Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:44 PM
Ignite Modification Date:
2025-12-24 @ 10:44 PM
NCT ID:
NCT03919435
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03919435
Study Brief:
Protocol Section:
NCT03919435