Trial Outcomes & Findings for Swab Testing to Optimize Pneumonia Treatment With Empiric Vancomycin (NCT NCT06272994)
NCT ID: NCT06272994
Last Updated: 2026-02-27
Results Overview
The number of hours out of the seven days following enrollment in the trial that the patient is alive and not receiving vancomycin estimated using a proportional odds ratio model with the ordinal status levels being alive and not on vancomycin, alive and on vancomycin, or dead.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
277 participants
Primary outcome timeframe
Baseline to seven days following enrollment.
Results posted on
2026-02-27
Participant Flow
Between April 2024 and January 2025, this pragmatic, prospective, randomized trial was conducted in a tertiary care, academic hospital ICU setting.
Participant milestones
| Measure |
No MRSA Nasal Swab
Subjects will not have a nasal swab collected.
|
MRSA Nasal Swab
Subjects will have a nasal swab collected and sent to the clinical laboratory for the MRSA nasal swab PCR test to be run. For the subjects assigned to the intervention group who have a negative MRSA nasal swab PCR result, providers will receive a pager alert which inform them of the negative result and will direct clinicians to clinical guidance recommending clinicians to discontinue vancomycin, if clinically appropriate.
|
|---|---|---|
|
Overall Study
STARTED
|
158
|
119
|
|
Overall Study
COMPLETED
|
158
|
119
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Unable to calculate BMI for two participants in the control group due to missing data
Baseline characteristics by cohort
| Measure |
No MRSA Nasal Swab
n=158 Participants
Subjects will not have a nasal swab collected.
|
MRSA Nasal Swab
n=119 Participants
Subjects will have a nasal swab collected and sent to the clinical laboratory for the MRSA nasal swab PCR test to be run. For the subjects assigned to the intervention group who have a negative MRSA nasal swab PCR result, providers will receive a pager alert which inform them of the negative result and will direct clinicians to clinical guidance recommending clinicians to discontinue vancomycin, if clinically appropriate.
|
Total
n=277 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
62 Years
n=24 Participants
|
62 Years
n=20 Participants
|
62 Years
n=40 Participants
|
|
Sex: Female, Male
Female
|
58 Participants
n=24 Participants
|
42 Participants
n=20 Participants
|
100 Participants
n=40 Participants
|
|
Sex: Female, Male
Male
|
100 Participants
n=24 Participants
|
77 Participants
n=20 Participants
|
177 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
6 Participants
n=24 Participants
|
7 Participants
n=20 Participants
|
13 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
138 Participants
n=24 Participants
|
106 Participants
n=20 Participants
|
244 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
14 Participants
n=24 Participants
|
6 Participants
n=20 Participants
|
20 Participants
n=40 Participants
|
|
Race/Ethnicity, Customized
White
|
123 Participants
n=24 Participants
|
96 Participants
n=20 Participants
|
219 Participants
n=40 Participants
|
|
Race/Ethnicity, Customized
Black/African American
|
26 Participants
n=24 Participants
|
16 Participants
n=20 Participants
|
42 Participants
n=40 Participants
|
|
Race/Ethnicity, Customized
Other
|
2 Participants
n=24 Participants
|
3 Participants
n=20 Participants
|
5 Participants
n=40 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
11 Participants
n=24 Participants
|
7 Participants
n=20 Participants
|
18 Participants
n=40 Participants
|
|
Requiring Vasopressor Support
|
79 Participants
n=24 Participants
|
46 Participants
n=20 Participants
|
125 Participants
n=40 Participants
|
|
Elixhauser Comorbidity Index
|
12 Index
n=24 Participants
|
15 Index
n=20 Participants
|
13 Index
n=40 Participants
|
|
Baseline Chronic Kidney Disease
Baseline Chronic Kidney Disease Present
|
25 Participants
n=24 Participants
|
28 Participants
n=20 Participants
|
53 Participants
n=40 Participants
|
|
Baseline Chronic Kidney Disease
Baseline End Stage Renal Disease Present
|
7 Participants
n=24 Participants
|
3 Participants
n=20 Participants
|
10 Participants
n=40 Participants
|
|
Immunocompromised
Immunocompromised Status
|
18 Participants
n=24 Participants
|
17 Participants
n=20 Participants
|
35 Participants
n=40 Participants
|
|
Immunocompromised
HIV
|
6 Participants
n=24 Participants
|
5 Participants
n=20 Participants
|
11 Participants
n=40 Participants
|
|
Immunocompromised
Solid Organ Transplant
|
10 Participants
n=24 Participants
|
11 Participants
n=20 Participants
|
21 Participants
n=40 Participants
|
|
Immunocompromised
Stem Cell Transplant
|
2 Participants
n=24 Participants
|
2 Participants
n=20 Participants
|
4 Participants
n=40 Participants
|
|
Body Mass Index
|
27 kg/m^2
STANDARD_DEVIATION 9 • n=24 Participants • Unable to calculate BMI for two participants in the control group due to missing data
|
28 kg/m^2
