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    Summary
    EudraCT Number:2014-004471-23
    Sponsor's Protocol Code Number:CB/ALICE/0010
    National Competent Authority:Lithuania - SMCA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2015-09-14
    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 ConcernedLithuania - SMCA
    A.2EudraCT number2014-004471-23
    A.3Full title of the trial
    Antivirals for influenza Like Illness? An rCt of Clinical and Cost effectiveness in primary CarE
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Antivirals for influenza-like illness? What is the best option for you?
    A.3.2Name or abbreviated title of the trial where available
    Antivirals for influenza like illness? Clinical and Cost-effectiveness
    A.4.1Sponsor's protocol code numberCB/ALICE/0010
    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 Oxford
    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 supportEuropean Commission's Seventh Framework Programme
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity of Oxford
    B.5.2Functional name of contact pointProf Chris Butler
    B.5.3 Address:
    B.5.3.1Street AddressNew Radcliffe House, 2nd Floor, Radcliffe Observatory Quarter
    B.5.3.2Town/ cityOxford
    B.5.3.3Post codeOX1 6GG
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+44 (0)1865 289363
    B.5.6E-mailchristopher.butler@phc.ox.ac.uk
    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 Tamiflu 75 mg hard capsules
    D.2.1.1.2Name of the Marketing Authorisation holderRoche
    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 nameTamiflu 75 mg hard capsules
    D.3.4Pharmaceutical form Capsule
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNOseltamivir Phosphate
    D.3.9.1CAS number 204255-11-8
    D.3.9.4EV Substance CodeAS1
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number75
    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.IMP: 2
    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 Tamiflu 6 mg/ml powder for oral suspension
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Registration 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.3.1Product nameTamiflu 6 mg/ml powder for oral suspension
    D.3.4Pharmaceutical form Powder for oral suspension
    D.3.4.1Specific paediatric formulation Yes
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNOseltamivir
    D.3.9.1CAS number 204255-11-8
    D.3.9.4EV Substance CodeAS2
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    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
    Influenza-like illness
    E.1.1.1Medical condition in easily understood language
    Flu-like illness
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.0
    E.1.2Level PT
    E.1.2Classification code 10022004
    E.1.2Term Influenza like illness
    E.1.2System Organ Class 10018065 - General disorders and administration site conditions
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To determine whether adding antiviral treatment to best usual primary care is effective in reducing time to return to usual daily activity
    E.2.2Secondary objectives of the trial
    To determine whether adding antiviral treatment to best usual primary care:
    1.Is cost effective
    2.Decreases the incidence of hospital admissions
    3.Decreases complications related to influenza like illness (ILI), especially pneumonia
    4.Decreases repeat attendance at the GP
    5.Decreases time to alleviation of ILI symptoms
    6.Decreases the incidence of new or worsening symptoms
    7.Decreases time to initial reduction in severity of symptoms
    8.Decreases duration of symptoms that are moderately severe or worse
    9.Reduces the use of additional symptomatic and prescribed medication, including antibiotics
    10.Reduces the transmission of infection within household
    11.Affects the self-management of ILI symptoms
    12.Benefits certain subgroups of patients more than others
    13.To assess the clinical performance of Idylla™ point of care test (POCT) for diagnosing viral respiratory infections in Primary Care
    14.To investigate the logistical, organisation and perceived barriers and opportun
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    As tertiary objectives we are going to:
    1.Assess the analytic performance of the Idylla™ point of care test (POCT) for diagnosing viral respiratory infections in Primary Care
    2. Investigate the logistical, organisation and perceived barriers and opportunities in inter- and intra- pandemic clinical research
    These sub-studies are part of the same protocol.
    E.3Principal inclusion criteria
    •Male or Female, aged at least one year
    •Presenting with ILI* in primary care during a period of increased influenza activity.
    * ILI=sudden onset of self-reported fever, with at least one respiratory symptom (cough, sore throat, running or congested nose) and one systematic symptom (headache, muscle ache, sweats or chills or tiredness), symptom duration of 72 hours or less
    •Is able and willing to comply with all trial requirements
    •Participant or legal guardian(s) of a child is willing and able to give informed consent
    •Agrees not to take antiviral agents apart from study antiviral agents according to patient randomisation
    E.4Principal exclusion criteria
    The participant may not enter the trial if ANY of the following apply:
    •Chronic renal failure e.g. known or estimated creatinine glomerular filtration rate < 60 mg/l (known = recorded in GP clinical records)
    •Condition or treatment associated with significant impaired immunity (e.g. long-term oral steroids, chemotherapy, or immune disorder) (known = recorded in GP clinical records)
    •Those who in the opinion of the responsible clinician should be prescribed immediate antiviral treatment
    •Allergic to oseltamivir, or any other trial medication
    •Scheduled elective surgery or other procedures requiring general anaesthesia during the subsequent two weeks
    •Participant with life expectancy estimate by a clinician to be less than 6 months
    •Patient with severe hepatic impairment
    •Responsible clinician considers urgent hospital admission is required
    •Any other significant disease or disorder which, in the opinion of the responsible clinician, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or may affect the participant’s ability to participate in the trial
    •Involvement, including completion of any follow up procedures, in another clinical trial of an investigational medicinal product in the last 90 days
    •Previous ALIC4E trial participation
    •Patients unable to be randomised within 72 hours after onset of symptoms
    •Requirement for any live viral vaccine in the next 7 days
    E.5 End points
    E.5.1Primary end point(s)
    Direct report by the participant or their legal guardian of time to return to usual daily activity, where returned to usual daily activity = yes and fever, head and muscle -ache ≤ minor problem
    E.5.1.1Timepoint(s) of evaluation of this end point
    Telephone call on day 14 post randomisation
    E.5.2Secondary end point(s)
    1.Cost effectiveness measures through health resource use and EQ-5D-5L
    2.Number of hospital admissions
    3.Attendance hospital emergency care, or Out of Hours (OOH) centres with symptoms or complications and the reasons for them and the basis for diagnosis, such as pneumonia
    4.Attendance at GP Practice, hospital emergency care, or Out of Hours (OOH) centres with ILI symptoms
    5.Time to alleviation of ILI symptoms
    6.Incidence of new or worsening symptoms
    7.Report of time to onset of symptom relief
    8.Duration of moderately severe or worse symptoms
    9.Use of over-the-counter medications and prescription medications, including antibiotics
    10. Report of new cases if ILI within household
    11.Patient reported self-management, medication use, rest and activity
    12.Analysis of benefit according to age, illness duration, severity and co-morbidity measures.
    13.Performance of the Idylla™ POCT compared to standard laboratory based PCR test in +ve and – ve predictive values, sensitivity, specificity and added diagnostic value
    E.5.2.1Timepoint(s) of evaluation of this end point
    After 14 day symptom diary is returned and day 28 telephone call made.
    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 No
    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 Yes
    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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned50
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA20
    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
    The end of trial will be defined as; when all patients entered into the study have completed the one month follow-up.
    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 months5
    E.8.9.1In the Member State concerned days31
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months6
    E.8.9.2In all countries concerned by the trial days30
    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: 1000
    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) Yes
    F.1.1.4.1Number of subjects for this age range: 200
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 500
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 300
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 2000
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 1500
    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 state675
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 4500
    F.4.2.2In the whole clinical trial 4500
    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)
    We will be dispensing the full course of oseltamivir to the participants so they should not require any further antivirals. The participants would still be able to have other medication prescribed to them by their GP following the trial if appropriate.

    Paracetamol will still be available to buy and use by the participants, according to the instructions, after they have completed the course given by the trial.
    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 Decision2015-10-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-09-17
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-05-09
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