Antibiotics vs. placebo for Kids' sinus infections: which works best?
NCT ID NCT07732699
First seen Jul 29, 2026 · Last updated Jul 30, 2026 · Updated 1 time
Summary
This trial tests whether common antibiotics—amoxicillin or amoxicillin-clavulanate—actually reduce symptoms in children aged 2 to 12 with acute sinusitis. About 1,100 children are randomly assigned to one of the two antibiotics or a placebo, and parents track daily symptoms. The goal is to see if antibiotics meaningfully improve recovery and whether factors like allergy or illness severity affect their effectiveness.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- amoxicillin, amoxicillin-clavulanate, or placebo
- What this could lead to
- If antibiotics prove clearly better than placebo, this could confirm their value for childhood sinus infections and help doctors choose the right one.
- What could go wrong
- This is a Phase 4 trial, but antibiotics may not work for all children, and some may experience side effects like diarrhea. The placebo group helps clarify true benefit.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 1,100 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Oct 2026
An estimate. Start dates often move.
- Expected to finish
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Mar 2032
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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2 to 12 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
5 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Cincinnati Children's Hospital
Cincinnati, Ohio, 45229, United States
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Duke University Hospital
Durham, North Carolina, 27705, United States
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Seattle Children's Hospital
Seattle, Washington, 98105, United States
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UPMC Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, 15213, United States
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University of Colorado, Denver
Denver, Colorado, 80204, United States
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