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Antibiotic

Trimethoprim-Sulfamethoxazole for Wegener's Granulomatosis (TEMPO Trial)

Phase 1 & 2
Waitlist Available
Research Sponsored by University of Pennsylvania
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Prednisone dose or equivalent less than or equal to 10mg at enrollment
Patients must be at least 18 year of age or older
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 weeks
Awards & highlights

TEMPO Trial Summary

This trial is studying the changes in the nasal microbiome, mycobiome, and host immunity in patients with a disease called granulomatosis with polyangiitis.

Who is the study for?
Adults diagnosed with Granulomatosis with Polyangiitis (GPA), who have been in remission for at least 3 months, and are expected to maintain stable immunosuppressive therapy. They must have had sinus issues due to GPA and be on a low dose of prednisone or equivalent. Excluded are those recently on antibiotics/antifungals, with HIV, severe kidney/liver issues, sulfa allergy, pregnancy plans within 6 months, recent nasal antibiotic use or cocaine use.Check my eligibility
What is being tested?
The TEMPO study is testing the effects of Trimethoprim-Sulfamethoxazole (TMP-SMX) on patients with GPA. It aims to understand changes in the nasal microbiome and host immunity by analyzing DNA from nasal swabs before, during, and after a 4-week TMP-SMX treatment period. The trial will follow each patient over six months.See study design
What are the potential side effects?
Potential side effects of TMP-SMX may include allergic reactions like skin rashes for those sensitive to sulfa drugs; gastrointestinal disturbances such as nausea or vomiting; blood disorders like anemia; liver enzyme elevations; and possible kidney function impairment.

TEMPO Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am taking 10mg or less of Prednisone daily.
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I am 18 years old or older.
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I have been in remission for 3 months and will be on stable medication for the next 6 months, except for small changes in prednisone.
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I am either male or female.
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My condition involves sinus or nasal problems due to GPA.

TEMPO Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
nasal microbiome in relative abundance ( host gene expression in proportion)

TEMPO Trial Design

1Treatment groups
Experimental Treatment
Group I: On DrugExperimental Treatment1 Intervention

Find a Location

Who is running the clinical trial?

University of PennsylvaniaLead Sponsor
1,992 Previous Clinical Trials
42,875,352 Total Patients Enrolled

Media Library

Trimethoprim Sulfamethoxazole (Antibiotic) Clinical Trial Eligibility Overview. Trial Name: NCT03919435 — Phase 1 & 2
Wegener's Granulomatosis Research Study Groups: On Drug
Wegener's Granulomatosis Clinical Trial 2023: Trimethoprim Sulfamethoxazole Highlights & Side Effects. Trial Name: NCT03919435 — Phase 1 & 2
Trimethoprim Sulfamethoxazole (Antibiotic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03919435 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has there been any prior research conducted utilizing Trimethoprim Sulfamethoxazole?

"Currently, 15 investigations are underway to assess the efficacy of Trimethoprim Sulfamethoxazole. Of these active studies, 3 have reached Phase 3. Although a majority of trials for this drug take place in Montreal, Quebec, 38 other medical centres across North America also offer it as part of their clinical research program."

Answered by AI

How many participants are currently being accepted into this research project?

"This research trial is not currently accepting new participants. It had a commencement date of March 27th 2019 and was last edited on June 1st 2022. Conversely, there are 20 polyangium-based studies actively recruiting and 15 Trimethoprim Sulfamethoxazole trials searching for patients at this moment in time."

Answered by AI

What ailments does Trimethoprim Sulfamethoxazole typically address?

"Trimethoprim-Sulfamethoxazole is a proven remedy for the three aforementioned maladies: shigella sonnei induced enteritis, otitis media, and shigellosis."

Answered by AI

Is enrollment currently open for this clinical experiment?

"This clinical trial is no longer open for new applicants, as the posting and subsequent editing of this study occurred on March 27th 2019 and June 1st 2022 respectively. For those still in search of medical studies to participate in, 20 research projects involving polyangium are recruiting now while 15 trials with Trimethoprim Sulfamethoxazole have current openings."

Answered by AI
~2 spots leftby Sep 2025