Topical or oral antibiotics for children with acute otitis media presenting with ear discharge: a randomised controlled non-inferiority trial|临床试验数据集|儿童健康数据集

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 Utrecht