In a cohort study of children with acute sinusitis who were treated in ambulatory settings, the risk of treatment failure was similar among those treated with amoxicillin and amoxicillin–clavulanate, and the risk of adverse gastrointestinal outcomes and yeast infections was higher among children treated with amoxicillin-clavulanate. “When treatment failure did occur, it almost always resulted in a management change in the outpatient setting; emergency department and inpatient encounters were rare,” the authors conclude.
Using nationwide data on children and adolescents 17 years of age or younger, the investigators identified patients with a new outpatient diagnosis of acute sinusitis and a same-day new prescription for amoxicillin-clavulanate or amoxicillin. Treatment failure was defined as requiring a prescription for a new antibiotic, an emergency department or inpatient admission for acute sinusitis, or an inpatient encounter for a sinusitis complication, on days 1 to 14 after cohort enrollment. Adverse events included gastrointestinal symptoms, hypersensitivity and skin reactions, acute kidney injury, and secondary infections.
“The cohort included 320,141 patients,” the authors write. “After propensity score matching, there were 198,942 patients (99,471 patients per group), including 100,340 (50.4%) who were female, 101,726 (51.1%) adolescents aged 12 to 17 years, 52,149 (26.2%) children aged 6 to 11 years, and 45,067 (22.7%) children aged 0 to 5 years. Treatment failure occurred in 1.7% overall; 0.01% had serious failure (an emergency department or inpatient encounter). There was no difference in the risk of treatment failure between the amoxicillin-clavulanate and amoxicillin groups (relative risk [RR], 0.98 [95% CI, 0.92-1.05]). The risk of gastrointestinal symptoms (RR, 1.15 [95% CI, 1.05-1.25]) and yeast infections (RR, 1.33 [95% CI, 1.16-1.54]) was higher with amoxicillin-clavulanate. After patients were stratified by age, the risk of treatment failure after amoxicillin-clavulanate was an RR of 0.98 (95% CI, 0.86-1.12) for ages 0 to 5 years; RR was 1.06 (95% CI, 0.92-1.21) for 6 to 11 years; and RR was 0.87 (95% CI, 0.79-0.95) for 12 to 17 years. The age-stratified risk of adverse events after amoxicillin-clavulanate was an RR of 1.23 (95% CI, 1.10-1.37) for ages 0 to 5 years; RR was 1.19 (95% CI, 1.04-1.35) for 6 to 11 years; and RR was 1.04 (95% CI, 0.95-1.14) for 12 to 17 years.”