Oral Versus Topical Antibiotics for Chronic Rhinosinusitis Exacerbations

Study Overview
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Brief Summary
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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.

Detailed Description
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See brief summary.

Official Title
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Oral Versus Topical Antibiotic Therapy for Treatment of Chronic Rhinosinusitis Exacerbations

Conditions
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Chronic Rhinosinusitis

Intervention / Treatment
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* Drug: oral levofloxacin
* Drug: nebulized levofloxacin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: oral placebo with nebulized intranasal levofloxacin<br>Placebo oral tablet by mouth daily for 14 consecutive days along with nebulized levofloxacin 125 mg twice daily for 14 consecutive days | Drug: oral levofloxacin<br> <br> Drug: nebulized levofloxacin<br> <br> |
| Active Comparator: oral antibiotics with nebulized intranasal placebo<br>Levofloxacin 500 mg by mouth once daily for 14 consecutive days, along with intranasal placebo solution twice daily for 14 consecutive days. | Drug: oral levofloxacin<br> <br> Drug: nebulized levofloxacin<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Baseline and 14 days after treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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. | 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 | 14 days after treatment | 
| Mean Change in the Total Bacterial Community | The bacterial community was determined using a 16S rRNA quantitative PCR processed using Quantitative Insights into Microbial Ecology (QIIME) software, version 1.8 to yield the number of operational taxonomic units in each subject sample. The count has a minimum of zero with an increasing score indicating a larger number of distinct bacterial species. | Baseline and 14 days after treatment |