Investigators examined the efficacy and safety of a new formulation of amoxicillin-clavulanate to treat acute otitis media (AOM) in children | Contemporary Pediatrics
Children with acute otitis media (AOM) are routinely and successfully treated with antimicrobials, with data showing that the combination of amoxicillin-clavulanate (A/C) to treat AOM in children aged younger than 3 years is associated with more favorable outcomes than placebo.
Although effective, antimicrobial treatment is associated with the unwanted adverse effect of diarrhea that studies show can affect between 25% to 48% of children. Children who experience this common adverse effect may have to wait to return to daycare until it resolves, which in turn may delay parents’ return to work.
Finding a way to maintain the efficacy of antimicrobial treatment while reducing this unwanted adverse effect was the objective of recent study by Hoberman and colleagues. Based on evidence showing that the clavulanate component of the routinely administered antimicrobial treatment is responsible for diarrhea, the investigators examined the efficacy and safety of a novel formulation of the antimicrobial in which the total effective dose of clavulanate is reduced.
The open-label study found that reducing the total dose of clavulanate was associated with the desired reduction in diarrhea and diaper dermatitis without appearing to compromise efficacy; however, the lead author of the study, Alejandro Hoberman, MD, chief, Division of General Academic Pediatrics, professor of Pediatrics and Clinical and Translational Science, Children’s Hospital of Pittsburgh of UPMC, Pennsylvania, emphasized that these findings will have to be properly studied in a larger clinical trial.