Trial record 20 of 230 for:    otitis

Does Tympanometry Predict Antibiotic Usage in Acute Otitis Media?

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified September 2013 by University of Alberta
Sponsor:
Information provided by (Responsible Party):
Andrew Dixon, University of Alberta
ClinicalTrials.gov Identifier:
NCT01941381
First received: September 10, 2013
Last updated: September 12, 2013
Last verified: September 2013
  Purpose

Due to recent efforts to decrease antibiotic overuse, and reports of high rates of spontaneous resolution for clinically diagnosed Acute Otitis Media(AOM), most physicians now wait 48-72 hours before starting antibiotics for common ear infections. The investigators are interested to see if those patients with documented middle ear effusions, as determined by tympanometry, have higher rates of eventual antibiotic usage than those with normal tympanometry results. If there is a significant disparity between those with a positive tympanogram and those without the investigators may be able to identify a group that will benefit from antibiotics and a group that would not need treatment.


Condition Intervention
Acute Otitis Media
Procedure: Tympanometry

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Does Tympanometry Predict Antibiotic Usage in Acute Otitis Media?

Resource links provided by NLM:


Further study details as provided by University of Alberta:

Primary Outcome Measures:
  • Are those children aged 6 months to 16 years who attend the Emergency Department and diagnosed with AOM more likely to fill a prescription for antibiotics over the next 7 days if their tympanogram is type B rather than types A or C? [ Time Frame: 8 days post-enrollment ] [ Designated as safety issue: No ]
    Follow-up phone calls will be made to families to determine antibiotic usage. This will be confirmed by accessing the provincial pharmacy database.


Secondary Outcome Measures:
  • Does a type B tympanogram increase reported pain? [ Time Frame: 3 and 8 days post enrollment ] [ Designated as safety issue: No ]
  • Does a type B tympanogram predict increased analgesic usage? [ Time Frame: 3 and 8 days post enrollment ] [ Designated as safety issue: No ]
  • Does a type B tympanogram predict amount of fever? [ Time Frame: 3 and 8 days post enrollment ] [ Designated as safety issue: No ]
  • Does a type B tympanogram predict increased sleep disturbance? [ Time Frame: 3 and 8 days post enrollment ] [ Designated as safety issue: No ]
  • Does a type B tympanogram predict amount of oral intake? [ Time Frame: 3 and 8 days post enrollment ] [ Designated as safety issue: No ]
  • Identify the proportion of AOM patients with type A,B and C tympanograms? [ Time Frame: 3 and 8 days post enrollment ] [ Designated as safety issue: No ]

Estimated Enrollment: 137
Study Start Date: October 2013
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Type B tympanogram
Patients with a clinical diagnosis of acute otitis media and a B type curve with tympanometry.
Procedure: Tympanometry
All patients enrolled with receive a tympanogram. There will be no difference between the follow up in the groups based on the tympanometry results. The study is simply observational
Type A/C tympanogram
Patients with a clinical diagnosis of acute otitis media and a type A or C curve with tympanometry
Procedure: Tympanometry
All patients enrolled with receive a tympanogram. There will be no difference between the follow up in the groups based on the tympanometry results. The study is simply observational

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   6 Months to 16 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

All children, aged 6 months to 16 years, with clinically diagnosed Otitis Media in the Pediatric Emergency Department of the University of Alberta Hospital, in whom the clinician decides to adopt a delayed antibiotic strategy (ie a period of 48-72H observation with antibiotics given only if symptoms are not resolving).

Criteria

Inclusion Criteria:

  • Clinical diagnosis of Acute Otitis Media
  • Clinician decision to adopt a delayed antibiotic treatment strategy

Exclusion Criteria:

  • Antibiotics within previous 2 weeks
  • Immunosuppressive Medication or Condition
  • Perforated Otitis Media
  • Previous complications secondary to Otitis Media
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01941381

Locations
Canada, Alberta
Stollery Children's Hospital Not yet recruiting
Edmonton, Alberta, Canada, T6G 2B7
Contact: Bruce Wright, MD    780-248-5575    bruce.wright2@albertahealthservices.ca   
Sponsors and Collaborators
University of Alberta
Investigators
Principal Investigator: Andrew C Dixon, MD University of Alberta
Principal Investigator: William R Craig, MD University of Alberta
  More Information

No publications provided

Responsible Party: Andrew Dixon, Assistant Professor, University of Alberta
ClinicalTrials.gov Identifier: NCT01941381     History of Changes
Other Study ID Numbers: Pro00040754
Study First Received: September 10, 2013
Last Updated: September 12, 2013
Health Authority: Canada: Ethics Review Committee

Keywords provided by University of Alberta:
Otitis Media
Tympanometry

Additional relevant MeSH terms:
Otitis
Otitis Media
Ear Diseases
Otorhinolaryngologic Diseases
Anti-Bacterial Agents
Antibiotics, Antitubercular
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antitubercular Agents

ClinicalTrials.gov processed this record on July 31, 2014