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    Clinical Trial Results:
    A Multicenter, Randomized, Observer-Blinded, Active-Controlled Study to Evaluate the Safety, Tolerability, Efficacy, and Pharmacokinetics of Ceftaroline Versus Comparator in Pediatric Subjects With Acute Bacterial Skin and Skin Structure Infections

    Summary
    EudraCT number
    		 2011-003812-22
    Trial protocol
    		 Outside EU/EEA   LT   LV   ES   PL  
    Global end of trial date
    13 May 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
    P903-23
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01400867
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Cerexa, Inc (a subsidiary of Allergan, plc)
    Sponsor organisation address
    185 Hudson Street, Plaza 5, Jersey City, United States, NJ 07302-3908
    Public contact
    Clinical Trial Registry Team, Cerexa, Inc (a subsidiary of Allergan, plc), +1 877-277-8566, khaeckl@cerexa.com
    Scientific contact
    Clinical Trial Registry Team, Cerexa, Inc (a subsidiary of Allergan, plc), +1 877-277-8566, khaeckl@cerexa.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?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    19 Nov 2014
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    13 May 2014
    Global end of trial reached?
    Yes
    Global end of trial date
    13 May 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Evaluate the safety and tolerability of ceftaroline versus comparator in pediatric subjects ages 2 months to < 18 years with acute bacterial skin and skin structure infections (ABSSSI)
    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
    29 Nov 2011
    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: 19
    Country: Number of subjects enrolled
    Spain: 12
    Country: Number of subjects enrolled
    Latvia: 21
    Country: Number of subjects enrolled
    Lithuania: 12
    Country: Number of subjects enrolled
    Argentina: 14
    Country: Number of subjects enrolled
    Chile: 14
    Country: Number of subjects enrolled
    United States: 33
    Country: Number of subjects enrolled
    South Africa: 7
    Country: Number of subjects enrolled
    Georgia: 31
    Worldwide total number of subjects
    163
    EEA total number of subjects
    64
    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)
    39
    Children (2-11 years)
    87
    Adolescents (12-17 years)
    37
    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 163 subjects between the ages of 2 months to < 18 years, with acute bacterial skin and skin structure infections (ABSSSI) 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 [1]
    Roles blinded
    		 Investigator, Assessor [2]
    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
    		 110 subjects were randomized (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 (cephalexin [preferred oral switch], clindamycin, or linezolid) was allowed on or after Study Day 4 if a subject met the protocol-specified criteria. The total duration of IV plus PO therapy was 5 to 14 days.
    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/kg

    Arm title
    		 Comparator
    Arm description
    		 53 subjects were randomized (ITT) to receive vancomycin or cefazolin with or without aztreonam for a minimum of 3 days of IV therapy. A switch to open-label oral study drug (cephalexin [preferred oral switch], clindamycin, or linezolid) was allowed on or after Study Day 4 if a subject met the protocol specified criteria. The total duration of IV plus PO therapy was 5 to 14 days.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Vancomycin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    IV vancomycin 15 mg/kg every 6 hours (q6h) (± 1 hour) was infused over at least 60 minutes (or at a maximum of 10 mg/min, whichever was longer).

    Investigational medicinal product name
    Cefazolin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    IV cefazolin 75 mg/kg/day divided q8h (± 1 hour) was infused over 60 (± 10) minutes.

    Investigational medicinal product name
    Aztreonam
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    IV aztreonam 30 mg/kg q8h (± 1 hour) was infused over 60 (± 10) minutes, at any time during IV therapy if an infection involving a Gram-negative pathogen was identified or suspected.

    Notes
    [1] - The number of roles blinded appears inconsistent with a single blinded trial. It is expected that there will be one role blinded in a single blind trial.
    Justification: This study was observer-blinded. At each study centre, at least 1 blinded investigator did not know the subject’s treatment assignment and conducted clinical assessments (including efficacy and safety).
    [2] - The roles blinded appear inconsistent with a simple blinded trial.
    Justification: This study was observer-blinded. At each study centre, at least 1 blinded investigator did not know the subject’s treatment assignment and conducted clinical assessments (including efficacy and safety).
    Number of subjects in period 1
    		Ceftaroline fosamil Comparator
    Started
    110
    53
    Completed
    103
    48
    Not completed
    7
    5
         Consent withdrawn by subject
    5
    2
         Other reason
    2
    -
         Lost to follow-up
    -
    2
         Subject didn't meet inclusion/exclusion criteria
    -
    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
    		 163 163
    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)
    		 39 39
        Children (2-11 years)
    		 87 87
        Adolescents (12-17 years)
    		 37 37
        Adults (18-64 years)
    		 0 0
        From 65-84 years
    		 0 0
        85 years and over
    		 0 0
    Gender categorical
    Units: Subjects
        Female
    		 73 73
        Male
    		 90 90
    Subject analysis sets

    Subject analysis set title
    Ceftaroline - Safety Set
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    The Safety Population consists of all patients 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 Population consists of all patients 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 Modified-Intent-to-Treat (MITT) Population consists of all patients who received any amount of study drug and have confirmed diagnosis of ABSSSI.

    Subject analysis set title
    Comparator - MITT Set
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    The Modified-Intent-to-Treat (MITT) Population consists of all patients who received any amount of study drug and have confirmed diagnosis of ABSSSI.

    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 minimal ABSSSI 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 ABSSSI disease criteria and all evaluability criteria.

    Subject analysis sets values
    		 Ceftaroline - Safety Set Comparator - Safety Set Ceftaroline - MITT Set Comparator - MITT Set Ceftaroline - Clinically Evaluable Set Comparator - Clinically Evaluable Set
    Number of subjects
    106
    53
    107
    52
    96
    45
    Age categorical
    Units: Subjects
        In utero
    0
    0
    0
    0
    0
    0
        Preterm newborn infants (gestational age < 37 wks)
    0
    0
    0
    0
    0
    0
        Newborns (0-27 days)
    0
    0
    0
    0
    0
    0
        Infants and toddlers (28 days-23 months)
    24
    13
    25
    12
    19
    10
        Children (2-11 years)
    59
    27
    59
    27
    57
    26
        Adolescents (12-17 years)
    23
    13
    23
    13
    20
    9
        Adults (18-64 years)
    0
    0
    0
    0
    0
    0
        From 65-84 years
    0
    0
    0
    0
    0
    0
        85 years and over
    0
    0
    0
    0
    0
    0
    Age continuous
    Units:
        
    ±
    ±
    ±
    ±
    ±
    ±
    Gender categorical
    Units: Subjects
        Female
    50
    21
    50
    21
    45
    18
        Male
    56
    32
    57
    31
    51
    27

    End points

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    End points reporting groups
    Reporting group title
    Ceftaroline fosamil
    Reporting group description
    		 110 subjects were randomized (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 (cephalexin [preferred oral switch], clindamycin, or linezolid) was allowed on or after Study Day 4 if a subject met the protocol-specified criteria. The total duration of IV plus PO therapy was 5 to 14 days.

    Reporting group title
    Comparator
    Reporting group description
    		 53 subjects were randomized (ITT) to receive vancomycin or cefazolin with or without aztreonam for a minimum of 3 days of IV therapy. A switch to open-label oral study drug (cephalexin [preferred oral switch], clindamycin, or linezolid) was allowed on or after Study Day 4 if a subject met the protocol specified criteria. The total duration of IV plus PO therapy was 5 to 14 days.

    Subject analysis set title
    Ceftaroline - Safety Set
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    The Safety Population consists of all patients 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 Population consists of all patients 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 Modified-Intent-to-Treat (MITT) Population consists of all patients who received any amount of study drug and have confirmed diagnosis of ABSSSI.

    Subject analysis set title
    Comparator - MITT Set
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    The Modified-Intent-to-Treat (MITT) Population consists of all patients who received any amount of study drug and have confirmed diagnosis of ABSSSI.

    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 minimal ABSSSI 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 ABSSSI 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 described as number of Calendar Days subjects received ceftaroline or comparator (IV or Oral).
    End point type
    Primary
    End point timeframe
    The Extent of Exposure was evaluated from the date of the first dose of specified study drug to the date of the last dose of specified 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: This was an exploratory study with an emphasis on safety and was not powered for comparative inferential analysis.
    End point values
    		 Ceftaroline - Safety Set Comparator - Safety Set
    Number of subjects analysed
    106
    53
    Units: Number of patients
        < 3 days
    2
    2
        3 - 5 days
    11
    8
        6 - 8 days
    26
    15
        9 - 15 days
    63
    28
        > 15 days
    4
    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, 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 (AEs) were evaluated from signing of the ICF through LFU visit (21 to 35 days after last dose of any study drug [IV or PO]). Cephalosporin class effects and additional AEs were closely monitored/followed until resolution or stabilization.
    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: This is an exploratory study with an emphasis on safety and is not powered for inferential statistical analysis.
    End point values
    		 Ceftaroline - Safety Set Comparator - Safety Set
    Number of subjects analysed
    106
    53
    Units: Number of patients
        Subjects with any TEAE
    51
    23
        Subjects with any drug-related TEAEs
    23
    12
        Subjects with any SAEs
    4
    1
        Subjects with any drug-related SAEs
    2
    0
        Discontinuations of any study drug due to AE
    4
    2
        Discontinuation of any IV study drug due to AE
    2
    1
        Deaths
    0
    0
    No statistical analyses for this end point

    Secondary: Clinical Response at Study Day 3 - MITT Set

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    End point title
    		 Clinical Response at Study Day 3 - MITT Set
    End point description
    Clinical Response at Day 3 is defined as ≥ 20% reduction from baseline in infection area (length × width).
    End point type
    Secondary
    End point timeframe
    Clinical Response at Study Day 3 was evaluated from Study Day 1 (the first day of IV study drug administration) to Study Day 3.
    End point values
    		 Ceftaroline - MITT Set Comparator - MITT Set
    Number of subjects analysed
    107
    52
    Units: Number of patients
        Responder
    91
    44
        Non-responder
    11
    4
        Incomplete data
    5
    4
    No statistical analyses for this end point

