The early use of antibiotics for ‘at risk’ children with influenza
Children with a long-term medical condition or disability who develop flu or flu-like illness are at greater risk of becoming unwell from further infections than otherwise healthy children. The ARCHIE study wishes to see if giving the antibiotic co-amoxiclav to these children within 5 days of them becoming ill with flu or influenza-like illness might:
- Help stop them from developing bacterial infections and becoming more unwell.
- Help them get better more quickly.
- Affect how well antibiotics work against similar infections in future.
WHY THIS IS IMPORTANT
Flu (influenza) and flu-like symptoms are among the commonest reasons why parents bring their children to see a general practitioner (GP) during winter. Flu vaccination helps protect children against some types (strains) of flu but other types of flu and viruses similar to flu can still cause flu or flu-like illness. The flu virus damages the linings of the throat and lungs. This makes children feel more unwell and increases the risk of bacterial infections including ear infections and pneumonia.
ARCHIE is a double-blind randomised placebo-controlled trial.
BENEFITS TO THE PATIENTS AND NHS
The findings of the ARCHIE Study will help us work out whether giving antibiotics to children with a long-term medical condition or disability early on when they have flu or flu-like illness is worthwhile. Giving antibiotics to children who do not need them may change the types of bacteria we find in their nose and throat and affect how well similar antibiotics work against infections in the future. Our findings 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).
Double-blind randomised placebo-controlled trial whose primary objective is to determine whether treatment with a 5-day course of co-amoxiclav early during an influenza/ILI episode in at risk children reduces the likelihood of re-consultation due to clinical deterioration.
‘At risk’ children are defined as children with underlying medical conditions or risk factors associated with an increased likelihood of developing influenza/ILI-related complications. Influenza/ILI is well recognised as a predisposing factor for secondary complications, including bacterial infections, which may result in children consulting a clinician more than once during the same illness episode due to clinical deterioration. Influenza and influenza-like illness (ILI) in children create a considerable burden on NHS resources each winter.
An effective, evidence-based policy on antibiotic use in at risk children during influenza season is needed to ensure that national antibiotic stockpiles are used in the most clinically appropriate and cost-effective way. This trial will determine whether early treatment with the antibiotic co-amoxiclav reduces the likelihood of re-consultation due to clinical deterioration in at risk children who present with influenza/ILI in primary care.
|Study Design:||Double-blind randomised placebo-controlled trial|
|Sponsor:||University of Oxford|
|Chief Investigator:||Dr Kay Wang, University of Oxford|
|Ethical approval:||EudraCT Number: 2013-002822-21|