{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,29]],"date-time":"2026-08-29T05:17:56Z","timestamp":1787980676081,"version":"build-2784847793"},"reference-count":42,"publisher":"Springer Science and Business Media LLC","issue":"1","license":[{"start":{"date-parts":[[2024,12,28]],"date-time":"2024-12-28T00:00:00Z","timestamp":1735344000000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2024,12,28]],"date-time":"2024-12-28T00:00:00Z","timestamp":1735344000000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Trials"],"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>\n                      Vancomycin, an antibiotic with activity against methicillin-resistant\n                      <jats:italic>Staphylococcus aureus<\/jats:italic>\n                      (MRSA), is frequently included in empiric treatment for community-acquired pneumonia (CAP) despite the fact that MRSA is rarely implicated in CAP. Conducting polymerase chain reaction (PCR) testing on nasal swabs to identify the presence of MRSA colonization has been proposed as an antimicrobial stewardship intervention to reduce the use of vancomycin. Observational studies have shown reductions in vancomycin use after implementation of MRSA colonization testing, and this approach has been adopted by CAP guidelines. However, the ability of this intervention to safely reduce vancomycin use has yet to be tested in a randomized controlled trial.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>STOP-Vanc is a pragmatic, prospective, single center, non-blinded randomized trial. The objective of this study is to test whether the use of MRSA PCR testing can safely reduce inappropriate vancomycin use in an intensive care setting. Adult patients with suspicion for CAP who are receiving vancomycin and admitted to the Medical Intensive Care Unit at Vanderbilt University Medical Center will be screened for eligibility. Eligible patients will be enrolled and randomized in a 1:1 ratio to either receive MRSA nasal swab PCR testing in addition to usual care (intervention group), or usual care alone (control group). PCR testing results will be transmitted through the electronic health record to the treating clinicians. Primary providers of intervention group patients with negative swab results will also receive a page providing clinical guidance recommending discontinuation of vancomycin. The primary outcome will be vancomycin-free hours alive, defined as the expected number of hours alive and free of the use of vancomycin within the first 7\u00a0days following trial enrollment estimated using a proportional odds ratio model. Secondary outcomes include 30-day all-cause mortality and time alive off vancomycin.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Discussion<\/jats:title>\n                    <jats:p>STOP-Vanc will provide the first randomized controlled trial data regarding the use of MRSA nasal swab PCR testing to guide antibiotic de-escalation. This study will provide important information regarding the effect of MRSA PCR testing and antimicrobial stewardship guidance on clinical outcomes in an intensive care unit setting.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial registration<\/jats:title>\n                    <jats:p>ClinicalTrials.gov NCT06272994. Registered on February 22, 2024.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1186\/s13063-024-08705-6","type":"journal-article","created":{"date-parts":[[2024,12,28]],"date-time":"2024-12-28T14:21:48Z","timestamp":1735395708000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":6,"title":["Swab Testing to Optimize Pneumonia treatment with empiric Vancomycin (STOP-Vanc): study protocol for a randomized controlled trial"],"prefix":"10.1186","volume":"25","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-5788-1481","authenticated-orcid":false,"given":"Jeffrey A.","family":"Freiberg","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Justin K.","family":"Siemann","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Edward T.","family":"Qian","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Benjamin J.","family":"Ereshefsky","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Cassandra","family":"Hennessy","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Joanna L.","family":"Stollings","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Taylor M.","family":"Rali","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Frank E.","family":"Harrell","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Cheryl L.","family":"Gatto","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Todd W.","family":"Rice","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"George E.","family":"Nelson","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"name":"for the Vanderbilt Center for Learning Healthcare","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2024,12,28]]},"reference":[{"key":"8705_CR1","doi-asserted-by":"publisher","first-page":"1309","DOI":"10.1056\/NEJMoa1914433","volume":"382","author":"JA Jernigan","year":"2020","unstructured":"Jernigan JA, Hatfield KM, Wolford H, Nelson RE, Olubajo B, Reddy SC, et al. 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Patients in the ICU receive twice daily nasal swabs for nasal decolonization while in the ICU as part of routine clinical practice. The risk to patients from the nasal swabs to detect MRSA is less than the risk from the routine nasal decolonization swabs as the swabs for MRSA detection do not contain any drugs. These routine nasal decolonization swabs are done as part of regular care without written consent from patients. Patients will have the same rights to refuse nasal MRSA swabs as their ability to refuse the routine nasal decolonization. In addition, this study does not make any decisions regarding the treatments offered to patients. Instead, it only provides information and antimicrobial stewardship guidance to patient\u2019s providers who retain complete autonomy over what is the appropriate care for their patients.In addition to the minimal risk posed by the study, obtaining informed consent prior to enrollment in this study would not be feasible or practicable for multiple reasons:1) The potential benefit of MRSA screening is dependent on early, rapid testing to generate results that are readily available to help guide the providers\u2019 decisions. This means that the swab must be ordered immediately at the time that the ICU provider decides to start or continue antibiotics, and prior to routine decolonization that is performed in all patients admitted to the ICUs at Vanderbilt University Medical Center. This event typically occurs simultaneously with a patient\u2019s arrival to the ICU. If the decision to obtain a MRSA nasal swab is delayed until written consent is acquired, it would be too late to study its effect.2) The MRSA nasal swabs are only considered valid if they are collected prior to nasal decolonization. Since nasal decolonization with the use of nasal swabs occurs regularly twice a day in all ICU patients at VUMC, and most critically ill patients are temporarily cognitively impaired due to their critical illness upon entry to the ICU, it would not be possible to obtain written consent prior to decolonization in most cases.3) The goal of the study is to test whether the use of a MRSA nasal swab would reduce the length of time that patients receive unnecessary antibiotics; thus, it must be done at the same time that the decision to start or continue antibiotics is made. Since the use of antibiotics in the ICU is an urgent intervention in many patients, it would be inappropriate and likely detrimental to delay the receipt of antibiotics in some of the most critically ill patients in order to get written consent for either the MRSA nasal swab or participation in the study.4) The decision to initiate antibiotics is often made when patients are critically ill and unable to consent for themselves; therefore, it would often not be feasible to obtain consent from a patient or their representative at the time at which the MRSA nasal swab would need to be performed.5) Consenting the participants may prompt either the clinical team or the participant to order (or ask for) the MRSA nasal swab in patients randomized to the control arm (and thus, randomized not to receive the nasal swab prior to decolonization). This would potentially lead the clinical team to order the MRSA nasal swab prior to decolonization in the control arm as well, which would not allow the study team to truly evaluate the role of an admission MRSA nasal swab in reducing vancomycin use. This contamination of the control arm would bias the study results to not being able to see the effect of the use of these pre-decolonization MRSA nasal swabs on vancomycin use.For these reasons collectively, this study could not be done practicably without a waiver of consent, and it would be impractical to obtain written informed consent. Therefore, given that this study presents minimal risk, it would not adversely affect the welfare or privacy rights of the participant, and it would be impracticable to obtain consent, a waiver of informed consent was requested and approved for this study. Additionally, while the topic of potential retrospective notification is too complex to delve into detail here, retrospective notification was felt to not be appropriate for this trial due to potentially increasing Hawthorne effect and changing clinical practice in the control arm. In addition, patients in the intervention arm will be notified by their providers if the results of the nasal swab result in a change in the care of the patient (i.e., stopping vancomycin).","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval and consent to participate\u00a0{24}"}},{"value":"Not applicable.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication\u00a0{32}"}},{"value":"The authors declare that they have no competing interests.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests\u00a0{28}"}}],"article-number":"854"}}