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    Clinical Trial Results:
    A Phase I, Open-Label, Single-Dose Study To Investigate The Pharmacokinetics, Safety, And Tolerability Of Dalbavancin In Hospitalized Children Of Age 3 Months To 11 Years Receiving Standard Intravenous Anti-Infective Treatment For Bacterial Infections

    Summary
    EudraCT number
    2013-003227-11
    Trial protocol
    EE  
    Global end of trial date
    16 Apr 2015

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

    Trial information

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    Trial identification
    Sponsor protocol code
    DUR001-106
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT01946568
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Allergan Pharmaceutical International Ltd
    Sponsor organisation address
    Clonshaugh Business & Technology Park, Coolock, Dublin, Ireland, D17 E400
    Public contact
    Clinical Trials Registry Team, Allergan plc, 001 877‐277‐8566, IR-CTRegistration@Allergan.com
    Scientific contact
    Therapeutic Area Head, Allergan plc, 001 862-261-7000, IR-CTRegistration@Allergan.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    Yes
    EMA paediatric investigation plan number(s)
    EMEA-000016-PIP01-07
    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
    16 Apr 2015
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    16 Apr 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of this clinical trial was to characterize the pharmacokinetics of dalbavancin in pediatric participants of age 3 months to 11 years (inclusive) following the intravenous administration of a single dose of dalbavancin.
    Protection of trial subjects
    All study participants were required to read and sign an Informed Consent Form.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    13 Aug 2013
    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
    United States: 36
    Worldwide total number of subjects
    36
    EEA total number of subjects
    0
    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)
    12
    Children (2-11 years)
    24
    Adolescents (12-17 years)
    0
    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
    Participants were treated and results were evaluated in 3 age cohorts as follows: Cohort 1: Age 6 to 11 years, inclusive Cohort 2: Age 2 to <6 years Cohort 3: Age 3 months to <2 years. To have at least 10 participants in each cohort, approximately 12 participants per cohort were planned to be enrolled.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Cohort 3: 3 Months to <2 Years
    Arm description
    Participants of age 3 months to <2 years received dalbavancin at a dose of 10 mg/kg as a 30-minute intravenous (IV) infusion.
    Arm type
    Experimental

    Investigational medicinal product name
    Dalbavancin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Intravenous dalbavancin was administered at a dose of 10 mg/kg as a 30-minute IV infusion to participants to participants 3 months to <2 years of age.

    Arm title
    Cohort 2: 2 to 6 Years
    Arm description
    Participants of age 2 years to <6 years received dalbavancin at a dose of 15-25 mg/kg as a 30-minute IV infusion.
    Arm type
    Experimental

    Investigational medicinal product name
    Dalbavancin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    Intravenous dalbavancin was administered at a dose of 15-25 mg/kg as a 30-minute IV infusion to participants between 2 to 6 years of age.

    Arm title
    Cohort 1: 6 to 11 Years
    Arm description
    Participants of age 6 years to 11 years, inclusive received dalbavancin at a dose of 15 mg/kg as a 30-minute IV infusion.
    Arm type
    Experimental

    Investigational medicinal product name
    Dalbavancin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Intravenous dalbavancin was administered at a dose of 15 mg/kg as a 30-minute IV infusion (not to exceed 1000 mg) to participants between 6 to 11 years of age.

    Number of subjects in period 1
    Cohort 3: 3 Months to <2 Years Cohort 2: 2 to 6 Years Cohort 1: 6 to 11 Years
    Started
    12
    13
    11
    Completed
    10
    12
    10
    Not completed
    2
    1
    1
         Not Treated
    1
    1
    -
         Lost to follow-up
    1
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Cohort 3: 3 Months to <2 Years
    Reporting group description
    Participants of age 3 months to <2 years received dalbavancin at a dose of 10 mg/kg as a 30-minute intravenous (IV) infusion.

    Reporting group title
    Cohort 2: 2 to 6 Years
    Reporting group description
    Participants of age 2 years to <6 years received dalbavancin at a dose of 15-25 mg/kg as a 30-minute IV infusion.

    Reporting group title
    Cohort 1: 6 to 11 Years
    Reporting group description
    Participants of age 6 years to 11 years, inclusive received dalbavancin at a dose of 15 mg/kg as a 30-minute IV infusion.

