Topical Antibiotics in Chronic Rhinosinusitis

Mayo Clinic

Status and phase: Completed; Phase 2; Phase 1

Conditions: Chronic Rhinosinusitis (Diagnosis)

Treatments: Drug: Tobramycin; Drug: Vancomycin; Drug: Mupirocin; Drug: Levofloxacin

Study type: Interventional

Funder types: Other

Identifiers

NCT03673956

18-006599

Details and patient eligibility

About

Researchers are trying to find out if patients develop antibiotic resistant organisms after the use of topical antibiotics in the treatment of chronic rhinosinusitis.

Full 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).

Enrollment: 19 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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19 participants in 4 patient groups

Mupirocin Topical Antibiotic Nasal Saline Rinse

Experimental group

Description:

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.

Treatment:

Drug: Mupirocin

Tobramycin Topical Antibiotic Nasal Saline Rinse

Experimental group

Description:

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.

Treatment:

Drug: Tobramycin

Levofloxacin Topical Antibiotic Nasal Saline Rinse

Experimental group

Description:

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.

Treatment:

Drug: Levofloxacin

Vancomycin Topical Antibiotic Nasal Saline Rinse

Experimental group

Description:

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.

Treatment:

Drug: Vancomycin