    Secondary: Clinical Response at Study Day 3 - MITT Set

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    End point title
    		 Clinical Response at Study Day 3 - MITT Set
    End point description
    Clinical response at Study Day 3 was measured by cessation of spread relative to baseline as measured by area.
    End point type
    Secondary
    End point timeframe
    Clinical Response at Study Day 3 was evaluated from Study Day 1 (the first day of IV study drug administration) to Study Day 3.
    End point values
    		 Ceftaroline - MITT Set Comparator - MITT Set
    Number of subjects analysed
    107
    52
    Units: Number of patients
        Responder
    98
    47
        Non-responder
    4
    1
        Incomplete data
    5
    4
    No statistical analyses for this end point

    Secondary: Clinical Response at Study Day 3 - MITT Set

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    End point title
    		 Clinical Response at Study Day 3 - MITT Set
    End point description
    Clinical Response was measured by cessation of spread relative to baseline as measured by length and width, separately, AND temperature < 37.6°C, on Study Day 3, irrespective of temperature collection method.
    End point type
    Secondary
    End point timeframe
    Clinical Response at Study Day 3 was evaluated from Study Day 1 (the first day of IV study drug administration) to Study Day 3.
    End point values
    		 Ceftaroline - MITT Set Comparator - MITT Set
    Number of subjects analysed
    107
    52
    Units: Number of patients
        Responder
    86
    39
        Non-responder
    16
    9
        Incomplete data
    5
    4
    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) was 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
    52
    Units: Number of patients
        Clinical cure
    101
    45
        Clinical failure
    0
    1
        Indeterminate
    6
    6
    No statistical analyses for this end point

    Secondary: Clinical Outcomes at TOC - Clinically Evaluable Set

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    End point title
    		 Clinical Outcomes 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 Clinically Evaluable population at Test-of-Cure.
    End point type
    Secondary
    End point timeframe
    Clinical Outcomes at Test-of-Cure (TOC) were evaluated 8 to 15 days after 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
    96
    45
    Units: Number of patients
        Clinical cure
    96
    44
        Clinical failure
    0
    1
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    21 to 35 days after last dose of any study drug [IV or PO]). If the LFU was conducted < 30 days after the last dose of study drug or was not conducted, AE/SAE information is obtained by telephone 30 days after the last dose of study drug.
    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
    4 / 106 (3.77%)
    1 / 53 (1.89%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Blood and lymphatic system disorders
    Lymphadenitis
         subjects affected / exposed
    0 / 106 (0.00%)
    1 / 53 (1.89%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Immune system disorders
    Hypersensitivity
         subjects affected / exposed
    1 / 106 (0.94%)
    0 / 53 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Clostridium difficile colitis
         subjects affected / exposed
    1 / 106 (0.94%)
    0 / 53 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Osteomyelitis
         subjects affected / exposed
    1 / 106 (0.94%)
    0 / 53 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia viral
         subjects affected / exposed
    1 / 106 (0.94%)
    0 / 53 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tonsillitis
         subjects affected / exposed
    0 / 106 (0.00%)
    1 / 53 (1.89%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         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
    23 / 106 (21.70%)
    19 / 53 (35.85%)
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    8 / 106 (7.55%)
    8 / 53 (15.09%)
         occurrences all number
    8
    8
    Vomiting
         subjects affected / exposed
    7 / 106 (6.60%)
    8 / 53 (15.09%)
         occurrences all number
    7
    8
    Skin and subcutaneous tissue disorders
    Rash
         subjects affected / exposed
    8 / 106 (7.55%)
    2 / 53 (3.77%)
         occurrences all number
    8
    2
    Pruritus
         subjects affected / exposed
    1 / 106 (0.94%)
    3 / 53 (5.66%)
         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
    23 Aug 2011
    The following changes were implemented with Amendment 1: removal of the requirement for ABSSSI specimens to be collected on all subjects; revision of the dosing regimen for study drug and PK sampling schedule. In addition, minor changes were made for clarity, consistency, and/or accuracy.
    17 Apr 2012
    The following changes were implemented with Amendment 2: addition of linezolid as a second option for PO study drug therapy; addition of the option for subjects who start the study on intravenous (IV) vancomycin and for whom no MRSA is identified to switch to IV cefazolin; addition of a clinical laboratory assessment time point and test to further evaluate safety; updates dosing regimen for cohorts and other clarifications. In addition, minor changes were made for clarity, consistency, and/or accuracy.
    20 Sep 2012
    The following changes were implemented with Amendment 3: addition of dosing information for Cohort 4; removal of the requirement for 3 days of hospitalization for enrolment; change in outpatient parenteral antimicrobial therapy (OPAT) criteria for clarification and modification of the lesion area and margin calculations requirements. In addition, minor changes were made for clarity, consistency, and/or accuracy.

    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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