RECRUITING

Interleukin-4Ra Blockade by Dupilumab Decreases Staphylococcus Colonization and Increases Microbial Diversity in CRSwNP

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Interleukin-4Ralpha Blockade by Dupilumab Decreases Staphylococcus Aureus Colonization and Increases Microbial Diversity in Chronic Rhinosinusitis With Nasal Polyposis (CRSwNP)

Quick Facts

Study Start:2022-09-01
Study Completion:2024-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05094570

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 65 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * History of CRSwNP including subjects with AERD
  2. * Sinonasal culture demonstrating staph aureus at visit 1
  3. * History of FESS with patent sinus ostia sufficient to obtain culture and tissue samples from the middle meatus
  4. * Asthma, if present, should be well controlled
  5. * Atopic dermatitis, if present, should be well controlled
  6. * Use of nasal saline irrigation and stable dosing (\>1 month) of topical corticosteroids is permitted
  7. * Intent of the physicians caring to start dupilumab therapy as part of subject's standard of care
  8. * Subject meets FDA approved criteria for the use of dupilumab for nasal polyps
  1. * Concurrent serious medical problem
  2. * Uncontrolled asthma (ACT \<20 at screening visit)
  3. * Recent (within 60 days) use of oral corticosteroids
  4. * Recent (within 60 days) urgent care, ED visit, or hospitalization for asthma
  5. * Current smoker or has smoked \>10 pack-years
  6. * Biologic therapy including asthma biologic therapy in last 3 months
  7. * Recent (within 1 month) change in CRS medical treatment (topical steroids, surfactants, irrigation protocol, etc. including changes in delivery volume or delivery methodology)
  8. * Recent (within 6 weeks) upper respiratory infection
  9. * Antibiotics within 6 weeks
  10. * Pregnant or breast-feeding women
  11. * Any contraindication to the use of dupilumab including hypersensitivity on previous administration

Contacts and Locations

Study Contact

Kristin W Wavell Shifflett, BS
CONTACT
4349246874
kww7d@virginia.edu
Deborah Murphy, BSN
CONTACT
4349823510
ddm9q@virginia.edu

Principal Investigator

Larry C Borish, MD
PRINCIPAL_INVESTIGATOR
University of Virginia

Study Locations (Sites)

University of Virginia Health System
Charlottesville, Virginia, 22908
United States

Collaborators and Investigators

Sponsor: University of Virginia

  • Larry C Borish, MD, PRINCIPAL_INVESTIGATOR, University of Virginia

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-09-01
Study Completion Date2024-12-31

Study Record Updates

Study Start Date2022-09-01
Study Completion Date2024-12-31

Terms related to this study

Keywords Provided by Researchers

  • Nasal polyps
  • Staph aureus
  • Interleukin-4/-13

Additional Relevant MeSH Terms

  • Nasal Polyps
  • Staphylococcus Aureus