Wait and See Antibiotic Prescription for Acute Otitis Media: A Randomized Controlled Trial - Full Text View

Sponsors and Collaborators:	Yale University National Center for Research Resources (NCRR)
Information provided by:	Yale University
ClinicalTrials.gov Identifier:	NCT00250900

Purpose

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

Condition	Intervention
Otitis Media	Behavioral: Prescription Fill Status

MedlinePlus related topics: Antibiotics Ear Infections

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Wait and See Antibiotic Prescription for Acute Otitis Media: A Randomized Controlled Trial

Further study details as provided by Yale University:

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

Estimated Enrollment:	240
Study Start Date:	July 2004
Estimated Study Completion Date:	August 2005

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.

Eligibility

Ages Eligible for Study:	6 Months to 12 Years
Genders Eligible for Study:	Both

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00250900

Locations

United States, Connecticut
Yale University
New Haven, Connecticut, United States, 06504

Sponsors and Collaborators

Yale University

National Center for Research Resources (NCRR)

Investigators

Principal Investigator:

David M Spiro, MD, MPH

Yale University

More Information

Publications of Results:

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.

Study ID Numbers:	WASPYALE2005, #AI01703 NIH, #MO1-RR00125 GCRC
Study First Received:	November 7, 2005
Last Updated:	November 29, 2006
ClinicalTrials.gov Identifier:	NCT00250900
Health Authority:	United States: Food and Drug Administration

Keywords provided by Yale University:

Otitis
Antibiotic
Prescription

Study placed in the following topic categories:

Otorhinolaryngologic Diseases
Otitis
Otitis Media
Ear Diseases

ClinicalTrials.gov processed this record on January 16, 2009