CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 4,892 enrolled
Drug / intervention
VAP diagnostic stewardship bundleother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05176353
NCT05176353N/ACompleted

Implementation of a Diagnostic Stewardship Bundle for Ventilator-associated Pneumonia Among Mechanically-ventilated Patients

University of Michigan·interventional·Posted Jan 4, 2022·Updated Dec 3, 2024

In Brief

A clinical study evaluating VAP diagnostic stewardship bundle for VAP - Ventilator Associated Pneumonia. Completed, enrolled 4,892 participants across 1 site.

Detailed 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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
20222023202420252026
First PostedJan 4, 2022
Enrollment StartFeb 11, 2022
Primary CompletionFeb 12, 2023
Study CompletionMar 14, 2023
TodayJul 2, 2026
Enrollment to primary: 1.0 yearsPosted 4.5 years ago

Interventions

VAP diagnostic stewardship bundleother

Multifaceted VAP diagnostic stewardship bundle targeting the respiratory culture testing workflow through a custom order set within the institutional electronic medical record. Interventions will be made at the three levels of the diagnostic testing pathway (ordering, collection and reporting of test results). Full details available in detailed study description.