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NCT05094570 · ClinicalTrials.gov registry record · Phase 4
Interleukin-4Ra Blockade by Dupilumab Decreases Staphylococcus Colonization and Increases Microbial Diversity in CRSwNP
A Phase 4 study of Staphylococcus Aureus and Nasal Polyps, sponsored by University of Virginia.
- Recruiting
- Registry status
- Phase 4
- Development phase
- 20
- Enrollment target
- 1
- Study location
NCT05094570: Recruiting Phase 4 study of Staphylococcus Aureus and Nasal Polyps, sponsored by University of Virginia.
NCT05094570 is a Phase 4 study of Staphylococcus Aureus and Nasal Polyps that is actively recruiting participants, run by University of Virginia. The registered enrollment target is 20 participants, below the 3,902-participant average among 8 other Staphylococcus Aureus trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05094570, a Phase 4 study of Staphylococcus Aureus and Nasal Polyps, is actively recruiting participants, sponsored by University of Virginia.
- RECRUITING
- Registry status
- Phase 4
- Development phase
- 20 participants
- Enrollment target
- 1
- Study location
Study Summary
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.
Primary Outcome
To demonstrate that dupilumab reduces staphylococcus aureus (phyla firmicutes) abundance. The abundance of Staph aureus will be determined using qPCR of the femA gene and compared at baseline and after 16 weeks of dupilumab treatment. Statistical differences in the quantity of staph aureus (as ascertained by qPCR) will be determined utilizing data obtained from all subjects comparing data obtained at the end of the study in comparison to the beginning of the study.
Conditions Studied
Interventions
- DRUG Dupilumab Prefilled Syringe
Study Locations (1)
Virginia
- University of Virginia Health System - Charlottesville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2022-09-01 |
| Est. Completion | 2026-12-31 |
| Phase | Phase 4 |
What NCT05094570 shows while recruiting
NCT05094570 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 3,902-participant average among 8 other Staphylococcus Aureus trials with a reported enrollment target (99% lower).
The record links to 2 conditions, with Staphylococcus Aureus appearing as the primary indexed condition, and to 1 intervention - of which Dupilumab Prefilled Syringe is the first listed.
NCT05094570 reports a single indexed study location in Virginia.
Frequently Asked Questions
What is clinical trial NCT05094570 about?
NCT05094570 is a clinical study titled "Interleukin-4Ra Blockade by Dupilumab Decreases Staphylococcus Colonization and Increases Microbial Diversity in CRSwNP". 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...
What is the current status of trial NCT05094570?
This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 20 participants. The study started on 2022-09-01. Estimated completion is 2026-12-31.
What conditions does trial NCT05094570 study?
This clinical trial studies the following conditions: Staphylococcus Aureus, Nasal Polyps.
What interventions are being tested in trial NCT05094570?
The interventions under investigation include: Dupilumab Prefilled Syringe (DRUG).
Who is sponsoring clinical trial NCT05094570?
This trial is sponsored by University of Virginia, which has 449 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05094570 being conducted?
This trial has 1 study location across Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Staphylococcus Aureus
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05094570's enrollment target sits among peer trials
20 8th of 8 higher than 1 of 8 other Staphylococcus Aureus trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Staphylococcus Aureus trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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