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    Summary
    EudraCT Number:2015-000629-35
    Sponsor's Protocol Code Number:version1.1.11/03/2015
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2015-07-13
    Trial results View 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 number2015-000629-35
    A.3Full title of the trial
    (Feasibility) Open label Randomised Controlled Trial of Hyperoxic O2 Therapy vs. Normoxic O2 Therapy in Sepsis
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    FEASIBILITY, OPEN LABEL, RANDOMISED CONTROLLED TRIAL OF HYPEROXIC O2 THERAPY VS. NORMOXIC O2 THERAPY IN SEPSIS
    A.3.2Name or abbreviated title of the trial where available
    HO2T or NO2T Trial
    A.4.1Sponsor's protocol code numberversion1.1.11/03/2015
    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 SponsorPlymouth Hospitals 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 supportPlymouth Hospitals NHS Trust Charitable Funds Committeee
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPlymouth Hospitals NHS Trust
    B.5.2Functional name of contact pointR&D Manager
    B.5.3 Address:
    B.5.3.1Street AddressResearch Office, Level 2 MSCP Bircham Park Offices, Morlaix Drive, Derriford
    B.5.3.2Town/ cityPlymouth
    B.5.3.3Post codePL6 8DH
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number01752431776
    B.5.6E-maillisa.vickers@nhs.net
    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 Medical Oxygen
    D.2.1.1.2Name of the Marketing Authorisation holderBOC Healthcare Ltd
    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.3.1Product nameMedical Oxygen
    D.3.4Pharmaceutical form Inhalation vapour, liquid
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPInhalation 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) 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 Yes
    D.3.11.13.1Other medicinal product typeinhaled medical oxygen
    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
    sepsis
    E.1.1.1Medical condition in easily understood language
    otherwise known as blood stream infection / blood poisoning or 'septicaemia'
    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 18.0
    E.1.2Level PT
    E.1.2Classification code 10040047
    E.1.2Term Sepsis
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective is to assess the feasibility of a study which answers the question:
    “In adult patients with sepsis presenting to the emergency department by ambulance does delivery of high flow oxygen (hyperoxic oxygen therapy) compared to titrated (normoxic) oxygen therapy reduce mortality at 90 days”

    NB. Mortality at 90 days (note: this is a feasibility study, multiple outcomes are of relevance in informing the definitive study).
    E.2.2Secondary objectives of the trial
    These are feasibility focussed and include a range of outcomes, which will inform the definitive study.
    - Can the study procedures be implemented as planned
    - Recruitment rate, characteristics of patients not recruited
    - Drop out rate and reasons for drop out.
    - Data collection success / missing data
    - Additional currently unidentified costs
    - Adequacy of follow up arrangements / number of patients lost to follow up
    - Collect data to identify survival and quality of life differences which may inform power calculation and primary outcome for the definitive study.
    - Optimal hours for patient recruitment
    - Identification of unexpected adverse events / reactions
    - identify patients for patient and public involvement.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Inclusion Criteria
    • Adult patients aged 18 years or above.
    • Diagnosed with presumed ‘Sepsis’
    • Arrive at Derriford Emergency Department by ambulance.
    • Provision of informed consent.
    • Willing to allow their General Practitioner and consultant, if appropriate,to be notified of participation in the study.
    E.4Principal exclusion criteria
    Exclusion Criteria
    The participant may not enter the study if ANY of the following apply:
    • Female participants who are pregnant
    • Existing diagnosis of chronic obstructive pulmonary disease (COPD)
    • A primary diagnosis (or suspected diagnosis) of:
    o an acute cerebral vascular event
    o acute coronary syndrome
    o acute pulmonary oedema
    o status asthmaticus
    o major cardiac arrhythmia (as part of primary diagnosis)
    o seizure
    o drug overdose
    o injury from burn or trauma
    • Participants who require immediate intubation and ventilation on arrival in the Emergency Department
    • Participants undergoing or have undergone cardiopulmonary resuscitation in the pre-hospital phase of their treatment.
    • Current participation in another Clinical Trial of an Investigational Medicinal Product (CTIMP).
    E.5 End points
    E.5.1Primary end point(s)
    To assess the feasibility of a study which answers the question:
    “In adult patients with sepsis presenting to the emergency department by ambulance does delivery of high flow oxygen (hyperoxic oxygen therapy) compared to titrated oxygen therapy (normoxic oxygen therapy) effect mortality at 90 days”
    E.5.1.1Timepoint(s) of evaluation of this end point
    90 days post admission to ED
    E.5.2Secondary end point(s)
    These are focussed on feasibility and include a range of outcomes, which will inform the definitive study. The following will be assessed:
    - Can the study procedures be implemented as planned?
    - Recruitment rate
    - Acceptability of interventions
    - Drop-out rate (and reasons)
    - Data collection success / missing data
    - Additional currently unidentified costs
    - Adequacy of follow up arrangements / number of patients lost to follow up
    - Collect data to identify survival and quality of life differences which may inform power calculation and primary outcome for the definitive study
    E.5.2.1Timepoint(s) of evaluation of this end point
    90 days post admission to ED
    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 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) No
    E.7.4Therapeutic use (Phase IV) Yes
    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 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 Yes
    E.8.2.3.1Comparator description
    No additional Oxygen therapy
    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
    The end of trial is the date of the last follow up of the last participant.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months8
    E.8.9.1In the Member State concerned days1
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months8
    E.8.9.2In all countries concerned by the trial days1
    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.1.1.1.1Number 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) No
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 100
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 100
    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 No
    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 No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state200
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 200
    F.4.2.2In the whole clinical trial 200
    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)
    Not appropriate in this patient population.
    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 Decision2015-07-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-08-10
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-11-10
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