Oral Versus Topical Antibiotics for Chronic Rhinosinusitis Exacerbations

Phase 3CompletedNCT01988779

University of Rochester33 enrolled

Overview

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.

See brief summary.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Chronic Rhinosinusitis

Interventions

oral levofloxacinDRUG

nebulized levofloxacinDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

University of Rochester Department of Otolaryngology Head and Neck Surgery

Rochester, New York, United States

Outcomes

Primary Outcomes

Change in Rhinosinusitis Disability Index (RSDI) Score

The Rhinosinusitis Disability Index is a 30-item questionnaire completed by the patient or subject. Each item has a value of zero to four, a higher score indicates a self-perception of worse symptoms. The minimum score is zero and the maximum score is 120. The difference score here is the post-treatment score minus the pre-treatment score, with lower meaning more improvement

Time frame: Baseline and 14 days after treatment

Secondary Outcomes

Change in Sino-nasal Outcome Test (SNOT-22) Score

The Sino-nasal outcome test is a 22-item questionnaire completed by the patient or subject. Each item has a value of zero to five, a higher score indicates a self-perception of worse symptoms. The minimum score is zero and the maximum score is 110. The difference score here is the post-treatment score minus the pre-treatment score, with lower meaning more improvement

Time frame: Baseline and 14 days after treatment

Change in Bilateral Endoscopy Findings Using POSE Score

The Perioperative Sinus Endoscopy (POSE) instrument is a specific tool to endoscopically assess the sinus cavities of patients who have undergone endoscopic sinus surgery. Each POSE score has a minimum of 0 and a maximum of 16, with a higher score indicating a worse outcome. Here, the Left and Right POSE scores are summed and the difference between baseline and the 14 day after treatment is reported. The change in bilateral POSE score can in principle be -32 to +32, with increased scores indicating worse outcome and negative scores indicating improvement over the treatment period.

Time frame: Baseline and 14 days after treatment

Number of Participants With Post-treatment Culture Negativity

Post-treatment culture negativity, defined as less than 1+ growth of organisms. A subject is counted '1' if both nares are free of bacterial growth, and '0' if growth is 1+ of more

Time frame: 14 days after treatment

Data from ClinicalTrials.gov

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