    Reporting group values
    Cohort 3: 3 Months to <2 Years Cohort 2: 2 to 6 Years Cohort 1: 6 to 11 Years Total
    Number of subjects
    12 13 11 36
    Age categorical
    Units: Subjects
        3 months to <2 Years
    12 0 0 12
        2 to <6 Years
    0 13 0 13
        6 to 11 Years
    0 0 11 11
    Age Continuous
    Here, for Cohort 3, the unit of measurement is 'months' and for cohorts 2 and 1, the unit is 'years'.
    Units: years
        arithmetic mean (standard deviation)
    10.71 ± 5.712 3.53 ± 1.158 9.35 ± 1.709 -
    Sex: Female, Male
    Units: Subjects
        Female
    2 5 2 9
        Male
    10 8 9 27

    End points

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    End points reporting groups
    Reporting group title
    Cohort 3: 3 Months to <2 Years
    Reporting group description
    Participants of age 3 months to <2 years received dalbavancin at a dose of 10 mg/kg as a 30-minute intravenous (IV) infusion.

    Reporting group title
    Cohort 2: 2 to 6 Years
    Reporting group description
    Participants of age 2 years to <6 years received dalbavancin at a dose of 15-25 mg/kg as a 30-minute IV infusion.

    Reporting group title
    Cohort 1: 6 to 11 Years
    Reporting group description
    Participants of age 6 years to 11 years, inclusive received dalbavancin at a dose of 15 mg/kg as a 30-minute IV infusion.

    Primary: Area Under The Plasma Concentration-Time Curve From Zero To Infinity (AUC0–Inf) of Dalbavancin

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    End point title
    Area Under The Plasma Concentration-Time Curve From Zero To Infinity (AUC0–Inf) of Dalbavancin [1]
    End point description
    Area under the concentration-time curve of the dalbavancin in plasma over the time interval from 0 extrapolated to infinity based on the population pharmacokinetic model. AUC0-inf was calculated as Dose (mg) divided by clearance (CL) in L/hr. AUC is expressed as microgram hours per milliliter (µg*hr/mL). The Pharmacokinetic analysis population comprised all treated participants who had at least 1 evaluable pharmacokinetic sample.
    End point type
    Primary
    End point timeframe
    Based on plasma concentrations at 0.5 hours, 4 hours, 12 hours, 24 hours, 144 hours and 648 hours post-dose
    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 dalbavancin in children and it is not powered for inferential statistical analysis.
    End point values
    Cohort 3: 3 Months to <2 Years Cohort 2: 2 to 6 Years Cohort 1: 6 to 11 Years
    Number of subjects analysed
    11
    11
    11
    Units: µg*hr/mL
        median (full range (min-max))
    7890 (6630 to 11000)
    22100 (8670 to 28800)
    18200 (11500 to 24000)
    No statistical analyses for this end point

    Primary: Maximum Observed Plasma Concentration (Cmax) of Dalbavancin

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    End point title
    Maximum Observed Plasma Concentration (Cmax) of Dalbavancin [2]
    End point description
    Maximum measured concentration of the dalbavancin in plasma based on the population pharmacokinetic model. Concentration is expressed as microgram per milliliter (µg/mL). The Pharmacokinetic analysis population comprised all treated participants who had at least 1 evaluable pharmacokinetic sample.
    End point type
    Primary
    End point timeframe
    Based on plasma concentrations at 0.5 hours, 4 hours, 12 hours, 24 hours,144 hours and 648 hours post-dose
    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 dalbavancin in children and it is not powered for inferential statistical analysis.
    End point values
    Cohort 3: 3 Months to <2 Years Cohort 2: 2 to 6 Years Cohort 1: 6 to 11 Years
    Number of subjects analysed
    11
    11
    11
    Units: µg/mL
        median (full range (min-max))
    141 (114 to 192)
    328 (221 to 443)
    247 (183 to 289)
    No statistical analyses for this end point

    Primary: Area Under the Plasma Concentration-Time Curve From Time 0 to 120 Hours Post-dose (AUC0-120) for Dalbavancin

