Acute Otitis Media: Adjuvant Therapy to Improve Outcome

• Sponsor: National Institute on Deafness and Other Communication Disorders (NIDCD) (NIH)
• Overall Status: Completed
• CT.gov ID: NCT00000363
• Collaborator: (none)
• Location: 1

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Otitis Media	Drug: Antihistamine; Drug: Corticosteroid	Phase 3

Study Design

• Study Type: Interventional
• Allocation: Randomized
• Masking: Double
• Primary Purpose: Treatment
• Study Completion Date: Jun 1, 2001

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

• Ages Eligible for Study: 2 Months to 1 Year
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Univ of Texas Med Branch Children's Hosp	Galveston	Texas	United States	77550

Sponsors and Collaborators

• National Institute on Deafness and Other Communication Disorders (NIDCD)

Investigators

• Study Chair: Dr. Tasnee Chonmaitree,

Study Documents (Full-Text)

None provided.

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.

• ClinicalTrials.gov Identifier: NCT00000363
• Other Study ID Numbers: NIDCD-1160; R01DC002620-04
• First Posted: Nov 3, 1999
• Last Update Posted: Apr 24, 2006
• Last Verified: Apr 1, 2006

• Keywords provided by , ,: Antibiotics; Adrenal Cortex Hormones; Histamine H1 Antagonists; Infant; Otitis Media
• Additional relevant MeSH terms: Otitis; Otitis Media; Histamine Antagonists; Histamine H1 Antagonists

Study Results

No Results Posted as of Apr 24, 2006