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    Summary
    EudraCT Number:2014-004224-22
    Sponsor's Protocol Code Number:TEMOPEDI
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2015-12-10
    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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2014-004224-22
    A.3Full title of the trial
    Temocillin pharmacokinetics in paediatrics
    Pharmacocinétique de la témocilline en pédiatrie
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Measuring the concentration profile of the antibiotic temocillin in the blood of children
    Etude du profile de concentration de la témocilline, un antibiotique, chez les enfants
    A.3.2Name or abbreviated title of the trial where available
    TEMOPEDI
    A.4.1Sponsor's protocol code numberTEMOPEDI
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02260102
    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 SponsorUniversité catholique de Louvain
    B.1.3.4CountryBelgium
    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 supportressources from the research laboratory of F. Van Bambeke
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversité Catholique de Louvain
    B.5.2Functional name of contact pointVan Bambeke
    B.5.3 Address:
    B.5.3.1Street Addressavenue Mounier 73 B1.73.05
    B.5.3.2Town/ cityBrussels
    B.5.3.3Post code1200
    B.5.3.4CountryBelgium
    B.5.4Telephone number3227647378
    B.5.6E-mailfrancoise.vanbambeke@uclouvain.be
    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 NEGABAN
    D.2.1.1.2Name of the Marketing Authorisation holderEUMEDICA SA
    D.2.1.2Country which granted the Marketing AuthorisationBelgium
    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 nameTemocilline
    D.3.4Pharmaceutical form Powder for solution for injection
    D.3.4.1Specific paediatric formulation No
    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 INNtemocillin
    D.3.9.1CAS number 61545-06-0
    D.3.9.3Other descriptive nameTEMOCILLIN SODIUM
    D.3.9.4EV Substance CodeSUB128094
    D.3.10 Strength
    D.3.10.1Concentration unit g gram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    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
    Male or female patient requiring temocillin
    a. for the treatment of urinary tract infections, or
    b. for the treatment of suspicion of cholangitis associated with cirrhosis, or
    c. as antibiotic prophylaxis following an hepatic transplant.
    Patient masculin ou féminin nécessitant la témocilline
    a. pour le traitement d’une infection urinaire
    b. pour le traitement d’une suspicion de cholangite associée à une cirrhose hépatique
    c. comme prophylaxie après une greffe hépatique
    E.1.1.1Medical condition in easily understood language
    child requiring temocillin for
    a. an urinary tract infection
    b. an infection of the biliary duct associated to an hepatic pathology
    c. the prevention of an infection after hepatic transplantation
    enfant nécessitant l'administration de témocilline pour
    a. infection urinaire
    b. infection de voies biliaires associée à une atteinte du foie
    c. prévention d'une infection après greffe de foie
    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 18.1
    E.1.2Level PT
    E.1.2Classification code 10024714
    E.1.2Term Liver transplant
    E.1.2System Organ Class 10042613 - Surgical and medical procedures
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.1
    E.1.2Level HLT
    E.1.2Classification code 10004607
    E.1.2Term Bile duct infections and inflammations
    E.1.2System Organ Class 10019805 - Hepatobiliary disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.1
    E.1.2Level SOC
    E.1.2Classification code 10042613
    E.1.2Term Surgical and medical procedures
    E.1.2System Organ Class 10042613 - Surgical and medical procedures
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.1
    E.1.2Level PT
    E.1.2Classification code 10046571
    E.1.2Term Urinary tract infection
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.1
    E.1.2Level HLGT
    E.1.2Classification code 10021879
    E.1.2Term Infections - pathogen unspecified
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.1
    E.1.2Level SOC
    E.1.2Classification code 10021881
    E.1.2Term Infections and infestations
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.1
    E.1.2Level HLT
    E.1.2Classification code 10019704
    E.1.2Term Hepatic therapeutic procedures
    E.1.2System Organ Class 10042613 - Surgical and medical procedures
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.1
    E.1.2Level PT
    E.1.2Classification code 10008605
    E.1.2Term Cholangitis acute
    E.1.2System Organ Class 10019805 - Hepatobiliary disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.1
    E.1.2Level SOC
    E.1.2Classification code 10019805
    E.1.2Term Hepatobiliary disorders
    E.1.2System Organ Class 10019805 - Hepatobiliary disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.1
    E.1.2Level HLGT
    E.1.2Classification code 10019818
    E.1.2Term Hepatobiliary therapeutic procedures
    E.1.2System Organ Class 10042613 - Surgical and medical procedures
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.1
    E.1.2Level HLGT
    E.1.2Classification code 10004606
    E.1.2Term Bile duct disorders
    E.1.2System Organ Class 10019805 - Hepatobiliary disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.1
    E.1.2Level LLT
    E.1.2Classification code 10024716
    E.1.2Term Liver transplantation
    E.1.2System Organ Class 10042613 - Surgical and medical procedures
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    1. Characterisation of the pharmacokinetics (PK) of temocillin (total and free concentrations) in 3 paediatric populations:
    a. children requiring antibiotic treatment for urinary tract infections
    b. cirrhotic children requiring antibiotic treatment due to suspicion of cholangitis
    c. children requiring antibiotic prophylaxis following an hepatic transplant
    2. Proposal and development of a dosing schedule that can ensure therapeutic concentrations (40% ƒT > MIC) and optimize treatment chances of success.
