Oral Versus Topical Antibiotics for Chronic Rhinosinusitis Exacerbations
| Status: | Recruiting |
|---|---|
| Conditions: | Sinusitis |
| Therapuetic Areas: | Otolaryngology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 10/29/2017 |
| Start Date: | October 2013 |
| End Date: | January 2020 |
| Contact: | Li-Xing Man, MD |
| Email: | Li-Xing_Man@urmc.rochester.edu |
| Phone: | 585-758-5700 |
Oral Versus Topical Antibiotic Therapy for Treatment of Chronic Rhinosinusitis Exacerbations
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.
(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.
See brief summary.
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.
We found this trial at
1
site
Rochester, New York 14642
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