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Topical Antibiotics in Chronic Rhinosinusitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03673956
Recruitment Status : Recruiting
First Posted : September 17, 2018
Last Update Posted : January 3, 2020
Sponsor:
Information provided by (Responsible Party):
Garret W. Choby, Mayo Clinic

Brief Summary:

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).


Condition or disease Intervention/treatment Phase
Chronic Rhinosinusitis (Diagnosis) Drug: Topical Antibiotic Nasal Saline Irrigation Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Topical Antibiotics in Chronic Rhinosinusitis
Actual Study Start Date : September 26, 2018
Estimated Primary Completion Date : December 1, 2020
Estimated Study Completion Date : July 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics

Arm Intervention/treatment
Experimental: Topical Antibiotic Nasal Saline Rinse
The topical antibiotics will prescribed to the patient in capsule form as compounded by the Mayo Clinic pharmacy, or suitable licensed 3rd party compounding pharmacy. One capsule will subsequently be added to a nasal saline irrigation bottle, and the patient will administer this irrigation to him or herself in the usual fashion twice per day.
Drug: Topical Antibiotic Nasal Saline Irrigation
The topical antibiotics will prescribed to the patient in capsule form as compounded by the Mayo Clinic pharmacy, or suitable licensed 3rd party compounding pharmacy. One capsule will subsequently be added to a nasal saline irrigation bottle, and the patient will administer this irrigation to him or herself in the usual fashion twice per day. The antibiotic prescribed may be either Tobramycin, Mupirocin, Gentamicin or Levofloxacin.




Primary Outcome Measures :
  1. Change from baseline in nasal swab antibiotic resistance as measured by gram stain, culture and sensitivity. [ Time Frame: Baseline, Post-intervention (within 21 days of intervention completion) ]
    Antibiotic resistance will be measured by nasal swab of the affected sinonasal cavity and sent for stain, culture and sensitivity.


Secondary Outcome Measures :
  1. Change in baseline in patient symptoms as measured by the Sino-Nasal Outcomes Test (SNOT-22) survey [ Time Frame: 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.

  2. Change in baseline in patient physical exam as measured by the Lund-Kennedy endoscopic exam scores. [ Time Frame: 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.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03673956


Contacts
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Contact: Christopher M Low, MD 507-538-1392 low.christopher1@mayo.edu

Locations
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United States, Minnesota
Mayo Clinic in Rochester Recruiting
Rochester, Minnesota, United States, 55905
Contact: Christopher M Low, MD         
Principal Investigator: Garret W Choby         
Sponsors and Collaborators
Mayo Clinic
Investigators
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Principal Investigator: Garret W Choby, MD Mayo Clinic
Additional Information:
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Responsible Party: Garret W. Choby, Senior Associate Consultant - Department of Otorhinolaryngology; Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT03673956    
Other Study ID Numbers: 18-006599
First Posted: September 17, 2018    Key Record Dates
Last Update Posted: January 3, 2020
Last Verified: December 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Sinusitis
Paranasal Sinus Diseases
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Anti-Bacterial Agents
Anti-Infective Agents