Antivirals for influenza-like illness? Are they effective?

Not Applicable

Completed

• Conditions: Influenza-like illness; Infections and Infestations

• Registration Number: ISRCTN27908921
• Lead Sponsor: niversity of Oxford

Brief Summary

2018 protocol in https://www.ncbi.nlm.nih.gov/pubmed/30002007 (added 17/10/2019) 2019 results in https://www.ncbi.nlm.nih.gov/pubmed/31839279 (added 17/12/2019)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-10-22
• Study Completion: 2019-01-31
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 464

Inclusion Criteria

1. Aged at least one year old
2. Presenting with influenza-like illness* in primary care during a period of increased influenza activity.
3. Is able and willing to comply with all trial requirements
4. Participant or legal guardian(s) of a child is willing and able to give informed consent
5. Agrees not to take antiviral agents apart from study antiviral agents according to patient randomisation

*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), with a symptom duration of 72 hours or less.

Exclusion Criteria

1. Chronic renal failure e.g. known (recorded in GP clinical records) or estimated creatinine glomerular filtration rate of less than 60 mg/L
2. Condition or treatment associated with significant impaired immunity (e.g. long­term oral steroids, chemotherapy, or
immune disorder)
3. Those who in the opinion of the responsible clinician should be prescribed immediate antiviral treatment
4. Allergic to oseltamivir, or any other trial medication
5. Scheduled elective surgery or other procedures requiring general anaesthesia during the subsequent two weeks
6. Participant with life expectancy estimate by a clinician to be less than 6 months
7. Patient with severe hepatic impairment
8. Responsible clinician considers urgent hospital admission is required
9. 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
10. Involvement, including completion of any follow up procedures, in another clinical trial of an investigational medicinal product in the last 90 days
11. Previous ALIC4E trial participation
12. Patients unable to be randomised within 72 hours after onset of symptoms
13. 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
Time to return to usual activity is determined using a symptom diary recorded between day 1-14 and a telephone call on days 14 and 28.