STANDARD_DEVIATION 8 • n=20 Participants • Unable to calculate BMI for two participants in the control group due to missing data
|
27 kg/m^2
STANDARD_DEVIATION 9 • n=40 Participants • Unable to calculate BMI for two participants in the control group due to missing data
|
|
SOFA score on ICU admission
|
7 SOFA score
n=24 Participants
|
6 SOFA score
n=20 Participants
|
7 SOFA score
n=40 Participants
|
|
Requiring Supplemental Oxygen
|
134 Participants
n=24 Participants
|
101 Participants
n=20 Participants
|
235 Participants
n=40 Participants
|
|
Requiring Mechanical Ventilation
|
45 Participants
n=24 Participants
|
31 Participants
n=20 Participants
|
76 Participants
n=40 Participants
|
|
Reference Creatinine
|
1.2 mg/dL
n=24 Participants
|
1.2 mg/dL
n=20 Participants
|
1.2 mg/dL
n=40 Participants
|
|
Blood or respiratory cultures collected
|
155 Participants
n=24 Participants
|
116 Participants
n=20 Participants
|
271 Participants
n=40 Participants
|
|
Number of blood or respiratory cultures collected
|
3 Number of cultures
n=24 Participants
|
3 Number of cultures
n=20 Participants
|
3 Number of cultures
n=40 Participants
|
|
Blood cultures collected
|
148 Participants
n=24 Participants
|
113 Participants
n=20 Participants
|
261 Participants
n=40 Participants
|
|
Number of blood cultures collected
|
2 Number of cultures
n=24 Participants
|
2 Number of cultures
n=20 Participants
|
2 Number of cultures
n=40 Participants
|
|
Respiratory cultures collected
|
101 Participants
n=24 Participants
|
72 Participants
n=20 Participants
|
173 Participants
n=40 Participants
|
|
Number of respiratory cultures collected
|
1 Number of cultures
n=24 Participants
|
1 Number of cultures
n=20 Participants
|
1 Number of cultures
n=40 Participants
|
|
Blood or respiratory cultures with MRSA
|
7 Participants
n=24 Participants
|
8 Participants
n=20 Participants
|
15 Participants
n=40 Participants
|
PRIMARY outcome
Timeframe: Baseline to seven days following enrollment.The number of hours out of the seven days following enrollment in the trial that the patient is alive and not receiving vancomycin estimated using a proportional odds ratio model with the ordinal status levels being alive and not on vancomycin, alive and on vancomycin, or dead.
Outcome measures
| Measure |
No MRSA Nasal Swab
n=158 Participants
Subjects will not have a nasal swab collected.
|
MRSA Nasal Swab
n=119 Participants
Subjects will have a nasal swab collected and sent to the clinical laboratory for the MRSA nasal swab PCR test to be run. For the subjects assigned to the intervention group who have a negative MRSA nasal swab PCR result, providers will receive a pager alert which inform them of the negative result and will direct clinicians to clinical guidance recommending clinicians to discontinue vancomycin, if clinically appropriate.
|
|---|---|---|
|
Vancomycin-free Hours Alive
|
105.7 Hours
Interval 97.2 to 115.6
|
109.7 Hours
Interval 98.5 to 120.5
|
SECONDARY outcome
Timeframe: Baseline to seven days following enrollment.The number of hours out of the 168 hours (7 days) following enrollment in the trial that the patient is alive and not receiving vancomycin.
Outcome measures
| Measure |
No MRSA Nasal Swab
n=158 Participants
Subjects will not have a nasal swab collected.
|
MRSA Nasal Swab
n=119 Participants
Subjects will have a nasal swab collected and sent to the clinical laboratory for the MRSA nasal swab PCR test to be run. For the subjects assigned to the intervention group who have a negative MRSA nasal swab PCR result, providers will receive a pager alert which inform them of the negative result and will direct clinicians to clinical guidance recommending clinicians to discontinue vancomycin, if clinically appropriate.
|
|---|---|---|
|
Time Alive Off Vancomycin
|
128 Hours
Interval 71.0 to 154.0
|
138 Hours
Interval 107.0 to 165.0
|
SECONDARY outcome
Timeframe: Thirty days following enrollment.Mortality within 30 days with date of study enrollment as day 0.
Outcome measures
| Measure |
No MRSA Nasal Swab
n=158 Participants
Subjects will not have a nasal swab collected.
|
MRSA Nasal Swab
n=119 Participants
Subjects will have a nasal swab collected and sent to the clinical laboratory for the MRSA nasal swab PCR test to be run. For the subjects assigned to the intervention group who have a negative MRSA nasal swab PCR result, providers will receive a pager alert which inform them of the negative result and will direct clinicians to clinical guidance recommending clinicians to discontinue vancomycin, if clinically appropriate.
|
|---|---|---|
|
30-day All-cause Mortality
|
56 Participants
|
31 Participants
|
Adverse Events
No MRSA Nasal Swab
Serious events: 0 serious events
Other events: 0 other events
Deaths: 56 deaths
MRSA Nasal Swab
Serious events: 0 serious events
Other events: 0 other events
Deaths: 31 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Jeffrey A. Freiberg, MD, PhD
Vanderbilt University Medical Center
Phone: 615-875-8663
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place