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Community-acquired PneumoniaSTOP-VancNCT06272994

Swab Testing to Optimize Pneumonia Treatment With Empiric Vancomycin

A study testing MRSA Nasal Swab PCR in people with Community-acquired Pneumonia, run by Vanderbilt University Medical Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Community-acquired Pneumonia
What is being tested?
MRSA Nasal Swab PCR
Could I receive a placebo?
No, everyone receives an active treatment
How many people
277 participants
Where
1 siteUnited States
Study dates
3 Apr 2024to 27 Feb 2025
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232

Other trials in United States

About this study

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

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.

Read the 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.

Being tested
MRSA Nasal Swab PCR
Keywords
MRSA, Vancomycin, Nasal Swab
Medical subject headings
Community-Acquired Pneumonia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MRSA Nasal Swab PCRDiagnostic test

    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.

Study groups in NCT06272994
Study groupRoleWhat they receive
No MRSA Nasal SwabNo interventionSubjects will not have a nasal swab collected.
MRSA Nasal SwabActive comparatorSubjects 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.
Receives: Diagnostic Test: MRSA Nasal Swab PCR

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Vancomycin-free Hours Alive

    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.

    Measured: Baseline to seven days following enrollment.

Secondary outcomes (2)
  1. Time Alive Off Vancomycin

    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.

    Measured: Baseline to seven days following enrollment.

  2. 30-day All-cause Mortality

    Mortality within 30 days with date of study enrollment as day 0.

    Measured: Thirty days following enrollment.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Feb 2024
  2. Study start3 Apr 2024
  3. Primary completion4 Feb 2025
  4. Study completion27 Feb 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
This study will be performed as a single center, pragmatic, randomized clinical trial.
Masking
None (open label)
Enrolment
277 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06272994
Sponsor's protocol ID
231724
Acronym
STOP-Vanc
Status last verified
Feb 2026
First submitted
15 Feb 2024
Last updated
27 Feb 2026
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
Yes: Individual participant data that underlie the results reported will be made available (including data dictionaries) after de-identification.

Publications

  • Jernigan JA, Hatfield KM, Wolford H, Nelson RE, Olubajo B, Reddy SC, McCarthy N, Paul P, McDonald LC, Kallen A, Fiore A, Craig M, Baggs J. Multidrug-Resistant Bacterial Infections in U.S. Hospitalized Patients, 2012-2017. N Engl J Med. 2020 Apr 2;382(14):1309-1319. doi: 10.1056/NEJMoa1914433.

    PubMed 32242356
  • Klein EY, Jiang W, Mojica N, Tseng KK, McNeill R, Cosgrove SE, Perl TM. National Costs Associated With Methicillin-Susceptible and Methicillin-Resistant Staphylococcus aureus Hospitalizations in the United States, 2010-2014. Clin Infect Dis. 2019 Jan 1;68(1):22-28. doi: 10.1093/cid/ciy399.

    PubMed 29762662
  • Jones BE, Ying J, Stevens V, Haroldsen C, He T, Nevers M, Christensen MA, Nelson RE, Stoddard GJ, Sauer BC, Yarbrough PM, Jones MM, Goetz MB, Greene T, Samore MH. Empirical Anti-MRSA vs Standard Antibiotic Therapy and Risk of 30-Day Mortality in Patients Hospitalized for Pneumonia. JAMA Intern Med. 2020 Apr 1;180(4):552-560. doi: 10.1001/jamainternmed.2019.7495.

    PubMed 32065604
  • Tongsai S, Koomanachai P. The safety and efficacy of high versus low vancomycin trough levels in the treatment of patients with infections caused by methicillin-resistant Staphylococcus aureus: a meta-analysis. BMC Res Notes. 2016 Sep 29;9(1):455. doi: 10.1186/s13104-016-2252-7.

    PubMed 27686168
  • van Hal SJ, Paterson DL, Lodise TP. Systematic review and meta-analysis of vancomycin-induced nephrotoxicity associated with dosing schedules that maintain troughs between 15 and 20 milligrams per liter. Antimicrob Agents Chemother. 2013 Feb;57(2):734-44. doi: 10.1128/AAC.01568-12. Epub 2012 Nov 19.

