Acute Otitis Media: Adjuvant Therapy to Improve Outcome

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Study Classification

INTERVENTIONAL

Study Completion Date

2001-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Otitis Media

Keywords

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Antibiotics Adrenal Cortex Hormones Histamine H1 Antagonists Infant Otitis Media

Study Design

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Allocation Method

RANDOMIZED

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Antihistamine

Intervention Type DRUG

Corticosteroid

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

2 Months

Maximum Eligible Age

1 Year

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Dr. Tasnee Chonmaitree

Role: STUDY_CHAIR

Locations

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Univ of Texas Med Branch Children's Hosp

Galveston, Texas, United States

Site Status

Countries

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United States

References

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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. doi: 10.1067/S0022-3476(03)00293-2.

Reference Type BACKGROUND

PMID: 14517524 (View on PubMed)

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. doi: 10.1016/s0165-5876(02)00372-5.

Reference Type BACKGROUND

PMID: 12633920 (View on PubMed)

Other Identifiers

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R01DC002620-04

Identifier Type: NIH

Identifier Source: secondary_id

View Link

NIDCD-1160

Identifier Type: -

Identifier Source: org_study_id