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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:2015-005676-25
    Sponsor's Protocol Code Number:AC16025
    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:2018-05-23
    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 number2015-005676-25
    A.3Full title of the trial
    Sensing using Neutrophil Activation Probe on the Intensive Therapy Unit
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Sensing using Neutrophil Activation Probe on the Intensive Therapy Unit
    A.3.2Name or abbreviated title of the trial where available
    Sensing using Neutrophil Activation Probe on ITU
    A.4.1Sponsor's protocol code numberAC16025
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02804854
    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 SponsorUniversity of Edinburgh
    B.1.3.4Country
    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 supportMedical Research Council
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity of Edinburgh
    B.5.2Functional name of contact pointKev Dhaliwal
    B.5.3 Address:
    B.5.3.1Street AddressE2.32
    B.5.3.2Town/ cityQueen's Medical Research Institute
    B.5.3.3Post codeEH16 4TJ
    B.5.4Telephone number0131 2429180
    B.5.6E-mailkev.dhaliwal@ed.ac.uk
    B.Sponsor: 2
    B.1.1Name of SponsorNHS Lothian
    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 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 nameNeutrophil activation probe (NAP)
    D.3.4Pharmaceutical form Endotracheopulmonary instillation, solution
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPEndotracheopulmonary use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNeutide
    D.3.9.2Current sponsor codeNAP
    D.3.9.4EV Substance CodeAS1
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number16 to ±25%
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Critical illness requiring ventilation
    E.1.1.1Medical condition in easily understood language
    A serious illness which requires the patient to need assistance with breathing
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10077264
    E.1.2Term Critical illness
    E.1.2System Organ Class 10018065 - General disorders and administration site conditions
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10003541
    E.1.2Term Assisted ventilation
    E.1.2System Organ Class 100000004865
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    1) To demonstrate and quantify the test reliability of this novel imaging test. Test reliability is a composite of the following two variables.

    a. Precision: Does the new test give the same result when the same lung segment is repeatedly tested.
    b. Accuracy: Does the new test give different results when lung segments known to be different (for example because of Xray results)?
    E.2.2Secondary objectives of the trial
    1) To demonstrate the safety of NAP/FE

    2) Additional secondary objectives are designed to assess test validity. They are divided into clinical and biological correlates. The secondary objectives are considered to be exploratory; therefore statistical analyses will not be pre-specified for all comparisons.

    a. Clinical: To assess the capability of NAP and FE to predict and correlate with the following outcomes/occurrences within the first 7 calendar days of admission:

    i. Oxygenation index
    ii. PF ratio
    iii. Ventilator free days (VFDs)
    iv. Ventilator associated event (VAE)
    • Occurrence of at least one event per patient
    • Number of events in studied cohort
    v. Berlin Criteria assessment for ARDS
    • Occurrence of at least one event per patient
    • Number of events in studied cohort
    • Time (days) to first occurrence
    • Severity at first occurrence
    vi. Mean sequential organ failure assessment (SOFA) score
    vii. Mortality
    • 7-day
    • ITU
    •
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    For all participants:
    • Participants aged 16 years or over
    • Participants who are predicted to require intubation for more than two calendar days, with this assessment made by a clinician (Registrar or Consultant in Intensive Care) who is independent of the study team.
    • Participants who have undergone chest radiological imaging within the preceding 48 hours prior to enrolment.
    • Participants who can undergo study bronchoscopy within the initial time period (C.D. 0-2) of first intubation in their present hospital admission (as determined by the absence of exclusion criteria for bronchoscopy laid out below).

    For BAL subset (up to a total of 10 participants)
    • Permission given to undertake a BAL by independent attending consultant
    • CONTROL BAL (n=5)
    o Absence of pulmonary infiltrates on the aforementioned chest radiological imaging
    • ABNORMAL BAL (n=5)
    o Pulmonary infiltrate on chest radiological imaging
    o Suspicion of community acquired pneumonia or ventilator associated pneumonia as determined by the clinical care team.


    E.4Principal exclusion criteria
    For enrolment into the study
    • Absence of consent from the participant or their personal or professional legal representative
    • Documented history of allergy to fluorescein
    • Pregnancy

    Prior to each bronchoscopy (as assessed within 24 hours of the start of the procedure)
    • Investigator not available to perform bronchoscopy with NAP/FE within the pre-specified time
    • Treatment withdrawal documented to take place within the next 24 hours
    • Presence of pneumothorax or intercostal chest drain
    • Refusal by the patient’s attending intensive care consultant

    Prior to each study blood sampling
    • Haemoglobin (Hb) < 6.5 g/dL.

    Prior to each BAL
    • Refusal to permit BAL by the participants attending consultant
    E.5 End points
    E.5.1Primary end point(s)
    NAP signal during multiple transbronchial passes of the same segment in the same patient.
    E.5.1.1Timepoint(s) of evaluation of this end point
    During each NAP/FE bronchoscopy procedure
    E.5.2Secondary end point(s)
    Completion of at least one NAP/FE examinations in 10 of the 75 recruited participants selected and consented to undergo broncho-alveolar lavage:
    o 5 with no pulmonary infiltrates on radiological imaging
    o 5 with at least one pulmonary infiltrate which is suspected to be due to community acquired or ventilator associated pneumonia
     Safety - assessed by occurrence of adverse reactions.
    E.5.2.1Timepoint(s) of evaluation of this end point
    End of study and last assessment on day 9 after enrolment (excepting mortality assessment at 90 days) for safety
    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 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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    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.8.4.1Number of sites anticipated in Member State concerned1
    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 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
    Last visit , last subject
    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
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial 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: 5
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 5
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 40
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 30
    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 2018-05-23. 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
    Adults with incapacity on the intensive care unit
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state75
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 75
    F.4.2.2In the whole clinical trial 75
    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 IMP is an imaging tool with no direct therapeutic benefit and there is no requirement or benefit from continuing the IMP.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2016-08-31
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-05-27
    P. End of Trial
    P.End of Trial StatusGB - no longer in EU/EEA
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