Oral Versus Topical Antibiotics for Chronic Rhinosinusitis Exacerbations
Completed · Phase 3 · Has a placebo group
Conditions studied: Chronic Rhinosinusitis
In brief
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.
Key facts
- Study ID
- NCT01988779
- Run by
- University of Rochester
- People needed
- 33
- Starts
- 2013-10-01
- Expected to finish
- 2020-12-31
- Last updated by the study team
- 2021-03-24
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Adults (age ≥ 18).
- Diagnosis of CRS.
- Worsening sinonasal symptoms.
- Previous bilateral endoscopic sinus surgery (ESS) (including maxillary antrostomy and anterior ethmoidectomy).
- English speaking.
- Open sinuses (open middle meatus bilaterally; determined on endoscopy).
- Positive sinonasal culture (1+ or greater) with sensitivity to one of the pre-chosen antibiotic regimens.
You may not qualify if…
- Patients < 18 years of age.
- Treatment with systemic or topical antibiotics within the last 1 month.
- Pregnant women.
- Non-English speaking persons.
- Systemically ill at initial visit necessitating treatment prior to culture data.
- Allergies to chosen susceptible antibiotics.
- Sinonasal culture with less than 1+ growth.
- Multiple organisms grown on culture that are not sensitive to a single antibiotic.
- Patients with ciliary function disorders (cystic fibrosis, Kartagener's syndrome, ciliary dyskinesia).
- Patients with immunodeficiencies.
Where it is running
- University of Rochester Department of Otolaryngology Head and Neck Surgery — Rochester, New York, United States
Full record on ClinicalTrials.gov
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