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    Clinical Trial Results:
    Pharmacokinetics of a Single-dose of Dalbavancin in Preterm Neonates to Infants Ages 3 Months with Suspected or Confirmed Bacterial Infection

    Summary
    EudraCT number
    		 2022-000415-32
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    03 Apr 2019

    Results information
    Results version number
    		 v1(current)
    This version publication date
    21 Jul 2022
    First version publication date
    21 Jul 2022
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    DAL-PK-02
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02688790
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Allergan
    Sponsor organisation address
    2525 Dupont Dr., Irvine, CA, United States, 92612
    Public contact
    Global Medical Services, AbbVie, 001 8006339110, abbvieclinicaltrials@abbvie.com
    Scientific contact
    Global Medical Services, AbbVie, 001 8006339110, abbvieclinicaltrials@abbvie.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?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    03 Apr 2019
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    03 Apr 2019
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The objectives of this study were: • To evaluate the pharmacokinetic (PK) profile of a single intravenous (IV) infusion dose of dalbavancin. • To evaluate the safety and tolerability of a single dalbavancin IV infusion.
    Protection of trial subjects
    This study was conducted in conformance with the International Conference on Harmonisation (ICH) E6 guideline for good clinical practice (GCP) and the principles of the Declaration of Helsinki, or the laws and regulations of the country in which the research was conducted, whichever afforded the greater protection to the individual. At the first study visit, the study was discussed with each parent, legal guardian, or legally authorized representative (LAR), and written informed consent and privacy-related documentation were obtained in accordance with applicable regulations.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    04 Nov 2016
    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: 8
    Worldwide total number of subjects
    8
    EEA total number of subjects
    0
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    1
    Newborns (0-27 days)
    1
    Infants and toddlers (28 days-23 months)
    6
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 This study enrolled pediatric patients with known or suspected bacterial infection. No more than 20% of these evaluable patients were to have urinary tract infections due to Gram-positive organisms.

    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 1
    Arm description
    		 Infants older than 28 days and less than 3 months old received a single intravenous infusion of 22.5 mg/kg dalbavancin on Day 1.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Dalbavancin
    Investigational medicinal product code
    DUR001
    Other name
    Dalvance for Injection
    Pharmaceutical forms
    Powder for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Administered as a single dose in a 30 minute intravenous infusion on Day 1.

    Arm title
    		 Cohort 2
    Arm description
    		 Term neonates (gestational age ≥ 37 weeks) up to and including 28 days old received a single intravenous infusion of 22.5 mg/kg dalbavancin on Day 1.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Dalbavancin
    Investigational medicinal product code
    DUR001
    Other name
    Dalvance for Injection
    Pharmaceutical forms
    Powder for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Administered as a single dose in a 30 minute intravenous infusion on Day 1.

    Arm title
    		 Cohort 3
    Arm description
    		 Preterm neonates (gestational age ≥ 32 to < 37 weeks) up to and including 28 days old received a single intravenous infusion of 22.5 mg/kg dalbavancin on Day 1.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Dalbavancin
    Investigational medicinal product code
    DUR001
    Other name
    Dalvance for Injection
    Pharmaceutical forms
    Powder for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Administered as a single dose in a 30 minute intravenous infusion on Day 1.

    Number of subjects in period 1
    		Cohort 1 Cohort 2 Cohort 3
    Started
    6
    1
    1
    Completed
    6
    1
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Cohort 1
    Reporting group description
    		 Infants older than 28 days and less than 3 months old received a single intravenous infusion of 22.5 mg/kg dalbavancin on Day 1.

    Reporting group title
    Cohort 2
    Reporting group description
    		 Term neonates (gestational age ≥ 37 weeks) up to and including 28 days old received a single intravenous infusion of 22.5 mg/kg dalbavancin on Day 1.

    Reporting group title
    Cohort 3
    Reporting group description
    		 Preterm neonates (gestational age ≥ 32 to < 37 weeks) up to and including 28 days old received a single intravenous infusion of 22.5 mg/kg dalbavancin on Day 1.

