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    The EU Clinical Trials Register currently displays   44339   clinical trials with a EudraCT protocol, of which   7369   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:2011-002177-34
    Sponsor's Protocol Code Number:10 150 02
    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:2011-09-06
    Trial 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 number2011-002177-34
    A.3Full title of the trial
    Population pharmacokinetics of levofloxacin in intensive care patients with severe community-acquired pneumonia
    Pharmacocinétique de population de la lévofloxacine chez des patients de réanimation présentant une pneumopathie communautaire
    A.3.2Name or abbreviated title of the trial where available
    Lévo-Pharm
    A.4.1Sponsor's protocol code number10 150 02
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorCHU de Toulouse
    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 supportAppel d'offre local 2010
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCHU de Toulouse
    B.5.2Functional name of contact pointDirection de la Recherche Clinique
    B.5.3 Address:
    B.5.3.1Street Address2 rue viguerie Hotel Dieu DRCI
    B.5.3.2Town/ cityToulouse
    B.5.3.3Post code31000
    B.5.3.4CountryFrance
    B.5.4Telephone number+330561 77 83 47+33
    B.5.6E-mailpasturaud.a@chu-toulouse.fr
    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 Yes
    D.2.1.1.1Trade name TAVANIC 5 mg/ml, solution pour perfusion
    D.2.1.1.2Name of the Marketing Authorisation holderSANOFI-AVENTIS FRANCE
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    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 nameTavanic
    D.3.2Product code NA
    D.3.4Pharmaceutical form Solution for injection/infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous drip use (Noncurrent)
    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) No
    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 No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    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 No
    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
    community-acquired pneumonia
    Pneumopathie communautaire
    E.1.1.1Medical condition in easily understood language
    community-acquired pneumonia
    E.1.1.2Therapeutic area Diseases [C] - Bacterial Infections and Mycoses [C01]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.0
    E.1.2Level LLT
    E.1.2Classification code 10032502
    E.1.2Term Other specified alveolar and parietoalveolar pneumopathies
    E.1.2System Organ Class 10038738 - Respiratory, thoracic and mediastinal disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The main objective of this study is to describe levofloxacin pharmacokinetics in ICU patients suffering from pneumonia with taking into account physio-pathological parameters
    L'objectif primaire est de décrire chez les patients de réanimation présentant une pneumopathie communautaire, la pharmacocinétique de la lévofloxacine en prenant en compte dans le modèle mathématique les paramètres physiopathologiques influençant cette cinétique de la lévofloxacine à la posologie de 500 mg en perfusion de 60 minutes deux fois par jour.
    E.2.2Secondary objectives of the trial
    to verify clinical and bacteriological efficiency and to know if the peak/MIC ratio > 5 and AUC/MIC ratio > 125
    L’objectif secondaire est de vérifier l’efficacité clinique et bactériologique, et de noter si les objectifs thérapeutiques en terme de rapport Pic/ CMI (>10) et ASC24h/CMI (>125) sont atteints.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    severe community-acquired pneumonia due to a strain sensible to levofloxacin
    Age > 18 years
    Informed consent
    SAPS II (simplified acute physiological score) > 20
    Awaited duration of survival higher than 7 days
    E.4Principal exclusion criteria
    Historia of allergy to levofloxacin
    Resistant strain to levofloxacin
    Pregnancy
    Contra-indications of levofloxacin use, renal failure
    E.5 End points
    E.5.1Primary end point(s)
    L’objectif principal étant de rechercher l’influence des paramètres physiopathologiques sur la pharmacocinétique de la lévofloxacine, les critères principaux correspondent aux données clinico-biologiques recueillies, aux concentrations sériques de la lévofloxacine mesurées sur les prélèvements réalisés par méthode HPLC et au recueil extemporané :
    o des doses administrées et ce dès la première dose
    o des dates et heures REELLES (sur 24h) d’administration
    o des dates et heures REELLES (sur 24h) de prélèvement.
    E.5.1.1Timepoint(s) of evaluation of this end point
    1er prélévement sanguin de l'étude : 5 minutes avant la 5ème administration du Tavanic
    2nd prélévement sanguin : 30 minutes après le 5ème administation du Tavanic
    3ème prélévement sanguin : 1 heure après
    4ème prélévement sanguin : 2 heure après 5ème prélévement sanguin : 4 heure après 6ème prélévement sanguin : 6 heure après 7ème prélévement sanguin : 8 heure après 8ème prélévement sanguin : 12 heure après
    E.5.2Secondary end point(s)
    L’évaluation de l'efficacité se basera sur l’évolution des paramètres suivants : température (<38,5°), leucocytes (<12000), Procalcitonine (0,5) et l’éradication du germe responsable s’il est retrouvé par le suivi bi-hebdomadaire des aspirations trachéales (quantitatives).
    E.5.2.1Timepoint(s) of evaluation of this end point
    Paramètres évalués tout au long de la recherche
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety No
    E.6.5Efficacy No
    E.6.6Pharmacokinetic Yes
    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 No
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    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 No
    E.8.7Trial has a data monitoring committee No
    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’étude pharmacocinétique pour un patient correspond au dernier prélèvement sanguin effectué juste avant la 6ème administration du Tavanic.
    La patient pourra sortir d'essai avant la fin de la recherche
    -sur sa propre décision et/ou celle d’un membre de sa famille ou de la personne de confiance,
    -par nécessité, après décision de l'investigateur.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2011-09-06. Yes
    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 Yes
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    The health of some patients will not allow them to sign the consent.
    Consent must be signed by the trusted person of the patient (or family member)
    L'état de santé de certains patients ne leur permettra pas d’exprimer leur volonté de participer ou non à l’étude a priori. Le consentement devra être recueilli signé d'un proche ou de la personne de confiance accompagnatrice du patient.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state65
    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)
    The management of patients who completed the research will be identical to the usual care
    La prise en charge des patients sortis d’étude ou ayant fini la recherche conformément au protocole, sera identique à la prise en charge habituelle
    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 Decision2011-08-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-11-07
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2014-09-12
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