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    The EU Clinical Trials Register currently displays   43857   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).

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    Summary
    EudraCT Number:2007-005823-14
    Sponsor's Protocol Code Number:I07005
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2008-02-21
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedFrance - ANSM
    A.2EudraCT number2007-005823-14
    A.3Full title of the trial
    Impact de la TEP dans la stratégie diagnostique des fièvres d'origine indéterminée ou des syndromes inflammatoires nus chez l'adulte immunocompétent.
    A.3.2Name or abbreviated title of the trial where available
    FUO-TEP
    A.4.1Sponsor's protocol code numberI07005
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorCHU de LIMOGES
    B.1.3.4CountryFrance
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product name18 FDG
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNFludesoxyglucose
    D.3.9.1CAS number 13981-56-1
    D.3.10 Strength
    D.3.10.1Concentration unit MBq megabecquerel(s)
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration numbertrace
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Information not present in EudraCT
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    D.3.11.5Radiopharmaceutical medicinal product Yes
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Les fièvres d'origine indéterminée ou les syndromes inflammatoires nus.
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10016563
    E.1.2Term Fever of unknown origin
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10061218
    E.1.2Term Inflammation
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main 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.
    E.2.2Secondary objectives of the trial
    •Comparer la rentabilité diagnostique de la TEP au 18FDG aux autres investigations morphologiques couramment utilisées dans les FUO et syndromes inflammatoires nus (scanner éventuellement couplé à la scintigraphie au gallium).
    •Etudier la sensibilité et la spécificité de la nouvelle stratégie.
    •Réaliser une étude coût / rentabilité diagnostique de cette nouvelle stratégie.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    •Les patients répondant aux critères actuels de FUO :
    -Fièvre prolongée depuis au moins 3 semaines,
    -température supérieure à 38.3°C,
    -pas de diagnostic après 3 jours d’hospitalisation.
    Les patients répondant aux critères de fièvre prolongée intermittente, sous-groupe des FUO, seront également inclus dans l’étude :
    -Fièvres répondant aux critères de FUO,
    -Intervalles libres entre les accès avec apparente rémission entre les crises,
    -Au moins 3 accès fébriles.

    •Les patients répondant aux critères précédents, sans diagnostic après consultation auprès d’un médecin senior expérimenté dans le domaine des fièvres prolongées et après un pré requis d’examens complémentaires résumé dans l’annexe 4. En effet, actuellement, les patients ne présentant pas d’altération de l’état général ne sont plus hospitalisés et sont explorés en première intention en ambulatoire.

    •Les syndromes inflammatoires sans signes cliniques d’orientation.
    Il s’agit de patients présentant :
    -Un syndrome inflammatoire biologique franc : VS ≥ 50 à la première heure, et élévation d’au moins un autre paramètre inflammatoire (haptoglobine, orosomucoïde, fibrinogène ou C réactive protéine),
    -Evolution depuis plus de 3 semaines,
    -Interrogatoire et examen clinique n’apportant aucun signe d’orientation diagnostique,
    -Négativité du bilan réalisé en 3 jours d’hospitalisation ou négativité des examens notés en annexe 4; ce bilan préalable à l’inclusion doit être récent (moins de 15 jours) ou il doit être vérifié à nouveau.
    •Les patients doivent être affiliés à un régime de sécurité sociale.
    •Recueil du consentement éclairé.
    E.4Principal exclusion criteria
    •Patients incapables de comprendre ou d’adhérer au protocole: la réalisation du protocole peut nécessiter plusieurs séries d’examens programmés.
    •Femme enceinte ou sans contraception.
    •Contre-indications classiques aux examens iodés, à la scintigraphie au gallium ou à la TEP au 18FDG.
    •Patients immunodéprimés, car les investigations diagnostiques sont différentes.
    •Patients présentant d’autres formes de FUO que la forme usuelle : VIH positifs, patients neutropéniques et FUO nosocomiales.
    •Patients mineurs et patients majeurs faisant l’objet d’une mesure de protection légale.
    •Patients privés de liberté.
    •Patients faisant l’objet d’une mesure de sauvegarde de justice.
    E.5 End points
    E.5.1Primary end point(s)
    Le critère principal de jugement est la proportion de patient chez qui une orientation étiologique de la fièvre prolongée ou du syndrome inflammatoire inexpliqué est réalisée. La référence actuelle est le scanner plus ou moins la scintigraphie au gallium. Les calculs se feront par l’étude de la rentabilité diagnostique.
    Une anomalie de la TEP est considérée comme contributive au diagnostic quand elle désigne un organe ou un tissu où la cause de la fièvre ou du syndrome inflammatoire va être diagnostiqué par d’autres techniques conventionnelles. Elle est non contributive si l’anomalie est sans rapport avec la cause des symptômes ou si aucun diagnostic n’est finalement réalisé.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Yes
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety No
    E.6.5Efficacy No
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Médico-économique
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised Information not present in EudraCT
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned12
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    La fin de l'essai est prévue une fois les inclusions terminées (2 ans) suivies d'une période de suivi des patients de 9 mois maximum et d'une période d'analyse des données de 3 mois.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state100
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    Les patients bénéficieront de la prise en charge habituelle en fonction du diagnostic.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2008-04-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-11-09
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2013-05-01
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