Freiberg Jeffrey A, Siemann Justin K, Qian Edward T, Ereshefsky Benjamin J, Hennessy Cassandra, Stollings Joanna L, Rali Taylor M, Harrell Frank E, Gatto Cheryl L, Rice Todd W, Nelson George E
Division of Infectious Diseases, Department of Medicine, Vanderbilt University Medical Center, Nashville, TN, USA.
Vanderbilt Institute for Infection, Immunology and Inflammation, Vanderbilt University Medical Center, Nashville, TN, USA.
Trials. 2024 Dec 28;25(1):854. doi: 10.1186/s13063-024-08705-6.
Vancomycin, an antibiotic with activity against methicillin-resistant Staphylococcus aureus (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.
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 days following trial enrollment estimated using a proportional odds ratio model. Secondary outcomes include 30-day all-cause mortality and time alive off vancomycin.
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.
ClinicalTrials.gov NCT06272994. Registered on February 22, 2024.
万古霉素是一种对耐甲氧西林金黄色葡萄球菌（MRSA）有活性的抗生素，尽管MRSA很少与社区获得性肺炎（CAP）相关，但在CAP的经验性治疗中经常使用。有人提议对鼻拭子进行聚合酶链反应（PCR）检测以确定MRSA定植的存在，作为一种抗菌管理干预措施，以减少万古霉素的使用。观察性研究表明，实施MRSA定植检测后万古霉素的使用有所减少，并且这种方法已被CAP指南采用。然而，这种干预措施能否安全地减少万古霉素的使用，尚未在随机对照试验中得到验证。
STOP-Vanc是一项务实、前瞻性、单中心、非盲随机试验。本研究的目的是测试使用MRSA PCR检测能否在重症监护环境中安全地减少不适当的万古霉素使用。将对在范德比尔特大学医学中心接受万古霉素治疗并入住医学重症监护病房的疑似CAP成年患者进行资格筛查。符合条件的患者将按1:1的比例入组并随机分组，一组除接受常规治疗外，还接受MRSA鼻拭子PCR检测（干预组），另一组仅接受常规治疗（对照组）。PCR检测结果将通过电子健康记录传输给主治医生。干预组鼻拭子结果为阴性的患者的主要提供者也将收到一页提供临床指导的内容，建议停用万古霉素。主要结局将是无万古霉素存活小时数，定义为使用比例优势比模型估计的试验入组后前7天内预期的存活且未使用万古霉素的小时数。次要结局包括30天全因死亡率和停用万古霉素后的存活时间。
STOP-Vanc将提供关于使用MRSA鼻拭子PCR检测以指导抗生素降阶梯治疗的首个随机对照试验数据。本研究将提供关于MRSA PCR检测和抗菌管理指导对重症监护病房环境中临床结局影响的重要信息。
ClinicalTrials.gov NCT06272994。于2024年2月22日注册。
