Topical Antibiotics in Chronic Rhinosinusitis

Chronic Rhinosinusitis (Diagnosis) Clinical Trial

Official title:

Topical Antibiotics in Chronic Rhinosinusitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03673956
• Other study ID #: 18-006599
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: September 26, 2018
• Est. completion date: February 1, 2021

Study information

• Verified date: March 2022
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: February 1, 2021
• Est. primary completion date: February 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Rhinosinusitis (Diagnosis)
• Sinusitis

Intervention

Drug:
• Mupirocin
30mg capsules dissolved in a standard 240mL saline irrigation rinse and self-administered through nasal saline irrigation twice per day over 30 days.
• Tobramycin
240mg capsules dissolved in a standard 240mL saline irrigation rinse and self-administered through nasal saline irrigation twice per day over 30 days.
• Levofloxacin
240mg capsules dissolved in a standard 240mL saline irrigation rinse and self-administered through nasal saline irrigation twice per day over 30 days.
• Vancomycin
240mg capsules dissolved in a standard 240mL saline irrigation rinse and self-administered through nasal saline irrigation twice per day over 30 days.

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)

External Links

•   Mayo Clinic Clinical Trials