The early use of Antibiotics in at Risk Children with InfluEnza-ARCHIE
Research type
Research Study
Full title
The early use of Antibiotics for at Risk CHildren with InfluEnza in primary care (ARCHIE): a double-blind randomised placebo-controlled trial
IRAS ID
121769
Contact name
Heather House
Contact email
Sponsor organisation
University of Oxford
Eudract number
2013-002822-21
Duration of Study in the UK
3 years, 6 months, 31 days
Research summary
Flu (influenza) and flu-like illness are among the commonest reasons why parents and carers take children to see a doctor or nurse in winter. Flu is a viral infection, which just causes a mild cough or cold-like sypmtoms 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 (asthma, diabetes, cancer, cerebral palsy, Down’s syndrome, heart problems, kidney problems , liver problems, or under 2 years of age who were born prematurely) 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 (between 6 months and 12 years of age) 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.The National Institute for Health Research (NIHR) is funding our research. We hope to recruit participants from general practices, across Thames Valley, Liverpool, Bristol and Southampton regions. In each region we will also aim to include recruitment from at least one out-of- hours centre and one accident and emergency department. Participant recruitment will be done by a healthcare professional appropriately trained in the study procedures and GCP. They 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 allocated a bottle of study medication, which may contain the antibiotic (co-amoxiclav) or a placebo. 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.
REC name
North West - Liverpool Central Research Ethics Committee
REC reference
13/NW/0621
Date of REC Opinion
10 Oct 2013
REC opinion
Further Information Favourable Opinion