Antivirals for influenza Like Illness? An rCt of Clinical and Cost effectiveness in primary CarE - Antivirals for influenza like illness? Clinical and Cost-effectiveness

niversity of Oxford0 个研究点目标入组 4,500 人开始时间: 2015年9月9日最近更新: 2018年10月1日

试验速览

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•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

•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

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