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    Clinical Trial Results:
    An Open-Label, Parallel-Group Study to Evaluate the Single-Dose Pharmacokinetics and Safety of Doripenem in Pediatric Patients 3 Months to 17 Years of Age, Inclusive

    Summary
    EudraCT number
    		 2011-005159-15
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    21 Nov 2008

    Results information
    Results version number
    		 v1
    This version publication date
    06 Jul 2016
    First version publication date
    08 Aug 2015
    Other versions
    		 v2

    Trial information

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    Trial identification
    Sponsor protocol code
    DORI-NOS-1008
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
    Sponsor organisation address
    Raritan, 920 Route 202, New Jersey, United States,
    Public contact
    Clinical Registry Group, Janssen-Cilag International NV, ClinicalTrialsEU@its.jnj.com
    Scientific contact
    Clinical Registry Group, Janssen-Cilag International NV, ClinicalTrialsEU@its.jnj.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    Yes
    EMA paediatric investigation plan number(s)
    		 EMEA-000015-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
    21 Nov 2008
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    21 Nov 2008
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of this study is to assess the pharmacokinetics of doripenem and its metabolite, doripenem-M-1, in pediatric subjects 3 months to 17 years of age, inclusive.
    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.Safety was assessed throughout the study by monitoring adverse events, conducting clinical laboratory tests (hematology, serum chemistry, and urinalysis), pregnancy test, vital signs (temperature, pulse, respiratory rate, and blood pressure), physical examination (height/length and weight), and recording concomitant medications.The study protocol and amendment were reviewed by an Institutional Review Board (IRB).
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    10 Jul 2007
    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: 50
    Worldwide total number of subjects
    50
    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)
    26
    Adolescents (12-17 years)
    12
    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 50 pediatric participants (boys and girls) 3 months to 17 years of age inclusive, were planned to be enrolled in this study.

    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
    		 >= 12 to <18 yr
    Arm description
    		 Subjects from age group (greater than or equal to [>=] 12 years to less than [<]18 years) received doripenem 15 milligram per kilogram (mg/kg) (approximately equivalent to 1,000 mg/70 kg adult) as an i.v. infusion (5 mg/mL infusion solution) over 1 hour via an indwelling catheter.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Doripenem
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravascular use
    Dosage and administration details
    Subjects from age group (>=12 years to <18 years) received doripenem 15 mg/kg (approximately equivalent to 1,000 mg/70 kg adult) as an i.v. infusion (5 mg/mL infusion solution) over 1 hour via an indwelling catheter.

    Arm title
    		 >=6 to <12yr
    Arm description
    		 Subjects from age group (>=6 years to <12 years) received doripenem 15 mg/kg (approximately equivalent to 1,000 mg/70 kg adult) as an i.v. infusion (5 mg/mL infusion solution) over 1 hour via an indwelling catheter
    Arm type
    		 Experimental

    Investigational medicinal product name
    Doripenem
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Subjects from age group (>=6 years to <12 years) received doripenem 15 mg/kg (approximately equivalent to 1,000 mg/70 kg adult) as an i.v. infusion (5 mg/mL infusion solution) over 1 hour via an indwelling catheter.

    Arm title
    		 >=2 to <6 yr
    Arm description
    		 Subjects from age group (>=2 years to <6 years) received doripenem 15 mg/kg (approximately equivalent to 1,000 mg/70 kg adult) as an i.v. infusion (5 mg/mL infusion solution) over 1 hour via an indwelling catheter
    Arm type
    		 Experimental

    Investigational medicinal product name
    Doripenem
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Subjects from age group (>=2 years to <6 years) received doripenem 15 mg/kg (approximately equivalent to 1,000 mg/70 kg adult) as an i.v. infusion (5 mg/mL infusion solution) over 1 hour via an indwelling catheter.

    Arm title
    		 >=3 mon to <2 yr
    Arm description
    		 Subjects from age group (>=3 months to <2 years) received 10 mg/kg doripenem as an i.v. infusion (5 mg/mL infusion solution) over 1 hour via an indwelling catheter
    Arm type
    		 Experimental

    Investigational medicinal product name
    Doripenem
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravascular use
    Dosage and administration details
    Subjects from age group (>=3 months to <2 years) received 10 mg/kg doripenem as an i.v. infusion (5 mg/mL infusion solution) over 1 hour via an indwelling catheter.

