Chronic Rhinosinusitis (Diagnosis)
Conditions
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).
Interventions
DRUGMupirocin
30mg capsules dissolved in a standard 240mL saline irrigation rinse and self-administered through nasal saline irrigation twice per day over 30 days.
DRUGTobramycin
240mg capsules dissolved in a standard 240mL saline irrigation rinse and self-administered through nasal saline irrigation twice per day over 30 days.
DRUGLevofloxacin
240mg capsules dissolved in a standard 240mL saline irrigation rinse and self-administered through nasal saline irrigation twice per day over 30 days.
DRUGVancomycin
240mg capsules dissolved in a standard 240mL saline irrigation rinse and self-administered through nasal saline irrigation twice per day over 30 days.
Sponsors
Mayo Clinic
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Mupirocin Antibiotic Nasal Saline Rinse 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.
Mupirocin: 30mg capsules dissolved in a standard 240mL saline irrigation rinse and self-administered through nasal saline irrigation twice per day over 30 days. | 12 |
| Tobramycin Topical Antibiotic Nasal Saline Rinse 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.
Tobramycin: 240mg capsules dissolved in a standard 240mL saline irrigation rinse and self-administered through nasal saline irrigation twice per day over 30 days. | 1 |
| Levofloxacin Topical Antibiotic Nasal Saline Rinse 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.
Levofloxacin: 240mg capsules dissolved in a standard 240mL saline irrigation rinse and self-administered through nasal saline irrigation twice per day over 30 days. | 5 |
| Vancomycin Topical Antibiotic Nasal Saline Rinse 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.
Vancomycin: 240mg capsules dissolved in a standard 240mL saline irrigation rinse and self-administered through nasal saline irrigation twice per day over 30 days. | 1 |
| Total | 19 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Did not use the prescribed topical antibiotics as directed | 1 | 0 | 0 | 0 |
| Overall Study | Lost to Follow-up | 1 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | Total | Tobramycin Topical Antibiotic Nasal Saline Rinse | Levofloxacin Topical Antibiotic Nasal Saline Rinse | Vancomycin Topical Antibiotic Nasal Saline Rinse | Mupirocin Antibiotic Nasal Saline Rinse |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Age, Categorical >=65 years | 9 Participants | 1 Participants | 3 Participants | 1 Participants | 4 Participants |
| Age, Categorical Between 18 and 65 years | 9 Participants | 0 Participants | 2 Participants | 0 Participants | 7 Participants |
| Race and Ethnicity Not Collected | 0 Participants | — | — | — | — |
| Region of Enrollment United States | 19 participants | 1 participants | 5 participants | 1 participants | 12 participants |
| Sex: Female, Male Female | 12 Participants | 0 Participants | 4 Participants | 1 Participants | 7 Participants |
| Sex: Female, Male Male | 7 Participants | 1 Participants | 1 Participants | 0 Participants | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 12 | 0 / 1 | 0 / 5 | 0 / 1 |
| other Total, other adverse events | 0 / 12 | 1 / 1 | 1 / 5 | 0 / 1 |
| serious Total, serious adverse events | 0 / 12 | 0 / 1 | 0 / 5 | 0 / 1 |
Outcome results
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.
Time frame: Post-intervention (within 21 days of intervention completion)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Mupirocin Antibiotic Nasal Saline Rinse | Subjects Who Developed Antibiotic Resistance Organisms | 0 Participants |
| Tobramycin Topical Antibiotic Nasal Saline Rinse | Subjects Who Developed Antibiotic Resistance Organisms | 0 Participants |
| Levofloxacin Topical Antibiotic Nasal Saline Rinse | Subjects Who Developed Antibiotic Resistance Organisms | 1 Participants |
| Vancomycin Topical Antibiotic Nasal Saline Rinse | Subjects Who Developed Antibiotic Resistance Organisms | 0 Participants |
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.
Time frame: Baseline, Post-intervention (within 21 days of intervention completion)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mupirocin Antibiotic Nasal Saline Rinse | Change in Patient Physical Exam as Measured by the Lund-Kennedy Endoscopic Exam Scores. | -5.3 units on a scale | Standard Deviation 2.8 |
| Tobramycin Topical Antibiotic Nasal Saline Rinse | Change in Patient Physical Exam as Measured by the Lund-Kennedy Endoscopic Exam Scores. | -3 units on a scale | — |
| Levofloxacin Topical Antibiotic Nasal Saline Rinse | Change in Patient Physical Exam as Measured by the Lund-Kennedy Endoscopic Exam Scores. | -2.4 units on a scale | Standard Deviation 2.4 |
| Vancomycin Topical Antibiotic Nasal Saline Rinse | Change in Patient Physical Exam as Measured by the Lund-Kennedy Endoscopic Exam Scores. | 0 units on a scale | — |
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.
Time frame: Baseline, Post-intervention (within 21 days of intervention completion)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mupirocin Antibiotic Nasal Saline Rinse | Change in Patient Symptoms as Measured by the Sino-Nasal Outcomes Test (SNOT-22) Survey | -18 units on a scale | Standard Deviation 21.8 |
| Tobramycin Topical Antibiotic Nasal Saline Rinse | Change in Patient Symptoms as Measured by the Sino-Nasal Outcomes Test (SNOT-22) Survey | 14 units on a scale | — |
| Levofloxacin Topical Antibiotic Nasal Saline Rinse | Change in Patient Symptoms as Measured by the Sino-Nasal Outcomes Test (SNOT-22) Survey | -25.5 units on a scale | Standard Deviation 34.6 |
| Vancomycin Topical Antibiotic Nasal Saline Rinse | Change in Patient Symptoms as Measured by the Sino-Nasal Outcomes Test (SNOT-22) Survey | -11 units on a scale | — |