Swab Testing to Optimize Pneumonia Treatment with Empiric Vancomycin
NCT ID: NCT06272994
Last Updated: 2025-03-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
277 participants
INTERVENTIONAL
2024-04-03
2025-02-27
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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No MRSA Nasal Swab
Subjects will not have a nasal swab collected.
No interventions assigned to this group
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.
MRSA 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.
Interventions
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MRSA 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.
Eligibility Criteria
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Inclusion Criteria
* 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
* Known to be a prisoner
18 Years
ALL
No
Sponsors
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Vanderbilt University Medical Center
OTHER
Responsible Party
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Jeffrey A Freiberg
Assistant Professor of Medicine, Division of Infectious Diseases, MD, PhD
Principal Investigators
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Jeffrey Freiberg, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Vanderbilt University Medical Center
Locations
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Vanderbilt University Medical Center
Nashville, Tennessee, United States
Countries
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References
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Freiberg JA, Siemann JK, Qian ET, Ereshefsky BJ, Hennessy C, Stollings JL, Rali TM, Harrell FE, Gatto CL, Rice TW, Nelson GE; Vanderbilt Center for Learning Healthcare. Swab Testing to Optimize Pneumonia treatment with empiric Vancomycin (STOP-Vanc): study protocol for a randomized controlled trial. Trials. 2024 Dec 28;25(1):854. doi: 10.1186/s13063-024-08705-6.
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Other Identifiers
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231724
Identifier Type: -
Identifier Source: org_study_id
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