    Number of subjects in period 1
    		>= 12 to <18 yr >=6 to <12yr >=2 to <6 yr >=3 mon to <2 yr
    Started
    12
    13
    13
    12
    Completed
    11
    11
    13
    12
    Not completed
    1
    2
    0
    0
         Adverse event, non-fatal
    -
    1
    -
    -
         Other
    1
    1
    -
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    >= 12 to <18 yr
    Reporting group description
    		 Subjects from age group (greater than or equal to [>=] 12 years to less than [<]18 years) received doripenem 15 milligram per kilogram (mg/kg) (approximately equivalent to 1,000 mg/70 kg adult) as an i.v. infusion (5 mg/mL infusion solution) over 1 hour via an indwelling catheter.

    Reporting group title
    >=6 to <12yr
    Reporting group description
    		 Subjects from age group (>=6 years to <12 years) received doripenem 15 mg/kg (approximately equivalent to 1,000 mg/70 kg adult) as an i.v. infusion (5 mg/mL infusion solution) over 1 hour via an indwelling catheter

    Reporting group title
    >=2 to <6 yr
    Reporting group description
    		 Subjects from age group (>=2 years to <6 years) received doripenem 15 mg/kg (approximately equivalent to 1,000 mg/70 kg adult) as an i.v. infusion (5 mg/mL infusion solution) over 1 hour via an indwelling catheter

    Reporting group title
    >=3 mon to <2 yr
    Reporting group description
    		 Subjects from age group (>=3 months to <2 years) received 10 mg/kg doripenem as an i.v. infusion (5 mg/mL infusion solution) over 1 hour via an indwelling catheter

    Reporting group values
    		 >= 12 to <18 yr >=6 to <12yr >=2 to <6 yr >=3 mon to <2 yr Total
    Number of subjects
    		 12 13 13 12 50
    Title for AgeCategorical
    Units: subjects
        infants and toddlers(28 days-23 months)
    		 0 0 0 12 12
        Children (2-11 years)
    		 0 13 13 0 26
        Adolescents (12-17 years)
    		 12 0 0 0 12
    Title for AgeContinuous
    Units: years
        arithmetic mean (standard deviation)
    		 14.8 ± 1.04 8.7 ± 2.09 4.1 ± 1.31 1.2 ± 0.65 -
    Title for Gender
    Units: subjects
        Female
    		 5 5 8 6 24
        Male
    		 7 8 5 6 26

    End points

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    End points reporting groups
    Reporting group title
    >= 12 to <18 yr
    Reporting group description
    		 Subjects from age group (greater than or equal to [>=] 12 years to less than [<]18 years) received doripenem 15 milligram per kilogram (mg/kg) (approximately equivalent to 1,000 mg/70 kg adult) as an i.v. infusion (5 mg/mL infusion solution) over 1 hour via an indwelling catheter.

    Reporting group title
    >=6 to <12yr
    Reporting group description
    		 Subjects from age group (>=6 years to <12 years) received doripenem 15 mg/kg (approximately equivalent to 1,000 mg/70 kg adult) as an i.v. infusion (5 mg/mL infusion solution) over 1 hour via an indwelling catheter

    Reporting group title
    >=2 to <6 yr
    Reporting group description
    		 Subjects from age group (>=2 years to <6 years) received doripenem 15 mg/kg (approximately equivalent to 1,000 mg/70 kg adult) as an i.v. infusion (5 mg/mL infusion solution) over 1 hour via an indwelling catheter

    Reporting group title
    >=3 mon to <2 yr
    Reporting group description
    		 Subjects from age group (>=3 months to <2 years) received 10 mg/kg doripenem as an i.v. infusion (5 mg/mL infusion solution) over 1 hour via an indwelling catheter

