About this trial
This study is being conducted at multiple hospitals and clinics to better understand whether antibiotics truly help children feel better when they have a sinus infection (acute sinusitis). 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 examine whether factors such as the severity of the child's illness or signs of allergies affect how well antibiotics work. The results will help guide better treatment decisions for children with sinus infections.
Eligibility criteria
Qualifiers
Age 2 years to <12 years.
Clinical diagnosis of AS.
Disqualifiers
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
Trial design
Treatments tested in this trial
- Amoxicillin
- Amoxi Clavulanate
- Amoxicillin Placebo
- Amoxicillin-Clavulanate Placebo
Treatment groups
Sponsors and collaborators
Nader Shaikh
Lead sponsor
University of Pittsburgh
Sponsor institution
Patient-Centered Outcomes Research Institute
Collaborator