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OpenTrials
Completed

NCT Number: NCT00250900

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

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

Completed

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Key information

Age range

6 month–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Yale University

New Haven, Connecticut, 06504, United States

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Prescription Fill Status

Behavioral

Primary outcomes

  1. Proportion of each group that filled the antibiotic prescription

Secondary outcomes

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

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

  • National Center for Research Resources (NCRR)

Registry information

Important dates

Study start
2004
Study completion
2005
First posted
Nov 8, 2005
Registry last updated
Nov 30, 2006

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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