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    End point title
    Area Under the Plasma Concentration-Time Curve From Time 0 to 120 Hours Post-dose (AUC0-120) for Dalbavancin [3]
    End point description
    Area under the concentration-time curve of the dalbavancin in plasma over the time interval from 0 up to 120 hours based on the population pharmacokinetic model. AUC is expressed as microgram hours per milliliter (µg*hr/mL). The Pharmacokinetic analysis population comprised all treated participants who had at least 1 evaluable pharmacokinetic sample.
    End point type
    Primary
    End point timeframe
    Based on plasma concentrations at 0.5 hours, 4 hours, 12 hours, 24 hours,144 hours and 648 hours post-dose
    Notes
    [3] - 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 dalbavancin in children and it is not powered for inferential statistical analysis.
    End point values
    Cohort 3: 3 Months to <2 Years Cohort 2: 2 to 6 Years Cohort 1: 6 to 11 Years
    Number of subjects analysed
    11
    11
    11
    Units: µg*hr/mL
        median (full range (min-max))
    5120 (4090 to 6460)
    12400 (7060 to 16300)
    9000 (6660 to 12100)
    No statistical analyses for this end point

    Primary: Area Under the Plasma Concentration-Time Curve From Time 0 to 648 Hours Post-dose (AUC0-648) for Dalbavancin

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    End point title
    Area Under the Plasma Concentration-Time Curve From Time 0 to 648 Hours Post-dose (AUC0-648) for Dalbavancin [4]
    End point description
    Area under the concentration-time curve of the dalbavancin in plasma from 0 to last measurable concentration. AUC is expressed as microgram hours per milliliter (µg*hr/mL). The Pharmacokinetic analysis population comprised all treated participants who had at least 1 evaluable pharmacokinetic sample.
    End point type
    Primary
    End point timeframe
    Based on plasma concentrations at 0.5 hours, 4 hours, 12 hours, 24 hours,144 hours and 648 hours post-dose
    Notes
    [4] - 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 dalbavancin in children and it is not powered for inferential statistical analysis.
    End point values
    Cohort 3: 3 Months to <2 Years Cohort 2: 2 to 6 Years Cohort 1: 6 to 11 Years
    Number of subjects analysed
    11
    11
    11
    Units: µg*hr/mL
        median (full range (min-max))
    7500 (6330 to 10200)
    20500 (8520 to 26500)
    16300 (10800 to 21400)
    No statistical analyses for this end point

    Primary: Time to Maximum Observed Plasma Concentration

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    End point title
    Time to Maximum Observed Plasma Concentration [5]
    End point description
    Time to Maximum Serum Concentration (Tmax) of dalbavancin based on the population pharmaokinetic model. The Pharmacokinetic analysis population comprised all treated participants who had at least 1 evaluable pharmacokinetic sample.
    End point type
    Primary
    End point timeframe
    Based on plasma concentrations at 0.5 hours, 4 hours, 12 hours, 24 hours,144 hours and 648 hours post-dose
    Notes
    [5] - 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 dalbavancin in children and it is not powered for inferential statistical analysis.
    End point values
    Cohort 3: 3 Months to <2 Years Cohort 2: 2 to 6 Years Cohort 1: 6 to 11 Years
    Number of subjects analysed
    11
    11
    11
    Units: hours
        median (full range (min-max))
    0.5 (0.5 to 0.5)
    0.5 (0.5 to 0.5)
    0.5 (0.5 to 0.5)
    No statistical analyses for this end point

    Primary: Terminal Phase Elimination Half-life (T1/2) for Dalbavancin

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    End point title
    Terminal Phase Elimination Half-life (T1/2) for Dalbavancin [6]
    End point description
    T1/2 of dalbavancin was derived based on population pharmacokinetic model-derived individual post hoc pharmacokinetic parameters. The Pharmacokinetic analysis population comprised all treated participants who had at least 1 evaluable pharmacokinetic sample.
    End point type
    Primary
    End point timeframe
    Based on plasma concentrations at 0.5 hours, 4 hours, 12 hours, 24 hours,144 hours and 648 hours post-dose
    Notes
    [6] - 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 dalbavancin in children and it is not powered for inferential statistical analysis.
    End point values
    Cohort 3: 3 Months to <2 Years Cohort 2: 2 to 6 Years Cohort 1: 6 to 11 Years
    Number of subjects analysed
    11
    11
    11
    Units: hours
        median (full range (min-max))
    279 (244 to 298)
    315 (271 to 332)
    390 (317 to 490)
    No statistical analyses for this end point

