Originally published by 2 Minute Medicine® (view original article). Reused on AccessMedicine with permission.

1. There is no significant difference in treatment failure between pediatric patients taking amoxicillin versus amoxicillin-clavulanate for acute sinusitis.

2. Adverse events were more common in patients who took amoxicillin-clavulanate as compared to amoxicillin.

Evidence Rating Level: 2 (Good)

Study Rundown:

Acute sinusitis is a prevalent condition in children, and antibiotics are frequently prescribed for its treatment although there is no agreement regarding the best empirical antibiotic. This study aimed to compare the effectiveness and safety of two commonly prescribed antibiotics, amoxicillin-clavulanate and amoxicillin, in the treatment of acute sinusitis in children – with amoxicillin-clavulanate representing the broader spectrum antibiotic. The main measurable outcome was treatment failure, defined as an aggregate of situations where patients had to get a new antibiotic, visit the emergency room, or stay in the hospital because of acute sinusitis or its complications. This cohort study found that there was no statistically significant difference in treatment failure rates between the two antibiotics. However, amoxicillin-clavulanate was associated with a heightened risk of adverse events, particularly gastrointestinal symptoms and yeast infections. A limitation of this study was that data regarding dosing (weight-based, standard versus high dose) was not captured, which could differ between groups and impact treatment failure. Nonetheless, these findings offer pertinent guidance to healthcare practitioners tasked with choosing empirical antibiotics for the treatment of acute sinusitis in pediatric patients.

In-Depth [retrospective cohort]:

This cohort study analyzed data from a nationwide database comprising 320,141 children and adolescents in the United States from 2017 to 2021. The primary focus was on assessing treatment failure within 2 weeks of the initial antibiotic prescription. To account for potential confounding factors, propensity score matching was employed. The study revealed that treatment failure rates were 1.7% in the amoxicillin-clavulanate group and 1.8% in the amoxicillin group. Importantly, there was no statistically significant difference in the risk of treatment failure between these two groups. The most notable disparity was observed in terms of adverse events, with amoxicillin-clavulanate recipients showing a 1.15 times higher risk of experiencing any adverse event. Further analysis stratified by age revealed distinctive patterns, with adolescents aged 12 to 17 benefiting from a significantly lower risk of adverse events with amoxicillin-clavulanate, while younger age groups exhibited varying risk profiles. These findings offer valuable insights into the empirical antibiotic selection for acute sinusitis and highlight the intricate interplay of age and potential side effects in clinical decision-making.

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