    Reporting group values
    		 Cohort 1 Cohort 2 Cohort 3 Total
    Number of subjects
    		 6 1 1 8
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 1 1
        Newborns (0-27 days)
    		 0 1 0 1
        Infants and toddlers (28 days-23 months)
    		 6 0 0 6
        Children (2-11 years)
    		 0 0 0 0
        Adolescents (12-17 years)
    		 0 0 0 0
        Adults (18-64 years)
    		 0 0 0 0
        From 65-84 years
    		 0 0 0 0
        85 years and over
    		 0 0 0 0
    Age continuous
    "99999" indicates not applicable
    Units: days
        arithmetic mean (standard deviation)
    		 49.3 ± 15.02 6.0 ± 99999 23.0 ± 99999 -
    Gender categorical
    Units: Subjects
        Female
    		 4 1 1 6
        Male
    		 2 0 0 2
    Race
    Units: Subjects
        White
    		 5 1 1 7
        Multiple
    		 1 0 0 1

    End points

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    End points reporting groups
    Reporting group title
    Cohort 1
    Reporting group description
    		 Infants older than 28 days and less than 3 months old received a single intravenous infusion of 22.5 mg/kg dalbavancin on Day 1.

    Reporting group title
    Cohort 2
    Reporting group description
    		 Term neonates (gestational age ≥ 37 weeks) up to and including 28 days old received a single intravenous infusion of 22.5 mg/kg dalbavancin on Day 1.

    Reporting group title
    Cohort 3
    Reporting group description
    		 Preterm neonates (gestational age ≥ 32 to < 37 weeks) up to and including 28 days old received a single intravenous infusion of 22.5 mg/kg dalbavancin on Day 1.

    Primary: Dalbavancin Plasma Concentrations Following Single Dose Administration

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    End point title
    		 Dalbavancin Plasma Concentrations Following Single Dose Administration [1]
    End point description
    End point type
    Primary
    End point timeframe
    Day 1 at the end of infusion (0-5 minutes) and between 2-6, 10-14, 20-28, 96-192, and 552-744 hours after start of infusion
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Statistical analyses were not conducted in this exploratory study.
    End point values
    		 Cohort 1 Cohort 2 Cohort 3
    Number of subjects analysed
    6
    1
    1
    Units: µg/mL
    median (full range (min-max))
        0-5 minutes post dose
    197.42 (133.82 to 236.60)
    250.85 (250.85 to 250.85)
    198.66 (198.66 to 198.66)
        2-6 hours post dose
    106.10 (86.87 to 128.60)
    120.39 (120.39 to 120.39)
    130.94 (130.94 to 130.94)
        10-14 hours post dose
    75.09 (61.76 to 103.74)
    88.38 (88.38 to 88.38)
    100.19 (100.19 to 100.19)
        20-28 hours post dose
    63.89 (50.75 to 100.15)
    84.45 (84.45 to 84.45)
    76.87 (76.87 to 76.87)
        96-192 hours post dose
    19.76 (10.98 to 29.33)
    17.50 (17.50 to 17.50)
    20.59 (20.59 to 20.59)
        552-744 hours post dose
    1.00 (0.00 to 1.94)
    2.05 (2.05 to 2.05)
    1.29 (1.29 to 1.29)
    No statistical analyses for this end point

    Primary: Number of Participants with Treatment-emergent Adverse Events

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    End point title
    		 Number of Participants with Treatment-emergent Adverse Events [2]
    End point description
    An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. A serious AE is any untoward medical occurrence that at any dose - Resulted in death; - Was life threatening; - Required inpatient hospitalization or prolongation of existing hospitalization; - Resulted in persistent or significant disability/incapacity; - Was a congenital anomaly or birth defect.
    End point type
    Primary
    End point timeframe
    Up to 35 days
    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: Statistical analyses were not conducted in this exploratory study.
    End point values
    		 Cohort 1 Cohort 2 Cohort 3
    Number of subjects analysed
    6
    1
    1
    Units: participants
        Treatment-emergent adverse events (TEAE)
    6
    0
    0
        Treatment-emergent serious adverse events (TESAE)
    1
    0
    0
        TEAE Leading to Treatment Discontinuation
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Time to Maximum Plasma Concentration (Tmax) of Dalbavancin

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    End point title
    		 Time to Maximum Plasma Concentration (Tmax) of Dalbavancin
    End point description
    End point type
    Secondary
    End point timeframe
    Day 1 at the end of infusion (EOI) and between 2-6, 10-14, 20-28, 96-192, and 552-744 hours after start of infusion
    End point values
    		 Cohort 1 Cohort 2 Cohort 3
    Number of subjects analysed
    6
    1
    1
    Units: hours
        median (full range (min-max))
    0.60 (0.57 to 0.67)
    0.58 (0.58 to 0.58)
    0.57 (0.57 to 0.57)
    No statistical analyses for this end point

