Topical or oral antibiotics for children with acute otitis media presenting with ear discharge: a randomised controlled non-inferiority trial

The PLOTS trial is a primary care-based, open randomised, controlled non-inferiority trial. Children presenting with AOMd and ear pain and/or fever were assigned to hydrocortisone-bacitracin-colistin eardrops (five drops, three times per day in the discharging ear(s)) or amoxicillin oral suspension (50 mg/kg body weight per day, divided over three doses) for 7 days. From December 2017 until March 2023, 58 children aged 6 months to 12 years were enrolled. Due to supply issues of the study medication, the trial was put on hold from 8 August 2018 through November 2021. The rationale and design haven been reported in detail elsewhere (see related publication). At baseline and after 2 weeks home visit data was collected. During these visits physical examination, including otoscopy was performed. Children were followed during 3 months. The first two weeks parents kept a daily diary of AOM-related symptoms, adverse events and complications. Thereafter, they kept a weekly diary recording AOM-recurrences, GP consultations, medications use, hospitals admissions and societal costs for AOM for 3 months. Parents completed the OM-specific QoL (OM-6) questionnaire at baseline, 2 weeks and at 3 months and a productivity loss questionnaires (iPCQ) at 2 weeks, 6 weeks and 3 months. In the metadata file all the variables are described. The data are sensitive since they involve personal information of patients. There are also restrictions on use by commercial parties, and on sharing openly based on (inter)national laws and regulations and written informed consent. Therefore these data (and additional clinical data) are only available after PI’s approval and upon signing a Data Sharing Agreement (see Terms of Access) and within a specially designed environment provided by the UMC UtrechtPLOTS试验是一项基于基层医疗的开放标签随机对照非劣效性试验（non-inferiority trial）。因急性中耳炎伴鼓膜穿孔（Acute Otitis Media with perforated tympanic membrane, AOMd）并伴有耳痛和/或发热的儿童被随机分配至两组：一组接受氢化可的松-杆菌肽-粘菌素滴耳液治疗（患流脓耳每日3次，每次5滴），另一组接受阿莫西林口服混悬液治疗（每日按体重50 mg/kg，分3次给药），两组疗程均为7天。 2017年12月至2023年3月期间，共纳入58名年龄介于6个月至12岁的儿童。由于研究药物供应短缺，该试验于2018年8月8日至2021年11月期间暂停。其研究依据与设计方案已在其他文献中详细报道（详见相关出版物）。 在基线期及第2周时开展家庭访视并采集数据。访视过程中会进行包括耳镜检查（otoscopy）在内的体格检查。所有入组儿童均接受了为期3个月的随访。 随访前2周，患儿家长需每日记录与AOMd相关的症状、不良事件及并发症；后续3个月则需每周记录AOMd复发情况、全科医师就诊情况、用药情况、住院情况及AOMd相关社会成本。 家长需在基线期、2周及3个月时完成中耳炎特异性生活质量量表（OM-6）问卷，并在2周、6周及3个月时完成工作损失相关问卷（iPCQ）。 本数据集的所有变量均在元数据文件中进行了详细说明。 由于涉及患者个人隐私信息，本数据集属于敏感数据。同时，依据国内外法律法规及书面知情同意要求，商业机构对本数据集的使用及公开共享均存在限制。 因此，本数据集（及额外临床数据）仅可在获得项目负责人批准、签署数据共享协议（详见访问条款），并在乌得勒支大学医学中心（UMC Utrecht）提供的专用研究环境中使用。