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NCT06788093 · ClinicalTrials.gov registry record · NA

Reducing Overuse of Antibiotics With Decision Support

A NA study of Asthma and Pneumonia, sponsored by Vanderbilt University Medical Center.

Recruiting
Registry status
NA
Development phase
2,800
Enrollment target
3
Study locations

NCT06788093 is a NA study of Asthma and Pneumonia that is actively recruiting participants, run by Vanderbilt University Medical Center. The registered enrollment target is 2,800 participants, above the 1,556-participant average among 374 other Asthma trials with a reported enrollment target (80% higher). The trial reports 3 study locations across 2 states.

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The verdict

NCT06788093, a NA study of Asthma and Pneumonia, is actively recruiting participants, sponsored by Vanderbilt University Medical Center.

RECRUITING
Registry status
NA
Development phase
2,800 participants
Enrollment target
3
Study locations

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.

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

FieldValue
Enrollment Target 2,800 participants
Start Date 2024-11-12
Est. Completion 2027-04
Phase NA

What the Registry Record Tells You About NCT06788093

The ClinicalTrials.gov registry entry for NCT06788093 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 2,800 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 1,556-participant average among 374 other Asthma trials with a reported enrollment target (80% higher). The listed sponsor is Vanderbilt University Medical Center, which has 677 total studies on file at ClinicalTrials.gov.

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.

NCT06788093 reports 3 study locations spanning 2 distinct geographic areas - top geographies include California, Tennessee.

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.

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).

Who is sponsoring clinical trial NCT06788093?

This trial is sponsored by Vanderbilt University Medical Center, which has 677 total clinical trials registered on ClinicalTrials.gov.

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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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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