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NOT YET RECRUITING
NCT07732699
PHASE4

Comparative Effectiveness of Available Treatments for Sinus and Ear Infections in Children (Acute Sinusitis)

Sponsor: Nader Shaikh

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

2 Years - 12 Years

Study Type

INTERVENTIONAL

Enrollment

1100

Start Date

2026-10-01

Completion Date

2032-03-17

Last Updated

2026-07-29

Healthy Volunteers

No

Interventions

DRUG

Amoxicillin

Amoxicillin administered orally at protocol-specified, weight-based dosing consistent with standard pediatric treatment guidelines for AS, for the defined treatment duration.

DRUG

Amoxi 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.

DRUG

Amoxicillin Placebo

Matching placebo administered orally according to the same dosing schedule and treatment duration as the active comparator arms

DRUG

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