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The University of Southampton
Medicine

Research project: ARCHIE The early use of Antibiotics for at Risk CHildren with InfluEnza in primary care

Currently Active: 
Yes

This is a 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 aged 6 months to 12 years inclusive who present in primary care or other equivalent ambulatory care settings with influenza/ILI and meet our trial eligibility criteria will be invited to join the trial. For each child entering the trial a healthcare professional will complete a baseline assessment and obtain two swabs: a nasal swab for detection of influenza by Polymerase Chain Reaction (PCR) and a throat swab for bacterial culture and sensitivity.

Participants will be randomised to receive either co-amoxiclav 400/57 or placebo, which will be taken orally twice daily for 5 days. Parents/guardians of trial participants will be given a study diary in which to record doses of study medication given to the child, temperature, symptoms and adverse events. Parents/guardians will also be asked to record in their study diaries items relating to healthcare resource utilisation, parent or child burden. Children will be given a diary where they will have the opportunity to record medication taken and document how they are feeling each day.

The primary outcome is to determine whether early treatment with co-amoxiclav reduces the likelihood of re-consultation due to clinical deterioration in ‘at risk’ children with influenza/influenza-like illness (ILI) within 28 days of study entry.

We will aim to recruit 650 children into the trial. This will include a loss to follow-up rate of 25%, giving an effective sample size of 484 children (242 children in each arm of the trial).

Local Investigators: Professors Paul Little and Mike Moore

Duration: October 2013 to March 2017

Funder: NIHR RfPB

Contact: Archie-trial@soton.ac.uk

Related research groups

Primary Care & Population Sciences
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