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TEMPO Study: Trimethoprim-Sulfamethoxazole in Granulomatosis With Polyangiitis (TEMPO)

Primary Purpose

Granulomatosis With Polyangiitis, Wegener Granulomatosis

Status
Active
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Trimethoprim Sulfamethoxazole
Sponsored by
University of Pennsylvania
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Granulomatosis With Polyangiitis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients must be at least 18 year of age or older
  • Both male and female gender will be included
  • Patients with GPA will be defined according to classification criteria or according to the investigator's judgment
  • Patients must have history of sinonasal involvement related to GPA
  • Patients must also be in remission for at least 3 months and expect to remain on stable immunosuppressive therapies for the next 24 weeks, with the exception of minor prednisone changes
  • Prednisone dose or equivalent less than or equal to 10mg at enrollment

Exclusion Criteria:

  • Receipt of oral antibiotics or antifungals within past 6 weeks including antimicrobials for prevention of Pneumocystis jiroveci pneumonia
  • Infection involving sinuses or nose in past 4 weeks
  • Receipt of topical nasal antibiotics (including mupirocin) within the past 4 weeks
  • Contra-indication or prior adverse reaction to TMP-SMX such as sulfa allergy, severe renal insufficiency (CrCl < 15 ml/min) or severe hepatic failure according to most recent labs in past 6 months
  • At risk for drug interactions related to TMP-SMX
  • Intra-nasal cocaine use in prior 3 months
  • Known history of HIV or primary immunodeficiency syndrome
  • Pregnant or planning to become pregnant in the next 6 months

Sites / Locations

  • Perelman Center for Advanced Medicine

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

On Drug

Arm Description

Outcomes

Primary Outcome Measures

nasal microbiome in relative abundance ( host gene expression in proportion)

Secondary Outcome Measures

Full Information

First Posted
April 5, 2019
Last Updated
July 13, 2023
Sponsor
University of Pennsylvania
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1. Study Identification

Unique Protocol Identification Number
NCT03919435
Brief Title
TEMPO Study: Trimethoprim-Sulfamethoxazole in Granulomatosis With Polyangiitis
Acronym
TEMPO
Official Title
Trimethoprim-Sulfamethoxazole Effects on the Nasal Microbiome in Granulomatosis With Polyangiitis
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 27, 2019 (Actual)
Primary Completion Date
September 30, 2025 (Anticipated)
Study Completion Date
September 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pennsylvania

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Granulomatosis With Polyangiitis, Wegener Granulomatosis

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
8 (Actual)

8. Arms, Groups, and Interventions

Arm Title
On Drug
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Trimethoprim Sulfamethoxazole
Intervention Description
Dosage: 160mg-800mg Frequency: 2 times a day Dosage Form: Pill (oral) Duration: 4 weeks
Primary Outcome Measure Information:
Title
nasal microbiome in relative abundance ( host gene expression in proportion)
Time Frame
24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients must be at least 18 year of age or older Both male and female gender will be included Patients with GPA will be defined according to classification criteria or according to the investigator's judgment Patients must have history of sinonasal involvement related to GPA Patients must also be in remission for at least 3 months and expect to remain on stable immunosuppressive therapies for the next 24 weeks, with the exception of minor prednisone changes Prednisone dose or equivalent less than or equal to 10mg at enrollment Exclusion Criteria: Receipt of oral antibiotics or antifungals within past 6 weeks including antimicrobials for prevention of Pneumocystis jiroveci pneumonia Infection involving sinuses or nose in past 4 weeks Receipt of topical nasal antibiotics (including mupirocin) within the past 4 weeks Contra-indication or prior adverse reaction to TMP-SMX such as sulfa allergy, severe renal insufficiency (CrCl < 15 ml/min) or severe hepatic failure according to most recent labs in past 6 months At risk for drug interactions related to TMP-SMX Intra-nasal cocaine use in prior 3 months Known history of HIV or primary immunodeficiency syndrome Pregnant or planning to become pregnant in the next 6 months
Facility Information:
Facility Name
Perelman Center for Advanced Medicine
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States

12. IPD Sharing Statement

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TEMPO Study: Trimethoprim-Sulfamethoxazole in Granulomatosis With Polyangiitis

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