    Primary: Maximum Observed Plasma Concentration (Cmax) of Doripenem

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    End point title
    		 Maximum Observed Plasma Concentration (Cmax) of Doripenem [1]
    End point description
    End point type
    Primary
    End point timeframe
    Up to 8 hour (hr) 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: No inferential statistics was planned to be performed on this primary endpoint.
    End point values
    		 >= 12 to <18 yr >=6 to <12yr >=2 to <6 yr >=3 mon to <2 yr
    Number of subjects analysed
    10 [2]
    10 [3]
    13 [4]
    12 [5]
    Units: Microgram per milliliter (mcg/mL)
        arithmetic mean (standard deviation)
    18.9 ± 5.9
    29.1 ± 6.34
    26.1 ± 3.02
    16.7 ± 4.43
    Notes
    [2] - Pharmacokinetic Analysis Set
    [3] - Pharmacokinetic Analysis Set
    [4] - Pharmacokinetic Analysis Set
    [5] - Pharmacokinetic Analysis Set
    No statistical analyses for this end point

    Primary: Time to Reach Maximum Observed Plasma Concentration (Tmax) of Doripenem

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    End point title
    		 Time to Reach Maximum Observed Plasma Concentration (Tmax) of Doripenem [6]
    End point description
    End point type
    Primary
    End point timeframe
    Up to 8 hour 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: No inferential statistics was planned to be performed on this primary endpoint.
    End point values
    		 >= 12 to <18 yr >=6 to <12yr >=2 to <6 yr >=3 mon to <2 yr
    Number of subjects analysed
    10 [7]
    10 [8]
    13 [9]
    12 [10]
    Units: Hour
        median (full range (min-max))
    0.98 (0.52 to 1.13)
    1 (0.5 to 1.1)
    1 (0.92 to 1.02)
    1 (0.97 to 1.5)
    Notes
    [7] - Pharmacokinetic Analysis Set
    [8] - Pharmacokinetic Analysis Set
    [9] - Pharmacokinetic Analysis Set
    [10] - Pharmacokinetic Analysis Set
    No statistical analyses for this end point

    Primary: Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC[0-infinity]) of Doripenem

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    End point title
    		 Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC[0-infinity]) of Doripenem [11]
    End point description
    End point type
    Primary
    End point timeframe
    Up to 8 hour post dose
    Notes
    [11] - 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: No inferential statistics was planned to be performed on this primary endpoint.
    End point values
    		 >= 12 to <18 yr >=6 to <12yr >=2 to <6 yr >=3 mon to <2 yr
    Number of subjects analysed
    10 [12]
    11 [13]
    12 [14]
    12 [15]
    Units: Microgram.hour per milliliter(mcg.hr/mL)
        arithmetic mean (standard deviation)
    31.1 ± 6.13
    44.8 ± 11.1
    40.6 ± 8.47
    29.8 ± 10.2
    Notes
    [12] - Pharmacokinetic Analysis Set
    [13] - Pharmacokinetic Analysis Set
    [14] - Pharmacokinetic Analysis Set
    [15] - Pharmacokinetic Analysis Set
    No statistical analyses for this end point

    Primary: Plasma Elimination Half-Life (t1/2) of Doripenem

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    End point title
    		 Plasma Elimination Half-Life (t1/2) of Doripenem [16]
    End point description
    End point type
    Primary
    End point timeframe
    Up to 8 hour post dose
    Notes
    [16] - 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: No inferential statistics was planned to be performed on this primary endpoint.
    End point values
    		 >= 12 to <18 yr >=6 to <12yr >=2 to <6 yr >=3 mon to <2 yr
    Number of subjects analysed
    10 [17]
    11 [18]
    12 [19]
    12 [20]
    Units: Hour
        arithmetic mean (standard deviation)
    0.944 ± 0.225
    0.919 ± 0.211
    0.937 ± 0.355
    1.01 ± 0.426
    Notes
    [17] - Pharmacokinetic Analysis Set
    [18] - Pharmacokinetic Analysis Set
    [19] - Pharmacokinetic Analysis Set
    [20] - Pharmacokinetic Analysis Set
    No statistical analyses for this end point

