Acute Otitis Media: Adjuvant Therapy to Improve Outcome
Status:
Completed
Trial end date:
2001-06-01
Target enrollment:
Participant gender:
Summary
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.
Phase:
Phase 3
Details
Lead Sponsor:
National Institute on Deafness and Other Communication Disorders (NIDCD)