drugset / Trial / NCT03935828

Effect of Topical Sinonasal Antibiotics

NCT03935828

RandomizedParallel-groupSingle-blindTreatment

Summary

In this study, patients who have had previous endoscopic sinus surgery and present with an acute exacerbation of chronic rhinosinusitis will be offered endoscopic-guided, culture-directed antibiotic therapy. They will then be randomized to receive oral or intranasal topical antibiotics. Both of these are considered standard of care, but there is some limited data suggesting superiority of topical antibiotics especially if guided by culture and in patients who have undergone previous surgery. However, a study that directly compares the two has not been published. Modified Lund-Kennedy endoscopic finding scores and subjective SNOT-22 questionnaires will be collected before and at 3-4 weeks after treatment. Medication-related sided effects will be noted and analyzed. After 6-8 month follow-up, we will analyze the rate of recurrence of exacerbations, need for further antibiotics, need for revision surgery, and SNOT-22 scores based on oral versus topical antibiotic treatment. Our objective is to evaluate both short and long-term response to both oral and topical administration of antibiotics in this patient population in order to determine if either route of administration is superior to the other.

Timeline

Start
2019-06
Primary completion
2020-12
Completion
2021-06

Drugs

EvaluationDrugModalityDoseRoute
Subject Amoxicillin Other / unclassified 500 mg Oral
Subject Amphotericin B Unknown 20 ug/ml Topical
Subject Cefuroxime Small molecule 500 mg Oral
Subject Clarithromycin Small molecule 500 mg Oral
Subject Clindamycin Unknown 300 mg Oral
Subject Levofloxacin Small molecule 0.4 mg/ml Topical
Subject Levofloxacin Small molecule 500 mg Topical
Subject Mupirocin Small molecule 0.4 mg/ml Topical
Subject Tobramycin Small molecule 0.7 mg/ml Topical
Subject Vancomycin Other / unclassified 1 mg/ml Topical