Cookies on this website
We use cookies to ensure that we give you the best experience on our website. If you click 'Continue' we'll assume that you are happy to receive all cookies and you won't see this message again. Click 'Find out more' for information on how to change your cookie settings.

INTRODUCTION: The UK government stockpiles co-amoxiclav to treat bacterial complications during influenza pandemics. This pragmatic trial examines whether early co-amoxiclav use reduces re-consultation due to clinical deterioration in "at risk" children presenting with influenza-like illness (ILI) in primary or ambulatory care. METHODS: "At risk" children aged 6 months to 12 years presenting within f5 days of ILI onset were randomly assigned to oral co-amoxiclav 400/57 or placebo twice daily for 5 days (dosing based on age±weight). "At risk" groups included children with respiratory, cardiac, and neurological conditions. Randomisation was stratified by region and used a non-deterministic minimisation algorithm to balance age and current seasonal influenza vaccination status. Our target sample size was 650 children, which would have allowed us to detect a reduction in the proportion of children re-consulting due to clinical deterioration from 40% to 26% with 90% power and 5% two-tailed alpha error, including allowance for 25% loss to follow-up and an inflation factor of 1.041. Participants, caregivers and investigators were blinded to treatment allocation. Intention-to-treat analysis included all randomised participants with primary outcome data on re-consultation due to clinical deterioration within 28 days. Safety analysis included all randomised participants. TRIAL REGISTRATION: ISRCTN 70714783. EudraCT 2013-002822-21. RESULTS: We recruited 271 children between February 11, 2015 and April 20, 2018. Primary outcome data were available for 265 children. Only 61/265 children (23.0%) re-consulted due to clinical deterioration. No evidence of a treatment effect was observed for re-consultation due to clinical deterioration (co-amoxiclav 33/133 (24.8%), placebo 28/132 (21.2%), adjusted risk ratio [RR] 1.16, 95% confidence interval [CI] 0.75 to 1.80). There was also no evidence of a difference between groups in the proportion of children for whom one or more adverse events were reported (co-amoxiclav 32/136 (23.5%), placebo 22/135 (16.3%), adjusted RR 1.45, 95% CI 0.90 to 2.34). Sixty-six adverse events were reported in total (co-amoxiclav n=37, placebo n=29). Nine serious adverse events were reported per group; none were considered related to study medication. CONCLUSION: Our trial did not find evidence that treatment with co-amoxiclav reduces risk of re-consultation due to clinical deterioration in "at risk" children who present early with ILI during influenza season. Our findings therefore do not support early co-amoxiclav use in children with seasonal ILI.

Original publication




Journal article


Eur Respir J

Publication Date