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Wait and See Antibiotic Prescription for Acute Otitis Media: A Randomized Controlled Trial

NCT ID: NCT00250900

Last Updated: 2006-11-30

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

NA

Total Enrollment

240 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-07-31

Study Completion Date

2005-08-31

Brief Summary

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To determine if a wait and see prescription for ear infections in childhood reduces use of antibiotics compared to an immediate prescription

Detailed Description

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We conducted a randomized, controlled trial evaluating a consecutive series of children diagnosed with AOM during a one year period in an urban pediatric emergency department, utilizing diagnostic recommendations from contemporary evidence-based guidelines. The objectives of the study were to determine whether treatment of AOM using a "Wait and See Prescription" (WASP) significantly reduces use of antimicrobials compared with a "Standard Prescription" (SP) and to evaluate the effects of this intervention on clinical symptoms and adverse outcomes related to antibiotic use.

Conditions

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Otitis Media

Keywords

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Otitis Antibiotic Prescription

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Prescription Fill Status

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Children between the ages of 6 months - 12 years who were diagnosed with Acute Otitis Media

Exclusion Criteria

* clinician suspicion or diagnosis of a concurrent bacterial infection
* patient appeared "toxic" as determined by the PEM clinician
* patient was hospitalized
* history of compromised immunity
* patient was treated with antimicrobials in the preceding seven days
* either tympanic membrane was perforated
* myringotomy tubes were present
* uncertain access to medical care
* primary language of the parent or guardian was neither English nor Spanish
* prior enrollment in the study
Minimum Eligible Age

6 Months

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Center for Research Resources (NCRR)

NIH

Sponsor Role collaborator

Yale University

OTHER

Sponsor Role lead

Principal Investigators

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David M Spiro, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Yale University

Locations

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Yale University

New Haven, Connecticut, United States

Site Status

Countries

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United States

References

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Spiro DM, Tay KY, Arnold DH, Dziura JD, Baker MD, Shapiro ED. Wait-and-see prescription for the treatment of acute otitis media: a randomized controlled trial. JAMA. 2006 Sep 13;296(10):1235-41. doi: 10.1001/jama.296.10.1235.

Reference Type RESULT
PMID: 16968847 (View on PubMed)

Other Identifiers

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#AI01703 NIH

Identifier Type: -

Identifier Source: secondary_id

#MO1-RR00125 GCRC

Identifier Type: -

Identifier Source: secondary_id

WASPYALE2005

Identifier Type: -

Identifier Source: org_study_id