Amoxicillin–clavulanate has been shown to be the most effective treatment for acute otitis media.
As compared to placebo treatment, what were the benefits of antibiotic treatment for children 6 to 23 months of age with acute otitis media in this clinical trial?
Children who were treated with amoxicillin–clavulanate, as compared with those who received placebo, had consistently more favorable short-term outcomes, including a sustained symptomatic response, an absence of otoscopic evidence of persistent middle-ear infection, and a reduced rate of residual middle-ear effusion.
As compared to placebo treatment, was speed of resolution different for children who received antibiotic treatment in this study?
Yes, among the children who received amoxicillin–clavulanate, 35% had initial resolution of symptoms by day 2, 61% by day 4, and 80% by day 7; among children who received placebo, 28% had initial resolution of symptoms by day 2, 54% by day 4, and 74% by day 7.
As compared to placebo-treated children, what adverse effects were significantly more common among children with acute otitis media who received antibiotic treatment?
Dermatitis in the diaper area and protocol-defined diarrhea occurred commonly, and often together, among children receiving antimicrobial agents. Both protocol-defined diarrhea and diaper area dermatitis occurred significantly more frequently among children who received amoxicillin–clavulanate than those that received placebo.