By Kat Procyk
A new Pitt-led study is determining the most effective treatment for sinus and ear infections in children.
The University of Pittsburgh School of Medicine received a contract from the Patient-Centered Outcomes Research Institute for a large clinical study that will compare the effectiveness of different treatments for sinus and ear infections in children.
Ear and sinus infections are the leading reasons children are prescribed antibiotics, with nearly 20 million prescriptions issued annually in the United States. However, no studies in the past 25 years have directly compared the two most commonly used antibiotics: amoxicillin and amoxicillin-clavulanate. As a result, doctors don’t know which antibiotic is most effective when treating children with these conditions.
“Millions of kids are treated every year for common infections, yet we still don’t know which antibiotic works best—or if all of them even need treatment,” said Nader Shaikh, principal investigator and professor of pediatrics, School of Medicine, and of clinical and translational science.
Shaikh is launching a six-year study that will enroll 1,100 children with ear infections and 1,100 children with sinus infections across four clinical centers. Children will be treated with either amoxicillin, amoxicillin-clavulanate or a placebo. The placebo ensures that parents and doctors don’t know which treatment the child is receiving.
“Using a placebo is safe in this study because children who don’t recover quickly are promptly given antibiotics—just as they are in everyday clinical care,” Shaikh said. “Those who improve stay on their initial treatment, whether it’s placebo or one of the antibiotics.
This mirrors real-world practice, where doctors choose between observation, amoxicillin or amoxicillin-clavulanate based on how the child is doing.”
The researchers will measure how much symptoms improve because of antibiotics and record any side effects children had from using antibiotics. Their findings will help them create a tool that parents and doctors can use to decide, based on the symptoms present, whether using antibiotics seems worthwhile. The study, “Comparative Effectiveness of Available Treatments for Sinus and Ear Infections in Children,” was awarded funding in June 2025.