Actively Recruiting
Treatment With Dupilumab to Reduce Staphylococcus Aureus and Increase Microbial Diversity in Adults With Chronic Rhinosinusitis With Nasal Polyps
Led by University of Virginia · Updated on 2025-04-01
20
Participants Needed
1
Research Sites
26 weeks
Total Duration
AI-Summary
What this Trial Is About
This research aims to evaluate how the drug dupilumab affects patients with chronic rhinosinusitis with nasal polyposis CRSwNP who have sinus colonization with Staphylococcus aureus. CRSwNP is a chronic inflammatory condition linked to a high presence of type 2 inflammation and frequent colonization by Staph bacteria, which can worsen symptoms. Researchers want to see if dupilumab can reduce Staph colonization and improve the variety of microbes in the sinuses, which may also relate to better immune responses and symptom improvement. Participants will receive dupilumab 300 mg via prefilled syringe as treatment. The study focuses on patients who test positive for Staphylococcus aureus in sinus cultures. The treatment period is 16 weeks, during which researchers will observe changes in Staph abundance and microbial diversity. Dupilumab is being studied for its ability to block interleukin-4 receptor alpha, a key factor in the inflammatory cycle of CRSwNP. During the study, participants will have sinus cultures taken at the start and monitored over the 16 weeks to measure Staph levels and microbial diversity. The study will also assess antimicrobial protein expression and inflammation markers, along with clinical symptoms like smell function and questionnaire responses. Safety and treatment effects will be followed throughout, with the primary outcome focused on the reduction of Staphylococcus aureus at 16 weeks.
CONDITIONS
Brief Title
Interleukin-4Ra Blockade by Dupilumab Decreases Staphylococcus Colonization and Increases Microbial Diversity in CRSwNP
Research Team
K
Kristin W Wavell Shifflett, BS
D
Deborah Murphy, BSN
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