Plain English Summary
Background and study aims
Flu (influenza) and flu-like illness are among the most common reasons why parents and carers take children to see a doctor or nurse in winter. Flu is a viral infection that just causes a mild cough or cold in most children. However, when some children get flu, they develop bacterial infections, such as chest or ear infections, which can make them feel even more unwell. 'At risk' children with underlying medical conditions such as asthma and diabetes are particularly prone to becoming more unwell from bacterial infections if they get flu.
We would like to find out whether giving an antibiotic called co-amoxiclav to 'at risk' children within 5 days of them becoming ill with flu or flu-like illness might:
1. Help stop them from developing bacterial infections and becoming more unwell
2. Help them get better more quickly
3. Affect how well antibiotics work against similar infections in future
Who can participate?
We are looking for 'at risk' children between 6 months and 12 years of age, who see a doctor or nurse within the first five days of developing flu or flu-like illness. 'At risk' children include children with medical conditions such as asthma, diabetes, cancer, cerebral palsy, Down's syndrome, heart problems, kidney problems and liver problems. 'At risk' children also include children under 2 years of age who were born prematurely.
What does the study involve?
A healthcare professional will gain consent for each child to take part in the study from a parent or guardian. The healthcare professional will then record some details about the child's flu-like illness. A nose swab and, if possible, a throat swab will be taken from each child. Each child will be randomly allocated to either receive an antibiotic (co-amoxiclav) or a placebo (dummy). Parents and guardians will be asked to give children one dose of medication twice a day for five days and to fill in a study diary. Parents and guardians will be asked if they would be willing for their child to have further optional throat swabs after three months, six months and twelve months.
What are the possible benefits and risks of participating?
This study will help us work out whether giving antibiotics to 'at risk' children early on when they have flu or flu-like illness is worthwhile. It may also help the government plan how to use antibiotics during future flu epidemics or pandemics (which is when lots of people get flu all at once). The study medication may help children get better more quickly and/or prevent them from becoming more unwell from a bacterial infection. However, we will not know this for sure until the end of the study.
Where is the study run from?
University of Oxford (UK).
When is the study starting and how long is it expected to run for?
It is anticipated that recruitment will start in winter 2014. Recruitment will take place over three winters (2014/5, 2015/6 and 2016/7). Each winter will be defined as October to March inclusive, although peak recruitment will occur between December and February, when influenza tends to go around most.
Who is funding the study?
National Institute for Health Research (UK).
Who is the main contact?
Dr Kay Wang
Mrs Patricia Carver
Department of Primary Health Care
Hythe Bridge Street
The early use of Antibiotics for at Risk CHildren with InfluEnza in primary care (ARCHIE): a double-blind randomised placebo-controlled trial
In 'at risk' children with influenza, early use of antibiotics reduces the likelihood of subsequent re-consultation due to clinical deterioration during the same illness episode.
More details can be found at:http://public.ukcrn.org.uk/Search/StudyDetail.aspx?StudyID=15212
Note: The recruitment is expected to commence in October 2014. The study is now in set up stage.
NRES Committee North West - Liverpool East, ref:13/NW/0621, First MREC approval date 10/10/2013, ref: 13/NW/0621
Double-blind randomised placebo-controlled trial
Primary study design
Secondary study design
Randomised controlled trial
Patient information sheet
Patient information can be found at: http://www.phctrials.ox.ac.uk/studies/archie
Influenza and influenza-like illness
Co-amoxiclav 400/57 or matching placebo for 5 days.
Follow Up Length: 12 month(s)
Study Entry: Single Randomisation only
Primary outcome measures
Proportion of children re-consulting due to clinical deterioration within 28 days of study entry.
Secondary outcome measures
1. Duration of fever from time of study entry.
2. Duration of symptoms from time of study entry.
3. Proportion of children prescribed medication (e.g. antibiotics, steroids) and/or requiring further investigations (e.g. chest X-ray) within 28 days of study entry.
4. Proportion of children in whom adverse events are reported within 28 days of study entry.
5. Proportion of children who are hospitalised or die within 28 days of study entry.
Other outcome measures:
6. Health-related quality of life using the EQ-5D-Y and EQ-5D-Y proxy on days 1, 4, 7, 14 and 28.
7. Healthcare resource utilisation and parental/informal care costs within 28 days of study entry.
8. Minimum inhibitory concentrations (MICs) of alpha-haemolytic streptococci (including Streptococcus pneumoniae), Haemophilus influenzae and Staphylococcus aureus in relation to a representative range of antibiotics 3 months, 6 months and 12 months after study entry.
9. Proportion of ampicillin-resistant alpha-haemolytic streptococci (including Streptococcus pneumoniae), Haemophilus influenzae and Staphylococcus aureus 12 months after study entry.
10. Prevalence of alpha-haemolytic streptococci (including Streptococcus pneumoniae), Haemophilus influenzae and Staphylococcus aureus at 12 months after study entry.
Overall trial start date
Overall trial end date
Participant inclusion criteria
1. Male and female, aged 6 months to 12 years inclusive
2. In 'at risk' category, including:
2.1. Aged under 2 years and born prematurely
2.2. Respiratory/renal conditions
2.3. Cardiac conditions/cancer/cerebral palsy
2.4. Hepatic/haematological conditions
2.6. Endocrine/metabolic conditions
3. Presenting with influenza-like illness (i.e., cough and fever) during influenza season
4. Presenting within 5 days of symptom onset
5. Permanently registered at a general practice in England
6. Parent/guardian able to complete study diary and questionnaires
Target number of participants
Planned Sample Size: 650; UK Sample Size: 650; Description: randomised 1:1
Participant exclusion criteria
1. Known contraindication to co-amoxiclav
2. Child given antibiotics within the last 72 hours
3. Child requires immediate antibiotics or hospital admission (clinicians judgement)
4. Presence of any reason to prevent healthcare professional from obtaining high nasal swab
5. Child with known cystic fibrosis
6. Child previously entered into the ARCHIE study
7. Child has been involved in another medicinal trial within the last 90 days
Recruitment start date
Recruitment end date
Countries of recruitment
Trial participating centre
Department of Primary Health Care
National Institute for Health Research
Funding Body Type
Funding Body Subtype
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting