Trial · NCT05176353
Ventilator-associated Pneumonia (VAP) Diagnostic Stewardship Trial
NCT05176353, Not applicable, Completed, University of Michigan; results first posted 2024-12-03
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Ventilator-associated Pneumonia (VAP) Diagnostic Stewardship Trial. Trials, record NCT05176353. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05176353
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Ventilator-associated Pneumonia (VAP) Diagnostic Stewardship Trial
- NCT number
- NCT05176353
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 4,892 participants, actual
- Lead sponsor
- University of Michigan
- Conditions
- VAP - Ventilator Associated Pneumonia
- Interventions
- VAP diagnostic stewardship bundle
- First posted
- 2022-01-04
- Last updated
- 2024-12-03
- Results first posted
- 2024-12-03
- Limitations and caveats
Ventilator-Associated Event numbers are complete and accurate, but number of unique persons affected by ventilator-associated events was not collected. Given the constraints of the clinicaltrials.gov reporting system, the number of events is replicated in number of persons affected. In fact, the number of persons affected could be equal to or less than that number.
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Total Number of Deaths in the Pre vs Post-intervention Time Periods Among Study Participants Per 1000 Mechanically Ventilated Patient Days | During the period of mechanical ventilation (generally ranging between 1-2 days and 1 year). | The number of deaths that occur across the entire study population will be divided by every 1000 days that the total number of patients were hospitalized in study ICUs, receiving mechanical ventilation. Data was collected retrospectively for 5 years prior to the intervention and for 1 year during the intervention period. |
| Primary | Change in Ventilator-associated Events (V-A Events) (Using Centers for Disease Control/National Healthcare Safety Network Definitions) Per 1000 Patient Days | During the period of mechanical ventilation (generally ranging between 1-2 days and 1 year). | The change in ventilator-associated events that occur across the entire study population will be divided by every 1000 days that the total number of patients were hospitalized in study ICUs, receiving mechanical ventilation, as shown by comparing pre-intervention data to post-intervention data. Data was collected retrospectively for 5 years prior to the intervention and for 1 year during the intervention period. |
| Primary | Median Duration of Mechanical Ventilation Per Patient | During the period of mechanical ventilation (generally ranging between 1-2 days and 1 year). | |
| Secondary | Number of Positive Respiratory Cultures (RCs) Per 1,000 Mechanically-ventilated Patient Days (MVPDs) | During the period of mechanical ventilation (generally ranging between 1-2 days and 1 year). | Positive respiratory cultures were defined as any respiratory culture growing a bacterial organism, regardless of total colony-forming units/mL |
| Secondary | Total ICU Antibiotic Utilization Rates | During the period of mechanical ventilation (generally ranging between 1-2 days and 1 year). | Rates are shown as total antibiotic days of therapy per 1000 mechanically-ventilated patient days. A "Day of therapy" is defined as a calendar day in which a patient received a systemically-administered antibiotic, regardless of dose. Receipt of multiple, unique antibiotics on a given calendar day were counted cumulatively, that is, if a patient received 3 unique antibiotics that was counted as three days of therapy. |
| Secondary | Broad-spectrum ICU Antibiotic Utilization Rates | During the period of mechanical ventilation (generally ranging between 1-2 days and 1 year). | Utilization rates are shown as broad-spectrum antibiotic days of therapy per 1000 mechanically-ventilated patient days. Broad-spectrum antibiotics were defined as antibiotics with expected coverage against methicillin-resistant Staphylococcus aureus or Pseudomonas aeruginosa. A "day of therapy" is defined as a calendar day in which a patient received a systemically-administered antibiotic, regardless of dose. Receipt of multiple, unique antibiotics on a given calendar day were counted cumulatively, that is, if a patient received 3 unique antibiotics that was counted as three days of therapy. . |
| Secondary | Number of Respiratory Cultures Ordered Per 1000 Mechanically-ventilated Patient Days | During the period of mechanical ventilation (generally ranging between 1-2 days and 1 year). | |
| Secondary | Percentage of Respiratory Cultures Obtained by Bronchoalveolar Lavage (BAL) | During the period of mechanical ventilation (generally ranging between 1-2 days and 1 year). | |
| Secondary | Percentage of Respiratory Cultures From BAL Samples With Alveolar Neutrophils <50% Following Study Intervention. | 6 months post-intervention |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Total Number of Deaths in the Pre vs Post-intervention Time Periods Among Study Participants Per 1000 Mechanically Ventilated Patient Days | During the period of mechanical ventilation (generally ranging between 1-2 days and 1 year). | Deaths per 1000 patient-days | NUMBER | |
| PRIMARY | Change in Ventilator-associated Events (V-A Events) (Using Centers for Disease Control/National Healthcare Safety Network Definitions) Per 1000 Patient Days | During the period of mechanical ventilation (generally ranging between 1-2 days and 1 year). | V-A events per 1000 pt days | NUMBER | |
| PRIMARY | Median Duration of Mechanical Ventilation Per Patient | During the period of mechanical ventilation (generally ranging between 1-2 days and 1 year). | Calendar Days | MEDIAN | |
