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    Clinical Trial Results:
    Pharmacokinetics of ciprofloxacine in pediatric patients, a pilot study – SAFE PEDRUG

    Summary
    EudraCT number
    2014-004638-24
    Trial protocol
    BE  
    Global end of trial date
    17 Mar 2017

    Results information
    Results version number
    v1(current)
    This version publication date
    03 Apr 2022
    First version publication date
    03 Apr 2022
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    SafePed01
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT02598362
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Ghent University Hospital
    Sponsor organisation address
    C. Heymanslaan 10, 9000, Belgium, Ghent
    Public contact
    HIRUZ CTU, Ghent University Hospital, +32 93320500, hiruz.ctu@uzgent.be
    Scientific contact
    HIRUZ CTU, Ghent University Hospital, +32 93320500, hiruz.ctu@uzgent.be
    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?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    06 Sep 2018
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    17 Mar 2017
    Global end of trial reached?
    Yes
    Global end of trial date
    17 Mar 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Investigating the feasibility of a study method for pharmacokinetics (with emphasis on renal clearance) of ciprofloxacin in children.
    Protection of trial subjects
    Ethics review and approval, informed consent, supportive care and routine monitoring.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    28 May 2015
    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
    Belgium: 23
    Worldwide total number of subjects
    23
    EEA total number of subjects
    23
    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)
    3
    Children (2-11 years)
    10
    Adolescents (12-17 years)
    10
    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
    23 patients were included starting from 28-May-2015. End of trial notification was dated 17-Mar-2018 (last patient last visit) and submitted to EC and CA on 28/08/2018.

    Pre-assignment
    Screening details
    fUTI group (UZ Brussels): patients aged 3 months-17years with rectal temperature of 38.5°C and significant leucocyturia or a positive urine nitrite test in a sterile urine sample and confirmed by culture. Profylaxis group (UZ Ghent): patients until age of 17years who use cipro for preventing urinary tract infectons.

    Period 1
    Period 1 title
    Overall trial (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
    fUTI arm (IV arm)
    Arm description
    UZ Brussels patients aged 3 months-17years with rectal temperature of 38.5°C and significant leucocyturia or a positive urine nitrite test in a sterile urine sample and confirmed by culture.
    Arm type
    Experimental

    Investigational medicinal product name
    Ciprofloxacin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    15mg/kg twice daily

    Arm title
    Profylaxis arm (oral arm)
    Arm description
    UZ Ghent patients until age of 17years who use cipro for preventing urinary tract infectons. Oral administration
    Arm type
    Active comparator

    Investigational medicinal product name
    Ciprofloxacin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for oral suspension
    Routes of administration
    Oral use
    Dosage and administration details
    Normal dose (usual 10mg/kg daily)

    Number of subjects in period 1
    fUTI arm (IV arm) Profylaxis arm (oral arm)
    Started
    10
    13
    Completed
    10
    13

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    fUTI arm (IV arm)
    Reporting group description
    UZ Brussels patients aged 3 months-17years with rectal temperature of 38.5°C and significant leucocyturia or a positive urine nitrite test in a sterile urine sample and confirmed by culture.

    Reporting group title
    Profylaxis arm (oral arm)
    Reporting group description
    UZ Ghent patients until age of 17years who use cipro for preventing urinary tract infectons. Oral administration

    Reporting group values
    fUTI arm (IV arm) Profylaxis arm (oral arm) Total
    Number of subjects
    10 13 23
    Age categorical
    Units: Subjects
        In utero
    0
        Preterm newborn infants (gestational age < 37 wks)
    0
        Newborns (0-27 days)
    0
        Infants and toddlers (28 days-23 months)
    0
        Children (2-11 years)
    0
        Adolescents (12-17 years)
    0
        Adults (18-64 years)
    0
        From 65-84 years
    0
        85 years and over
    0
    Age continuous
    Units: years
        median (full range (min-max))
    9.86 (0.51 to 15.5) 6.43 (0.31 to 15.4) -
    Gender categorical
    Units: Subjects
        Female
    8 6 14
        Male
    2 7 9
    Diagnose
    Units: Subjects
        Acute pyelonephritis
    9 9 18
        Cystitis
    1 2 3
        recurrent lower UTI
    0 2 2
    Comorbidities
    Units: Subjects
        CAKUT
    3 7 10
        Neurogenic bladder
    1 0 1
        BBD
    2 1 3
        CAKUT and stone disease
    1 1 2
        CAKUT and renal insufficiency
    0 1 1
        CAKUT and BBD
    0 1 1
        stone disease
    0 1 1
        None
    3 1 4
    Urine culture
    Units: Subjects
        Escherichia coli
    4 5 9
        Pseudomonas aeruginosa
    3 4 7
        Klebsiella pneumoniae
    1 1 2
        Proteus strains
    0 1 1
        No growth
    2 2 4
    Weight
    Units: kg
        median (full range (min-max))
    26.7 (8.21 to 75.30) 18.3 (6.47 to 106) -
    Serum cystatin C
    Units: mg/l
        median (full range (min-max))
    0.71 (0.63 to 0.84) 0.86 (0.61 to 2.88) -
    Serum creatinine
    Units: mg/dl
        median (full range (min-max))
    0.49 (0.28 to 0.81) 0.64 (0.38 to 1.54) -
    Kidney function
    Units: ml/min/1.73m²
        median (full range (min-max))
    98.4 (73.7 to 116) 65.5 (6.75 to 84.6) -

    End points

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    End points reporting groups
    Reporting group title
    fUTI arm (IV arm)
    Reporting group description
    UZ Brussels patients aged 3 months-17years with rectal temperature of 38.5°C and significant leucocyturia or a positive urine nitrite test in a sterile urine sample and confirmed by culture.

    Reporting group title
    Profylaxis arm (oral arm)
    Reporting group description
    UZ Ghent patients until age of 17years who use cipro for preventing urinary tract infectons. Oral administration

    Subject analysis set title
    End group
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Group created as data are analysed as a one armed trial.

    Primary: ciprofloxacin clearance

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    End point title
    ciprofloxacin clearance [1]
    End point description
    End point type
    Primary
    End point timeframe
    From start until end of study
    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: See article
    End point values
    End group
    Number of subjects analysed
    22
    Units: l/h/kg
        median (full range (min-max))
    0.22 (0.16 to 0.43)
    No statistical analyses for this end point

    Secondary: Volume of distribution

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    End point title
    Volume of distribution
    End point description
    End point type
    Secondary
    End point timeframe
    From start until end of study
    End point values
    End group
    Number of subjects analysed
    Units: l/kg
        median (full range (min-max))
    0.55 (0.06 to 2.88)
    No statistical analyses for this end point

    Secondary: Bioavailibility

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    End point title
    Bioavailibility
    End point description
    End point type
    Secondary
    End point timeframe
    From start until end study
    End point values
    End group
    Number of subjects analysed
    Units: percentage
        number (not applicable)
    59.6
    No statistical analyses for this end point

    Secondary: absorption

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    End point title
    absorption
    End point description
    End point type
    Secondary
    End point timeframe
    From start until end study
    End point values
    End group
    Number of subjects analysed
    Units: per hour
        number (not applicable)
    0.596
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    Adverse events will be reported between the first dose administration of trial medication and the last trial related activity
    Assessment type
    Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    21.1
    Reporting groups
    Reporting group title
    fUTI arm (IV arm)
    Reporting group description
    UZ Brussels patients aged 3 months-17years with rectal temperature of 38.5°C and significant leucocyturia or a positive urine nitrite test in a sterile urine sample and confirmed by culture.

    Reporting group title
    Profylaxis arm (oral arm)
    Reporting group description
    UZ Ghent patients until age of 17years who use cipro for preventing urinary tract infectons. Oral administration

    Serious adverse events
    fUTI arm (IV arm) Profylaxis arm (oral arm)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 13 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    fUTI arm (IV arm) Profylaxis arm (oral arm)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 13 (0.00%)
    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: No adverse events have been collected

    More information

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    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

    Online references

    http://www.ncbi.nlm.nih.gov/pubmed/29987142
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