Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43861   clinical trials with a EudraCT protocol, of which   7284   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Download PDF

    Clinical Trial Results:
    An Evaluation of the Pharmacokinetic Profile and Safety of a Single Dose of Daptomycin in Pediatric Subjects Aged Two to Six Years Who are Concurrently Receiving Standard Antibiotic Therapy for Proven or Suspected Gram-positive Infection

    Summary
    EudraCT number
    		 2015-002781-23
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    20 Nov 2008

    Results information
    Results version number
    		 v1(current)
    This version publication date
    05 Apr 2016
    First version publication date
    02 Aug 2015
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    DAP-PEDS-07-02
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00679835
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Cubist Pharmaceuticals
    Sponsor organisation address
    65 Hayden Avenue, Lexington, United States, 02421
    Public contact
    Medical Director, Cubist Pharmaceuticals, +1 781-860-8660 ,
    Scientific contact
    Medical Director, Cubist Pharmaceuticals, +1 781-860-8660 ,
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    26 May 2009
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    20 Nov 2008
    Global end of trial reached?
    Yes
    Global end of trial date
    20 Nov 2008
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of this study was to evaluate single-dose pharmacokinetic (PK) data on intravenous (i.v.) daptomycin administered at 8 milligrams per kilogram (mg/kg) as a 1 hour infusion or 10 mg/kg as either a 1 or 2 hour infusion in pediatric subjects aged 2 to 6 years, inclusive, with proven or suspected Gram-positive infection who were receiving standard antibiotic therapy.
    Protection of trial subjects
    This open-label study did not employ any blinding methods. Screening assessments included demographics and medical history, physical examination, vital signs, brief neurologic examination, electrocardiogram, and clinical laboratory tests (chemistry, hematology, urinalysis, serum creatinine, and serum creatine phosphokinase). Study subjects were monitored for adverse events. After the first 6 subjects enrolled in Group 1 had completed laboratory testing and the follow-up visit, the Investigators and the Sponsor’s medical and PK representatives reviewed pertinent PK and safety data and decided whether or not to continue enrollment to 12 subjects.
    Background therapy
    		 -
    Evidence for comparator
    		 This was a non-comparative study.
    Actual start date of recruitment
    03 Jun 2008
    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: 12
    Worldwide total number of subjects
    12
    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)
    0
    Children (2-11 years)
    12
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Written parental (or appropriate legal representative) informed consent and written subject assent (as appropriate) was obtained, and subjects met all of the inclusion and none of the exclusion criteria prior to enrollment in this study. Eligible subjects received open-label study drug treatment.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Daptomycin 8 mg/kg
    Arm description
    		 Subjects received a single dose of daptomycin over a duration of 1 hour.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Daptomycin
    Investigational medicinal product code
    Other name
    Cubicin®
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    All subjects received a single-dose of daptomycin 8 mg/kg dissolved in 0.9% sodium chloride for injection. Daptomycin was administered i.v. over 1 hour via a syringe pump. The dosing volume was 25 millitres (mL) and the infusion rate was 0.42 mL per minute for the 1-hour infusion.

    Arm title
    		 Daptomycin 10 mg/kg
    Arm description
    		 Subjects received a single dose of daptomycin over a duration of 1 hour.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Daptomycin
    Investigational medicinal product code
    Other name
    Cubicin®
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    All subjects received a single-dose of daptomycin 10 mg/kg dissolved in 0.9% sodium chloride for injection. Daptomycin was administered i.v. over 1 hour via a syringe pump. The dosing volume was 25 mL and the infusion rate was 0.42 mL per minute for the 1-hour infusion.

    Number of subjects in period 1
    		Daptomycin 8 mg/kg Daptomycin 10 mg/kg
    Started
    6
    6
    Subjects that received a complete dose
    6
    6
    Completed
    6
    6

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    Daptomycin 8 mg/kg
    Reporting group description
    		 Subjects received a single dose of daptomycin over a duration of 1 hour.

    Reporting group title
    Daptomycin 10 mg/kg
    Reporting group description
    		 Subjects received a single dose of daptomycin over a duration of 1 hour.

