Topical Antibiotics in Chronic Rhinosinusitis

Study Overview
=================
Brief 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).

Official Title
-----------------
Topical Antibiotics in Chronic Rhinosinusitis

Conditions
-----------------
Chronic Rhinosinusitis (Diagnosis)

Intervention / Treatment
-----------------
* Drug: Mupirocin
* Drug: Tobramycin
* Drug: Levofloxacin
* Drug: Vancomycin


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mupirocin Topical Antibiotic Nasal Saline Rinse<br>Subjects with a history of chronic rhinosinusitis (CRS) who had previously undergone endonasal sinus surgery (minimum of maxillary antrostomy and anterior ethmoidectomy), will receive a trial of Mupirocin topical antibiotic rinses. Subjects will undergo a baseline assessment including an aerobic sinus bacterial culture with antibiotic sensitivity to determine baseline microbial antibiotic resistance and to direct selection of appropriate topical antibiotic therapy. | Drug: Mupirocin<br>* 30mg capsules dissolved in a standard 240mL saline irrigation rinse and self-administered through nasal saline irrigation twice per day over 30 days.<br>|
| Experimental: Tobramycin Topical Antibiotic Nasal Saline Rinse<br>Subjects with a history of chronic rhinosinusitis (CRS) who had previously undergone endonasal sinus surgery (minimum of maxillary antrostomy and anterior ethmoidectomy), will receive a trial of Tobramycin topical antibiotic rinses. Subjects will undergo a baseline assessment including an aerobic sinus bacterial culture with antibiotic sensitivity to determine baseline microbial antibiotic resistance and to direct selection of appropriate topical antibiotic therapy. | Drug: Tobramycin<br>* 240mg capsules dissolved in a standard 240mL saline irrigation rinse and self-administered through nasal saline irrigation twice per day over 30 days.<br>|
| Experimental: Levofloxacin Topical Antibiotic Nasal Saline Rinse<br>Subjects with a history of chronic rhinosinusitis (CRS) who had previously undergone endonasal sinus surgery (minimum of maxillary antrostomy and anterior ethmoidectomy), will receive a trial of Levofloxacin topical antibiotic rinses. Subjects will undergo a baseline assessment including an aerobic sinus bacterial culture with antibiotic sensitivity to determine baseline microbial antibiotic resistance and to direct selection of appropriate topical antibiotic therapy. | Drug: Levofloxacin<br>* 240mg capsules dissolved in a standard 240mL saline irrigation rinse and self-administered through nasal saline irrigation twice per day over 30 days.<br>|
| Experimental: Vancomycin Topical Antibiotic Nasal Saline Rinse<br>Subjects with a history of chronic rhinosinusitis (CRS) who had previously undergone endonasal sinus surgery (minimum of maxillary antrostomy and anterior ethmoidectomy), will receive a trial of Vancomycin topical antibiotic rinses. Subjects will undergo a baseline assessment including an aerobic sinus bacterial culture with antibiotic sensitivity to determine baseline microbial antibiotic resistance and to direct selection of appropriate topical antibiotic therapy. | Drug: Vancomycin<br>* 240mg capsules dissolved in a standard 240mL saline irrigation rinse and self-administered through nasal saline irrigation twice per day over 30 days.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjects Who Developed Antibiotic Resistance Organisms | Number of subjects who developed new antibiotic resistance organisms measured by nasal swab of the affected sinonasal cavity and sent for stain, culture, and sensitivity. | Post-intervention (within 21 days of intervention completion) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Patient Symptoms as Measured by the Sino-Nasal Outcomes Test (SNOT-22) Survey | Scores are measured from 0-5 in a 22-item validated survey. Total scores range from 0-110 with higher scores indicating greater burden of sinonasal symptoms. | Baseline, Post-intervention (within 21 days of intervention completion) | 
| Change in Patient Physical Exam as Measured by the Lund-Kennedy Endoscopic Exam Scores. | Scores are measured on a 0-2 scale for nasal polyps, edema, and secretions in both right and left nasal cavities. Total scores range from 0 to 12 with higher scores indicating greater evidence of sinonasal disease on physical exam. | Baseline, Post-intervention (within 21 days of intervention completion) |