Ear infection dilemma: do antibiotics work better than a placebo for young children?

NCT ID NCT07730814

First seen Jul 28, 2026 · Last updated Jul 29, 2026 · Updated 1 time

Summary

This trial investigates whether antibiotics like amoxicillin or amoxicillin-clavulanate ease symptoms of ear infections (acute otitis media) in children aged 6 months to 3 years better than a placebo. Over 1,100 children are randomly assigned to one of three groups, and families track daily symptoms using a simple diary. The goal is to see if antibiotics truly reduce symptom burden and to identify factors like age or fever that might influence treatment success.

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 a placebo (inactive pill)
What this could lead to
If this trial succeeds, it could clarify whether antibiotics truly help children with ear infections feel better faster, potentially reducing unnecessary antibiotic use.
What could go wrong
This is a single trial, and results may not apply to all children. Placebo-controlled antibiotic trials carry risks like worsening infection if antibiotics are truly needed.

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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.

Contacts and locations

Locations

  • Cincinnati Children's Hospital

    Cincinnati, Ohio, 45229, United States

  • Duke University Hospital

    Durham, North Carolina, 27705, United States

  • Seattle Children's Hospital

    Seattle, Washington, 98105, United States

  • UPMC Children's Hospital of Pittsburgh

    Pittsburgh, Pennsylvania, 15213, United States

  • University of Colorado, Denver

    Denver, Colorado, 80204, United States

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