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

在医学文献中，偏远地区的土著儿童患严重耳部感染的比率最高。在任何时候，大量儿童都有鼓膜膨出（急性中耳炎），但大多数是完全无症状的。在我们之前的抗生素研究中，50%的儿童在治疗1周后仍然存在急性中耳炎（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（尽管阿奇霉素在降低感染水平方面似乎更好）。目前，当地临床医生：i)不确定抗生素是否有任何作用；ii)在没有充分证据表明有实质性益处的情况下，不愿投入资源进行病例发现。在这项随机对照试验中，我们将确定两剂阿奇霉素对无症状急性中耳炎儿童间隔1周的益处，以改善健康结局。该试验结果将成为指导高危儿童无症状AOM医学管理的最佳证据。我们预计，它将在转向更有效地预防和管理中耳炎在澳大利亚土著儿童的重要贡献。它还将对所有不利人群产生影响，这些人群的不良后果很常见，对推荐治疗的依从性很差。

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.