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

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Yale University
ClinicalTrials.gov Identifier:
NCT00250900
First received: November 7, 2005
Last updated: November 29, 2006
Last verified: November 2005
  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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Wait and See Antibiotic Prescription for Acute Otitis Media: A Randomized Controlled Trial

Resource links provided by NLM:


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
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, see Learn About Clinical Studies.

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
Investigators
Principal Investigator: David M Spiro, MD, MPH Yale University
  More Information

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

Keywords provided by Yale University:
Otitis
Antibiotic
Prescription

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

ClinicalTrials.gov processed this record on October 29, 2014