Antivirals for influenza Like Illness? An rCt of Clinical and Cost effectiveness in primary CarE (ALICE)
- Conditions
- fluInfluenza-like illness1004743810024970
- Registration Number
- NL-OMON45203
- Lead Sponsor
- niversity of Oxford, contact person Prof. Christopher Butler
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 135
•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
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 ml/min (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 ALICE 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>To determine whether adding antiviral treatment to best usual primary care is<br /><br>effective in reducing time to return to usual daily activity.The outcome<br /><br>measured is 'Time to return to usual daily activity'. </p><br>
- Secondary Outcome Measures
Name Time Method <p>To determine whether adding antiviral treatment to best usual primary care:<br /><br>1. Is cost effective<br /><br>2. Decreases the incidence of hospital admissions<br /><br>3. Decreases complications related to influenza like illness (ILI), especially<br /><br>pneumonia<br /><br>4. Decreases repeat attendance at the GP<br /><br>5. Decreases time to alleviation of ILI symptoms<br /><br>6. Decreases the incidence of new or worsening symptoms<br /><br>7. Decreases time to initial reduction in severity of symptoms<br /><br>8. Decreases duration of symptoms that are moderately severe or worse<br /><br>9. Reduces the use of additional symptomatic and prescribed medication,<br /><br>including antibiotics<br /><br>10. Reduces the transmission of infection within household<br /><br>11. Affects the self-management of ILI symptoms<br /><br>12. Benefits certain subgroups of patients more than others</p><br>