Oral Versus Topical Antibiotics for Chronic Rhinosinusitis Exacerbations

• Status: Completed
• Trial end date: 2020-12-31
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to treat patients with a diagnosis of chronic rhinosinusitis (CRS) and a history of bilateral endoscopic sinus surgery during times of worsening symptoms and signs of acute infection on nasal endoscopy with one of two treatments: (1) oral antibiotics and twice daily intranasal saline irrigations or (2) oral placebo and twice daily intranasal antibiotic irrigations. The two treatments will be compared to see if there is any difference in patient outcomes. This will help guide treatment strategies for patients with CRS in the future.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Rochester
• Treatments: Anti-Bacterial Agents; Antibiotics, Antitubercular; Levofloxacin; Ofloxacin

Criteria

Inclusion Criteria:

1. Adults (age ≥ 18).

2. Diagnosis of CRS.

3. Worsening sinonasal symptoms.

4. Previous bilateral endoscopic sinus surgery (ESS) (including maxillary antrostomy and anterior ethmoidectomy).

5. English speaking.

6. Open sinuses (open middle meatus bilaterally; determined on endoscopy).

7. Positive sinonasal culture (1+ or greater) with sensitivity to one of the pre-chosen antibiotic regimens.

Exclusion Criteria:

1. Patients < 18 years of age.

2. Treatment with systemic or topical antibiotics within the last 1 month.

3. Pregnant women.

4. Non-English speaking persons.

5. Systemically ill at initial visit necessitating treatment prior to culture data.

6. Allergies to chosen susceptible antibiotics.

7. Sinonasal culture with less than 1+ growth.

8. Multiple organisms grown on culture that are not sensitive to a single antibiotic.

9. Patients with ciliary function disorders (cystic fibrosis, Kartagener's syndrome, ciliary dyskinesia).

10. Patients with immunodeficiencies.