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NCT05176353 · ClinicalTrials.gov registry record · NA
Ventilator-associated Pneumonia (VAP) Diagnostic Stewardship Trial
A NA study, sponsored by University of Michigan.
- Completed
- Registry status
- NA
- Development phase
- 4,892
- Enrollment target
NCT05176353 is a NA study that has completed, run by University of Michigan. The registered enrollment target is 4,892 participants.
The verdict
NCT05176353, a NA study, has completed, sponsored by University of Michigan.
- COMPLETED
- Registry status
- NA
- Development phase
- 4,892 participants
- Enrollment target
Study Summary
This is a prospective pilot/feasibility trial of a bundled diagnostic stewardship intervention at the level of the microbiologic testing pathway in ventilator-associated pneumonia (VAP). The study utilized a pre/post design and was initially registered as a single-arm trial because the study intervention could only be applied prospectively to a single group (all patients hospitalized in study ICUs requiring ventilation during the trial intervention period). The study objectives are to safely and effectively reduce antibiotic overuse and its attendant hazards (adverse drug events, Clostridioides difficile diarrhea and generation of multidrug-resistant organisms) among mechanically-ventilated patients. Participating ICUs will have the following three modifications made in their respiratory culture workflows for mechanically-ventilated patients: 1) providers will be required to select a valid indication for respiratory culture performance (worsening ventilator requirements, purulent sputum production, and/or new radiographic infiltrate on chest imaging); 2) respiratory cultures will be preferentially obtained via bronchoscopic or nonbronchoscopic BAL (by respiratory therapists) rather than via endotracheal aspiration; and 3) BAL samples will be sent for cell count and differentials, and respiratory culture results will not be released for samples with \<50% neutrophils. The study will carefully monitor adherence to study interventions, ICU-specific antibiotic utilization rates, and important safety metrics including rates of mortality, ventilator-dependence and ventilator-associated events. The trial hypotheses are: * Implementation of a VAP diagnostic stewardship bundle will be successfully implemented without significant increases in mortality or ventilator-associated events. * Implementation of a VAP diagnostic stewardship bundle will be associated with a reduction in ICU-specific antibiotic utilization rates
Interventions
- OTHER VAP diagnostic stewardship bundle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 4,892 participants |
| Start Date | 2022-02-11 |
| Est. Completion | 2023-03-14 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05176353
The ClinicalTrials.gov registry entry for NCT05176353 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 4,892 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Michigan, which has 1,327 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which VAP diagnostic stewardship bundle is the first listed.
NCT05176353 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05176353 about?
NCT05176353 is a clinical study titled "Ventilator-associated Pneumonia (VAP) Diagnostic Stewardship Trial". This is a prospective pilot/feasibility trial of a bundled diagnostic stewardship intervention at the level of the microbiologic testing pathway in ventilator-associated pneumonia (VAP). The study utilized a pre/post design and was initially registered as a single-arm trial because the study interve...
What is the current status of trial NCT05176353?
This trial is currently completed. It is a NA study. The enrollment target is 4,892 participants. The study started on 2022-02-11. Estimated completion is 2023-03-14.
What interventions are being tested in trial NCT05176353?
The interventions under investigation include: VAP diagnostic stewardship bundle (OTHER).
Who is sponsoring clinical trial NCT05176353?
This trial is sponsored by University of Michigan, which has 1,327 total clinical trials registered on ClinicalTrials.gov.
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