Topical Antibiotics in Chronic Rhinosinusitis

NCT03673956 | Completed Phase 1 Results FDA Drug

• 1 other identifier: 18-006599
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Rhinosinusitis (Diagnosis)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Change in Patient Symptoms as Measured by the Sino-Nasal Outcomes Test (SNOT-22) Survey

  Baseline, Post-intervention (within 21 days of intervention completion)

• Change in Patient Physical Exam as Measured by the Lund-Kennedy Endoscopic Exam Scores.

  Baseline, Post-intervention (within 21 days of intervention completion)

Study Arms (4)

Mupirocin Topical Antibiotic Nasal Saline Rinse

EXPERIMENTAL

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.

Drug: Mupirocin

Tobramycin Topical Antibiotic Nasal Saline Rinse

EXPERIMENTAL

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.

Drug: Tobramycin

Levofloxacin Topical Antibiotic Nasal Saline Rinse

EXPERIMENTAL

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.

Drug: Levofloxacin

Vancomycin Topical Antibiotic Nasal Saline Rinse

EXPERIMENTAL

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.

Drug: Vancomycin

Interventions

Mupirocin DRUG

30mg capsules dissolved in a standard 240mL saline irrigation rinse and self-administered through nasal saline irrigation twice per day over 30 days.

Mupirocin Topical Antibiotic Nasal Saline Rinse

Tobramycin DRUG

240mg capsules dissolved in a standard 240mL saline irrigation rinse and self-administered through nasal saline irrigation twice per day over 30 days.

Tobramycin Topical Antibiotic Nasal Saline Rinse

Levofloxacin DRUG

240mg capsules dissolved in a standard 240mL saline irrigation rinse and self-administered through nasal saline irrigation twice per day over 30 days.

Levofloxacin Topical Antibiotic Nasal Saline Rinse

Vancomycin DRUG

240mg capsules dissolved in a standard 240mL saline irrigation rinse and self-administered through nasal saline irrigation twice per day over 30 days.

Vancomycin Topical Antibiotic Nasal Saline Rinse

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Disease

Interventions

Mupirocin; Tobramycin; Levofloxacin; Vancomycin

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epoxy Compounds; Ethers, Cyclic; Ethers; Organic Chemicals; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fatty Acids; Lipids; Nebramycin; Kanamycin; Aminoglycosides; Glycosides; Carbohydrates; Ofloxacin; Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Glycopeptides; Glycoconjugates; Peptides; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Dr. Garret W. Choby
• Organization: Mayo Clinic

Choby.Garret@mayo.edu

507-284-2533

Study Officials

• Garret W Choby, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Associate Consultant - Department of Otorhinolaryngology; Principal Investigator

Study Record Dates

• First Submitted: September 13, 2018
• First Posted: September 17, 2018
• Study Start: September 26, 2018
• Primary Completion: February 1, 2021
• Study Completion: February 1, 2021
• Last Updated: April 20, 2022
• Results First Posted: April 20, 2022

Record last verified: 2022-03

Locations

US (1)