TEMPO Study: Trimethoprim-Sulfamethoxazole in Granulomatosis With Polyangiitis

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Brief Title

TEMPO Study: Trimethoprim-Sulfamethoxazole in Granulomatosis With Polyangiitis

Official Title

Trimethoprim-Sulfamethoxazole Effects on the Nasal Microbiome in Granulomatosis With Polyangiitis

Brief 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. 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 Phase

Phase 1/Phase 2

Study Type

Interventional


Primary Outcome

nasal microbiome in relative abundance ( host gene expression in proportion)


Condition

Granulomatosis With Polyangiitis

Intervention

Trimethoprim Sulfamethoxazole

Study Arms / Comparison Groups

 On Drug
Description:  

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

30

Start Date

March 27, 2019

Completion Date

May 27, 2022

Primary Completion Date

March 27, 2022

Eligibility Criteria

        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
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT03919435

Organization ID

831864


Responsible Party

Principal Investigator

Study Sponsor

University of Pennsylvania


Study Sponsor

, , 


Verification Date

November 2020