Granulomatosis With PolyangiitisPhase 1/2TEMPONCT03919435
TEMPO Study: Trimethoprim-Sulfamethoxazole in Granulomatosis With Polyangiitis
A Phase 1/2 study testing Trimethoprim Sulfamethoxazole in people with Granulomatosis With Polyangiitis and Wegener Granulomatosis, run by University of Pennsylvania at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Granulomatosis With Polyangiitis, Wegener Granulomatosis
- What is being tested?
- Trimethoprim Sulfamethoxazole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Mar 2019to 30 Dec 2027
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Perelman Center for Advanced Medicine
Philadelphia, Pennsylvania, 19104
About this study
Official title: 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.
- Being tested
- Trimethoprim Sulfamethoxazole
- Medical subject headings
- Granulomatosis with Polyangiitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trimethoprim SulfamethoxazoleDrug
Dosage: 160mg-800mg Frequency: 2 times a day Dosage Form: Pill (oral) Duration: 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| On Drug | Experimental | Not described Receives: Drug: Trimethoprim Sulfamethoxazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
nasal microbiome in relative abundance ( host gene expression in proportion)
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2019
- Study start27 Mar 2019
- Primary completion30 Dec 2027 (estimated)
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Granulomatosis With PolyangiitisStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rennie Rhee, M.D., MSCE, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03919435
- Sponsor's protocol ID
- 831864
- Acronym
- TEMPO
- Status last verified
- Sep 2026
- First submitted
- 5 Apr 2019
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trimethoprim-Sulfamethoxazole Effects on the Nasal Microbiome in Granulomatosis With Polyangiitis
- ClinicalTrials.gov ID
- NCT03919435
- Acronym / sponsor ID
- TEMPO / 831864
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 8 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- 27 Mar 2019 (actual)
- Primary completion
- 30 Dec 2027 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 18 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| On Drug | Experimental | Drug: Trimethoprim Sulfamethoxazole |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Trimethoprim SulfamethoxazoleDosage: 160mg-800mg Frequency: 2 times a day Dosage Form: Pill (oral) Duration: 4 weeks | Drug | On Drug |
Primary outcome
nasal microbiome in relative abundance ( host gene expression in proportion)
Time frame: 24 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Trimethoprim Sulfamethoxazole in people with Granulomatosis With Polyangiitis and Wegener Granulomatosis, run by University of Pennsylvania at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
nasal microbiome in relative abundance ( host gene expression in proportion) (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2026.