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临床试验/NCT01941381
NCT01941381已完成不适用

Does Tympanometry Predict Antibiotic Usage in Acute Otitis Media?

University of Alberta1 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2013年10月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
140
试验地点
1
主要终点
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?

研究概览

简要总结

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.

详细描述

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 media really a question that concerns the treatment, or is it a question of diagnosis? The published correspondence that these two papers generated, suggested that diagnosis of AOM is indeed a concern. A technique named tympanometry could prove to be useful.

Tympanometry is a well established technique for documentation of middle ear effusion. Tympanometry measures the compliance of the tympanic membrane over a range of pressures. A graphic curve is generated which can be compared to normals or examples of pathologic conditions. Primary care physicians have used this technique successfully among children with and without a diagnosis of AOM.{15} Two studies involving tympanometry and otitis media{16-17} have shown tympanograms consistent with clear middle ear effusion(Type B) in 50-60% of patients clinically diagnosed with AOM. This strongly suggests that AOM is being over diagnosed! Interestingly Spiro et al showed that rates of antibiotic prescription were not different in physicians who were aware of tympanogram results and those who were blinded. This indicates a lack of knowledge around the impact on outcome of the initial tympanogram.

Currently at the Stollery, (and as suggested by CPS and AMA) well children who are diagnosed with AOM are given a prescription for antibiotics, but told to wait 48 hours before filling them, in the expectation that many of these children will have a complete resolution of their symptoms. They are encouraged to take analgesics to keep them comfortable. However, the current state of knowledge indicates that antibiotics provide superior symptom control in the first 24-48H and provide superior resolution rates to placebo in clinically diagnosed AOM. The delayed antibiotic strategy has similar long term outcomes to immediate antibiotic treatment. It is not clear if patients with middle ear effusion documented by adjunctive tests, such as tympanometry represent a distinctly different group than those diagnosed by observation of the tympanic membrane only. Spiro's study indicates that physicians do not know and therefore are not changing their practice on the basis of tympanogram results.

This then brings us to the investigators' primary research question. Are those children aged 6 months to 16 years who attend the Stollery Emergency Department and are diagnosed with AOM (and sent home with conservative management) 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?

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
6 Months 至 16 Years(Child)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • Antibiotics within previous 2 weeks
  • Immunosuppressive Medication or Condition
  • Perforated Otitis Media
  • Previous complications secondary to Otitis Media

结局指标

主要结局

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?

时间窗: 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.

次要结局

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

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Andrew Dixon

Assistant Professor

University of Alberta

研究点 (1)

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