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Reducing Overuse of Antibiotics With Decision Support
NCT06788093 · View on ClinicalTrials.gov ↗
Study Summary
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 Studied
Interventions
- BEHAVIORAL ED Clinical Decision Support (CDS-ED)
- BEHAVIORAL Transitions Clinical Decision Support (CDS-Tr)
Study Locations (3)
California
- Benioff Children's Hospital - Oakland — Oakland
- Benioff Children's Hospital - San Francisco — San Francisco
Tennessee
- Monroe Carell Jr Children's Hospital at Vanderbilt — Nashville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2,800 participants |
| Start Date | 2024-11-12 |
| Est. Completion | 2027-04 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06788093
The ClinicalTrials.gov registry entry for NCT06788093 describes a study currently listed as recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 2,800 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Vanderbilt University Medical Center, which has 695 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 4 conditions, with Asthma appearing as the primary indexed condition, and to 2 interventions — of which ED Clinical Decision Support (CDS-ED) is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06788093 reports 3 study locations spanning 2 distinct geographic areas — top geographies include California, Tennessee. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT06788093 about?
NCT06788093 is a clinical study titled "Reducing Overuse of Antibiotics With Decision Support". 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 i...
What is the current status of trial NCT06788093?
This trial is currently recruiting. It is a NA study. The enrollment target is 2,800 participants. The study started on 2024-11-12. Estimated completion is 2027-04.
What conditions does trial NCT06788093 study?
This clinical trial studies the following conditions: Asthma, Pneumonia, Lower Respiratory Tract Infection, Bronchiolitis, Viral. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06788093?
The interventions under investigation include: ED Clinical Decision Support (CDS-ED) (BEHAVIORAL), Transitions Clinical Decision Support (CDS-Tr) (BEHAVIORAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06788093?
This trial is sponsored by Vanderbilt University Medical Center, which has 695 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT06788093 being conducted?
This trial has 3 study locations across California, Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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