Clinical Trial: Does Tympanometry Predict Antibiotic Usage in Acute Otitis Media?

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

Official Title: Does Tympanometry Predict Antibiotic Usage in Acute Otitis Media?

Brief Summary: 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.

Detailed Summary:

INTRODUCTION Acute Otitis Media (AOM) is the most common childhood infection for which antibiotics are prescribed.{1-2} Several important factors have altered the prescription practices for AOM in the past decade. North America has seen an epidemic of microbial resistance, attributable in a large part to the over-prescription of antibiotics.{3-4} Evidence has shown that AOM is commonly over diagnosed and antibiotics are prescribed unnecessarily.{5-7} In addition a number of studies comparing antibiotic treatment to placebo, although proving superiority for antibiotic treatment, had very high rates of resolution with placebo. A meta analysis of 7 RCT's show a 73% success rate for Amoxicillin versus 60% for placebo.{8}

These results prompted interest in a watch and wait strategy for the treatment of AOM for children 6 months to 10 years of age. Three important studies were performed assessing the outcomes of delaying antibiotics for 48-72H, two in primary care{9-10} and one in a pediatric emergency department.{11} All three showed no difference in outcomes with 2-4 week follow-up. There was a significant reduction in antibiotic usage with the watch and wait approach, a reduction of about 70%. These studies led both the American Academy of Pediatrics and the Canadian Pediatric Society to recommend adopting a conservative non-antibiotic treatment strategy for AOM in the first 48-72H.{12} However in early 2011, 2 papers were published that suggested that antibiotic use in AOM was beneficial.{13, 14} What set both of these two papers apart from other papers was the definition of acute otitis media: in one study the children were enrolled by study clinicians who were otoscopists who had successfully completed an otoscopic validation program, in the second study middle ear fluid had to be present by means of pneumatic otoscopy. The question then arises, is the treatment of otitis
Sponsor: University of Alberta

Current Primary Outcome: 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 ]

Follow-up phone calls will be made to families to determine antibiotic usage. This will be confirmed by accessing the provincial pharmacy database.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Does a type B tympanogram increase reported pain? [ Time Frame: 3 and 8 days post enrollment ]
  • Does a type B tympanogram predict increased analgesic usage? [ Time Frame: 3 and 8 days post enrollment ]
  • Does a type B tympanogram predict amount of fever? [ Time Frame: 3 and 8 days post enrollment ]
  • Does a type B tympanogram predict increased sleep disturbance? [ Time Frame: 3 and 8 days post enrollment ]
  • Does a type B tympanogram predict amount of oral intake? [ Time Frame: 3 and 8 days post enrollment ]
  • Identify the proportion of AOM patients with type A,B and C tympanograms? [ Time Frame: 3 and 8 days post enrollment ]


Original Secondary Outcome: Same as current

Information By: University of Alberta

Dates:
Date Received: September 10, 2013
Date Started: October 2013
Date Completion: June 2018
Last Updated: October 25, 2016
Last Verified: October 2016