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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00250900
Recruitment Status : Completed
First Posted : November 8, 2005
Last Update Posted : November 30, 2006
National Center for Research Resources (NCRR)
Information provided by:
Yale University

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

Condition or disease Intervention/treatment
Otitis Media Behavioral: Prescription Fill Status

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Wait and See Antibiotic Prescription for Acute Otitis Media: A Randomized Controlled Trial
Study Start Date : July 2004
Estimated Study Completion Date : August 2005

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. Proportion of each group that filled the antibiotic prescription

Secondary Outcome Measures :
  1. Clinical course of the illness; side effects of medications; days of school/work missed; unscheduled medical visits

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   6 Months to 12 Years   (Child)
Sexes Eligible for Study:   All

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00250900

United States, Connecticut
Yale University
New Haven, Connecticut, United States, 06504
Sponsors and Collaborators
Yale University
National Center for Research Resources (NCRR)
Principal Investigator: David M Spiro, MD, MPH Yale University

Publications of Results: Identifier: NCT00250900     History of Changes
Other Study ID Numbers: WASPYALE2005
#AI01703 NIH
#MO1-RR00125 GCRC
First Posted: November 8, 2005    Key Record Dates
Last Update Posted: November 30, 2006
Last Verified: November 2005

Keywords provided by Yale University:

Additional relevant MeSH terms:
Otitis Media
Ear Diseases
Otorhinolaryngologic Diseases
Anti-Bacterial Agents
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents