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

This study has been completed.
Sponsor:
Collaborator:
National Center for Research Resources (NCRR)
Information provided by:
Yale University
ClinicalTrials.gov Identifier:
NCT00250900
First received: November 7, 2005
Last updated: November 29, 2006
Last verified: November 2005
History of Changes
  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:

U.S. FDA Resources

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:

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
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013