ALICE is a randomised controlled trial in Primary Care that aims to determine whether adding antiviral treatment to best usual primary care is effective in reducing time to return to usual daily activity and so the clinical and cost effectiveness of…
ID
Source
Brief title
Condition
- Viral infectious disorders
- Respiratory tract infections
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
To determine whether adding antiviral treatment to best usual primary care is
effective in reducing time to return to usual daily activity.The outcome
measured is 'Time to return to usual daily activity'.
Secondary outcome
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
Background summary
Title: Antivirals for influenza-Like Illness? An rCt of Clinical and Cost
effectiveness in primary CarE (ALICE)
Given the findings of a reduction of 0.5 to 1 day in the time to first
alleviation of symptoms from treatment of ILI (influenza-Like Illness) with
antivirals, important questions remain:
Does this effect found in efficacy studies translate into meaningful benefit in
every day primary care? Specifically, what are the overall costs and benefits
of this shortened symptom duration from the perspective of the individual
sufferer, for the health services, and for society? Or do patients considered
to be at higher risk from complications of influenza (due to age or
co-morbidity for example) receive additional benefit from antiviral treatment
in primary care?
Answering these questions will reduce important clinical uncertainty for
primary care clinicians about whether to prescribe antiviral agents for ILI.
Study objective
ALICE is a randomised controlled trial in Primary Care that aims to determine
whether adding antiviral treatment to best usual primary care is effective in
reducing time to return to usual daily activity and so the clinical and cost
effectiveness of adding antiviral agents to best usual primary care of people
suffering from influenza-like illness (ILI).
Study design
The ALICE trial is a open, prospective, international, non-industry sponsored,
pragmatic randomised controlled trial in Primary Care. The trial will be
executed in approximately 20 European primary care networks. An adaptive trial
design will be used to test the study hypothesis.
Intervention
ALICE will be initiated with two open, intervention arms with patient
assignment by remote randomisation:
1. Oseltamivir, in the recommended doses for children and adults, with best
usual primary care
2. Best usual primary care
Those whom the responsible clinician considers should receive immediate
treatment with antiviral agents will not be eligible for the trial (this is one
of the exclusion criteria).
Study burden and risks
All patients will complete a symptom diary for 2 weeks (this may take up to 5
minutes every day). At baseline patients aged <16 will have an oropharyngeal
and nasal swab taken. Those >=16 will have a nasopharyngeal swab taken. Around
day 3, day 14 and after one 1 month the patients will be contacted by telephone
to complete a short questionnaire.
There are some common side effects when taking Oseltamivir, such as a headache
and nausea. Some of the less common side effects include dizziness, fatigue ,
abdominal pain and insomnia.
There are no guaranteed benefits from taking part. However, this study aims to
improve the treatment of flu-like illnesses in the future.
New Radcliffe House 2nd Floor, Radcliffe Observatory Quarter
Oxford OX1 6GG
GB
New Radcliffe House 2nd Floor, Radcliffe Observatory Quarter
Oxford OX1 6GG
GB
Listed location countries
Age
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
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 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
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2014-004471-23-NL |
| CCMO | NL54143.041.15 |