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    Summary
    EudraCT Number:2010-023668-42
    Sponsor's Protocol Code Number:CRI 102194
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:GB - no longer in EU/EEA
    Date on which this record was first entered in the EudraCT database:2011-01-04
    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 ConcernedUK - MHRA
    A.2EudraCT number2010-023668-42
    A.3Full title of the trial
    Pulmonary surfactant (S) biology in ventilated children on a paediatric intensive care unit with acute (A) hypoxic respiratory (R) failure- a pilot (P) study (S): (SARPS)
    A.3.2Name or abbreviated title of the trial where available
    SARPS
    A.4.1Sponsor's protocol code numberCRI 102194
    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 SponsorSouthampton University Hospital NHS Trust
    B.1.3.4CountryUnited Kingdom
    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 Yes
    D.2.1.1.1Trade name Curosurf
    D.2.1.1.2Name of the Marketing Authorisation holderChiesi Limited
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 Endotracheopulmonary instillation, suspension
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPEndotracheopulmonary use
    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) 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 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 Yes
    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
    acute hypoxic respiratory failure in children ventilated on paediatric intensive care
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.1
    E.1.2Level PT
    E.1.2Classification code 10040047
    E.1.2Term Sepsis
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.1
    E.1.2Level PT
    E.1.2Classification code 10018985
    E.1.2Term Haemorrhage intracranial
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.1
    E.1.2Level PT
    E.1.2Classification code 10006093
    E.1.2Term Bradycardia
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.1
    E.1.2Level PT
    E.1.2Classification code 10021097
    E.1.2Term Hypotension
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.1
    E.1.2Level PT
    E.1.2Classification code 10006475
    E.1.2Term Bronchopulmonary dysplasia
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.1
    E.1.2Level PT
    E.1.2Classification code 10035759
    E.1.2Term Pneumothorax
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.1
    E.1.2Level PT
    E.1.2Classification code 10037394
    E.1.2Term Pulmonary haemorrhage
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.1
    E.1.2Level PT
    E.1.2Classification code 10058490
    E.1.2Term Hyperoxia
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.1
    E.1.2Level PT
    E.1.2Classification code 10011705
    E.1.2Term Cyanosis neonatal
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.1
    E.1.2Level PT
    E.1.2Classification code 10002974
    E.1.2Term Apnoea
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.1
    E.1.2Level PT
    E.1.2Classification code 10033318
    E.1.2Term Oxygen saturation decreased
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.1
    E.1.2Level PT
    E.1.2Classification code 10014408
    E.1.2Term Electroencephalogram abnormal
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.1
    E.1.2Level PT
    E.1.2Classification code 10063349
    E.1.2Term Endotracheal intubation complication
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Does a single dose of exogenous surfactant (100mg/kg CUROSURF® (poractant alfa) administered via the endotracheal tube substantially alter surfactant metabolism in children with AHRF
    E.2.2Secondary objectives of the trial
    a) Can choline chloride (trimethyl-D9) be use effectively to study surfactant metabolism in children with AHRF?
    b) Is diminished production a major cause of AHRF in children?

    c) Is there significant hydrolysis and oxidative damage of surfactant phospholipid in children with AHRF?
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Inclusion criteria
    Age less than 16 years
    Ventilated on PICU (controls and cases)
    CASES: Acute hypoxic respiratory failure (AHRF) (controls) as defined by degree of observed hypoxia assessed using the P/F ratio P/F ratio of < 300 mmHg (Calculated by dividing the arterial partial pressure of oxygen (PaO2 = P) by the fractional concentration of oxygen in the inspired gas mixture delivered by the ventilator (FiO2 = F)
    CONTROLS: Ventilated children who do not meet the criteria for AHRF as defined above
    Informed consent from the child's parents
    E.4Principal exclusion criteria
    Exclusion criteria
    Failure to obtain informed consent from the child's parents
    Extreme cardiovascular instability
    Intractable intra cranial hypertension
    Pulmonary haemorrhages
    Persistent pulmonary air leak
    Advanced malignancy
    Cardiopulmonary resuscitation
    Children not likely to survive the time period of the intervention
    Patients who are pregnant
    Immediate families of investigators or site personnel directly affiliated with the study. Immediate family is defined as child or sibling, whether biological or legally adopted.
    Participation in a investigational clinical trial
    E.5 End points
    E.5.1Primary end point(s)
    The primary end point is the measurement of the rate of synthesis of surfactant in healthy lungs compared with the rate in lungs of children with acute hypoxic respiratory failure before and after the installation of curosurf.
    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 Yes
    E.6.4Safety No
    E.6.5Efficacy Yes
    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 Yes
    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) 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 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 Information not present in EudraCT
    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
    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 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.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) Yes
    F.1.1.4Infants and toddlers (28 days-23 months) Yes
    F.1.1.5Children (2-11years) Yes
    F.1.1.6Adolescents (12-17 years) Yes
    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 Information not present in EudraCT
    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 Yes
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Children sedated and ventilated on paediatric intensive care for the treatment of acute hypoxaemic respiratory failure. Consent will be sort from their parents (or other adults who have parental responsibility0
    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)
    N/A
    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 Decision2011-02-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-01-25
    P. End of Trial
    P.End of Trial StatusGB - no longer in EU/EEA
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