Antivirals for influenza-like illness? What is the best option for you?

Phase 1

• Conditions: Influenza-like illness; MedDRA version: 18.1Level: PTClassification code 10022004Term: Influenza like illnessSystem Organ Class: 10018065 - General disorders and administration site conditions; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2014-004471-23-NL
• Lead Sponsor: niversity of Oxford

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-01-05
• Study Completion: 2018-05-09
• Last Update Posted: 24 August 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 3266

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

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified