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Trimethoprim-Sulfamethoxazole for Wegener's Granulomatosis (TEMPO Trial)
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.
TEMPO Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTEMPO Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.TEMPO Trial Design
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Who is running the clinical trial?
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- I am allergic to sulfa drugs, or have severe kidney or liver problems.I am taking 10mg or less of Prednisone daily.I have not used nasal antibiotics in the last 4 weeks.I have not taken oral antibiotics or antifungals in the last 6 weeks.I have a history of HIV or a primary immunodeficiency.I am 18 years old or older.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.I have had a sinus or nose infection in the last month.Patients with granulomatosis with polyangiitis (GPA) will be determined by specific classification criteria or by the doctor's assessment.I am either male or female.My condition involves sinus or nasal problems due to GPA.You have used cocaine through your nose in the last 3 months.I am at risk for reactions from taking TMP-SMX.
- Group 1: On Drug
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
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."
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."
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."
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."
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