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    Clinical Trial Results:
    Impact de la TEP dans la stratégie diagnostique des fièvres d'origine indéterminée ou des syndromes inflammatoires nus chez l'adulte immunocompétent.

    Summary
    EudraCT number
    2007-005823-14
    Trial protocol
    FR  
    Global end of trial date
    01 May 2013

    Results information
    Results version number
    v1(current)
    This version publication date
    04 Jun 2021
    First version publication date
    04 Jun 2021
    Other versions
    Summary report(s)
    statistical report

    Trial information

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    Trial identification
    Sponsor protocol code
    I07005
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT01200771
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Limoges University Hospital
    Sponsor organisation address
    2 avenue Martin Luther King, LIMOGES, France, 87042
    Public contact
    Pr Kim LY, Limoges University Hospital, +33 555058076, kim.ly@chu-limoges.fr
    Scientific contact
    Pr Kim LY, Limoges University Hospital, +33 555058076, kim.ly@chu-limoges.fr
    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
    Interim
    Date of interim/final analysis
    21 Dec 2015
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    01 May 2013
    Global end of trial reached?
    Yes
    Global end of trial date
    01 May 2013
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Evaluer la rentabilité diagnostique de la TEP (proportion de patients chez qui le diagnostic étiologique est réalisé grâce à la TEP), réalisé précocement, chez un groupe de patients présentant une fièvre prolongée d’origine indéterminée (FUO) ou un syndrome inflammatoire nu.
    Protection of trial subjects
    Non protection specific
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    30 May 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
    France: 111
    Worldwide total number of subjects
    111
    EEA total number of subjects
    111
    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)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    65
    From 65 to 84 years
    44
    85 years and over
    2

    Subject disposition

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    Recruitment
    Recruitment details
    -

    Pre-assignment
    Screening details
    no pre-assignment period

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

    Arms
    Arm title
    all patients
    Arm description
    -
    Arm type
    Experimental

    Investigational medicinal product name
    18FDG
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    Dosage and administration folowed the SPCs

    Number of subjects in period 1
    all patients
    Started
    111
    Completed
    103
    Not completed
    8
         secondary exclusion
    8

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    overall study
    Reporting group description
    -

    Reporting group values
    overall study Total
    Number of subjects
    111 111
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    65 65
        From 65-84 years
    44 44
        85 years and over
    2 2
    Age continuous
    Units: years
        median (standard deviation)
    58.2 ± 16.7 -
    Gender categorical
    Units: Subjects
        Female
    52 52
        Male
    59 59
    Subject analysis sets

    Subject analysis set title
    all patients
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    patients with TEP and scanner

    Subject analysis sets values
    all patients
    Number of subjects
    103
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    61
        From 65-84 years
    41
        85 years and over
    1
    Age continuous
    Units: years
        median (standard deviation)
    58.2 ± 16.7
    Gender categorical
    Units: Subjects
        Female
    50
        Male
    53

    End points

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    End points reporting groups
    Reporting group title
    all patients
    Reporting group description
    -

    Subject analysis set title
    all patients
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    patients with TEP and scanner

    Primary: Assess the contribution of FDG-PET/CT in the early diagnostic work-up of patients with FUO or chronic inflammatory syndrome

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    End point title
    Assess the contribution of FDG-PET/CT in the early diagnostic work-up of patients with FUO or chronic inflammatory syndrome [1]
    End point description
    End point type
    Primary
    End point timeframe
    3 month
    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 statistical report joined
    End point values
    all patients
    Number of subjects analysed
    103
    Units: number
    20
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    overall study
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    15.1
    Reporting groups
    Reporting group title
    all patients
    Reporting group description
    -

    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 EA recolted for this study, only SAE
    Serious adverse events
    all patients
    Total subjects affected by serious adverse events
         subjects affected / exposed
    7 / 103 (6.80%)
         number of deaths (all causes)
    2
         number of deaths resulting from adverse events
    2
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Acute myeloid leukaemia
         subjects affected / exposed
    1 / 103 (0.97%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Injury, poisoning and procedural complications
    Wrist fracture
         subjects affected / exposed
    1 / 103 (0.97%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Nervous system disorders
    Headache coma hemiplegia
         subjects affected / exposed
    1 / 103 (0.97%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    headache vomiting
         subjects affected / exposed
    1 / 103 (0.97%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    General disorders and administration site conditions
    Death
         subjects affected / exposed
    1 / 103 (0.97%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Respiratory, thoracic and mediastinal disorders
    Respiratory distress
         subjects affected / exposed
    1 / 103 (0.97%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Septic shock
         subjects affected / exposed
    1 / 103 (0.97%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    all patients
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 103 (0.00%)

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    03 Aug 2010
    prolongation of inclusion period
    20 Jun 2011
    prolongation of inclusion period increasing of inclusion number update of patient following

    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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    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.

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