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

Otitis Media Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00250900
• Other study ID #: WASPYALE2005
• Secondary ID: #AI01703 NIH#MO1
• Status: Completed
• Phase: N/A
• First received: November 7, 2005
• Last updated: November 29, 2006
• Start date: July 2004
• Est. completion date: August 2005

Study information

• Verified date: November 2005
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 240
• Est. completion date: August 2005
• Gender: Both
• Age group: 6 Months to 12 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Otitis
• Otitis Media

Intervention

Behavioral:
• Prescription Fill Status

Locations

Country	Name	City	State
United States	Yale University	New Haven	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
Yale University	National Center for Research Resources (NCRR)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of each group that filled the antibiotic prescription
Secondary	Clinical course of the illness; side effects of medications; days of school/work missed; unscheduled medical visits