Actively Recruiting

Phase Not Applicable
Age: 6Months - 17Years
All Genders
NCT06788093

Reducing Overuse of Antibiotics With Decision Support

Led by Vanderbilt University Medical Center · Updated on 2026-01-22

2800

Participants Needed

3

Research Sites

124 weeks

Total Duration

On this page

Sponsors

V

Vanderbilt University Medical Center

Lead Sponsor

A

Agency for Healthcare Research and Quality (AHRQ)

Collaborating Sponsor

AI-Summary

What this Trial Is About

Eliminating inappropriate antibiotic use in pediatric lower respiratory tract infections (LRTI) is the central focus of this research. LRTIs (pneumonia, bronchiolitis, and infection-related exacerbations of asthma) account for nearly one-third of all emergency department (ED) visits and 40% of all infection-related hospitalizations in US children. LRTIs also account for more antibiotic use in children's hospitals than any other condition, despite most LRTIs being viral in nature. Inappropriate antibiotics are associated with substantial adverse effects. Accordingly, national guidelines strongly discourage routine antibiotic use for bronchiolitis and acute asthma and argue for significantly reducing antibiotic exposure (initiation, spectrum, and duration) in pneumonia. To address the problem of inappropriate antibiotic use, hospital-based antimicrobial stewardship programs (ASPs) are now common nationwide, and these programs have demonstrated effectiveness in some hospital settings. Unfortunately, traditional ASP approaches do not translate well to the fast-paced and unpredictable ED environment, and hospital-based ASP resources are finite and not always immediately available. Clinical decision support (CDS) embedded within the electronic health record (EHR) is a strategy that could address the ED antibiotic stewardship gap. Informed by a deep understanding of the key facilitators and barriers to using CDS to support appropriate antibiotic use in ED and hospital settings, the investigators have developed two stewardship-focused CDS interventions for pediatric LRTI. The overarching goal of this research is to rigorously evaluate the implementation and effectiveness of these CDS tools, alone and in combination, against usual care only in a pragmatic randomized clinical trial at 3 U.S. children's hospitals.

CONDITIONS

Official Title

Reducing Overuse of Antibiotics With Decision Support

Who Can Participate

Age: 6Months - 17Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Child has an emergency department encounter or admission to an inpatient hospital team
  • Electronic health record shows suspected lower respiratory tract infection with qualifying symptoms like cough or shortness of breath and abnormal respiratory effort
Not Eligible

You will not qualify if you...

History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety

AI-Screening

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Trial Site Locations

Total: 3 locations

1

Benioff Children's Hospital - Oakland

Oakland, California, United States, 94609

Not Yet Recruiting

2

Benioff Children's Hospital - San Francisco

San Francisco, California, United States, 94158

Not Yet Recruiting

3

Monroe Carell Jr Children's Hospital at Vanderbilt

Nashville, Tennessee, United States, 37232

Actively Recruiting

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Research Team

J

Justine Stassun, MS

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

SEQUENTIAL

Primary Purpose

HEALTH_SERVICES_RESEARCH

Number of Arms

4

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