Takeaway
- There is no evidence that early co-amoxiclav treatment lowers the risk of clinical deterioration in ‘at risk’ children with influenza-like illness (ILI) in primary or ambulatory care.
Why this matters
- Findings do not support immediate antibiotic prescribing in ‘at risk’ children with seasonal ILI in primary or ambulatory care outside influenza pandemic periods.
Study design
- In the double-blind, placebo-controlled ARCHIE trial, 271 ‘at risk’ children with ILI (age, 6 months to 12 years) who were randomly assigned (1:1) to receive either oral co-amoxiclav 400/57 (n=136) or placebo (n=135) twice daily for 5 days.
- Primary outcome: re-consultation because of clinical deterioration within 28 days.
- Funding: NIHR Programme Grants for Applied Research Programme.
Key results
- There was no significant difference between co-amoxiclav and placebo groups in the risk of re-consultation because of clinical deterioration (adjusted risk ratio [aRR], 1.16; 95% CI, 0.75-1.80; P=.513).
- No significant differences were seen between the 2 groups in (aRR; 95% CI):
- medication prescription or further investigations (1.24; 0.84-1.83; P=.274); and
- hospitalisation or death (1.00; 0.36-2.77; P=.997).
- No significant difference was seen between the 2 groups in the proportion of children who reported ≥1 adverse event (aRR, 1.45; 95% CI, 0.90-2.34; P=.131).
- Overall, 37 adverse events were reported in the co-amoxiclav group and 29 in the placebo group.
- Overall, 9 serious adverse events were reported in each group, but none were related to the study drug.
Limitations
- Small sample size.
This clinical summary originally appeared on Univadis, part of the Medscape Professional Network.
