Acute Otitis Media: Adjuvant Therapy to Improve Outcome

National Institutes of Health (NIH)

Status and phase: Completed; Phase 3

Conditions: Otitis Media

Treatments: Drug: Corticosteroid; Drug: Antihistamine

Study type: Interventional

Funder types: NIH

Identifiers

NCT00000363

R01DC002620-04 (U.S. NIH Grant/Contract)

NIDCD-1160

Details and patient eligibility

About

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.

Sex: All

Ages: 2 months to 1 year old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Have had two documented prior episodes of acute otitis media.
• Have no current middle ear effusion (fluid).

Exclusion criteria

• Have chronic otitis media.
• Have acute otitis media in addition to chronic otitis media.