Clinical trial NCT03673956: Topical Antibiotics in Chronic Rhinosinusitis
Official title: Topical Antibiotics in Chronic Rhinosinusitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Chronic Rhinosinusitis (Diagnosis)
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2018-09-17
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Eligibility 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

Primary outcomes:
measure: Subjects Who Developed Antibiotic Resistance Organisms
timeFrame: Post-intervention (within 21 days of intervention completion)
Secondary outcomes:
measure: Change in Patient Symptoms as Measured by the Sino-Nasal Outcomes Test (SNOT-22) Survey
timeFrame: Baseline, Post-intervention (within 21 days of intervention completion)
measure: Change in Patient Physical Exam as Measured by the Lund-Kennedy Endoscopic Exam Scores.
timeFrame: Baseline, Post-intervention (within 21 days of intervention completion)
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Garret W Choby, MD
role: PRINCIPAL_INVESTIGATOR
References: