A primary care-based, open, individually randomised, controlled, non-inferiority trial. The trial aims to recruit 350 children aged 6 months to 12 years with AOMd and ear pain and/or fever. Participants will be randomised to 7 days of hydrocortisone-bacitracin-colistin eardrops five drops three times daily or amoxicillin oral suspension 50 mg/kg body weight per day, divided over three doses. Parents will keep a daily diary of AOM symptoms, adverse events and complications for 2 weeks. In addition, they will record AOM recurrences, healthcare utilisation and societal costs for 3 months. The primary outcome is the proportion of children without ear pain and fever at day 3. Secondary outcomes include ear pain and fever intensity/severity; days with ear discharge; eardrum perforation at 2 weeks; adverse events during first 2 weeks; costs; and cost effectiveness at 2 weeks and 3 months. The primary analyses will be intention-to-treat and per-protocol analyses will be conducted as well.
The medical research ethics committee Utrecht, The Netherlands has given ethical approval (17-400/G-M). Parents/guardians of participants will provide written informed consent. Study results will be submitted for publication in peer-reviewed medical journals and presented at relevant (inter)national scientific meetings.
The Netherlands National Trial Register; NTR6723. Date of registration: 27 November 2017.
以初级保健为基础,打开,单独随机,控制,非自卑审判。该试验旨在招募350名年龄在6个月至12岁之间患有AOMd和耳痛和/或发烧的儿童。参与者将被随机分配给氢化可的松-杆菌肽-粘菌素滴耳剂7天,每天3次,或每天50mg/kg体重的阿莫西林口服混悬液,分成三个剂量。家长将保持AOM症状的每日日记,2周的不良事件和并发症。此外,他们将记录AOM复发,3个月的医疗保健利用率和社会成本。主要结果是第3天没有耳痛和发烧的儿童比例。次要结果包括耳痛和发热强度/严重程度;耳部分泌物天数;2周时鼓膜穿孔;前2周不良事件;费用;2周和3个月时的成本效益。主要分析将是意向治疗,也将进行符合方案的分析。
乌得勒支医学研究伦理委员会,荷兰已获得道德批准(17-400/G-M)。参与者的父母/监护人将提供书面知情同意书。研究结果将提交给同行评审的医学期刊发表,并在相关(国际)国家科学会议上发表。
荷兰国家审判登记册;NTR6723。注册日期:2017年11月27日。