    Primary: Apparent Volume of Distribution (Vdss) of Doripenem

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    End point title
    		 Apparent Volume of Distribution (Vdss) of Doripenem [21]
    End point description
    End point type
    Primary
    End point timeframe
    Up to 8 hour post dose
    Notes
    [21] - 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: No inferential statistics was planned to be performed on this primary endpoint.
    End point values
    		 >= 12 to <18 yr >=6 to <12yr >=2 to <6 yr >=3 mon to <2 yr
    Number of subjects analysed
    10 [22]
    11 [23]
    12 [24]
    12 [25]
    Units: Liter
        arithmetic mean (standard deviation)
    17.8 ± 4.71
    10.6 ± 4.38
    6.34 ± 1.32
    4.86 ± 3.56
    Notes
    [22] - Pharmacokinetic Analysis Set
    [23] - Pharmacokinetic Analysis Set
    [24] - Pharmacokinetic Analysis Set
    [25] - Pharmacokinetic Analysis Set
    No statistical analyses for this end point

    Primary: Systemic Clearance (CL) of Doripenem

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    End point title
    		 Systemic Clearance (CL) of Doripenem [26]
    End point description
    End point type
    Primary
    End point timeframe
    Up to 8 hour post dose
    Notes
    [26] - 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: No inferential statistics was planned to be performed on this primary endpoint.
    End point values
    		 >= 12 to <18 yr >=6 to <12yr >=2 to <6 yr >=3 mon to <2 yr
    Number of subjects analysed
    10 [27]
    11 [28]
    12 [29]
    12 [30]
    Units: Liter per hour (L/h)
        arithmetic mean (standard deviation)
    16.7 ± 3.6
    10.5 ± 4.78
    6.29 ± 1.62
    3.88 ± 1.67
    Notes
    [27] - Pharmacokinetic Analysis Set
    [28] - Pharmacokinetic Analysis Set
    [29] - Pharmacokinetic Analysis Set
    [30] - Pharmacokinetic Analysis Set
    No statistical analyses for this end point

    Primary: Renal Clearance (CLr) of Doripenem

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    End point title
    		 Renal Clearance (CLr) of Doripenem [31]
    End point description
    End point type
    Primary
    End point timeframe
    Up to 8 hour post dose
    Notes
    [31] - 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: No inferential statistics was planned to be performed on this primary endpoint.
    End point values
    		 >= 12 to <18 yr >=6 to <12yr >=2 to <6 yr >=3 mon to <2 yr
    Number of subjects analysed
    10 [32]
    8 [33]
    9 [34]
    11 [35]
    Units: Liter per hour (L/h)
        arithmetic mean (standard deviation)
    12.4 ± 5.78
    6.8 ± 1.68
    3.33 ± 2
    2.18 ± 3.02
    Notes
    [32] - Pharmacokinetic Analysis Set
    [33] - Pharmacokinetic Analysis Set
    [34] - Pharmacokinetic Analysis Set
    [35] - Pharmacokinetic Analysis Set
    No statistical analyses for this end point

    Primary: Creatinine clearance [CLcr] of Doripenem

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    End point title
    		 Creatinine clearance [CLcr] of Doripenem [36]
    End point description
    End point type
    Primary
    End point timeframe
    Up to 8 hour post dose
    Notes
    [36] - 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: No inferential statistics was planned to be performed on this primary endpoint.
    End point values
    		 >= 12 to <18 yr >=6 to <12yr >=2 to <6 yr >=3 mon to <2 yr
    Number of subjects analysed
    10 [37]
    11 [38]
    10 [39]
    11 [40]
    Units: mL/min/kg
        arithmetic mean (standard deviation)
    3.06 ± 0.77
    5.52 ± 1.94
    11.3 ± 7.84
    16.6 ± 8.63
    Notes
    [37] - Pharmacokinetic Analysis Set
    [38] - Pharmacokinetic Analysis Set
    [39] - Pharmacokinetic Analysis Set
    [40] - Pharmacokinetic Analysis Set
    No statistical analyses for this end point