    PubMed 23165462
  • Fortuna G, Salas-Alanis JC, Guidetti E, Marinkovich MP. A critical reappraisal of the current data on drug-induced linear immunoglobulin A bullous dermatosis: a real and separate nosological entity? J Am Acad Dermatol. 2012 Jun;66(6):988-94. doi: 10.1016/j.jaad.2011.09.018. Epub 2011 Dec 9.

    PubMed 22169257
  • Madigan LM, Fox LP. Vancomycin-associated drug-induced hypersensitivity syndrome. J Am Acad Dermatol. 2019 Jul;81(1):123-128. doi: 10.1016/j.jaad.2019.02.002. Epub 2019 Feb 6.

    PubMed 30738120
  • Huang V, Clayton NA, Welker KH. Glycopeptide Hypersensitivity and Adverse Reactions. Pharmacy (Basel). 2020 Apr 21;8(2):70. doi: 10.3390/pharmacy8020070.

    PubMed 32326261
  • Wilhelm MP. Vancomycin. Mayo Clin Proc. 1991 Nov;66(11):1165-70. doi: 10.1016/s0025-6196(12)65799-1.

    PubMed 1943250
  • Rybak MJ, Le J, Lodise TP, Levine DP, Bradley JS, Liu C, Mueller BA, Pai MP, Wong-Beringer A, Rotschafer JC, Rodvold KA, Maples HD, Lomaestro BM. Therapeutic monitoring of vancomycin for serious methicillin-resistant Staphylococcus aureus infections: A revised consensus guideline and review by the American Society of Health-System Pharmacists, the Infectious Diseases Society of America, the Pediatric Infectious Diseases Society, and the Society of Infectious Diseases Pharmacists. Am J Health Syst Pharm. 2020 May 19;77(11):835-864. doi: 10.1093/ajhp/zxaa036. No abstract available.

    PubMed 32191793
  • Parente DM, Cunha CB, Mylonakis E, Timbrook TT. The Clinical Utility of Methicillin-Resistant Staphylococcus aureus (MRSA) Nasal Screening to Rule Out MRSA Pneumonia: A Diagnostic Meta-analysis With Antimicrobial Stewardship Implications. Clin Infect Dis. 2018 Jun 18;67(1):1-7. doi: 10.1093/cid/ciy024.

    PubMed 29340593
  • Dadzie P, Dietrich T, Ashurst J. Impact of a Pharmacist-driven Methicillin-resistant Staphylococcus aureus Polymerase Chain Reaction Nasal Swab Protocol on the De-escalation of Empiric Vancomycin in Patients with Pneumonia in a Rural Healthcare Setting. Cureus. 2019 Dec 13;11(12):e6378. doi: 10.7759/cureus.6378.

    PubMed 31938656
  • Huffman V, Andrade DC, Ham J, Brown K, Melnitsky L, Lopez Cohen A, Parmar J. Impact of Nasal Swabs on Empiric Treatment of Respiratory Tract Infections (INSERT-RTI). Pharmacy (Basel). 2020 Jun 11;8(2):101. doi: 10.3390/pharmacy8020101.

    PubMed 32545231
  • Woolever NL, Schomberg RJ, Cai S, Dierkhising RA, Dababneh AS, Kujak RC. Pharmacist-Driven MRSA Nasal PCR Screening and the Duration of Empirical Vancomycin Therapy for Suspected MRSA Respiratory Tract Infections. Mayo Clin Proc Innov Qual Outcomes. 2020 Aug 15;4(5):550-556. doi: 10.1016/j.mayocpiqo.2020.05.002. eCollection 2020 Oct.

    PubMed 33083704
  • Dunaway S, Orwig KW, Arbogast ZQ, Myers ZL, Sizemore JA, Giancola SE. Evaluation of a pharmacy-driven methicillin-resistant Staphylococcus aureus surveillance protocol in pneumonia. Int J Clin Pharm. 2018 Jun;40(3):526-532. doi: 10.1007/s11096-018-0647-3. Epub 2018 May 2.

    PubMed 29721739

Questions about this trial

What is this clinical trial studying?

A study testing MRSA Nasal Swab PCR in people with Community-acquired Pneumonia, run by Vanderbilt University Medical Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 Feb 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Vancomycin-free Hours Alive (time frame: Baseline to seven days following enrollment.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06272994, which also lists 25 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2026.

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