Condition: Nasal Polyps · Staphylococcus Aureus · Sponsor: University of Virginia
Hypothesis: The investigators hypothesize that in patients with CRSwNP who demonstrate sinus colonization with staphylococcus aureus, the administration of dupilumab will be associated with decreased staph colonization and an increase in microbial diversity. Primary Objective will be to demonstrate that dupilumab reduces staphylococcus aureus (phyla firmicutes) abundance while increasing microbial diversity in patients with CRSwNPs who are culture positive for staph aureus at enrollment. Secondary Objectives will be to correlate reduction in Staph aureus abundance and improved bacterial diversity with increased expression of anti-microbial proteins (ß-defensins1-4) and cathelicidin LL-37. In addition, the investigators will correlate improvements in microbial diversity/decreased staph abundance with clinical improvements as assessed via questionnaires and objective/subjective smell function and also as improvements in cellular/immune T2 inflammation as assessed by reduced expression of T2 cytokines/chemokines and eosinophil/eosinophil-derived proteins.
This description comes directly from the study's public registry record.
Kristin W Wavell Shifflett, BS · 4349246874 · kww7d@virginia.edu
Deborah Murphy, BSN · 4349823510 · ddm9q@virginia.edu
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| University of Virginia Health System | Charlottesville, Virginia, United States | Recruiting |
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Source record: clinicaltrials.gov/study/NCT05094570