favorable
    6
    9
        Streptococcus agalactiae - Unfavorable
    0
    0
        Streptococcus dysgalactiae - Patients reported
    9
    0
        Streptococcus dysgalactiae - Favorable
    9
    0
        Streptococcus dysgalactiae - Unfavorable
    0
    0
        Enterococcus faecalis - Patients reported
    6
    5
        Enterococcus faecalis - Favorable
    5
    4
        Enterococcus faecalis - Unfavorable
    1
    1
        Escherichia coli - Patients reported
    12
    10
        Escherichia coli - Favorable
    12
    9
        Escherichia coli - Unfavorable
    0
    1
        Klebsiella pneumoniae - Patients reported
    7
    4
        Klebsiella pneumoniae - Favorable
    6
    3
        Klebsiella pneumoniae - Unfavorable
    1
    1
        Klebsiella oxytoca - Patients reported
    4
    1
        Klebsiella oxytoca - Favorable
    4
    1
        Klebsiella oxytoca - Unfavorable
    0
    0
        Proteus mirabilis - Patients reported
    7
    2
        Proteus mirabilis - Favorable
    6
    2
        Proteus mirabilis - Unfavorable
    1
    0
        Morganella morganii - Paitents reported
    4
    2
        Morganella morganii - Favorable
    4
    2
        Morganella morganii - Unfavorable
    0
    0
        Enterobacter cloacae - Patients reported
    4
    5
        Enterobacter cloacae - Favorable
    4
    5
        Enterobacter cloacae - Unfavorable
    0
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse events were collected from time of administration of the first dose of study therapy up to and including the TOC visit. Serious AEs were collected from time of signature of informed consent up to and including the LFU visit.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    17.0
    Reporting groups
    Reporting group title
    Vancomycin/Aztreonam
    Reporting group description
    		 Vancomycin Plus Aztreonam

    Reporting group title
    Ceftaroline fosamil 600 mg 120 min IV
    Reporting group description
    		 -