    Secondary: Number of Participants with Treatment-emergent Adverse Events

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    End point title
    Number of Participants with Treatment-emergent Adverse Events
    End point description
    An adverse event (AE) was any untoward medical occurrence in a clinical investigation participant administered a product; the event need not necessarily have a causal relationship with the treatment or usage. An AE is considered treatment emergent if the AE starts during or after study drug administration through the last follow-up visit (Day 28). The safety population consists of participants enrolled in the study who have received any amount of the study drug.
    End point type
    Secondary
    End point timeframe
    Up to 28 days
    End point values
    Cohort 3: 3 Months to <2 Years Cohort 2: 2 to 6 Years Cohort 1: 6 to 11 Years
    Number of subjects analysed
    11
    12
    11
    Units: participants
    4
    9
    6
    No statistical analyses for this end point

    Secondary: Percentage of Participants With Abnormal Hematology and Chemistry Laboratory Values

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    End point title
    Percentage of Participants With Abnormal Hematology and Chemistry Laboratory Values
    End point description
    The percentage of participants with abnormal hematology and chemistry laboratory values that occurred in more than 1 participant are reported. Here, Laboratory abnormalities were assessed using local laboratory criteria in which ULN indicates Upper Limit of Normal and LLN is Lower Limit of Normal. The safety population consists of participants enrolled in the study who have received any amount of the study drug and were evaluable for laboratory abnormality.
    End point type
    Secondary
    End point timeframe
    Up to Day 7
    End point values
    Cohort 3: 3 Months to <2 Years Cohort 2: 2 to 6 Years Cohort 1: 6 to 11 Years
    Number of subjects analysed
    10
    12
    11
    Units: percentage of participants
    number (not applicable)
        Basophils (>1.2 x ULN)
    0
    0
    45.5
        Eosinophil (>1.2 x ULN)
    30
    0
    9.1
        Leukocytes (<0.6 x LLN)
    0
    16.7
    0
        Lymphocytes (<0.6 x LLN)
    0
    16.7
    0
        Monocytes (>1.2 x ULN)
    50
    8.3
    9.1
        Neutrophils (<0.6 x LLN)
    0
    16.7
    0
        Carbon dioxide (<0.9 x LLN)
    20.0
    25.0
    9.1
        Carbon dioxide (>1.1 x ULN)
    0
    0
    27.3
        Potassium (<0.9 x LLN)
    0
    25.0
    0
    No statistical analyses for this end point

    Secondary: Percentage of Participants with Change in Vital Signs

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    End point title
    Percentage of Participants with Change in Vital Signs
    End point description
    Vital signs included supine blood pressure and pulse rate. Categorical summaries of vital signs data were reported as absolute vital signs, increases in vital signs, and decreases in vital signs. For 3 months to <2 years of age group, criteria for supine systolic BP was <80 mmHg, supine diastolic BP was <55, supine pulse rate was <80 to >120 mmHg. For 2 to <6 years of age group, criteria for supine systolic BP was <95 mmHg, supine diastolic BP was <60, supine pulse rate was <65 to >110 mmHg. For 6 to 11 years of age group, criteria for supine systolic BP was <100 mmHg, supine diastolic BP was <60, supine pulse rate was <60 to >95 mmHg. The criteria for reporting increase and decrease in supine systolic BP was >=30 and supine diastolic BP was >=20 mmHg for all age groups. The safety population consists of participants enrolled in the study who have received any amount of the study drug.
    End point type
    Secondary
    End point timeframe
    Up to 28 days
    End point values
    Cohort 3: 3 Months to <2 Years Cohort 2: 2 to 6 Years Cohort 1: 6 to 11 Years
    Number of subjects analysed
    11
    12
    11
    Units: percentage of participants
    number (not applicable)
        Absolute Supine Systolic BP
    9.1
    41.7
    45.5
        Absolute Supine Diastolic BP
    63.6
    83.3
    81.8
        Absolute Supine Pulse Rate <80
    0
    0
    0
        Absolute Supine Pulse Rate >120
    100.0
    91.7
    72.7
        Increase in Supine Systolic BP
    9.1
    0
    9.1
        Increase in Supine Diastolic BP
    27.3
    33.3
    9.1
        Decrease in Supine Systolic BP
    9.1
    8.3
    18.2
        Decrease in Supine Diastolic BP
    36.4
    0
    45.5
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Up to 28 days
    Adverse event reporting additional description
    The safety population consists of participants enrolled in the study who have received any amount of the study drug.
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    17.1
    Reporting groups
    Reporting group title
    Cohort 3: 3 Months to <2 Years
    Reporting group description
    Participants of age 3 months to <2 years received dalbavancin at a dose of 10 mg/kg as a 30-minute intravenous (IV) infusion.

