Acute otitis media is one of the most common diseases of childhood and is one of the major
causes of hearing loss in children. Despite the availability of effective antibiotic therapy
for otitis media, treatment failures, persistent effusions, and recurrences are common. This
Phase III outpatient study aims to test whether adjuvant therapy (an antihistamine or a
corticosteroid), in addition to antibiotic therapy, improves the acute and long-term
outcomes of patients with acute otitis media. This study is targeted to recruiting 200
infants (age less than one year); patient (and parent) participation is estimated to
continue for one year after enrollment.
- Have had two documented prior episodes of acute otitis media.
- Have no current middle ear effusion (fluid).
- Have chronic otitis media.
- Have acute otitis media in addition to chronic otitis media.