HYPOTHESIS. Antibiotic-steroid eardrops are non-inferior to oral antibiotics in resolving ear pain and/or fever at day 3 (72 hours after randomisation) in children with AOM presenting with acute ear discharge due to a spontaneous eardrum perforation (AOMd).
RESEARCH QUESTIONS. 1) Are antibiotic-steroid eardrops non-inferior to oral antibiotics in children with AOMd in resolution of AOM symptoms?; 2) What are the costs and cost-effectiveness of antibiotic-steroid eardrops as compared with oral antibiotics in children with AOMd?
STUDY DESIGN. Primary care based, pragmatic, randomised controlled non-inferiority trial with a follow-up of 3 months.
STUDY POPULATION. 350 children aged 6 months to 10 years visiting their GP with AOMd.
INTERVENTIONS. Hydrocortisone-bacitracin-colistin (Bacicoline-B) eardrops, 5 drops, 3 times/day in the discharging ear(s) for 7 days versus amoxicillin suspension 40 mg/kg body weight/day, divided over 3 oral doses for 7 days.
PRIMARY OUTCOME. Proportion of children without ear pain and/or fever at day 3.
SECONDARY OUTCOMES. Duration and severity of AOM symptoms (ear pain and fever), days with ear discharge; at 2 weeks: adverse events, eardrum perforation; at 3 months: AOM recurrences; cost-effectiveness;
SAMPLE SIZE CALCULATION. The proportion of children without ear pain and/or fever at day 3 is expected to be 65%. Taking a clinically acceptable non-inferiority margin of 15%, an alpha of 0.025 and beta of 0.20 (80% power), each treatment arm should include at least 159 children. To allow for a maximum of 10% loss to follow-up, we will include 350 children.
DATA ANALYSIS. Risk ratios and risk differences with 95% CIs will be calculated. Primarily, all analyses will be performed according to the ITT principle, but we will also perform per-protocol analyses.
ECONOMIC EVALUATION. Costs will be compared with the number of days without ear pain and/or fever at 2 weeks and 3 months. ICERs will be calculated.
TIME SCHEDULE. Dec 2016-Dec 2020; 48 months.