    Primary: Total amount excreted into urine [Ae] of Doripenem

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    End point title
    		 Total amount excreted into urine [Ae] of Doripenem [41]
    End point description
    End point type
    Primary
    End point timeframe
    Up to 8 hour post dose
    Notes
    [41] - 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: No inferential statistics was planned to be performed on this primary endpoint.
    End point values
    		 >= 12 to <18 yr >=6 to <12yr >=2 to <6 yr >=3 mon to <2 yr
    Number of subjects analysed
    10 [42]
    8 [43]
    9 [44]
    11 [45]
    Units: percent, dose (%,dose)
        arithmetic mean (standard deviation)
    74.4 ± 24.9
    72.4 ± 24.5
    48.1 ± 24.8
    50.6 ± 50
    Notes
    [42] - Pharmacokinetic Analysis Set
    [43] - Pharmacokinetic Analysis Set
    [44] - Pharmacokinetic Analysis Set
    [45] - Pharmacokinetic Analysis Set
    No statistical analyses for this end point

    Primary: Maximum Observed Plasma Concentration (Cmax) of Metabolite Doripenem-M-1

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    End point title
    		 Maximum Observed Plasma Concentration (Cmax) of Metabolite Doripenem-M-1 [46]
    End point description
    End point type
    Primary
    End point timeframe
    Up to 8 hour post dose
    Notes
    [46] - 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: No inferential statistics was planned to be performed on this primary endpoint.
    End point values
    		 >= 12 to <18 yr >=6 to <12yr >=2 to <6 yr >=3 mon to <2 yr
    Number of subjects analysed
    10 [47]
    11 [48]
    13 [49]
    12 [50]
    Units: Microgram per milliliter (mcg/mL)
        arithmetic mean (standard deviation)
    2.15 ± 0.82
    3.15 ± 1.81
    2.7 ± 0.92
    1.73 ± 0.856
    Notes
    [47] - Pharmacokinetic Analysis Set
    [48] - Pharmacokinetic Analysis Set
    [49] - Pharmacokinetic Analysis Set
    [50] - Pharmacokinetic Analysis Set
    No statistical analyses for this end point

    Primary: Time to Reach Maximum Observed Plasma Concentration (Tmax) of Metabolite Doripenem-M-1

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    End point title
    		 Time to Reach Maximum Observed Plasma Concentration (Tmax) of Metabolite Doripenem-M-1 [51]
    End point description
    End point type
    Primary
    End point timeframe
    Up to 8 hour post dose
    Notes
    [51] - 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: No inferential statistics was planned to be performed on this primary endpoint.
    End point values
    		 >= 12 to <18 yr >=6 to <12yr >=2 to <6 yr >=3 mon to <2 yr
    Number of subjects analysed
    10 [52]
    10 [53]
    13 [54]
    12 [55]
    Units: Hour
        median (full range (min-max))
    0.98 (0.52 to 1.48)
    1.01 (0.97 to 1.1)
    1 (0.92 to 1.02)
    1 (0.97 to 2)
    Notes
    [52] - Pharmacokinetic Analysis Set
    [53] - Pharmacokinetic Analysis Set
    [54] - Pharmacokinetic Analysis Set
    [55] - Pharmacokinetic Analysis Set
    No statistical analyses for this end point

    Primary: Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC[0-infinity]) ofInfinite Time (AUC[0-infinity]) of Metabolite Doripenem-M-1

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    End point title
    		 Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC[0-infinity]) ofInfinite Time (AUC[0-infinity]) of Metabolite Doripenem-M-1 [56]
    End point description
    End point type
    Primary
    End point timeframe
    Up to 8 hour post dose
    Notes
    [56] - 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: No inferential statistics was planned to be performed on this primary endpoint.
    End point values
    		 >= 12 to <18 yr >=6 to <12yr >=2 to <6 yr >=3 mon to <2 yr
    Number of subjects analysed
    10 [57]
    11 [58]
    13 [59]
    12 [60]
    Units: Microgram.hour per
        arithmetic mean (standard deviation)
    5.07 ± 1.55
    6.48 ± 2.02
    6.28 ± 2.38
    4.89 ± 2.98
    Notes
    [57] - Pharmacokinetic Analysis Set
    [58] - Pharmacokinetic Analysis Set
    [59] - Pharmacokinetic Analysis Set
    [60] - Pharmacokinetic Analysis Set
    No statistical analyses for this end point

