Influenza-like illness MedDRA version: 19.0 Level: PT Classification code 10022004 Term: Influenza like illness System Organ Class: 10018065 - General disorders and administration site conditions
Conditions
Interventions
Trade Name: Tamiflu 75 mg hard capsules
Product Name: Tamiflu 75 mg hard capsules
Pharmaceutical Form: Capsule
INN or Proposed INN: Oseltamivir Phosphat
Sponsors
University of Oxford
Eligibility
Sex/Gender
All
Inclusion criteria
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 Are the trial subjects under 18? yes Number of subjects for this age range: 1000 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 2000 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 1500
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine whether adding antiviral treatment to best usual primary care is effective in reducing time to return to usual daily activity ; Secondary Objective: 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 opportunities in inter ;Primary 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;Timepoint(s) of evaluation of this end point: Telephone call on day 14 post randomisation | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary 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 ;Timepoint(s) of evaluation of this end point: After 14 day symptom diary is returned and day 28 telephone call made. | — |
Countries
Belgium, Czech Republic, Denmark, Hungary, Ireland, Lithuania, Netherlands, Poland, Sweden, United Kingdom
Contacts
Public ContactProf Chris Butler
University of Oxford
Outcome results
None listed