NCT03919435: TEMPO

TEMPO Study: Trimethoprim-Sulfamethoxazole in Granulomatosis With Polyangiitis

Active, enrolled Phase 1, PHASE2 Last updated 19 November 2025

What this trial tests

Phase 1, PHASE2 trial testing Trimethoprim Sulfamethoxazole in Granulomatosis With Polyangiitis in 8 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

27 March 2019

Primary endpoint
30 December 2027

30 December 2027

Quick facts

Lead sponsor	University of Pennsylvania
Phase	Phase 1, PHASE2
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	prevention
Enrollment	8
Start date	27 March 2019
Primary completion	30 December 2027
Estimated completion	30 December 2027
Sites	1 location across United States

Drugs / interventions tested

• Trimethoprim Sulfamethoxazole

Conditions studied

• Granulomatosis With Polyangiitis — all drugs for Granulomatosis With Polyangiitis →
• Wegener Granulomatosis — all drugs for Wegener Granulomatosis →

Sponsor

University of Pennsylvania

Who can join

18 and older, any sex, with Granulomatosis With Polyangiitis or Wegener Granulomatosis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.