October 11, 2023
Medpage Today has reported on a large observational database study examining outcomes of amoxicillin-clavulanate for pediatric acute sinusitis compared to amoxicillin alone. While the two options carried similarly low risk of treatment failure, adverse events associated with the frequently prescribed antibiotics occurred disproportionally more often with the broad-spectrum choice. The news was welcomed by experts in the article given the uptake of the pneumococcal vaccine since its introduction and the growing threat of antibiotic resistance.
The study authors also note acute sinusitis accounts for approximately 4.9 million prescriptions among U.S. children. It is among the leading causes for a child to be given a prescription. Treatment direction for pediatric acute sinusitis varies. IDSA recommends amoxicillin-clavulanate whereas the AAP recommends either amoxicillin or amoxicillin-clavulanate use. The study points to amoxicillin as sufficient core treatment, has fewer adverse events, and allays some concerns regarding resistance by avoiding overuse and improving outcomes.
The study relied on MarketScan Commercial Claims and Encounters Database and included 320,141 kids diagnosed with acute sinusitis who got a same-day new prescription dispensation of amoxicillin-clavulanate or amoxicillin from 2017 to 2021. Girls made up just over half the cohort. Yeast infections and gastrointestinal symptoms were the most common side effects, with more occurring in the amoxicillin-clavulanate group. Urgent care visits were also slightly more common in that group, as well.
Data regarding race, ethnicity, and socioeconomic status were not available. Other limitations study authors noted were lack of available microbiologic data, an inability to evaluate medication adherence, some missing prescriber data, and missing information regarding patient weight and weight-based dosing.
PIDS member and paper author Tim Savage commented, “This study aimed to tackle a question that hasn’t been evaluated on a broad scale since the introduction of the pneumococcal conjugate vaccines: how do the clinical effectiveness and safety of amoxicillin and amoxicillin-clavulanate compare when treating acute sinusitis in ambulatory children in a real-world setting? By studying more than 300,000 patients treated with one or the other of the two antibiotics, we found that the risk of any treatment failure was low overall (~1.7%), and the risk of treatment failure leading to hospitalization was extremely low (~0.01%). Importantly, the risks of these treatment failures were not different in patients treated with amoxicillin versus those treated with amoxicillin-clavulanate. Unsurprisingly, we also found that amoxicillin-clavulanate was associated with more visits to the office for GI symptoms and yeast infections. Contextualizing these findings with the knowledge that bacterial resistance is driven by broader antibiotics (like amoxicillin-clavulanate), amoxicillin is likely a good first choice for new diagnoses of acute sinusitis in children requiring antibiotics. We hope the findings of this study inform antibiotic stewardship efforts and help kids avoid side effects of excessively broad antibiotics.”