    Reporting group title
    Cohort 1: 6 to 11 Years
    Reporting group description
    Participants of age 6 years to 11 years, inclusive received dalbavancin at a dose of 15 mg/kg as a 30-minute IV infusion.

    Reporting group title
    Cohort 2: 2 to 6 Years
    Reporting group description
    Participants of age 2 years to <6 years received dalbavancin at a dose of 15-25 mg/kg as a 30-minute IV infusion.

    Serious adverse events
    Cohort 3: 3 Months to <2 Years Cohort 1: 6 to 11 Years Cohort 2: 2 to 6 Years
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 11 (9.09%)
    2 / 11 (18.18%)
    2 / 12 (16.67%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Gastrointestinal disorders
    Abdominal pain
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 11 (9.09%)
    0 / 12 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Acute respiratory failure
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Arthralgia
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 11 (9.09%)
    0 / 12 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Device-related sepsis
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 11 (0.00%)
    1 / 12 (8.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Abdominal abscess
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 11 (0.00%)
    1 / 12 (8.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    Cohort 3: 3 Months to <2 Years Cohort 1: 6 to 11 Years Cohort 2: 2 to 6 Years
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    3 / 11 (27.27%)
    5 / 11 (45.45%)
    9 / 12 (75.00%)
    Investigations
    Acoustic stimulation tests abnormal
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 11 (9.09%)
    1 / 12 (8.33%)
         occurrences all number
    0
    1
    1
    Audiogram abnormal
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 11 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    1
    0
    1
    Blood pressure increased
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 11 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    0
    1
    Gastrointestinal stoma output increased
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 11 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    0
    1
    Heart rate increased
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 11 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    0
    1
    Injury, poisoning and procedural complications
    Laceration
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 11 (9.09%)
    0 / 12 (0.00%)
         occurrences all number
    0
    1
    0
    Procedural pain
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 11 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    0
    1
    Nervous system disorders
    Headache
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 11 (9.09%)
    0 / 12 (0.00%)
         occurrences all number
    0
    1
    0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 11 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    0
    1
    Leukocytosis
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 11 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    0
    1
    Leukopenia
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 11 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    0
    1
    Thrombocytopenia
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 11 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    0
    1
    General disorders and administration site conditions
    Infusion site discomfort
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 11 (9.09%)
    0 / 12 (0.00%)
         occurrences all number
    0
    1
    0
    Immune system disorders
    Hypersensitivity
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 11 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    0
    1
    Gastrointestinal disorders
    Chapped lips
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 11 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    0
    1
    Nausea
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 11 (9.09%)
    0 / 12 (0.00%)
         occurrences all number
    0
    1
    0
    Oral pain
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 11 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    0
    1
    Vomiting
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 11 (9.09%)
    0 / 12 (0.00%)
         occurrences all number
    0
    1
    0
    Respiratory, thoracic and mediastinal disorders
    Cough
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 11 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    0
    1
    Acute respiratory failure
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 11 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    0
    1
    Skin and subcutaneous tissue disorders
    Dermatitis diaper
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 11 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    1
    0
    1
    Pruritus
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 11 (0.00%)
    2 / 12 (16.67%)
         occurrences all number
    0
    0
    2
    Dermatitis
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 11 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    0
    1
    Scab
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    0
    Rash
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 11 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    0
    1
    Urticaria
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 11 (9.09%)
    0 / 12 (0.00%)
         occurrences all number
    0
    1
    0
    Metabolism and nutrition disorders
    Hypoalbuminaemia
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 11 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    0
    1

