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Comparative Effectiveness of Available Treatments for Sinus and Ear Infections in Children (Acute Otitis Media)
Sponsor: Nader Shaikh
Summary
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.
Key Details
Gender
All
Age Range
6 Months - 36 Months
Study Type
INTERVENTIONAL
Enrollment
1100
Start Date
2026-10-01
Completion Date
2032-03-17
Last Updated
2026-07-28
Healthy Volunteers
No
Conditions
Interventions
Amoxicillin
Amoxicillin administered orally at protocol-specified, weight-based dosing consistent with standard pediatric treatment guidelines for AOM, for the defined treatment duration.
Amoxicillin-Clavulanate
Amoxicillin-clavulanate administered orally at protocol-specified, weight-based dosing consistent with standard pediatric treatment guidelines for AOM, for the defined treatment duration.
Amoxicillin Placebo
Matching placebo administered orally according to the same dosing schedule and treatment duration as the active comparator arms
Amoxicillin-Clavulanate Placebo
Matching placebo administered orally according to the same dosing schedule and treatment duration as the active comparator arms
Locations (5)
University of Colorado, Denver
Denver, Colorado, United States
Duke University Hospital
Durham, North Carolina, United States
Cincinnati Children's Hospital
Cincinnati, Ohio, United States
UPMC Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, United States
Seattle Children's Hospital
Seattle, Washington, United States