BACKGROUND Chronic suppurative otitis media (CSOM) is a significant health issue affecting Aboriginal Australians. Long-term hearing loss can cause communication problems, educational disadvantage, and social isolation. Current standard treatment for CSOM in our region is twice daily dry mopping of the pus from the ear canal followed by instillation of ciprofloxacin antibiotic ear drops for up to 16 weeks, or until the discharge resolves for a period of 3 days. The treatment is long, laborious and fails to resolve ear discharge in 70% of cases in remote communities. Bacterial pathogens also persist. Povidone-iodine ear wash is the preferred method of clearing ear discharge in Western Australia. However, evidence of its effectiveness is lacking. In systematic reviews, topical antibiotics (ciprofloxacin) have been shown to be more effective than oral antibiotics or topical antiseptics. Currently, it is unclear whether there are any benefits of combining these treatments. METHODS This protocol describes a 2 × 2 factorial randomised controlled trial of two different interventions (povidone-iodine ear wash and oral cotrimoxazole), given as adjunctive therapy to standard treatment for CSOM. 280 children, between 2 months and 17 years of age, Indigenous or non-Indigenous, living in participating Northern Territory (NT) communities are randomised to standard treatment (dry mopping and ciprofloxacin drops) plus one of two topical treatments (dilute povidone-iodine ear wash or no wash) and one of two oral medication treatments (16 weeks of cotrimoxazole or placebo). DISCUSSION Current treatment of CSOM in our region shows that eradication of bacterial pathogens from the middle ear space and dry ears is often not achieved. This trial will evaluate the efficacy of adjunctive treatments of antiseptic ear washes and oral antibiotics. Clinical, microbiological and hearing outcomes will be reported. TRIAL REGISTRATION This trial (ACTRN12614000234617) was registered with ANZCTR on 05 April 2014.

中文翻译：

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澳大利亚原住民儿童慢性化脓性中耳炎的聚维酮碘洗耳液和口服曲美唑：析因设计随机对照试验的研究方案。

背景技术慢性化脓性中耳炎（CSOM）是影响澳大利亚原住民的重要健康问题。长期听力损失会导致沟通问题，教育劣势和社会孤立。目前，本地区CSOM的标准治疗方法是每天两次从耳道干擦脓液，然后滴注环丙沙星抗生素滴耳液长达16周，或者直到分泌物消退3天。这种治疗方法耗时长，费力，并且在偏远社区中有70％的病例无法解决耳部分泌物。细菌病原体也持续存在。在西澳大利亚州，聚维酮碘洗耳液是清除耳朵分泌物的首选方法。但是，缺乏其有效性的证据。在系统评价中，已显示局部抗生素（环丙沙星）比口服抗生素或局部防腐剂更有效。目前，尚不清楚结合使用这些治疗方法是否有任何益处。方法该方案描述了一项2×2因数随机对照试验，采用两种不同的干预措施（聚维酮碘洗耳液和口服考特莫唑），作为CSOM的标准治疗方法的辅助治疗。居住在北领地（NT）社区的280名2个月至17岁的土著或非土著儿童被随机分配到标准治疗（干擦和环丙沙星滴剂）外加两种局部治疗之一（稀聚维酮碘）洗头或不洗头）和两种口服药物治疗之一（cotrimoxazole或安慰剂16周）。讨论我们地区目前对CSOM的治疗方法表明，通常无法实现从中耳间隙和干耳根除细菌病原体的工作。该试验将评估抗菌洗耳液和口服抗生素的辅助治疗效果。将报告临床，微生物学和听力结果。试验注册该试验（ACTRN12614000234617）已于2014年4月5日在ANZCTR注册。