    Serious adverse events
    		 Vancomycin/Aztreonam Ceftaroline fosamil 600 mg 120 min IV
    Total subjects affected by serious adverse events
         subjects affected / exposed
    15 / 255 (5.88%)
    31 / 506 (6.13%)
         number of deaths (all causes)
    2
    3
         number of deaths resulting from adverse events
    0
    0
    Vascular disorders
    Deep vein thrombosis
         subjects affected / exposed
    1 / 255 (0.39%)
    2 / 506 (0.40%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypertension
         subjects affected / exposed
    1 / 255 (0.39%)
    0 / 506 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral arterial occlusive disease
         subjects affected / exposed
    0 / 255 (0.00%)
    1 / 506 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Venous thrombosis
         subjects affected / exposed
    0 / 255 (0.00%)
    1 / 506 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pregnancy, puerperium and perinatal conditions
    Abortion spontaneous
         subjects affected / exposed
    0 / 255 (0.00%)
    1 / 506 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Generalised oedema
         subjects affected / exposed
    0 / 255 (0.00%)
    1 / 506 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyrexia
         subjects affected / exposed
    1 / 255 (0.39%)
    0 / 506 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Immune system disorders
    Drug hypersensitivity
         subjects affected / exposed
    0 / 255 (0.00%)
    1 / 506 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Pneumonia aspiration
         subjects affected / exposed
    0 / 255 (0.00%)
    1 / 506 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Pulmonary embolism
         subjects affected / exposed
    1 / 255 (0.39%)
    0 / 506 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary haemosiderosis
         subjects affected / exposed
    1 / 255 (0.39%)
    0 / 506 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary oedema
         subjects affected / exposed
    1 / 255 (0.39%)
    0 / 506 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory failure
         subjects affected / exposed
    1 / 255 (0.39%)
    0 / 506 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    Alcohol withdrawal syndrome
         subjects affected / exposed
    1 / 255 (0.39%)
    0 / 506 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Confusional state
         subjects affected / exposed
    1 / 255 (0.39%)
    0 / 506 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Investigations
    Hepatic enzyme increased
         subjects affected / exposed
    0 / 255 (0.00%)
    1 / 506 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Metal poisoning
         subjects affected / exposed
    0 / 255 (0.00%)
    1 / 506 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Toxicity to various agents
         subjects affected / exposed
    0 / 255 (0.00%)
    1 / 506 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Atrial fibrillation
         subjects affected / exposed
    0 / 255 (0.00%)
    1 / 506 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac failure
         subjects affected / exposed
    0 / 255 (0.00%)
    3 / 506 (0.59%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Cardiac failure congestive
         subjects affected / exposed
    1 / 255 (0.39%)
    0 / 506 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Cardiomyopathy
         subjects affected / exposed
    0 / 255 (0.00%)
    1 / 506 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Coronary artery disease
         subjects affected / exposed
    0 / 255 (0.00%)
    1 / 506 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myocardial infarction
         subjects affected / exposed
    1 / 255 (0.39%)
    1 / 506 (0.20%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Ventricular tachycardia
         subjects affected / exposed
    1 / 255 (0.39%)
    0 / 506 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    0 / 255 (0.00%)
    1 / 506 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Anal fistula
         subjects affected / exposed
    0 / 255 (0.00%)
    1 / 506 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Large intestine perforation
         subjects affected / exposed
    0 / 255 (0.00%)
    1 / 506 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancreatitis acute
         subjects affected / exposed
    0 / 255 (0.00%)
    1 / 506 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Upper gastrointestinal haemorrhage
         subjects affected / exposed
    1 / 255 (0.39%)
    0 / 506 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Drug eruption
         subjects affected / exposed
    0 / 255 (0.00%)
    1 / 506 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Toxic epidermal necrolysis
         subjects affected / exposed
    0 / 255 (0.00%)
    1 / 506 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urticaria
         subjects affected / exposed
    1 / 255 (0.39%)
    1 / 506 (0.20%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Nephropathy toxic
         subjects affected / exposed
    1 / 255 (0.39%)
    0 / 506 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal failure acute
         subjects affected / exposed
    2 / 255 (0.78%)
    1 / 506 (0.20%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Abdominal infection
         subjects affected / exposed
    0 / 255 (0.00%)
    1 / 506 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abscess limb
         subjects affected / exposed
    0 / 255 (0.00%)
    1 / 506 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchopneumonia
         subjects affected / exposed
    1 / 255 (0.39%)
    0 / 506 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diabetic gangrene
         subjects affected / exposed
    1 / 255 (0.39%)
    0 / 506 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gangrene
         subjects affected / exposed
    1 / 255 (0.39%)
    0 / 506 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    0 / 255 (0.00%)
    1 / 506 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lung infection
         subjects affected / exposed
    0 / 255 (0.00%)
    1 / 506 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    0 / 255 (0.00%)
    2 / 506 (0.40%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia staphylococcal
         subjects affected / exposed
    1 / 255 (0.39%)
    0 / 506 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    0 / 255 (0.00%)
    1 / 506 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Wound infection
         subjects affected / exposed
    0 / 255 (0.00%)
    1 / 506 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Hypokalaemia
         subjects affected / exposed
    0 / 255 (0.00%)
    1 / 506 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 2%
    Non-serious adverse events
    		 Vancomycin/Aztreonam Ceftaroline fosamil 600 mg 120 min IV
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    46 / 255 (18.04%)
    82 / 506 (16.21%)
    Investigations
    Hepatic enzyme increased
         subjects affected / exposed
    7 / 255 (2.75%)
    3 / 506 (0.59%)
         occurrences all number
    7
    3
    Vascular disorders
    Hypertension
         subjects affected / exposed
    8 / 255 (3.14%)
    7 / 506 (1.38%)
         occurrences all number
    8
    8
    Nervous system disorders
    Headache
         subjects affected / exposed
    12 / 255 (4.71%)
    17 / 506 (3.36%)
         occurrences all number
    13
    17
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    9 / 255 (3.53%)
    10 / 506 (1.98%)
         occurrences all number
    9
    10
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    5 / 255 (1.96%)
    12 / 506 (2.37%)
         occurrences all number
    5
    12
    Constipation
         subjects affected / exposed
    8 / 255 (3.14%)
    9 / 506 (1.78%)
         occurrences all number
    8
    9
    Nausea
         subjects affected / exposed
    11 / 255 (4.31%)
    20 / 506 (3.95%)
         occurrences all number
    11
    20
    Vomiting
         subjects affected / exposed
    5 / 255 (1.96%)
    13 / 506 (2.57%)
         occurrences all number
    5
    15
    Skin and subcutaneous tissue disorders
    Pruritus generalised
         subjects affected / exposed
    6 / 255 (2.35%)
    4 / 506 (0.79%)
         occurrences all number
    6
    4
    Rash
         subjects affected / exposed
    6 / 255 (2.35%)
    10 / 506 (1.98%)
         occurrences all number
    6
    11
    Metabolism and nutrition disorders
    Hypokalaemia
         subjects affected / exposed
    8 / 255 (3.14%)
    14 / 506 (2.77%)
         occurrences all number
    9
    14

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    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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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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