This study is being conducted at multiple hospitals and clinics to better understand whether antibiotics truly help children feel better when they have an ear infection (acute otitis media). Children in the study are randomly assigned (like flipping a coin) to receive either amoxicillin, amoxicillin-clavulanate, or a placebo (a look-alike medicine with no active antibiotic). Neither families nor study staff know which treatment the child is receiving during the study. The main goal is to compare how severe children's symptoms are each day while on these treatments. Parents or caregivers will report symptoms daily using a simple electronic diary. The study will also look at whether certain factors such as how sick the child is at the start, presence of fever, age, or how well antibiotics work. The results will help guide better treatment decisions for children with ear infections.
Age 6 months to <36 months.
Clinical diagnosis of AOM.
Known allergy or other contraindication to oral amoxicillin or clavulanate
Prior use of systemic antibiotics in the last 7 days
History of renal impairment
History of hepatic impairment
Nader Shaikh
Lead sponsor
University of Pittsburgh
Sponsor institution
Patient-Centered Outcomes Research Institute
Collaborator