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

NCT ID NCT07730814

Disease control Sponsor: Nader Shaikh Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

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

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 1,100 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Oct 2026

An estimate. Start dates often move.

Expected to finish

Mar 2032

An estimate. End dates often move.

Lead sponsor

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

6 to 36 months

Sex

Anyone

Healthy volunteers

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

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria * Age 6 months to \<36 months. * Clinical diagnosis of AOM. 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 * Mastoiditis * Conjunctivitis * Temperature ≥39°C and AOM-SOS score ≥35 * Cochlear implants * Spontaneous tympanic membrane perforation with otorrhea at presentation (participants who develop perforation and otorrhea after consent remain eligible)

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Conditions

The condition(s) this trial relates to.

ear infection infectious otitis media otitis media

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Acute otitis media (AOM)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    5 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • 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

More trials for these conditions

Other studies related to the condition(s) this trial covers.