    Primary: Plasma Elimination Half-Life (t1/2) of Metabolite Doripenem-M-1

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    End point title
    		 Plasma Elimination Half-Life (t1/2) of Metabolite Doripenem-M-1 [61]
    End point description
    End point type
    Primary
    End point timeframe
    Up to 8 hour post dose
    Notes
    [61] - 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: No inferential statistics was planned to be performed on this primary endpoint.
    End point values
    		 >= 12 to <18 yr >=6 to <12yr >=2 to <6 yr >=3 mon to <2 yr
    Number of subjects analysed
    10 [62]
    11 [63]
    13 [64]
    12 [65]
    Units: Hour
        arithmetic mean (standard deviation)
    1.76 ± 0.369
    1.55 ± 0.465
    1.61 ± 0.743
    1.61 ± 0.47
    Notes
    [62] - Pharmacokinetic Analysis Set
    [63] - Pharmacokinetic Analysis Set
    [64] - Pharmacokinetic Analysis Set
    [65] - Pharmacokinetic Analysis Set
    No statistical analyses for this end point

    Primary: Total amount excreted into urine [Ae] of Metabolite Doripenem-M-1

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    End point title
    		 Total amount excreted into urine [Ae] of Metabolite Doripenem-M-1 [66]
    End point description
    End point type
    Primary
    End point timeframe
    Up to 8 hour post dose
    Notes
    [66] - 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: No inferential statistics was planned to be performed on this primary endpoint.
    End point values
    		 >= 12 to <18 yr >=6 to <12yr >=2 to <6 yr >=3 mon to <2 yr
    Number of subjects analysed
    10 [67]
    8 [68]
    8 [69]
    11 [70]
    Units: percent, dose (%,dose)
        arithmetic mean (standard deviation)
    11.8 ± 5.3
    12.8 ± 3.76
    8.76 ± 2.78
    10.2 ± 12.2
    Notes
    [67] - Pharmacokinetic Analysis Set
    [68] - Pharmacokinetic Analysis Set
    [69] - Pharmacokinetic Analysis Set
    [70] - Pharmacokinetic Analysis Set
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Timeframe for AE
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    11.1
    Reporting groups
    Reporting group title
    >= 12 to <18 yr
    Reporting group description
    		 Subjects from age group (>=12 years to <18 years) received doripenem 15 mg/kg (approximately equivalent to 1,000 mg/70 kg adult) as an i.v. infusion (5 mg/mL infusion solution) over 1 hour via an indwelling catheter

    Reporting group title
    >=6 to <12yr
    Reporting group description
    		 Subjects from age group (>=6 years to <12 years) received doripenem 15 mg/kg (approximately equivalent to 1,000 mg/70 kg adult) as an i.v. infusion (5 mg/mL infusion solution) over 1 hour via an indwelling catheter

    Reporting group title
    >=2 to <6 yr
    Reporting group description
    		 Subjects from age group (>=2 years to <6 years) received doripenem 15 mg/kg (approximately equivalent to 1,000 mg/70 kg adult) as an i.v. infusion (5 mg/mL infusion solution) over 1 hour via an indwelling catheter

    Reporting group title
    >=3 mon to <2 yr
    Reporting group description
    		 Subjects from age group (>=3 months to <2 years) received 10 mg/kg doripenem as an i.v. infusion (5 mg/mL infusion solution) over 1 hour via an indwelling catheter

