TEMPO Study: Trimethoprim-Sulfamethoxazole in Granulomatosis With Polyangiitis

• Register: ClinicalTrials.gov
• Last refreshed on: 25 July 2023
• Main ID: NCT03919435
• Date of registration: 05/04/2019
• Prospective Registration: No
• Primary sponsor: University of Pennsylvania
• Public title: TEMPO Study: Trimethoprim-Sulfamethoxazole in Granulomatosis With Polyangiitis TEMPO
• Scientific title: Trimethoprim-Sulfamethoxazole Effects on the Nasal Microbiome in Granulomatosis With Polyangiitis
• Date of first enrolment: March 27, 2019
• Target sample size: 8
• Recruitment status: Active, not recruiting
• URL: https://clinicaltrials.gov/ct2/show/NCT03919435
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Prevention. Masking: None (Open Label).
• Phase: Phase 1/Phase 2

Countries of recruitment

United States

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Wegener Granulomatosis

Granulomatosis With Polyangiitis

Intervention(s)

Drug: Trimethoprim Sulfamethoxazole

Primary Outcome(s)

nasal microbiome in relative abundance ( host gene expression in proportion) [Time Frame: 24 weeks]

Secondary ID(s)

831864

Source(s) of Monetary Support

Please refer to primary and secondary sponsors