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

Yale University logo

Yale University

Status

Completed

Conditions

Otitis Media

Treatments

Behavioral: Prescription Fill Status

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT00250900
#MO1-RR00125 GCRC
#AI01703 NIH
WASPYALE2005

Details and patient eligibility

About

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

Full 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.

Sex

All

Ages

6 months to 12 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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