TEMPO Study: Trimethoprim-Sulfamethoxazole in Granulomatosis With Polyangiitis
Status:
Active, not recruiting
Trial end date:
2022-05-27
Target enrollment:
Participant gender:
Summary
Granulomatosis with polyangiitis (GPA; Wegener's) is a multi-organ autoimmune disease
characterized by necrotizing granulomatous inflammation and vasculitis. Upper respiratory
involvement occurs in up to 90% of patients with GPA and is often the first manifestation of
the disease. Patients with upper respiratory tract disease are more at risk of local and
systemic relapse. Microbial organisms may be involved in inducing disease activity in GPA.
Previous culture-dependent studies found that patients with GPA were more likely to be
chronic nasal carriers of Staphylococcus aureus compared to non-GPA chronic rhinosinusitis
and healthy controls; additionally, GPA patients with S. aureus colonization are more likely
to experience a future relapse. This led to a randomized placebo-controlled trial of
trimethoprim-sulfamethoxazole (TMP-SMX) which showed this antibiotic/antifungal was effective
in preventing relapse in GPA. Whether the benefits of TMP-SMX are related to its
antimicrobial properties versus anti-inflammatory effects is still unknown. The objective of
this study is to prospectively evaluate the changes in the nasal microbiome, mycobiome, and
host immunity in patients with GPA before, during, and after receipt of TMP-SMX for 4 weeks.
The target enrollment number is 30 participants, and the investigators will include patients
seen at the Penn Vasculitis Center with GPA (diagnosed according to the American College of
Rheumatology Classification Criteria or based on investigator's judgment). To analyze nasal
microbiome and host immunity, participants will be swabbed with nasal swab and cytobrush for
DNA sequencing and other studies. An optional research blood draw is also included. The
investigators and coordinators will follow each patient longitudinally over a 6-month period.
Phase:
Phase 1/Phase 2
Details
Lead Sponsor:
University of Pennsylvania
Treatments:
Sulfamethoxazole Trimethoprim Trimethoprim, Sulfamethoxazole Drug Combination