Topical Antibiotics in Chronic Rhinosinusitis
| Status: | Recruiting |
|---|---|
| Conditions: | Sinusitis |
| Therapuetic Areas: | Otolaryngology |
| Healthy: | No |
| Age Range: | 18 - 80 |
| Updated: | 9/30/2018 |
| Start Date: | September 26, 2018 |
| End Date: | July 1, 2019 |
| Contact: | Christopher M Low, MD |
| Email: | low.christopher1@mayo.edu |
| Phone: | 507-538-1392 |
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).
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).
Inclusion Criteria:
- Male or female, between 18-80 years old, diagnosed with chronic rhinosinusitis who
have undergone previous functional endoscopic sinus surgery including at minimum
maxillary antrostomy and anterior ethmoidectomy
- Active mucopurulence on endoscopic examination with corresponding culture
demonstrating pathogenic bacterial growth
- Completion of written informed consent
- No prior enrollment into this study
- Refractory to maximal medical therapy
Exclusion Criteria:
- Patient has not had prior endoscopic sinus surgery consisting of at minimum maxillary
antrostomy and anterior ethmoidectomy
- Patient is currently being treated with oral antibiotics
- Patient has been treated with oral or topical antibiotics within the past 14 days
- Participation in an investigational drug study simultaneously with participation in
this study
- Concurrent use of oral steroids
- Allergy to Tobramycin, Mupirocin, Gentamicin and Levofloxacin
- Known to currently be pregnant
We found this trial at
1
site
200 First Street SW
Rochester, Minnesota 55905
Rochester, Minnesota 55905
507-284-2511
Principal Investigator: Garret W Choby
Mayo Clinic Rochester Mayo Clinic is a nonprofit worldwide leader in medical care, research and...
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