    Serious adverse events
    		 >= 12 to <18 yr >=6 to <12yr >=2 to <6 yr >=3 mon to <2 yr
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    2 / 13 (15.38%)
    0 / 12 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    Surgical and medical procedures
    Abscess Drainage
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    1 / 13 (7.69%)
    0 / 12 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Central Venous Catheterisation
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    1 / 13 (7.69%)
    0 / 12 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 >= 12 to <18 yr >=6 to <12yr >=2 to <6 yr >=3 mon to <2 yr
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    7 / 12 (58.33%)
    7 / 13 (53.85%)
    9 / 13 (69.23%)
    4 / 12 (33.33%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 13 (0.00%)
    0 / 13 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    1
    0
    0
    1
    Hypotension
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 13 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    0
    0
    1
    General disorders and administration site conditions
    Chest Discomfort
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 13 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Drug Withdrawal Syndrome
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 13 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    0
    0
    1
    Pyrexia
         subjects affected / exposed
    1 / 12 (8.33%)
    1 / 13 (7.69%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Suprapubic Pain
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 13 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Respiratory, thoracic and mediastinal disorders
    Choking
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 13 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    0
    0
    1
    Pleural Effusion
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 13 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Pulmonary Oedema
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 13 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Respiratory Distress
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 13 (7.69%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Tachypnoea
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 13 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Wheezing
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 13 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    0
    0
    1
    Psychiatric disorders
    Mental Status Changes
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 13 (7.69%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Investigations
    Alanine Aminotransferase Increased
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 13 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Aspartate Aminotransferase Increased
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 13 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Blood Potassium Increased
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 13 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Blood Pressure Increased
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 13 (7.69%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Cardiac Murmur
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    1 / 13 (7.69%)
    0 / 12 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Creatinine Urine Increased
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 13 (7.69%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Eosinophil Count Increased
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 13 (7.69%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Crystal Urine Present
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    1 / 13 (7.69%)
    0 / 12 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Gamma-Glutamyltransferase Increased
         subjects affected / exposed
    2 / 12 (16.67%)
    1 / 13 (7.69%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    2
    1
    0
    0
    Haematocrit Decreased
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    1 / 13 (7.69%)
    0 / 12 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Haemoglobin Decreased
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    1 / 13 (7.69%)
    0 / 12 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Heart Rate Increased
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 13 (7.69%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Oxygen Saturation Decreased
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 13 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    2
    0
    0
    0
    Protein S Increased
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 13 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Protein Urine Present
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 13 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Urine Ketone Body Present
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    1 / 13 (7.69%)
    0 / 12 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Cardiac disorders
    Cardiac Failure
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 13 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    0
    0
    1
    Pericardial Effusion
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 13 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Tachycardia
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 13 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 13 (7.69%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Dizziness Postural
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 13 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Headache
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 13 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Blood and lymphatic system disorders
    Lymphadenopathy
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    1 / 13 (7.69%)
    0 / 12 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Ear and labyrinth disorders
    Middle Ear Effusion
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    1 / 13 (7.69%)
    0 / 12 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Gastrointestinal disorders
    Abdominal Pain
         subjects affected / exposed
    1 / 12 (8.33%)
    1 / 13 (7.69%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Constipation
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    1 / 13 (7.69%)
    0 / 12 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Diarrhoea
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 13 (0.00%)
    2 / 13 (15.38%)
    1 / 12 (8.33%)
         occurrences all number
    1
    0
    2
    1
    Tongue Disorder
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    1 / 13 (7.69%)
    0 / 12 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Vomiting
         subjects affected / exposed
    0 / 12 (0.00%)
    2 / 13 (15.38%)
    3 / 13 (23.08%)
    0 / 12 (0.00%)
         occurrences all number
    0
    2
    3
    0
    Skin and subcutaneous tissue disorders
    Pruritus
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    1 / 13 (7.69%)
    0 / 12 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Rash
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 13 (7.69%)
    1 / 13 (7.69%)
    0 / 12 (0.00%)
         occurrences all number
    0
    1
    1
    0
    Renal and urinary disorders
    Crystalluria
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 13 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Ketonuria
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    1 / 13 (7.69%)
    0 / 12 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Proteinuria
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 13 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Infections and infestations
    Oral Candidiasis
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 13 (7.69%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Skin Infection
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    1 / 13 (7.69%)
    0 / 12 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Metabolism and nutrition disorders
    Decreased Appetite
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    1 / 13 (7.69%)
    0 / 12 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Hyperphosphataemia
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 13 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    0
    0
    1
    Hypokalaemia
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    1 / 13 (7.69%)
    1 / 12 (8.33%)
         occurrences all number
    0
    0
    1
    1
    Hypovolaemia
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 13 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    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 Jul 2008
    The major reasons for amendments to the original protocol includes at least 5 participants were to be enrolled in the youngest age group instead of 4 participants, upon completion of enrollment for each age group, interim pharmacokinetic analysis was performed to assess preliminary exposure of participants to doripenem, language was updated throughout protocol to reflect incorporation of interim analysis and to state that “study conclusions will be based on the final pharmacokinetic analysis after enrollment of all participants across all age cohorts.

    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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