NCT06788093Recruiting
Reducing Overuse of Antibiotics With Decision Support
Reducing Overuse of Antibiotics With Decision Support in Lower Respiratory Tract Infections
Source: ClinicalTrials.gov · Last updated 22 Jan 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 2800 (estimated)
- First submitted
- 16 Jul 2024
- Start date
- 12 Nov 2024
- Primary completion date
- Apr 2027
- Lead sponsor
- Vanderbilt University Medical Center
- Diseases
- Asthma
- NCT number
- NCT06788093
What you commit to
- Study type: Interventional
- Planned participants: 2800
- From 12 Nov 2024 to the primary completion date, Apr 2027
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Who the study is looking for
- ED encounter or admission to an inpatient hospital team.
- EHR-based positive screen for suspected LRTI, defined as a qualifying chief complaint (e.g., cough, shortness of breath, etc.), plus triage documentation of abnormal respiratory effort and/or cough.
Age in the registry: 6 months to 17 years · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Monroe Carell Jr. Children's Hospital at Vanderbilt Coordinator of this site? Confirm its status | Nashville | United States | Recruiting |
| Benioff Children's Hospital - Oakland Coordinator of this site? Confirm its status | Oakland | United States | Not yet recruiting |
| Benioff Children's Hospital - San Francisco Coordinator of this site? Confirm its status | San Francisco | United States | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.