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

November 29, 2006 updated by: Yale University
To determine if a wait and see prescription for ear infections in childhood reduces use of antibiotics compared to an immediate prescription

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment

240

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 months to 12 years (CHILD)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Proportion of each group that filled the antibiotic prescription

Secondary Outcome Measures

Outcome Measure
Clinical course of the illness; side effects of medications; days of school/work missed; unscheduled medical visits

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yale University

Collaborators

National Center for Research Resources (NCRR)

Investigators

  • Principal Investigator: David M Spiro, MD, MPH, Yale University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2004

Study Completion

August 1, 2005

Study Registration Dates

First Submitted

November 7, 2005

First Submitted That Met QC Criteria

November 7, 2005

First Posted (ESTIMATE)

November 8, 2005

Study Record Updates

Last Update Posted (ESTIMATE)

November 30, 2006

Last Update Submitted That Met QC Criteria

November 29, 2006

Last Verified

November 1, 2005

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WASPYALE2005
  • #AI01703 NIH
  • #MO1-RR00125 GCRC

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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