跳至主要内容
临床试验/NCT00250900
NCT00250900已完成不适用

Wait and See Antibiotic Prescription for Acute Otitis Media: A Randomized Controlled Trial

Yale University2 个研究点 分布在 1 个国家目标入组 240 人开始时间: 2004年7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
240
试验地点
2
主要终点
Proportion of each group that filled the antibiotic prescription

研究概览

简要总结

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

详细描述

We conducted a randomized, controlled trial evaluating a consecutive series of children diagnosed with AOM during a one year period in an urban pediatric emergency department, utilizing diagnostic recommendations from contemporary evidence-based guidelines. The objectives of the study were to determine whether treatment of AOM using a "Wait and See Prescription" (WASP) significantly reduces use of antimicrobials compared with a "Standard Prescription" (SP) and to evaluate the effects of this intervention on clinical symptoms and adverse outcomes related to antibiotic use.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
6 Months 至 12 Years(Child)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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

结局指标

主要结局

Proportion of each group that filled the antibiotic prescription

次要结局

  • Clinical course of the illness; side effects of medications; days of school/work missed; unscheduled medical visits

研究者

申办方类型
Other

研究点 (2)

Loading locations...

相似试验