Clinical Trials Logo
  1. Home
  2. Granulomatosis With Polyangiitis
  3. NCT03919435

TEMPO Study: Trimethoprim-Sulfamethoxazole in Granulomatosis With Polyangiitis — TEMPO  

Granulomatosis With Polyangiitis Clinical Trial

Official title:
Trimethoprim-Sulfamethoxazole Effects on the Nasal Microbiome in Granulomatosis With Polyangiitis

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03919435
Study type Interventional
Source University of Pennsylvania
Contact
Status Active, not recruiting
Phase Phase 1/Phase 2
Start date March 27, 2019
Completion date September 30, 2025
View Details
See also
  Status Clinical Trial Phase
Completed NCT01731561 - Comparison Study of Two Rituximab Regimens in the Remission of ANCA Associated Vasculitis Phase 3
Completed NCT01862068 - Neutrophils as Prognostic Factors in Granulomatosis With Polyangiitis (Formerly Named Wegener's Granulomatosis)
Completed NCT01750697 - A Phase IIa Study of Intravenous Rituximab in Pediatric Participants With Severe Granulomatosis With Polyangiitis (Wegener's) or Microscopic Polyangiitis Phase 2
Not yet recruiting NCT02126098 - Observation Study of Clinical Manifestation and Outcome in Chinese Patients With Pulmonary Vasculitis N/A
Terminated NCT01586858 - Rituximab for ANCA-associated Vasculitis (RAVE) Long-Term Follow-Up Study N/A
Not yet recruiting NCT04871191 - Study of Salvage Therapy to Treat Patients With Granulomatosis With Polyangiitis Phase 2
Terminated NCT05376319 - PR3-AAV Resilient Remission or PRRR Phase 2
Not yet recruiting NCT05353179 - Study on Pharmacokinetics of Meperizumab Injection and NUCALA® in Healthy Male Volunteers Early Phase 1
Completed NCT02169219 - Pilot Study of Short-Course Glucocorticoids and Rituximab for Treatment of ANCA-Associated Vasculitis Phase 4
Completed NCT01613599 - An Observational Study of The Safety of MabThera/Rituxan (Rituximab) in Participants With Granulomatosis With Polyangiitis (Wegener's) or Microscopic Polyangiitis
Active, not recruiting NCT05716334 - Biosimilars of Rituximab in ANCA-associated Vasculitis Compared to the Originator
Recruiting NCT04944524 - Comparison of Tofacitinib and Methotrexate in the Maintained Treatment of GPA Phase 4
Completed NCT03430388 - Yellow Fever Vaccine in Patients With Rheumatic Diseases N/A
Completed NCT03410290 - Journey of Patients With Vasculitis From First Symptom to Diagnosis
Recruiting NCT03482479 - Low Dose Naltrexone to Improve Physical Health in Patients With Vasculitis Phase 2
Active, not recruiting NCT01940094 - The Assessment of Prednisone In Remission Trial - Centers of Excellence Approach Phase 3
Recruiting NCT01405807 - Alemtuzumab for ANCA Associated Refractory Vasculitis Phase 4
Active, not recruiting NCT01933724 - The Assessment of Prednisone In Remission Trial (TAPIR) - Patient Centric Approach Phase 3
Completed NCT05703802 - Establishment of an ELISA for the Recognition of Procalcitonin Variants in Patients With Hyperprocalcitonemia.
Active, not recruiting NCT03967925 - Rituximab and Belimumab Combination Therapy in PR3 Vasculitis Phase 2