Topical Antibiotics in Chronic Rhinosinusitis
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|ClinicalTrials.gov Identifier: NCT03673956|
Recruitment Status : Recruiting
First Posted : September 17, 2018
Last Update Posted : January 3, 2020
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).
|Condition or disease||Intervention/treatment||Phase|
|Chronic Rhinosinusitis (Diagnosis)||Drug: Topical Antibiotic Nasal Saline Irrigation||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Topical Antibiotics in Chronic Rhinosinusitis|
|Actual Study Start Date :||September 26, 2018|
|Estimated Primary Completion Date :||December 1, 2020|
|Estimated Study Completion Date :||July 1, 2021|
Experimental: Topical Antibiotic Nasal Saline Rinse
The topical antibiotics will prescribed to the patient in capsule form as compounded by the Mayo Clinic pharmacy, or suitable licensed 3rd party compounding pharmacy. One capsule will subsequently be added to a nasal saline irrigation bottle, and the patient will administer this irrigation to him or herself in the usual fashion twice per day.
Drug: Topical Antibiotic Nasal Saline Irrigation
The topical antibiotics will prescribed to the patient in capsule form as compounded by the Mayo Clinic pharmacy, or suitable licensed 3rd party compounding pharmacy. One capsule will subsequently be added to a nasal saline irrigation bottle, and the patient will administer this irrigation to him or herself in the usual fashion twice per day. The antibiotic prescribed may be either Tobramycin, Mupirocin, Gentamicin or Levofloxacin.
- Change from baseline in nasal swab antibiotic resistance as measured by gram stain, culture and sensitivity. [ Time Frame: Baseline, Post-intervention (within 21 days of intervention completion) ]Antibiotic resistance will be measured by nasal swab of the affected sinonasal cavity and sent for stain, culture and sensitivity.
- Change in baseline in patient symptoms as measured by the Sino-Nasal Outcomes Test (SNOT-22) survey [ Time Frame: Baseline, Post-intervention (within 21 days of intervention completion) ]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.
- Change in baseline in patient physical exam as measured by the Lund-Kennedy endoscopic exam scores. [ Time Frame: Baseline, Post-intervention (within 21 days of intervention completion) ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03673956
|Contact: Christopher M Low, MDfirstname.lastname@example.org|
|United States, Minnesota|
|Mayo Clinic in Rochester||Recruiting|
|Rochester, Minnesota, United States, 55905|
|Contact: Christopher M Low, MD|
|Principal Investigator: Garret W Choby|
|Principal Investigator:||Garret W Choby, MD||Mayo Clinic|