Acute Otitis Media: Adjuvant Therapy to Improve Outcome

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.

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Key information

Conditions

Otitis Media Ear Diseases Otitis Otorhinolaryngologic Diseases

Age range

2 month–1 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Univ of Texas Med Branch Children's Hosp

Galveston, Texas, 77550, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Antihistamine

Drug

Corticosteroid

Drug

Sponsors and collaborators

Lead sponsor

National Institute on Deafness and Other Communication Disorders (NIDCD)

Nih

Registry information

Important dates

Study completion: 2001
First posted: Nov 3, 1999
Registry last updated: Apr 24, 2006

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed