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Azithromycin versus placebo in the treatment of asymptomatic acute otitis media in young Aboriginal children : A RCT

阿奇霉素与安慰剂治疗年轻原住民儿童无症状急性中耳炎：一项随机对照试验

基本信息

批准号：
nhmrc : 436023
负责人：
A/Pr Heidi Smith-Vaughan
金额：
$ 90.52万
依托单位：
Menzies School of Health Research
依托单位国家：
澳大利亚
项目类别：
NHMRC Project Grants
财政年份：
2007
资助国家：
澳大利亚
起止时间：
2007-01-01 至 2010-12-31
项目状态：
已结题

来源：
https://researchdata.edu.au/azithromycin-versus-placebo-children-rct/100838
关键词：
Azithromycin versus placebo treatment asymptomatic

项目摘要

Remote Aboriginal children have the highest rates of severe ear infection reported in the medical literature. At any time, large numbers of children have a bulging eardrum (acute otitis media) but most are completely asymptomatic. In our previous antibiotic study, acute otitis media (AOM) persisted in 50% of children after 1 week of treatment. In terms of clinical success, it didn't make any difference whether azithromycin or amoxicillin was used (although azithromycin seemed to be better at reducing the level of infection). Currently local clinicians are: i) uncertain whether antibiotics make any difference at all; and ii) reluctant to devote resources to case-finding without good evidence of substantial benefit. In this randomised controlled trial, we will determine the benefits of 2 doses of azithromycin given 1 week apart in children with asymptomatic acute otitis media will improve health outcomes. The results of the trial will become the best available evidence to guide the medical management of asymptomatic AOM in high-risk children. We anticipate that it will make an important contribution in the shift toward more effective prevention and management of otitis media in Australian Aboriginal children. It will also have implications for all disadvantaged populations where adverse outcomes are common and compliance with recommended treatment is poor.

医学文献中报道的偏远原住民儿童严重耳部感染的发生率最高。任何时候，都有大量儿童出现鼓膜鼓胀（急性中耳炎），但大多数完全没有症状。在我们之前的抗生素研究中，50% 的儿童在治疗 1 周后仍患有急性中耳炎 (AOM)。就临床成功而言，使用阿奇霉素或阿莫西林没有任何区别（尽管阿奇霉素似乎在降低感染水平方面更有效）。目前当地临床医生： i) 不确定抗生素是否有任何影响； ii) 在没有充分证据表明有实质性益处的情况下，不愿投入资源进行案件调查。在这项随机对照试验中，我们将确定间隔 1 周给予 2 剂阿奇霉素对无症状急性中耳炎儿童的益处，以改善健康结果。试验结果将成为指导高危儿童无症状 AOM 医疗管理的最佳证据。我们预计它将为澳大利亚原住民儿童更有效地预防和管理中耳炎做出重要贡献。它还将对所有不良后果常见且对推荐治疗的依从性较差的弱势群体产生影响。