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New study aims to cut antibiotic overuse in children with ear infections

NCT ID NCT06034080

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This study looks at two methods to help doctors prescribe fewer antibiotics for children with ear infections when they aren't needed. One method uses changes to electronic health records and feedback reports for doctors. The other adds a shared decision-making tool that involves parents more. The goal is to keep parents satisfied while reducing unnecessary antibiotic use and following national guidelines.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
EHR changes and audit/feedback reports
What this could lead to
If successful, this could provide a proven method to safely reduce antibiotic overuse in children with ear infections, helping to fight antibiotic resistance.
What could go wrong
This is a behavioral study, not a drug trial, so results depend on clinician and parent cooperation. It may not work in all clinics or change prescribing habits long-term.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 1,566 people

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

Started

Feb 2025

Expected to finish

Jun 2029

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 months to 17 years

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: A. Implementation of Interventions 1. Clinic at a participating organization 2. Provides care to children with AOM 3. Administrative or local approval for participation B. Secondary Electronic Health Record Data 1. Aged 6 months-17-years-old (inclusive) 2. Diagnosis of AOM by ICD10 code C. Video recordings or direct observation of the use of a shared decision aid Parent participation: 1. Child aged 6 months-17 years (inclusive) 2. Diagnosed with AOM by clinician 3. Parent or legal guardian is present and is \>=18 years or older Clinician Participation: 1. Licensed clinician and not a medical trainee 2. Age 18 \>= years or older D. Pre-implementation interviews of clinicians and administrators 1. Licensed clinician (physician or advanced practice clinician) that cares for children with AOM at a participating organization or an administrator/manager at a participating organization. 2. Aged \>=18 years-no maximum E. Pre-implementation focus groups of parents 1. Parent or legal guardian of a child aged 6 months-17 years (inclusive) that has had AOM diagnosed at a participating organization. 2. 18 years of age or older and able/willing to consent F. Parents enrolled for surveys 1\. Parent or legal guardian of a child aged 6 months-17 years (inclusive) that has had AOM diagnosed at a participating organization. 2. Willing to participate and able to complete electronic surveys at enrollment and 10 days after enrollment. 3. Working phone 4. Age \>=18 years of age G. Post-intervention focus groups of parents 1. Parent or legal guardian of a child aged 6 months-17 years (inclusive) that has had AOM diagnosed at a participating organization. 2. 18 years of age or older and able/willing to consent H. Post-intervention surveys of clinicians and administrators 1. Licensed clinician (physician or advanced practice clinician) that cares for children with AOM at a participating organization or an administrator/manager at a participating organization. 2. Aged \>=18 years-no maximum Exclusion Criteria: A. Implementation of Interventions 1\. Clinics that exclusively provide telehealth B. Secondary Electronic Health Record Data 1\. None C. Video recordings or direct observation of the use of a shared decision aid Parent participation: 1\. None Clinician Participation: 1\. None D. Pre-implementation interviews of clinicians and administrators 1. Medical trainee (student, resident, fellow, etc.) E. Pre-implementation focus groups of parents 1\. None F. Parents enrolled for surveys 1. Complicated or recurrent AOM as determined by the study team G. Post-intervention focus groups of parents 1. None H. Post-intervention surveys of clinicians and administrators 1\. Medical trainee (student, resident, fellow, etc.)

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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.

  1. The places running it

    3 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

  • AllianceChicago

    RECRUITING

    Chicago, Illinois, 60654, United States

  • Denver Health and Hospital Authority

    RECRUITING

    Denver, Colorado, 80204, United States

  • Intermountain Health

    RECRUITING

    Murray, Utah, 84107, United States

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