| SECONDARY | Number of Positive Respiratory Cultures (RCs) Per 1,000 Mechanically-ventilated Patient Days (MVPDs) | During the period of mechanical ventilation (generally ranging between 1-2 days and 1 year). | positive RCs per 1,000 MVPDs | NUMBER | |
| SECONDARY | Total ICU Antibiotic Utilization Rates | During the period of mechanical ventilation (generally ranging between 1-2 days and 1 year). | days of therapy per 1000 patient-days | NUMBER | |
| SECONDARY | Broad-spectrum ICU Antibiotic Utilization Rates | During the period of mechanical ventilation (generally ranging between 1-2 days and 1 year). | days of therapy per 1000 patient-days | NUMBER | |
| SECONDARY | Number of Respiratory Cultures Ordered Per 1000 Mechanically-ventilated Patient Days | During the period of mechanical ventilation (generally ranging between 1-2 days and 1 year). | Cultures ordered per 1000 patient-days | NUMBER | |
| SECONDARY | Percentage of Respiratory Cultures Obtained by Bronchoalveolar Lavage (BAL) | During the period of mechanical ventilation (generally ranging between 1-2 days and 1 year). | Some providers ordered more than one culture per patient over the course of their hospital stay. | percentage of respiratory cultures | NUMBER |
| SECONDARY | Percentage of Respiratory Cultures From BAL Samples With Alveolar Neutrophils <50% Following Study Intervention. | 6 months post-intervention | This outcome measure only applied to the post-intervention arm. This was an optional test that providers could order, but many providers cancelled the test. Thus few BAL cell count/differentials were sent. | Percentage of respiratory cultures | NUMBER |
Source ClinicalTrials.gov
Results by group17
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Total Number of Deaths in the Pre vs Post-intervention Time Periods Among Study Participants Per 1000 Mechanically Ventilated Patient Days | Pre-VAP Diagnostic Stewardship | 72 | 95% Confidence Interval 62 to 75 | Deaths per 1000 patient-days | |
| Total Number of Deaths in the Pre vs Post-intervention Time Periods Among Study Participants Per 1000 Mechanically Ventilated Patient Days | VAP Diagnostic Stewardship | 73 | 95% Confidence Interval 64 to 82 | Deaths per 1000 patient-days | |
| Change in Ventilator-associated Events (V-A Events) (Using Centers for Disease Control/National Healthcare Safety Network Definitions) Per 1000 Patient Days | Pre-VAP Diagnostic Stewardship | 15 | 95% Confidence Interval 13 to 17 | V-A events per 1000 pt days | |
| Change in Ventilator-associated Events (V-A Events) (Using Centers for Disease Control/National Healthcare Safety Network Definitions) Per 1000 Patient Days | VAP Diagnostic Stewardship | 10 | 95% Confidence Interval 7 to 14 | V-A events per 1000 pt days | |
| Median Duration of Mechanical Ventilation Per Patient | Pre-VAP Diagnostic Stewardship | 3 | Inter-Quartile Range 2 to 7 | Calendar Days | |
| Median Duration of Mechanical Ventilation Per Patient | VAP Diagnostic Stewardship | 3 | Inter-Quartile Range 2 to 7 | Calendar Days | |
| Number of Positive Respiratory Cultures (RCs) Per 1,000 Mechanically-ventilated Patient Days (MVPDs) | Pre-VAP Diagnostic Stewardship | 127 | 95% Confidence Interval 122 to 131 | positive RCs per 1,000 MVPDs | |
| Number of Positive Respiratory Cultures (RCs) Per 1,000 Mechanically-ventilated Patient Days (MVPDs) | VAP Diagnostic Stewardship | 102 | 95% Confidence Interval 92 to 112 | positive RCs per 1,000 MVPDs | |
| Total ICU Antibiotic Utilization Rates | Pre-VAP Diagnostic Stewardship | 1361 | 95% Confidence Interval 1346 to 1376 | days of therapy per 1000 patient-days | |
| Total ICU Antibiotic Utilization Rates | VAP Diagnostic Stewardship | 1335 | 95% Confidence Interval 1300 to 1372 | days of therapy per 1000 patient-days |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Pre-VAP Diagnostic Stewardship | 4,205 | |
| Overall Study | STARTED | VAP Diagnostic Stewardship | 687 | |
| Overall Study | COMPLETED | Pre-VAP Diagnostic Stewardship | 4,205 | |
| Overall Study | COMPLETED | VAP Diagnostic Stewardship | 687 | |
| Overall Study | NOT COMPLETED | Pre-VAP Diagnostic Stewardship | 0 | |
| Overall Study | NOT COMPLETED | VAP Diagnostic Stewardship | 0 |
Source ClinicalTrials.gov
Adverse events2
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| serious | ventilator associated events | Respiratory, thoracic and mediastinal disorders | Pre-VAP Diagnostic Stewardship | 278 | 4,205 | 278 |
| serious | ventilator associated events | Respiratory, thoracic and mediastinal disorders | VAP Diagnostic Stewardship | 34 | 687 | 34 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Pre-VAP Diagnostic Stewardship | 1,666 | 4,205 |
| Total, all-cause mortality | VAP Diagnostic Stewardship | 284 | 687 |
| Total, other adverse events | Pre-VAP Diagnostic Stewardship | 0 | 0 |
| Total, other adverse events | VAP Diagnostic Stewardship | 0 | 0 |
| Total, serious adverse events | Pre-VAP Diagnostic Stewardship | 278 | 4,205 |
| Total, serious adverse events | VAP Diagnostic Stewardship | 34 | 687 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| UL1TR002240 | Michigan Institute for Clinical and Health Research (MICHR) | MASHOUR, GEORGE ALEXANDER; LUMENG, JULIE C | UNIVERSITY OF MICHIGAN AT ANN ARBOR | NATIONAL CENTER FOR ADVANCING TRANSLATIONAL SCIENCES | 2017 to 2022 |
Source NIH RePORTER
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Pre-VAP Diagnostic Stewardship vs VAP Diagnostic Stewardship: deaths from any cause | Trial comparisons |
| Pre-VAP Diagnostic Stewardship vs VAP Diagnostic Stewardship: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05176353
GET https://conductscience.org/api/trials/v1/NCT05176353/registered