Status:
COMPLETED
Wait and See Antibiotic Prescription for Acute Otitis Media: A Randomized Controlled Trial
Lead Sponsor:
Yale University
Collaborating Sponsors:
National Center for Research Resources (NCRR)
Conditions:
Otitis Media
Eligibility:
All Genders
6-12 years
Phase:
NA
Brief Summary
To determine if a wait and see prescription for ear infections in childhood reduces use of antibiotics compared to an immediate prescription
Detailed Description
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 rec...
Eligibility Criteria
Inclusion
- Children between the ages of 6 months - 12 years who were diagnosed with Acute Otitis Media
Exclusion
- 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
Key Trial Info
Start Date :
July 1 2004
Trial Type :
INTERVENTIONAL
End Date :
August 1 2005
Estimated Enrollment :
240 Patients enrolled
Trial Details
Trial ID
NCT00250900
Start Date
July 1 2004
End Date
August 1 2005
Last Update
November 30 2006
Active Locations (1)
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1
Yale University
New Haven, Connecticut, United States, 06504