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Swab Testing to Optimize Pneumonia Treatment With Empiric Vancomycin

Swab Testing to Optimize Pneumonia Treatment With Empiric Vancomycin (STOP-Vanc)

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06272994
Acronym
STOP-Vanc
Enrollment
277
Registered
2024-02-22
Start date
2024-04-03
Completion date
2025-02-27
Last updated
2026-02-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Community-acquired Pneumonia

Keywords

MRSA, Vancomycin, Nasal Swab

Brief summary

This is a single center, pragmatic, randomized clinical trial (pRCT) examining whether reporting the results of a negative rapid PCR back to the provider via a pager alert results in decreased vancomycin utilization for critically ill adults with community-acquired pneumonia when compared with usual care.

Detailed description

Methicillin-resistant Staphylococcus aureus (MRSA) is a critical antimicrobial resistant threat responsible for greater than 300,000 inpatient infections and 15,000 deaths per year in the United States. Community-acquired pneumonia (CAP) is a major driver of hospital antibiotic use. Nationally, there are around 600,000 CAP-related hospital admissions annually. However, MRSA is an infrequent cause of community-acquired pneumonia (CAP), accounting for less than 1% of cases. Despite this, MRSA is a frequently feared cause of CAP, which leads to the frequent use of vancomycin, an anti-MRSA antibiotic, in empiric CAP treatment. Inappropriate antibiotic use can lead to avoidable adverse drug events and costs, as well as drive antimicrobial resistance. Empiric vancomycin use in patients hospitalized for pneumonia has demonstrated increased mortality, acute kidney injury (AKI), and secondary infections. The use of vancomycin is unfortunately associated with a high risk for toxicity and serious adverse events. Up to two-thirds of patients receiving high dose vancomycin develop AKI. Additionally, bone marrow suppression, linear IgA bullous dermatosis, anaphylaxis, and life-threatening hypersensitivity reactions are seen with vancomycin use. Furthermore, vancomycin is a costly antibiotic to use in the hospital as it requires careful monitoring due to its narrow therapeutic range and high risk of toxicity. There is growing data to support the use of MRSA nasal swabs as a screening method to guide de-escalation of vancomycin use in CAP. A 2018 meta-analysis found using nasal swabs for MRSA screening had an overall 96.5% negative predictive value (NPV) for pneumonia, which was increased to 98.1% among patients with CAP or Healthcare-associated pneumonia (HCAP). Multiple retrospective studies along with one prospective study utilizing MRSA nasal swab-based de-escalation protocols have shown MRSA nasal swab use to be effective in decreasing vancomycin use and associated costs without having any negative effects on patient outcomes. Among these studies, significant decreases in hospital length of stay and rate of AKI have been shown. Furthermore, the use of MRSA detection in nasal swabs is now consistent with guideline-based management of CAP. However, all the aforementioned studies are quasi-experimental analyses. To date there are no randomized controlled studies of the use of MRSA nasal swab guided antibiotic de-escalation.

Interventions

DIAGNOSTIC_TESTMRSA Nasal Swab PCR

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.

Sponsors

Vanderbilt University Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

This study will be performed as a single center, pragmatic, randomized clinical trial.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Adult (age greater than or equal to 18) patients admitted/transferred to the Vanderbilt University Medical Center (VUMC) Medical Intensive Care Unit (MICU) from the VUMC Emergency Department or from a hospital floor within 48 hours of admission. * Suspicion for pneumonia on admission (defined as an indication for antibiotics of "respiratory infection" and/or an order for a respiratory culture i.e., sputum culture, tracheal aspirate culture, or bronchoalveolar lavage (BAL) culture). * No topical nasal decolonization during hospitalization prior to collection of MRSA nasal swab PCR. * Must match both of the following in either order: * The patient has been admitted to and physically located in the MICU. * The patient has received a continuing vancomycin order, or a pharmacokinetics consult for a continuing vancomycin order, no later than 24 hours following their physical admission to the MICU.

Exclusion criteria

* Hospital stay of longer than 48 hours prior to MICU admission. * Known to be a prisoner

Design outcomes

Primary

MeasureTime frameDescription
Vancomycin-free Hours AliveBaseline 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.

Secondary

MeasureTime frameDescription
Time Alive Off VancomycinBaseline 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.
30-day All-cause MortalityThirty days following enrollment.Mortality within 30 days with date of study enrollment as day 0.

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORJeffrey Freiberg, MD, PhD

Vanderbilt University Medical Center

Participant flow

Recruitment details

Between April 2024 and January 2025, this pragmatic, prospective, randomized trial was conducted in a tertiary care, academic hospital ICU setting.

Baseline characteristics

Characteristic
Age, Continuous62 Years
Baseline Chronic Kidney Disease
Baseline Chronic Kidney Disease Present
28 Participants
Baseline Chronic Kidney Disease
Baseline End Stage Renal Disease Present
10 Participants
Blood cultures collected113 Participants
Blood or respiratory cultures collected271 Participants
Blood or respiratory cultures with MRSA8 Participants
Body Mass Index28 kg/m^2
STANDARD_DEVIATION 8
Elixhauser Comorbidity Index12 Index
Ethnicity (NIH/OMB)
Hispanic or Latino
6 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
106 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
6 Participants
Immunocompromised
HIV
5 Participants
Immunocompromised
Immunocompromised Status
35 Participants
Immunocompromised
Solid Organ Transplant
10 Participants
Immunocompromised
Stem Cell Transplant
4 Participants
Number of blood cultures collected2 Number of cultures
Number of blood or respiratory cultures collected3 Number of cultures
Number of respiratory cultures collected1 Number of cultures
Race/Ethnicity, Customized
Black/African American
16 Participants
Race/Ethnicity, Customized
Other
2 Participants
Race/Ethnicity, Customized
Unknown
11 Participants
Race/Ethnicity, Customized
White
96 Participants
Reference Creatinine1.2 mg/dL
Requiring Mechanical Ventilation31 Participants
Requiring Supplemental Oxygen134 Participants
Requiring Vasopressor Support125 Participants
Respiratory cultures collected72 Participants
Sex: Female, Male
Female
58 Participants
Sex: Female, Male
Male
77 Participants
SOFA score on ICU admission7 SOFA score

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
56 / 15831 / 119
other
Total, other adverse events
0 / 1580 / 119
serious
Total, serious adverse events
0 / 1580 / 119

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 3, 2026