Acute Otitis Media: Adjuvant Therapy to Improve Outcome

National Institute on Deafness and Other Communication Disorders (NIDCD)

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Conditions

Otitis Media

Interventions

AntihistamineDRUG

CorticosteroidDRUG

Eligibility

Sex: ALLMin age: 2 MonthsMax age: 1 Year

Medical Language ↔ Plain English

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.

Locations (1)

Univ of Texas Med Branch Children's Hosp

Galveston, Texas, United States

Data from ClinicalTrials.gov

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