Shorter Antibiotic Courses for Ear Infections

(RELAX Trial)

Overseen By Holly M Frost, MD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Intermountain Health Care, Inc.

Disqualifiers: Complicated infection, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines the effectiveness of short courses of antibiotics for treating ear infections in children aged 2 and older. The study will compare two approaches: one with more intensive doctor training and feedback (High Intensity Intervention) and another with less intensive methods (Low Intensity Intervention) to determine which yields better outcomes. Clinics will be randomly assigned to one of these approaches to assess their effectiveness. Children with a straightforward ear infection (acute otitis media) who have been prescribed oral antibiotics may be suitable candidates for this trial. As an unphased trial, this study provides a unique opportunity to enhance understanding of effective treatments for ear infections in children.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that these interventions are safe for increasing short antibiotic prescriptions for ear infections?

Research has shown that the safety of shorter antibiotic courses for ear infections remains unclear. Some studies suggest shorter treatments do not lead to more side effects than longer ones, but the evidence is weak. Therefore, the safety of shorter courses cannot be fully assured.

The trial aims to change the duration of prescribed antibiotics, not to introduce new drugs. The goal is to safely reduce antibiotic use and avoid unnecessary exposure. This method is based on practices that have reduced antibiotic use without causing harm, though more research is needed specifically for ear infections.

In summary, while no strong evidence indicates increased risk with shorter antibiotic courses, the findings are inconclusive. Prospective participants should know that the trial seeks to change prescribing habits rather than introduce new medications, which is generally considered safer. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the trial for shorter antibiotic courses for ear infections because it explores innovative ways to effectively treat these common conditions with potentially less medication. Unlike the standard approach, which often involves longer courses of antibiotics, this study is investigating whether shorter, high-intensity or low-intensity interventions can achieve the same or better outcomes. This could lead to reduced antibiotic exposure, lowering the risk of side effects and antibiotic resistance, and making treatment easier and more convenient for patients. By potentially reducing the duration of treatment while maintaining effectiveness, this trial could revolutionize how ear infections are managed.

What evidence suggests that this trial's interventions could be effective for acute otitis media?

Previous studies have found that shorter antibiotic courses work as well as longer ones for treating infections like acute otitis media (AOM), an ear infection. Research has shown that shorter antibiotic treatments can significantly reduce the number of days children need medication while still effectively managing the infection. Importantly, shorter courses also tend to cause fewer side effects than longer treatments.

In this trial, the high-intensity intervention involves healthcare providers receiving detailed training and feedback, which studies have shown improves their ability to prescribe shorter antibiotic courses. Meanwhile, the low-intensity intervention includes basic education and updates to electronic health records, which have also been effective in encouraging the use of shorter treatments. Both approaches in this trial aim to safely reduce unnecessary antibiotic use, an important goal in managing ear infections in children. ^{1 2 3 6 7}

Who Is on the Research Team?

Timothy C Jenkins, MD

Principal Investigator

Denver Health and Hospital Authority

Holly M Frost, MD

Principal Investigator

Intermountain Health Care, Inc.

Sophie E Katz, MD

Principal Investigator

Vanderbilt University Medical Center

Jason Newland, MD

Principal Investigator

Washington University School of Medicine

Are You a Good Fit for This Trial?

The RELAX trial is for children aged 2-17 with uncomplicated ear infections (AOM) who are prescribed oral antibiotics. Clinicians and administrators involved must be licensed, practice at a study site, and not be medical trainees.

Inclusion Criteria

My child, aged 2-17, was diagnosed with AOM and prescribed oral antibiotics.

I am a licensed medical professional over 18, not in training, working at the study site.

I am the parent/guardian of a child 2-17 years old with AOM, ready to consent.

Exclusion Criteria

Not a parent or legal guardian, does not speak English or Spanish

Medical trainee

Medical trainee

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-implementation

Mixed-methods approach including quantitative analyses, semi-structured interviews, focus groups, surveys, and cost analyses

6 months

Implementation

High-intensity and low-intensity interventions are implemented in community-based clinics and urgent care centers

5 years

Evaluation

Evaluation of intervention effectiveness using the Reach Effectiveness Adoption Implementation Maintenance framework

5 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

What Are the Treatments Tested in This Trial?

Interventions

• High Intensity Intervention
• Low Intensity Intervention

Trial Overview This study compares two interventions to shorten antibiotic use for kids' ear infections. High-Intensity includes clinician education, feedback, peer comparison, EHR changes; Low-Intensity has just education and EHR changes.

How Is the Trial Designed?

Group I: Low Intensity Experimental Treatment 1 Intervention

Community-based clinics and/or urgent care centers that are assigned to the low intensity arm will receive the low intensity intervention.

Group II: High Intensity Experimental Treatment 1 Intervention

Community-based clinics and/or urgent care centers that are assigned to the high intensity arm will receive the high intensity intervention.

Who Is Running the Clinical Trial?

Intermountain Health Care, Inc.

Lead Sponsor

Trials

142

Recruited

1,965,000+

Denver Health and Hospital Authority

Lead Sponsor

Trials

106

Recruited

403,000+

Agency for Healthcare Research and Quality (AHRQ)

Collaborator

Trials

415

Recruited

6,777,000+

Vanderbilt University Medical Center

Collaborator

Trials

922

Recruited

939,000+

Washington University School of Medicine

Collaborator

Trials

2,027

Recruited

2,353,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10690393/

Reducing length of antibiotics for children with ear infections This study aims to fill this gap by evaluating the effectiveness and implementation outcomes of two low-cost interventions of differing intensities.

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37855227/

Reducing length of antibiotics for children with ear infections This study aims to fill this gap by evaluating the effectiveness and implementation outcomes of two low-cost interventions of differing intensities to increase ...

3. mdpi.com mdpi.com/2227-9067/12/10/1408

Interventions to Minimize Unnecessary Antibiotic Use for ... The highest averted days of antibiotic therapy were found with applying interventions to reduce durations of therapy (12.6 million days) and promote watchful ...

4. publications.aap.org publications.aap.org/pediatrics/article/156/3/e2024070155/203127/Increasing-Short-Course-Treatment-of-Acute-Otitis

Increasing Short-Course Treatment of Acute Otitis Media in ... However, in our care setting, this intervention was not effective and in fact had a small, negative impact on our primary outcome. This may ...

5. thelancet.com thelancet.com/journals/eclinm/article/PIIS2589-5370(25)00329-3/fulltext

Shorter versus longer-duration antibiotic treatments for ... Shorter- and longer-duration antibiotics show similar efficacy for bloodstream infections, with shorter courses reducing hospital stay. Consistent effects were ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7052812/

Short‐course antibiotics for acute otitis media - PubMed Central Six trials containing 614 children found non‐significant results for treatment failure at one month or less in short versus long‐course regimens of antibiotics ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S258953702400302X

Optimising antibiotic exposure by customising the duration ... The risk of treatment failure was higher with shorter courses (<7 days) compared to longer courses (≥7 days). A subsequent RCT confirmed that a shorter ...