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Completed

NCT Number: NCT03673956

Topical Antibiotics in Chronic Rhinosinusitis

Researchers are trying to find out if patients develop antibiotic resistant organisms after the use of topical antibiotics in the treatment of chronic rhinosinusitis.

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Key information

Conditions

Chronic Rhinosinusitis (Diagnosis) Disease Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

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.

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.

Primary outcomes

  1. Subjects Who Developed Antibiotic Resistance Organisms

    Time frame: 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 outcomes

  1. Change 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 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.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Sep 17, 2018
Registry last updated
Apr 20, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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