Acute Otitis Media Clinical Trial
Official title:
Does Tympanometry Predict Antibiotic Usage in Acute Otitis Media?
NCT number | NCT01941381 |
Other study ID # | Pro00040754 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | October 2013 |
Est. completion date | September 2018 |
Verified date | October 2018 |
Source | University of Alberta |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 140 |
Est. completion date | September 2018 |
Est. primary completion date | September 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 6 Months to 16 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Canada | Stollery Children's Hospital | Edmonton | Alberta |
Lead Sponsor | Collaborator |
---|---|
University of Alberta |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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? | Follow-up phone calls will be made to families to determine antibiotic usage. This will be confirmed by accessing the provincial pharmacy database. | 8 days post-enrollment | |
Secondary | Does a type B tympanogram increase reported pain? | 3 and 8 days post enrollment | ||
Secondary | Does a type B tympanogram predict increased analgesic usage? | 3 and 8 days post enrollment | ||
Secondary | Does a type B tympanogram predict amount of fever? | 3 and 8 days post enrollment | ||
Secondary | Does a type B tympanogram predict increased sleep disturbance? | 3 and 8 days post enrollment | ||
Secondary | Does a type B tympanogram predict amount of oral intake? | 3 and 8 days post enrollment | ||
Secondary | Identify the proportion of AOM patients with type A,B and C tympanograms? | 3 and 8 days post enrollment |
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