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临床试验/ACTRN12608000424303
ACTRN12608000424303招募中3 期

A double blind placebo-controlled randomized clinical trial of the use of oral azithromycin in Aboriginal children between 6 months and 30 months of age presenting with asymptomatic acute otitis media without perforation

Menzies School of Health Research0 个研究点目标入组 300 人开始时间: 2008年8月25日最近更新:
适应症

试验速览

阶段
3 期
状态
招募中
入组人数
300

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional
分配方式
Randomised controlled trial
主要目的
Treatment
盲法
Blinded (masking used)

入排标准

年龄范围
6 Months 至 30 Months(—)
性别
All

入选标准

  • 1. Informed consent obtained and signed
  • 2. All Aboriginal children aged 6 months and 30 months of age on the date of randomisation who are resident in participating communities will be eligible to be screened for asymptomatic acute otitis media without perforation.
  • 3. The following inclusion criteria for the randomized controlled trial (RCT) will be applied to children diagnosed with asymptomatic acute otitis media:
  • a.) A bulging tympanic membrane.
  • b.) No associated symptoms at the time of diagnosis (including ear pain or fever).
  • 4. Children who have a diagnosis of asymptomatic acute otitis media who are able to attend the clinic for follow up visits at day 7, day 14 and day 28.

排除标准

  • 1. Acute otitis media with ear pain or fever
  • 2. Acute otitis media with recent onset of perforation and discharge (within 7 days)
  • 3. Chronic suppurative otitis media
  • 4. Previously been randomised into this study
  • 5. Have received antibiotics in the previous 7 days (not including topical antibiotics)
  • 6. A more severe illness requiring antibiotics
  • 7. Azithromycin allergy
  • 8. Immunodeficiency

研究者

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