    Reporting group values
    		 Daptomycin 8 mg/kg Daptomycin 10 mg/kg Total
    Number of subjects
    		 6 6 12
    Age categorical
    Age of all enrolled subjects by category.
    Units: Subjects
        Children (2-11 years)
    		 6 6 12
    Age continuous
    Age of all enrolled subjects.
    Units: years
        arithmetic mean (standard deviation)
    		 3.85 ± 1.88 4.43 ± 1.136 -
    Gender categorical
    Gender of all enrolled subjects.
    Units: Subjects
        Female
    		 3 2 5
        Male
    		 3 4 7

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    Daptomycin 8 mg/kg
    Reporting group description
    		 Subjects received a single dose of daptomycin over a duration of 1 hour.

    Reporting group title
    Daptomycin 10 mg/kg
    Reporting group description
    		 Subjects received a single dose of daptomycin over a duration of 1 hour.

    Primary: Pharmacokinetics of daptomycin: Apparent elimination half-life

    		 Close Top of page
    End point title
    		 Pharmacokinetics of daptomycin: Apparent elimination half-life [1]
    End point description
    The apparent elimination half-life (t1/2) of daptomycin presented in hours calculated as natural logarithm of 2 divided by the terminal slope of the concentration versus time curve (Kel).
    End point type
    Primary
    End point timeframe
    Up to 24 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: This study was a Phase 1, single dose, open-label, non-comparative study and therefore only descriptive analyses were performed. No statistical tests were performed.
    End point values
    		 Daptomycin 8 mg/kg Daptomycin 10 mg/kg
    Number of subjects analysed
    6
    6
    Units: hours
        arithmetic mean (standard deviation)
    5.35 ± 1.41
    5.67 ± 0.62
    No statistical analyses for this end point

    Primary: Pharmacokinetics of daptomycin: Volume of distribution

    		 Close Top of page
    End point title
    		 Pharmacokinetics of daptomycin: Volume of distribution [2]
    End point description
    Terminal exponential volume of distribution (Vz) presented in millilitres per kilogram based on the terminal phase calculated as the ratio of plasma clearance (CL) and Kel.
    End point type
    Primary
    End point timeframe
    Up to 24 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: This study was a Phase 1, single dose, open-label, non-comparative study and therefore only descriptive analyses were performed. No statistical tests were performed.
    End point values
    		 Daptomycin 8 mg/kg Daptomycin 10 mg/kg
    Number of subjects analysed
    6
    6
    Units: millilitre(s) per kilogram
        arithmetic mean (standard deviation)
    142.3 ± 12.28
    154.8 ± 32.98
    No statistical analyses for this end point

    Primary: Pharmacokinetics of daptomycin: Maximum plasma concentration

    		 Close Top of page
    End point title
    		 Pharmacokinetics of daptomycin: Maximum plasma concentration [3]
    End point description
    Maximum plasma concentration (Cmax) presented in micrograms per millilitre over the entire sampling phase directly obtained from the experimental plasma concentration time data, without interpolation.
    End point type
    Primary
    End point timeframe
    Up to 24 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: This study was a Phase 1, single dose, open-label, non-comparative study and therefore only descriptive analyses were performed. No statistical tests were performed.
    End point values
    		 Daptomycin 8 mg/kg Daptomycin 10 mg/kg
    Number of subjects analysed
    6
    6
    Units: microgram(s) per millilitre
        arithmetic mean (standard deviation)
    68.42 ± 9.33
    79.18 ± 10.17
    No statistical analyses for this end point

    Primary: Pharmacokinetics of daptomycin: Time to maximum concentration

    		 Close Top of page
    End point title
    		 Pharmacokinetics of daptomycin: Time to maximum concentration [4]
    End point description
    Time to maximum concentration (Tmax) presented in hours defined as the sampling time at which Cmax occurred, obtained directly from the experimental plasma concentration time data, without interpolation.
    End point type
    Primary
    End point timeframe
    Up to 24 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: This study was a Phase 1, single dose, open-label, non-comparative study and therefore only descriptive analyses were performed. No statistical tests were performed.
    End point values
    		 Daptomycin 8 mg/kg Daptomycin 10 mg/kg
    Number of subjects analysed
    6
    6
    Units: hours
        arithmetic mean (standard deviation)
    0.86 ± 0.27
    1.04 ± 0.04
    No statistical analyses for this end point

