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    Summary
    EudraCT Number:2014-002221-35
    Sponsor's Protocol Code Number:P2013/PE1
    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:2014-08-01
    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 number2014-002221-35
    A.3Full title of the trial
    Prospective Randomized Study Comparing the Efficacy and Safety of Pleural Drainage by Video-Assisted Thoracoscopic With Pleural Drain Associated With Urokinase in the Treatment of Parapneumonic Pleural Effusion in Children
    Etude prospective randomisée comparant l’efficacité et la sécurité du drainage pleural par thoracoscopie vidéo-assistée au drainage pleural par drain percutané associé à l’urokinase dans la prise en charge de l’épanchement pleural parapneumonique chez l’enfant
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study comparing in children surgical drainage with medical drainage to evacuate the excess liquid around the lung in case of pneumonia
    Etude comparant chez les enfants le drainage chirurgical et le drainage médical pour évacuer l'excès de liquide apparaissant autour du poumon lors d'une pneumonie
    A.3.2Name or abbreviated title of the trial where available
    UROVATS
    A.4.1Sponsor's protocol code numberP2013/PE1
    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 SponsorHôpital Universitaire Des Enfants Reine Fabiola
    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 supportHôpital Universitaire Des Enfants Reine Fabiola
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationHôpital Universitaire Des Enfants Reine Fabiola
    B.5.2Functional name of contact pointClinical Research Unit
    B.5.3 Address:
    B.5.3.1Street AddressAvenue J.J. Crocq 15
    B.5.3.2Town/ cityBrussels
    B.5.3.3Post code1020
    B.5.3.4CountryBelgium
    B.5.4Telephone number003224773654
    B.5.5Fax number003224773897
    B.5.6E-mailbernard.wenderickx@huderf.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 Actosolv 100 000
    D.2.1.1.2Name of the Marketing Authorisation holderEumedica
    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.3.4Pharmaceutical form Solution for injection/infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntrapleural use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNUROKINASE
    D.3.9.1CAS number 9039-53-6
    D.3.9.4EV Substance CodeSUB05055MIG
    D.3.10 Strength
    D.3.10.1Concentration unit IU international unit(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100000
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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
    Parapneumonic pleural effusion
    pleural effusion parapneumonique
    E.1.1.1Medical condition in easily understood language
    pleural effusion
    pleural effusion
    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 17.0
    E.1.2Level PT
    E.1.2Classification code 10071699
    E.1.2Term Infectious pleural effusion
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.0
    E.1.2Level PT
    E.1.2Classification code 10014569
    E.1.2Term Empyema drainage
    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
    Comparison of the efficacy, in terms of drainge duration, of pleural drainage by Video-Assisted Thoracoscopic with pleural drainage by percutaneous drain associated with urokinase in the treatment of parapneumonic pleural effusion in children
    Comparer l’efficacité, en terme de durée de drainage, du drainage pleural par thoracoscopie vidéo-assistée au drainage pleural par drain percutané associé à l’urokinase dans la prise en charge de l’épanchement pleural parapneumonique chez l’enfant
    E.2.2Secondary objectives of the trial
    Compare the two techniques in terms of efficacy, safety, tolerance and cost-effectiveness
    Comparer des deux techniques en termes d’efficacité, d'innocuité, de tolérance et de rapport coût-efficacité
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Eligible ages : 1 year to 15 years
    - Eligible genders : both
    - pleural fluid depth of at least 15mm, confirmed by ultrasound
    - At least one of the following severity criteria :
    1) fever continuing 48h after starting correct antibiotherapy
    2) respiratory distress
    3) mediastinal shift on the chest X-ray
    - Garçon ou fille âgé entre 1 et 15 ans
    - Pneumonie avec épanchement pleural drainable confirmé par échographie thoracique (lame liquidienne > 15 mm)
    - Au moins un critère de gravité suivant :
    1) persistance de pyrexie 48 heures après le début d’une antibiothérapie bien conduite
    2) détresse respiratoire
    3) refoulement du médiastin à la radiographie de thorax
    E.4Principal exclusion criteria
    - previous drainage by either Video-Assisted Thoracoscopic or pleural drainage by percutaneous drain with or without fribrinolytic
    - congenital pulmonary disorders with lung function impairment
    - chronic pulmonary disease associated with lung function impairment
    - hemodynamic instability
    - acquired immune deficiency
    - secondary immune deficiency induced
    - coagulopathy disorder (contraindication of thrombolytic therapy)
    - pregnancy or breastfeeding patient
    - Drainage préalable par drain percutané ou chirurgical
    - Affection congénitale pulmonaire ou altérant directement ou indirectement la fonction pulmonaire
    - Affection pulmonaire chronique altérant la fonction pulmonaire
    - Choc avec instabilité hémodynamique
    - Immunodéficience congénitale ou acquise maligne ou médicamenteuse
    - Anomalie de la coagulation contre-indiquant l’usage de fibrinolytiques
    E.5 End points
    E.5.1Primary end point(s)
    Duration of drainage, in days
    Durée de drainage, en jours
    E.5.1.1Timepoint(s) of evaluation of this end point
    End of drainage is defined as a drainage of < 1ml/kg/24h
    Fin du drainage définie comme un drain ramenant < 1 ml/kg/24h
    E.5.2Secondary end point(s)
    - Mortality rate
    - Length of hospital stay
    - Duration of oxygen therapy
    - Duration of intravenous antibiotic therapy
    - Duration of fever > 38.5°C after the initiation of therapy
    - Patient disconfort
    - serious and non-serious adverse event related to the therapy
    - Inflammatory markers measurement
    - Cost-effectiveness
    - taux de mortalité
    - Durée d’hospitalisation totale
    - Durée d’oxygéno-dépendance
    - Durée d’antibiothérapie intraveineuse
    - Durée de pyrexie (> 38.5°C après intervention)
    - Inconfort du patient
    - Complications associés à la technique de drainage
    - Marqueurs inflammatoires sanguins
    - Coût total de l’hospitalisation relative à l’épanchement pleural
    E.5.2.1Timepoint(s) of evaluation of this end point
    - Evaluation of coagulation parameters at 48H post therapy initiation and at the drain removal (safety)
    - Serious and non serious adverse events recorded throughout the patient hospital stay (safety)
    - Safety visit performed 3 months after patient hospital discharged.
    - Duration in terms of days for (length of hospital stay, duration of oxygen therapy, duration of intravenous antibiotic therapy, duration of fever > 38.5°C after therapy initiation (efficacy)
    - Evaluation of leucocyte, neutrophile count, and CRP at 48H post therapy initiation and at the drain removal (efficacy)
    - Post-therapy initiation analgesic consumption until patient hospital discharge (tolerability)
    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 Yes
    E.6.5Efficacy Yes
    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 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) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    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 Yes
    E.8.2.3.1Comparator description
    Pleural Drainage by Video-Assisted Thoracoscopic
    E.8.2.4Number of treatment arms in the trial2
    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
    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 Yes
    F.1.1Number of subjects for this age range: 40
    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: 10
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 20
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 10
    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 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 2014-08-01. 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 No
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    children aged 1 to 15y
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state40
    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 Decision2014-09-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-12-18
    P. End of Trial
    P.End of Trial StatusCompleted
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