Back to resultsWait and See Antibiotic Prescription for Acute Otitis Media: A Randomized Controlled Trial
Primary Purpose
Otitis Media
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Prescription Fill Status
Sponsored by
About this trial
This is an interventional treatment trial for Otitis Media focused on measuring Otitis, Antibiotic, Prescription
Eligibility Criteria
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
Sites / Locations
- Yale University
Outcomes
Primary Outcome Measures
Proportion of each group that filled the antibiotic prescription
Secondary Outcome Measures
Clinical course of the illness; side effects of medications; days of school/work missed; unscheduled medical visits
Full Information
NCT ID
NCT00250900
First Posted
November 7, 2005
Last Updated
November 29, 2006
Sponsor
Yale University
Collaborators
National Center for Research Resources (NCRR)
1. Study Identification
Unique Protocol Identification Number
NCT00250900
Brief Title
Wait and See Antibiotic Prescription for Acute Otitis Media: A Randomized Controlled Trial
Official Title
Wait and See Antibiotic Prescription for Acute Otitis Media: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
November 2005
Overall Recruitment Status
Completed
Study Start Date
July 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
August 2005 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Yale University
Collaborators
National Center for Research Resources (NCRR)
4. Oversight
5. Study Description
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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Otitis Media
Keywords
Otitis, Antibiotic, Prescription
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
240 (false)
8. Arms, Groups, and Interventions
Intervention Type
Behavioral
Intervention Name(s)
Prescription Fill Status
Primary Outcome Measure Information:
Title
Proportion of each group that filled the antibiotic prescription
Secondary Outcome Measure Information:
Title
Clinical course of the illness; side effects of medications; days of school/work missed; unscheduled medical visits
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
12 Years
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David M Spiro, MD, MPH
Organizational Affiliation
Yale University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yale University
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06504
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
16968847
Citation
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.
Results Reference
result
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Wait and See Antibiotic Prescription for Acute Otitis Media: A Randomized Controlled Trial
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