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    07 Nov 2013
    1. 5 participants were enrolled under version 1 of protocol dated 11-April-2013. 2. No participants were enrolled under version 2.1 dated 07-November-2013. 3. Study Design was changed from all participants to be enrolled in parallel to participants in cohort 1 and 2 to be enrolled in parallel, and participants in cohort 3 to be enrolled after safety data from the other 2 cohorts had been reviewed and shared with the FDA to reflect communications from FDA requesting that enrollment in cohort 3 begin after safety data from the older cohorts were reviewed and shared with FDA. 4. Other assessments and analyses stated that interim analysis of PK and safety would be performed in approximately the first 6 evaluable participants. 5. The wording of criterion#1 was clarified in inclusion criteria which reflects that participants with urinary tract infection could be enrolled. 6. Inclusion Criterion#5 was changed to remove “normal” from the audiologic assessment and to change the time within which the audiologic assessment had to be performed from with 3 days before study drug administration to within 7 days before in order to clarify that participant may be enrolled during the 7 days before the first dose of study drug, regardless of the results of audiology assessments. This change reflects the lack of association between dalbavancin treatment and ototoxicity, but audiology assessments would continue to be performed due to previous regulatory commitment. 7. “Half-lives”, treatment with an investigational drug within 30 days or 5 half-lives, whichever was longer, were removed from exclusion criterion#1 to make it more clinically relevant.
    07 Nov 2013
    8. Exclusion Criteria#2, History of fluctuant hearing; persistent tinnitus; balance disorder; otologic surgery or disease; tumor of the head, neck, or auditory system; head injury; Meniere’s disease; autoimmune inner ear disease; perilymphatic fistula; CNS disorder resulting in hearing deficits; or significant noise exposure was removed because audiology assessments would provide necessary data regarding baseline and follow-up hearing for each participant. 9. Exclusion Criteria#3 significant exposure (greater than one week duration of therapy) to aminoglycoside antibiotics or chemotherapy currently or within a week prior to enrollment into the study or current use of loop diuretics was removed because there is no known drug interaction between dalbavancin and the drugs listed. Additionally, audiology assessments would provide necessary data regarding baseline and follow-up hearing for each participant. 10. Exclusion Criteria#4 was modified to clarify that participants currently receiving IV vancomycin should be excluded. The safety of dalbavancin co-administered with other glycopeptides has not been established. However, given the short half-life of vancomycin, and the likely subtherapeutic concentration of vancomycin in children, prior use of intravenous vancomycin should not prohibit the administration of dalbavancin, as long as dalbavancin is administered at least 8 hours after the last dose of vancomycin. 11. Exclusion Criteria#6, “or physical exam evidence of malnutrition” was removed to make it more clinically relevant. 12. New text, “Patients enrolled with an abnormal baseline audiology exam may be replaced if needed” was added to Overall Study Design and Plan to ensure enough evaluable participants were available for analysis.
    07 Nov 2013
    13. Table 1 was removed from Treatment Administration and “Reconstituted dalbavancin must be further diluted by addition of 5% Dextrose for Injection, USP and mixed gently (see the Pharmacy Manual)” was added. 14. In Packing and Labeling “by addition to a 250 ml infusion bag of 5% Dextrose Injection, USP” was deleted. 15. In Pharmacokinetic Sampling, proper collection of PK samples was clarified and allowed for collection of extra PK sample if needed. 16. 19 participants were enrolled under version 2.2, also dated 07-November-2013. This amendment was due to a corporate name change, from Durata Therapeutics, Inc. to Durata Therapeutics International B.V.
    12 Sep 2014
    1. 12 participants were enrolled under version 3.0. 2. Study Design was changed to add ± 2 minutes to the 30-minute dalbavancin infusion in order to maintain consistency with Pharmacy Manual. 3. Dalbavancin dose was adjusted to 10 mg/kg for participants in Cohort 3 in the study design as based on interim PK analysis, it was inferred that dose of 10 mg/kg in participants 3 months to < 2 years of age expected to provide dalbavancin exposure similar to that previously observed in clinical studies with adults. 4. Results of interim PK analysis were added in study design to support revision to dalbavancin dosing for remaining participants. 5. An exclusion criterion was added for participants diagnosed with cystic fibrosis as PK and audiology rest results more variable in cystic fibrosis participants than in other children. 6. Approximate duration of study was changed from 1.0 years, ending in June 2014, to 2.0 years, ending in October 2015 to reflect recruitment. 7. Storage time was changed for both reconstituted and diluted dalbavancin from 24 hours to 48 hours in Storage and Accountability section to maintain consistency with approved product information for dalbavancin. 8. The language was simplified regarding audiologic testing. 9. Window of ±5 minutes was added to PK sampling within 30 minutes of dalbavancin IV infusion to maintain consistency with windows for other PK sample collections.

    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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