Clinical Trial: Acute Otitis Media: Adjuvant Therapy to Improve Outcome


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Acute Otitis Media: Adjuvant Therapy to Improve Outcome

This study is no longer recruiting patients.

Sponsored by:	National Institute on Deafness and Other Communication Disorders (NIDCD)
Information provided by:	National Institute on Deafness and Other Communication Disorders (NIDCD)

Purpose

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.

Condition	Treatment or Intervention	Phase
Otitis Media	Drug: Antihistamine Drug: Corticosteroid	Phase III

MedlinePlus related topics: Ear Infections

Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Efficacy Study

Eligibility

Ages Eligible for Study: 2 Months - 1 Year, Genders Eligible for Study: Both

Criteria

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.

Location Information

Texas
Univ of Texas Med Branch Children's Hosp, Galveston, Texas, 77550, United States

Study chairs or principal investigators

Dr. Tasnee Chonmaitree, Study Chair

More Information

Publications

Chonmaitree T, Saeed K, Uchida T, Heikkinen T, Baldwin CD, Freeman DH Jr, McCormick DP. A randomized, placebo-controlled trial of the effect of antihistamine or corticosteroid treatment in acute otitis media. J Pediatr. 2003 Sep;143(3):377-85.

McCormick DP, Saeed K, Uchida T, Baldwin CD, Deskin R, Lett-Brown MA, Heikkinen T, Chonmaitree T. Middle ear fluid histamine and leukotriene B4 in acute otitis media: effect of antihistamine or corticosteroid treatment. Int J Pediatr Otorhinolaryngol. 2003 Mar;67(3):221-30.

Study ID Numbers: NIDCD-1160; RO1 DC 02620-04
Record last reviewed: October 2003
Record first received: November 2, 1999
ClinicalTrials.gov Identifier: NCT00000363
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2004-10-22

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