ACTRN12614000234617已完成4 期
Among Aboriginal children (2 months of age and up to 17 years of age) with chronic suppurative otitis media, is oral cotrimoxazole (for 4 months) and/or povidone-iodine ear wash (until ear discharge resolves) in addition to standard treatment (cleaning and dry mopping with tissue spears plus topical ciprofloxacin until ear discharge resolves) superior to standard treatment alone for resolving ear discharge? A 2x2 factorial randomised controlled trial
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 280
研究概览
简要总结
To be published
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
- 2 Months 至 17 Years（—）
- 性别
- All
入选标准
- •Indigenous children 2 months to 17 years of age and residing in participating communities, with a diagnosis of unilateral or bilateral chronic suppurative otitis media (CSOM) are eligible to participate in this study.
排除标准
- •Children who are ineligible include those who; i) have been previously randomised; ii) have ciprofloxacin, cotrimoxazole or iodine allergy; iii) had mastoid surgery in the preceding 12 months; iv) have ear surgery scheduled in the next 4 months; v) have congenital ear or hearing problems; vi) are known to have immunodeficiency; or vii) are pregnant.
研究者
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