Effect of Topical Sinonasal Antibiotics

Chronic Rhinosinusitis (Diagnosis) Clinical Trial

Official title: Effect of Topical Sinonasal Antibiotics in Post-Surgical Patients With an Acute Exacerbation of Chronic Rhinosinusitis

Status Not yet recruiting

Clinical Trial 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.

Clinical Trial Description

n/a

Related Conditions & MeSH terms

• Antibiotic Side Effect
• Chronic Disease
• Chronic Rhinosinusitis (Diagnosis)
• Sinusitis

• NCT number: NCT03935828
• Study type: Interventional
• Source: United States Naval Medical Center, San Diego
• Contact: Michael J Coulter, M.D.
• Phone: 618-886-6474
• Email: michael.j.coulter15.mil@mail.mil
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: June 2019
• Completion date: June 2021