AMOXICILLIN VERSUS AMOXICILLIN-CLAVULANATE VERSUS PLACEBO IN ACUTE OTITIS MEDIA IN CHILDREN – A PARALLEL-GROUP TRIPLE-BLINDED RANDOMIZED CONTROLLED SUPERIORITY TRIAL
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 219
- 试验地点
- 3
- 主要终点
- The primary outcome is condition of the child, measured daily in days 1-7 and at days 10 and 14 with AOM-SOS score version 6.0. The treatment effectiveness measured as risk ratios and generalized estimation equations (GEE) are used to convert the daily mean comparisons into relative effect estimates
研究概览
简要总结
The main objective is to compare amoxicillin to placebo and amoxicillin-clavulanate in the treatment of acute otitis media in children.
入排标准
- 年龄范围
- 0 years 至 17 years（0-17 Years）
- 接受健康志愿者
- 否
入选标准
- •Age 6-35 months and diagnosis of AOM along the prespecified criteria
排除标准
- •complicated AOM , spontaneous perforation of the tympanic membrane, known allergy to aminopenicillins, antibiotic treatment for another infectious disease, present or during 2 preceding weeks, tympanostomy tube or chronic perforation of the tympanic membrane, anatomic defect or anomaly affecting the susceptibility to AOM, immune defect, either primary or secondary, severe chronic kidney disease, known hearing defect
结局指标
主要结局
The primary outcome is condition of the child, measured daily in days 1-7 and at days 10 and 14 with AOM-SOS score version 6.0. The treatment effectiveness measured as risk ratios and generalized estimation equations (GEE) are used to convert the daily mean comparisons into relative effect estimates
The primary outcome is condition of the child, measured daily in days 1-7 and at days 10 and 14 with AOM-SOS score version 6.0. The treatment effectiveness measured as risk ratios and generalized estimation equations (GEE) are used to convert the daily mean comparisons into relative effect estimates
次要结局
- Secondary outcomes are proportions of children - needing rescue antibiotics - with no improvement of overall condition by the first scheduled control visit (day 2-4) - with no improvement of otoscopic signs (7-9 day visit) - with middle ear effusion at days 2, 7 and 14 - with development of contralateral AOM during the treatment - with spontaneous perforation of the tympanic membrane during the treatment - with side effects (for ex. diarrhea, rash)
研究者
Marjo Helena Renko
Scientific
Pohjois-Savon hyvinvointialue