Acute Otitis Media: Adjuvant Therapy to Improve Outcome

Completed · Phase 3

Conditions studied: Otitis Media

In brief

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.

Key facts

Study ID

NCT00000363

Run by

National Institute on Deafness and Other Communication Disorders (NIDCD)

Expected to finish

2001-06-01

Last updated by the study team

2006-04-24

Who can join

Age: 0 and older, up to 1. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

• Univ of Texas Med Branch Children's Hosp — Galveston, Texas, United States

Full record on ClinicalTrials.gov

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