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: 2020年1月13日

适应症

试验速览

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•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.

•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

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