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Tiny study probes why antibiotic may tame rare vasculitis

NCT ID NCT03919435

Knowledge-focused Sponsor: University of Pennsylvania Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study looks at how the antibiotic TMP-SMX changes the bacteria and fungi living in the noses of people with granulomatosis with polyangiitis (GPA), a rare autoimmune disease. Researchers want to understand why this antibiotic helps prevent disease flare-ups. Eight adults with GPA and a history of sinus problems will take TMP-SMX for 4 weeks, and their nasal microbiome will be tracked over 6 months using swabs and optional blood draws.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Trimethoprim-sulfamethoxazole (TMP-SMX), an antibiotic pill
What this could lead to
If successful, this study could reveal whether TMP-SMX prevents GPA relapses by killing bacteria or by reducing inflammation, guiding better treatments.
What could go wrong
This is a very small, early-phase study with only 8 participants, so results may not apply to all GPA patients. It is designed to observe changes, not to test a new treatment.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

8 people

The number who actually took part.

Started

Mar 2019

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

granulomatosis with polyangiitis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Granulomatosis with polyangiitis Wegener granulomatosis

Contacts and locations

Locations

  • Perelman Center for Advanced Medicine

    Philadelphia, Pennsylvania, 19104, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.