    Secondary: Maximum Plasma Concentration (Cmax) of Dalbavancin

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    End point title
    		 Maximum Plasma Concentration (Cmax) of Dalbavancin
    End point description
    "99999" indicates values that could not be calculated due to a sample size of 1.
    End point type
    Secondary
    End point timeframe
    Day 1 at the end of infusion and between 2-6, 10-14, 20-28, 96-192, and 552-744 hours after start of infusion
    End point values
    		 Cohort 1 Cohort 2 Cohort 3
    Number of subjects analysed
    6
    1
    1
    Units: µg/mL
        arithmetic mean (standard deviation)
    191.58 ± 39.96
    250.85 ± 99999
    198.66 ± 99999
    No statistical analyses for this end point

    Secondary: Area Under the Plasma Concentration Versus Time Curve from Time 0 to t (AUC0-t) for Dalbavancin

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    End point title
    		 Area Under the Plasma Concentration Versus Time Curve from Time 0 to t (AUC0-t) for Dalbavancin
    End point description
    "99999" indicates values that could not be calculated due to a sample size of 1.
    End point type
    Secondary
    End point timeframe
    Day 1 at the end of infusion and between 2-6, 10-14, 20-28, 96-192, and 552-744 hours after start of infusion
    End point values
    		 Cohort 1 Cohort 2 Cohort 3
    Number of subjects analysed
    6
    1
    1
    Units: h*µg/mL
        arithmetic mean (standard deviation)
    9412.32 ± 2941.69
    13016.77 ± 99999
    10329.65 ± 99999
    No statistical analyses for this end point

    Secondary: Area Under the Plasma Concentration Versus Time Curve from Time 0 to Infinity (AUC0-inf) for Dalbavancin

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    End point title
    		 Area Under the Plasma Concentration Versus Time Curve from Time 0 to Infinity (AUC0-inf) for Dalbavancin
    End point description
    "99999" indicates values that could not be calculated due to a sample size of 1.
    End point type
    Secondary
    End point timeframe
    Day 1 at the end of infusion and between 2-6, 10-14, 20-28, 96-192, and 552-744 hours after start of infusion
    End point values
    		 Cohort 1 Cohort 2 Cohort 3
    Number of subjects analysed
    5
    1
    1
    Units: h*µg/mL
        arithmetic mean (standard deviation)
    10353.37 ± 2582.47
    13380.93 ± 99999
    10536.28 ± 99999
    No statistical analyses for this end point

    Secondary: Area Under the Plasma Concentration-time Curve from Time Zero to 120 Hours (AUC0-120) for Dalbavancin

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    End point title
    		 Area Under the Plasma Concentration-time Curve from Time Zero to 120 Hours (AUC0-120) for Dalbavancin
    End point description
    "99999" indicates values that could not be calculated due to a sample size of 1.
    End point type
    Secondary
    End point timeframe
    Day 1 at the end of infusion and between 2-6, 10-14, 20-28, 96-192, and 552-744 hours after start of infusion
    End point values
    		 Cohort 1 Cohort 2 Cohort 3
    Number of subjects analysed
    6
    1
    1
    Units: h*µg/mL
        arithmetic mean (standard deviation)
    6247.891 ± 1493.993
    7758.40 ± 99999
    6512.44 ± 99999
    No statistical analyses for this end point

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

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    End point title
    		 Terminal Elimination Half-life (T1/2) for Dalbavancin
    End point description
    "99999" indicates values that could not be calculated due to a sample size of 1.
    End point type
    Secondary
    End point timeframe
    Day 1 at the end of infusion and between 2-6, 10-14, 20-28, 96-192, and 552-744 hours after start of infusion
    End point values
    		 Cohort 1 Cohort 2 Cohort 3
    Number of subjects analysed
    5
    1
    1
    Units: hours
        arithmetic mean (standard deviation)
    103.26 ± 9.14
    122.89 ± 99999
    111.20 ± 99999
    No statistical analyses for this end point

    Secondary: Apparent Total Body Clearance of Dalbavancin from Plasma (CL)

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    End point title
    		 Apparent Total Body Clearance of Dalbavancin from Plasma (CL)
    End point description
    "99999" indicates values that could not be calculated due to a sample size of 1.
    End point type
    Secondary
    End point timeframe
    Day 1 at the end of infusion and between 2-6, 10-14, 20-28, 96-192, and 552-744 hours after start of infusion
    End point values
    		 Cohort 1 Cohort 2 Cohort 3
    Number of subjects analysed
    5
    1
    1
    Units: mL/h
        arithmetic mean (standard deviation)
    7.74 ± 1.85
    5.04 ± 99999
    5.77 ± 99999
    No statistical analyses for this end point

    Secondary: Volume of Distribution of Dalbavancin at Steady-state (Vss)

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    End point title
    		 Volume of Distribution of Dalbavancin at Steady-state (Vss)
    End point description
    "99999" indicates values that could not be calculated due to a sample size of 1.
    End point type
    Secondary
    End point timeframe
    Day 1 at the end of infusion and between 2-6, 10-14, 20-28, 96-192, and 552-744 hours after start of infusion
    End point values
    		 Cohort 1 Cohort 2 Cohort 3
    Number of subjects analysed
    5
    1
    1
    Units: mL
        arithmetic mean (standard deviation)
    1031.29 ± 156.83
    819.34 ± 99999
    831.52 ± 99999
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Up to 35 days
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    22.1
    Reporting groups
    Reporting group title
    Cohort 1
    Reporting group description
    		 Infants older than 28 days and less than 3 months old received a single intravenous infusion of 22.5 mg/kg dalbavancin on Day 1.

    Reporting group title
    Cohort 2
    Reporting group description
    		 Term neonates (gestational age ≥ 37 weeks) up to and including 28 days old received a single intravenous infusion of 22.5 mg/kg dalbavancin on Day 1.

    Reporting group title
    Cohort 3
    Reporting group description
    		 Preterm neonates (gestational age ≥ 32 to < 37 weeks) up to and including 28 days old received a single intravenous infusion of 22.5 mg/kg dalbavancin on Day 1.

    Serious adverse events
    		 Cohort 1 Cohort 2 Cohort 3
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Nervous system disorders
    Hydrocephalus
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 1 (0.00%)
    0 / 1 (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
    Gastrointestinal disorders
    Necrotising colitis
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 1 (0.00%)
    0 / 1 (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
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Cohort 1 Cohort 2 Cohort 3
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    6 / 6 (100.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    Investigations
    Blood alkaline phosphatase increased
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    0
    Fungal test positive
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    0
    Liver function test increased
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    0
    Injury, poisoning and procedural complications
    Procedural pain
         subjects affected / exposed
    2 / 6 (33.33%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    2
    0
    0
    Vascular disorders
    Brachiocephalic vein thrombosis
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    0
    Cardiac disorders
    Atrial thrombosis
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    0
    Bradycardia
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    0
    Left ventricular dysfunction
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    0
    Tachycardia
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    0
    Nervous system disorders
    Paroxysmal sympathetic hyperactivity
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    0
    Seizure
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    0
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    3 / 6 (50.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    3
    0
    0
    Hypothermia
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    0
    Withdrawal syndrome
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    0
    Constipation
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    0
    Flatulence
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    0
    Gastrooesophageal reflux disease
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    0
    Vomiting
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    0
    Respiratory, thoracic and mediastinal disorders
    Apnoea
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    0
    Pleural effusion
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    2
    0
    0
    Skin and subcutaneous tissue disorders
    Dermatitis diaper
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    0
    Rash
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    0
    Psychiatric disorders
    Irritability
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    0
    Infections and infestations
    Bacterial tracheitis
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    0
    Oral hairy leukoplakia
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    0
    Stoma site cellulitis
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    0
    Metabolism and nutrition disorders
    Feeding intolerance
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    0
    Hypovolaemia
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    30 Mar 2016
    (1) revise the amount of blood to be collected for safety laboratory assessments; (2) correct the PK blood sampling windows for samples collected on Day 7 (± 2 days) and Day 28 (± 4 days) in terms of time in hours; (3) specify that those participants who have had laboratory evaluations conducted as part of standard of care within 72 hours of Day 1 will not be required to have an additional blood sample collected at screening for eligibility; (4) clarify that audiology ABR testing will be optional; (5) update the information to be recorded for concomitant medications in the eCRF; (6) clarify the number of participants with urinary tract infection due to Gram-positive organisms that may be enrolled; (7) clarify laboratory data will not be transferred electronically; (8) clarify the timing of the IP infusion and flushing.
    09 Aug 2016
    (1) allowing PK blood collection from the peripheral IV line (PIV), central venous catheter (CVC) or peripherally inserted central catheter (PICC) line; and (2) to clarify how dalbavancin is administered.
    17 Apr 2018
    (1) update the sponsor information; (2) reduce the required number of participants from 24 to approximately 22; (3) allow Cohorts 2 and 3 to be enrolled in parallel after 4 participants are enrolled in Cohort 1; (4) remove the hospitalization requirement; (5) clarify that urine output, and not creatinine clearance, should be used at screening to assess renal function;(6) add the email address for SAE submission; (7) add criteria for Potential Hy’s law; and (8) confirm the dose of 22.5 mg/kg for Cohorts 2 and 3, based on interim population PK analysis results and safety review from 4 participants in Cohort 1.

    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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