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

RecruitingPhase 4Ages 2 Years - 12 YearsAllNader Shaikh
NCT07732699 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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 receipt of fewer than three doses of a pneumococcal conjugate vaccine * Parent or caregiver unable to complete study surveys in English or Spanish * Previous randomization into either MEASURE trial within the last 6 months * Periorbital redness and/or swelling, proptosis, or swelling of the forehead * Individuals who qualify for both the AS and AOM trials (to avoid dual enrollment) will be excluded from the AS trial.
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What it tests

  • Amoxicillin
  • Amoxi Clavulanate
  • Amoxicillin Placebo
  • Amoxicillin-Clavulanate Placebo
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Where

5 sites
University of Colorado, Denver
Denver, United States
Duke University Hospital
Durham, United States
Cincinnati Children's Hospital
Cincinnati, United States
UPMC Children's Hospital of Pittsburgh
Pittsburgh, United States
Seattle Children's Hospital
Seattle, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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