Comparative Effectiveness of Available Treatments for Sinus and Ear Infections in Children (Acute Sinusitis)
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 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.
Description
This is a multi-center, randomized, double-blind, placebo-controlled study designed to better understand whether the choice of antibiotic affects symptom burden in children with acute sinusitis (AS). Children enrolled in the study are randomly assigned to receive amoxicillin, amoxicillin-clavulanate, or a matching placebo. Neither the families nor the study team know which treatment a child is receiving during the study period. The primary objective is to compare average daily symptom severity across treatment groups using validated caregiver-reported symptom scales collected through daily ele…
Eligibility
- Age range
- 2–12 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Age 2 years to \<12 years. * Clinical diagnosis of AS. Exclusion Criteria: * 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 * Phenylketonuria or allergy to aspartame * History of craniofacial abnormalities * Concurrent bacterial infection requiring systemic antibiotic therapy (e.g., pneumonia, streptococcal pharyngitis) * Ill appearance, systemic toxicity, or immunodeficiency * Incomplete pneumococcal vaccination, defined as r…
Interventions
- DrugAmoxicillin
Amoxicillin administered orally at protocol-specified, weight-based dosing consistent with standard pediatric treatment guidelines for AS, for the defined treatment duration.
- DrugAmoxi Clavulanate
Amoxicillin-clavulanate administered orally at protocol-specified, weight-based dosing consistent with standard pediatric treatment guidelines for AOM or AS, for the defined treatment duration.
- DrugAmoxicillin Placebo
Matching placebo administered orally according to the same dosing schedule and treatment duration as the active comparator arms
- DrugAmoxicillin-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, DenverDenver, Colorado
- Duke University HospitalDurham, North Carolina
- Cincinnati Children's HospitalCincinnati, Ohio
- UPMC Children's Hospital of PittsburghPittsburgh, Pennsylvania
- Seattle Children's HospitalSeattle, Washington