NCT03673956

Topical Antibiotics in Chronic Rhinosinusitis

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Researchers are trying to find out if patients develop antibiotic resistant organisms after the use of topical antibiotics in the treatment of chronic rhinosinusitis.

Detailed description

There is a certain group of patients that has chronic rhinosinusitis that has continued even with treatment including saline and steroid nasal irrigations as well as oral steroids and antibiotics and surgery. In these patients, the use of topical antibiotic nasal rinses may be of benefit to their disease. The use of topical antibiotic nasal rinses is commonly used as standard of care already throughout the country for refractory chronic rhinosinusitis including here at the Mayo Clinic. Our pharmacy has compounded this medication for this specific purpose. As such, this study is not aimed at a 'novel medication', but rather to investigate the efficacy of a medication already in common use but without great evidence. The investigators are doing this research study to find out if patients develop antibiotic resistant organisms after the use of topical antibiotics in the treatment of chronic rhinosinusitis. In addition, this study will look at the effects of topical antibiotics on patient symptoms as measured by a patient survey called the Sino-Nasal Outcomes Test (SNOT-22) and in-office an exam of the inside of their nose, including with a scope (a camera on the end of a long tube).

Conditions

• Chronic Rhinosinusitis (Diagnosis)

Interventions

Type	Name	Description
DRUG	Mupirocin	30mg capsules dissolved in a standard 240mL saline irrigation rinse and self-administered through nasal saline irrigation twice per day over 30 days.
DRUG	Tobramycin	240mg capsules dissolved in a standard 240mL saline irrigation rinse and self-administered through nasal saline irrigation twice per day over 30 days.
DRUG	Levofloxacin	240mg capsules dissolved in a standard 240mL saline irrigation rinse and self-administered through nasal saline irrigation twice per day over 30 days.
DRUG	Vancomycin	240mg capsules dissolved in a standard 240mL saline irrigation rinse and self-administered through nasal saline irrigation twice per day over 30 days.

Timeline

• Start date: 2018-09-26
• Primary completion: 2021-02-01
• Completion: 2021-02-01
• First posted: 2018-09-17
• Last updated: 2022-04-20
• Results posted: 2022-04-20

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study