    Primary: Pharmacokinetics of daptomycin: Area under the plasma concentration-time curve

    		 Close Top of page
    End point title
    		 Pharmacokinetics of daptomycin: Area under the plasma concentration-time curve [5]
    End point description
    Area under the plasma concentration-time curve from 0 to infinity (AUC0-∞) is presented in micrograms times hours per millilitre.
    End point type
    Primary
    End point timeframe
    Up to 24 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: This study was a Phase 1, single dose, open-label, non-comparative study and therefore only descriptive analyses were performed. No statistical tests were performed.
    End point values
    		 Daptomycin 8 mg/kg Daptomycin 10 mg/kg
    Number of subjects analysed
    6
    6
    Units: microgram(s) times hours per millilitre
        arithmetic mean (standard deviation)
    429.14 ± 113.01
    549.7 ± 139.35
    No statistical analyses for this end point

    Primary: Pharmacokinetics of daptomycin: Clearance

    		 Close Top of page
    End point title
    		 Pharmacokinetics of daptomycin: Clearance [6]
    End point description
    Plasma clearance (CL) calculated as dose divided by AUC0-∞ is presented in millilitres per hour(s) per kilogram.
    End point type
    Primary
    End point timeframe
    Up to 24 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: This study was a Phase 1, single dose, open-label, non-comparative study and therefore only descriptive analyses were performed. No statistical tests were performed.
    End point values
    		 Daptomycin 8 mg/kg Daptomycin 10 mg/kg
    Number of subjects analysed
    6
    6
    Units: millilitre(s) per hour(s) per kilogram
        arithmetic mean (standard deviation)
    19.47 ± 5.01
    19.14 ± 4.51
    No statistical analyses for this end point

    Secondary: Safety of daptomycin: Treatment-emergent adverse events

    		 Close Top of page
    End point title
    		 Safety of daptomycin: Treatment-emergent adverse events
    End point description
    The number of subjects with at least one treatment-emergent adverse event was reported by dosing group.
    End point type
    Secondary
    End point timeframe
    Up to 9 days after dosing.
    End point values
    		 Daptomycin 8 mg/kg Daptomycin 10 mg/kg
    Number of subjects analysed
    6
    6
    Units: Subjects
    2
    4
    No statistical analyses for this end point

    Adverse events

    		 Close Top of page
    Adverse events information
    Timeframe for reporting adverse events
    Up through 7 days post-dose.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    11.0
    Reporting groups
    Reporting group title
    Daptomycin 10 mg/kg
    Reporting group description
    		 -

    Reporting group title
    Daptomycin 8 mg/kg
    Reporting group description
    		 -

    Serious adverse events
    		 Daptomycin 10 mg/kg Daptomycin 8 mg/kg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 6 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Infections and infestations
    GROIN ABSCESS
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Daptomycin 10 mg/kg Daptomycin 8 mg/kg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    4 / 6 (66.67%)
    2 / 6 (33.33%)
    Investigations
    BODY TEMPERATURE INCREASED
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    Vascular disorders
    PHLEBITIS
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    Nervous system disorders
    HEADACHE
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    HYPOAESTHESIA
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    1
    General disorders and administration site conditions
    CATHETER RELATED COMPLICATION
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    IRRITABILITY
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    1
    Ear and labyrinth disorders
    CERUMEN IMPACTION
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    Respiratory, thoracic and mediastinal disorders
    COUGH
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    TONSILLAR HYPERTROPHY
         subjects affected / exposed
    2 / 6 (33.33%)
    0 / 6 (0.00%)
         occurrences all number
    2
    0
    Skin and subcutaneous tissue disorders
    DRY SKIN
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    PRURITUS
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    Musculoskeletal and connective tissue disorders
    PAIN IN EXTREMITY
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    1

    More information

    		 Close Top of page

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

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Fri Apr 26 10:12:35 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA