Topical Antibiotics in Chronic Rhinosinusitis

Phase 1

Completed

Conditions: Chronic Rhinosinusitis (Diagnosis)

Interventions: Drug: Mupirocin
Drug: Tobramycin
Drug: Vancomycin
Drug: Levofloxacin

Registration Number: NCT03673956

Lead Sponsor: Mayo Clinic

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).

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 19

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mupirocin Topical Antibiotic Nasal Saline Rinse	Mupirocin	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.
Tobramycin Topical Antibiotic Nasal Saline Rinse	Tobramycin	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.
Vancomycin Topical Antibiotic Nasal Saline Rinse	Vancomycin	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.
Levofloxacin Topical Antibiotic Nasal Saline Rinse	Levofloxacin	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.

Primary Outcome Measures

Name	Time	Method
Subjects Who Developed Antibiotic Resistance Organisms	Post-intervention (within 21 days of intervention completion)	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.

Secondary Outcome Measures

Name	Time	Method
Change in Patient Physical Exam as Measured by the Lund-Kennedy Endoscopic Exam Scores.	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.
Change in Patient Symptoms as Measured by the Sino-Nasal Outcomes Test (SNOT-22) Survey	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.