    1. Caractérisation de la pharmacocinétique (PK) de la témocilline (concentrations totale et libre) dans trois populations pédiatriques:
    a. Enfants nécessitant un traitement antibiotique pour infection urinaire
    b. Enfants cirrhotiques nécessitant un traitement antibiotique pour suspicion de cholangite
    c. Enfants nécessitant une prophylaxie antibiotique après une greffe hépatique
    2. Proposition et développement d’un schéma de dosage qui assure des concentrations thérapeutiques (40% ƒT > CMI) et optimise les chances de succès thérapeutique.
    E.2.2Secondary objectives of the trial
    Characterization of MICs (Minimal Inhibitory Concentrations) of microbiological strains (when available) to temocillin.

    Caractérisation des CMIs de la témocilline pour les souches qui pourront être collectées
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Male or female patient requiring temocillin
    a. for the treatment of urinary tract infections, or
    b. for the treatment of suspicion of cholangitis associated with cirrhosis, or
    c. as antibiotic prophylaxis following an hepatic transplant.
    2. Requirement of hospitalization (not for social or other non-medical reasons) for at least up to 5 days
    3. Patients aged 6 months - 3 years at the beginning of the treatment with temocillin
    4. Parents or legal representatives able to give written informed consent in accordance with GCP and local regulatory requirements, prior to any study procedure
    Critères d’inclusion
    1. Patient masculin ou féminin nécessitant la témocilline
    a. pour le traitement d’une infection urinaire
    b. pour le traitement d’une suspicion de cholangite associée à une cirrhose hépatique
    c. comme prophylaxie après une greffe hépatique
    2. Nécessité d’hospitalisation (à l’exclusion des raisons sociales ou autre raison non médicale) pour au moins 5 jours
    3. Patients âgés de 6 mois à 3 ans au début du traitement par la témocilline
    4. Parents ou représentants légaux capables de donner un consentement éclairé en accord avec les GCP et règles locales avant le début de l’étude
    E.4Principal exclusion criteria
    1. Ig-E mediated allergy to penicillins
    2. Previous treatment with temocillin for the current cholangitis episode
    3. Estimated life-expectancy of < 5 days due to major co-morbid conditions
    4. Other serious illnesses (e.g. HIV), serious infections requiring other antibiotics, malignancy
    5. Patients with acute or chronic renal failure (eGFR < 30ml/min)
    6. Patients having participated in another study < 30 days before inclusion in the present study
    Allergie Ig-E médiée aux pénicillines
    2. Traitement préalable à la témocilline pour l’épisode de cholangite en cours
    3. Espérance de vie < 5 jours en raison de comorbidités sévères
    4. Autres pathologies sous-jacentes sévères (par exemple HIV), infections sévères requérant d’autres antibiotiques, cancer
    5. Patients avec insuffisance rénale aiguë ou chronique (eGFR < 30ml/min)
    6. Patients ayant participé à une autre étude < 30 jours avant l’inclusion dans la présente étude
    E.5 End points
    E.5.1Primary end point(s)
    - measure of temocillin (total and free concentrations) in all blood samples collected and pharmacokinetic analysis
    - mesure des concentrations en témocilline (totale et libre) dans tous les échantillons de sang collectés et analyse pharmacocinétique
    E.5.1.1Timepoint(s) of evaluation of this end point
    Sample analysis: 1 month after termination of the treatment of the last patient
    Pharmacokinetic analysis: maximum 1 year after termination of the study
    analyse des échantillons: un mois après la fin du traitement du dernier patient
    analyse pharmacocinétique: < un an après la fin de l'étude
    E.5.2Secondary end point(s)
    none
    non applicable
    E.5.2.1Timepoint(s) of evaluation of this end point
    not applicable
    not applicable
    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 Yes
    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
    LVLS
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    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 Yes
    F.1.1Number of subjects for this age range: 45
    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) Yes
    F.1.1.4.1Number of subjects for this age range: 22
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 23
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) No
    F.1.3Elderly (>=65 years) No
    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 No
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    target population is children < 3 years. Consent will be give by parents or legal representatives.
    La population cible est constituée d'enfants de moins de 3 ans. Le consentement sera donné par les parents ou leurs représentants légaux.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state45
    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)
    None
    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 Decision2015-12-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-11-16
    P. End of Trial
    P.End of Trial StatusCompleted
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