Phase 2
N=19
Topical Antibiotics in Chronic Rhinosinusitis
Chronic Rhinosinusitis (Diagnosis)
Bottom Line
View on ClinicalTrials.gov: NCT03673956 ↗Enrolled (actual)
19
Serious AEs
0.0%
Results posted
Apr 2022
Primary outcome: Primary: Subjects Who Developed Antibiotic Resistance Organisms — 0; 0; 1; 0 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Mupirocin (Drug); Tobramycin (Drug); Levofloxacin (Drug); Vancomycin (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Mayo Clinic
- Primary completion
- Feb 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Subjects Who Developed Antibiotic Resistance Organisms |
0; 0; 1; 0 | — |
| SECONDARY Change in Patient Symptoms as Measured by the Sino-Nasal Outcomes Test (SNOT-22) Survey |
-18; 14; -25.5; -11 | — |
| SECONDARY Change in Patient Physical Exam as Measured by the Lund-Kennedy Endoscopic Exam Scores. |
-5.3; -3; -2.4; 0 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT03673956). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.