Extrait

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 [email protected]

Critère d'inclusion

• Influenza and influenza-like illness

Liens

• isrctn
• ictrp