NCT00250900

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
240

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2004

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2004

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2005

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 7, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 8, 2005

Completed
Last Updated

November 30, 2006

Status Verified

November 1, 2005

First QC Date

November 7, 2005

Last Update Submit

November 29, 2006

Conditions

Otitis Media

Keywords

OtitisAntibioticPrescription

Outcome Measures

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

Interventions

Prescription Fill StatusBEHAVIORAL

Eligibility Criteria

Age6 Months - 12 Years
Sexall
Age GroupsChild (0-17)

You may qualify if:

  • Children between the ages of 6 months - 12 years who were diagnosed with Acute Otitis Media

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yale University

New Haven, Connecticut, 06504, United States

Location

Related Publications (1)

  • Spiro DM, Tay KY, Arnold DH, Dziura JD, Baker MD, Shapiro ED. Wait-and-see prescription for the treatment of acute otitis media: a randomized controlled trial. JAMA. 2006 Sep 13;296(10):1235-41. doi: 10.1001/jama.296.10.1235.

    PMID: 16968847RESULT

MeSH Terms

Conditions

Otitis MediaOtitis

Condition Hierarchy (Ancestors)

Ear DiseasesOtorhinolaryngologic Diseases

Study Officials

  • David M Spiro, MD, MPH

    Yale University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 7, 2005

First Posted

November 8, 2005

Study Start

July 1, 2004

Study Completion

August 1, 2005

Last Updated

November 30, 2006

Record last verified: 2005-11

Locations

US(1)