Topical Antibiotics in Chronic Rhinosinusitis

• ClinicalTrials.gov Identifier: NCT03673956
• Recruitment Status: Recruiting
• First Posted: September 17, 2018
• Last Update Posted: January 8, 2021
• Sponsor: Mayo Clinic
• Information provided by (Responsible Party): Garret W. Choby, Mayo Clinic

Study Description

Brief Summary:

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 40 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Topical Antibiotics in Chronic Rhinosinusitis
• Actual Study Start Date: September 26, 2018
• Estimated Primary Completion Date: December 1, 2021
• Estimated Study Completion Date: July 1, 2022

Arms and Interventions

Arm

Intervention/treatment

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.

Outcome Measures

Primary Outcome Measures :

1. 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.

Secondary Outcome Measures :

1. 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.
2. 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 80 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Contacts

Contact: Christopher M Low, MD; 507-538-1392; low.christopher1@mayo.edu

Locations

United States, Minnesota

Mayo Clinic in Rochester; Recruiting

Rochester, Minnesota, United States, 55905

Contact: Christopher M Low, MD

Principal Investigator: Garret W Choby

Sponsors and Collaborators

Mayo Clinic

Investigators

• Principal Investigator: Garret W Choby, MD; Mayo Clinic

More Information

Additional Information:

Mayo Clinic Clinical Trials 

• Responsible Party: Garret W. Choby, Senior Associate Consultant - Department of Otorhinolaryngology; Principal Investigator, Mayo Clinic
• ClinicalTrials.gov Identifier: NCT03673956
• Other Study ID Numbers: 18-006599
• First Posted: September 17, 2018
• Last Update Posted: January 8, 2021
• Last Verified: January 2021

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:

Sinusitis; Respiratory Tract Infections; Infections; Paranasal Sinus Diseases; Nose Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Anti-Bacterial Agents; Anti-Infective Agents