- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03919435
TEMPO Study: Trimethoprim-Sulfamethoxazole in Granulomatosis With Polyangiitis (TEMPO)
July 13, 2023 updated by: Rennie Rhee, M.D., MSCE, University of Pennsylvania
Trimethoprim-Sulfamethoxazole Effects on the Nasal Microbiome in Granulomatosis With Polyangiitis
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.
Study Overview
Status
Active, not recruiting
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
8
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19104
- Perelman Center for Advanced Medicine
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: On Drug
|
Dosage: 160mg-800mg Frequency: 2 times a day Dosage Form: Pill (oral) Duration: 4 weeks
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
nasal microbiome in relative abundance ( host gene expression in proportion)
Time Frame: 24 weeks
|
24 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 27, 2019
Primary Completion (Estimated)
September 30, 2025
Study Completion (Estimated)
September 30, 2025
Study Registration Dates
First Submitted
April 5, 2019
First Submitted That Met QC Criteria
April 17, 2019
First Posted (Actual)
April 18, 2019
Study Record Updates
Last Update Posted (Actual)
July 14, 2023
Last Update Submitted That Met QC Criteria
July 13, 2023
Last Verified
July 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Skin Diseases
- Respiratory Tract Diseases
- Immune System Diseases
- Autoimmune Diseases
- Lung Diseases
- Vasculitis
- Skin Diseases, Vascular
- Lung Diseases, Interstitial
- Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis
- Granulomatosis with Polyangiitis
- Systemic Vasculitis
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Enzyme Inhibitors
- Anti-Bacterial Agents
- Cytochrome P-450 Enzyme Inhibitors
- Antiprotozoal Agents
- Antiparasitic Agents
- Antimalarials
- Folic Acid Antagonists
- Anti-Dyskinesia Agents
- Anti-Infective Agents, Urinary
- Cytochrome P-450 CYP2C8 Inhibitors
- Trimethoprim
- Sulfamethoxazole
- Trimethoprim, Sulfamethoxazole Drug Combination
Other Study ID Numbers
- 831864
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Granulomatosis With Polyangiitis
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Hospital for Special Surgery, New YorkRoche Pharma AG; Genentech, Inc.TerminatedGranulomatosis With Polyangiitis (Wegener's Granulomatosis)United States
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Assistance Publique - Hôpitaux de ParisFrench Vasculitis Study GroupCompletedEosinophilic Granulomatosis With Polyangiitis (EGPA)France
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University of PennsylvaniaUniversity of South Florida; University of OxfordCompletedVasculitis | Churg-Strauss Syndrome (CSS) | Microscopic Polyangiitis (MPA) | Eosinophilic Granulomatosis With Polyangiitis (Churg-Strauss) (EGPA) | Granulomatosis With Polyangiitis (Wegener's) (GPA) | Wegener Granulomatosis (WG) | ANCA-Associated Vasculitis (AAV)United States
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InflaRx GmbHIqvia Pty LtdTerminatedGranulomatosis With Polyangiitis (GPA) | Microscopic Polyangiitis (MPA)United States, Canada
-
InflaRx GmbHCompletedGranulomatosis With Polyangiitis (GPA) | Microscopic Polyangiitis (MPA)Germany, Russian Federation, Belgium, France, Spain, Czechia, Italy, Netherlands, Sweden, Switzerland, United Kingdom
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Imperial College LondonAstraZenecaEnrolling by invitationEGPA - Eosinophilic Granulomatosis With PolyangiitisUnited Kingdom
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University of PennsylvaniaNational Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) and other collaboratorsCompletedMicroscopic Polyangiitis (MPA) | Granulomatosis With Polyangiitis (Wegener's) (GPA)United States, Belgium, France, United Kingdom, Denmark, Canada, Japan, Australia, New Zealand, Sweden, Czechia, Italy, Greece, Mexico, Norway
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University of South FloridaNational Heart, Lung, and Blood Institute (NHLBI); National Institute of Arthritis... and other collaboratorsActive, not recruitingVasculitis | Granulomatosis With Polyangiitis | Wegener GranulomatosisUnited States
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Portsmouth Hospitals NHS TrustCompletedChurg-Strauss SyndromeUnited Kingdom
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