Study Summary

Children with underlying medical conditions such as asthma, diabetes and cerebral palsy are ‘at risk’ of becoming more unwell from bacterial infections if they get flu. ARCHIE is a double-blind randomised placebo-controlled trial which aims to determine whether giving the antibiotic co-amoxiclav to ‘at risk’ children within five days of them becoming ill with flu or influenza-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

Practice Involvement: We are looking for practices to

· Identify and flag potentially eligible patients via a database screen prompt

· On presentation of an eligible patient during the winter season to call the ARCHIE recruitment hotline to inform central trial office if family happy to be contacted (approx. 5-10 min call)

A CRN nurse will then attend patient at home for consent, baseline, randomization and study medication dispensing. CRN nurse will carry out follow up including medical notes review. The practice may be asked to give additional information if their participant has an SAE.

Patient Involvement: In addition to the child completing a five day course of study medication a nose and throat swab will be taken. Family will be asked to complete weekly diary for a month after study entry.

Recruitment Status: Seasonal from October to April

Funder: NIHR’s Programme Grants for Applied Research Programme

For further information, please contact your local research facilitator