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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.
See brief summary.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| oral placebo with nebulized intranasal levofloxacin | Active Comparator | Placebo oral tablet by mouth daily for 14 consecutive days along with nebulized levofloxacin 125 mg twice daily for 14 consecutive days |
|
| oral antibiotics with nebulized intranasal placebo | Active Comparator | Levofloxacin 500 mg by mouth once daily for 14 consecutive days, along with intranasal placebo solution twice daily for 14 consecutive days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| oral levofloxacin | Drug |
| ||
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Li-Xing Man, MD, MPA, Msc | University of Rochester | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Rochester Department of Otolaryngology Head and Neck Surgery | Rochester | New York | 14642 | United States |
8 participants screen failed before randomization to the intervention.
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| ID | Title | Description |
|---|---|---|
| FG000 | Oral Placebo With Nebulized Intranasal Levofloxacin | Placebo oral tablet by mouth daily for 14 consecutive days along with nebulized levofloxacin 125 mg twice daily for 14 consecutive days oral levofloxacin nebulized levofloxacin |
| FG001 | Oral Antibiotics With Nebulized Intranasal Placebo | Levofloxacin 500 mg by mouth once daily for 14 consecutive days, along with intranasal placebo solution twice daily for 14 consecutive days. oral levofloxacin nebulized levofloxacin |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Oral Placebo With Nebulized Intranasal Levofloxacin | Placebo oral tablet by mouth daily for 14 consecutive days along with nebulized levofloxacin 125 mg twice daily for 14 consecutive days oral levofloxacin nebulized levofloxacin |
| BG001 | Oral Antibiotics With Nebulized Intranasal Placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Posted | Mean | Standard Deviation | units on a scale | Baseline and 14 days after treatment |
|
6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Oral Placebo With Nebulized Intranasal Levofloxacin | Placebo oral tablet by mouth daily for 14 consecutive days along with nebulized levofloxacin 125 mg twice daily for 14 consecutive days oral levofloxacin nebulized levofloxacin |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| epistaxis | General disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Research Program Manager | UR Medicine Otolaryngology | 5852751186 | paul_allen@urmc.rochester.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 7, 2019 | Nov 16, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D064704 | Levofloxacin |
| ID | Term |
|---|---|
| D015242 | Ofloxacin |
| D024841 | Fluoroquinolones |
| D042462 | 4-Quinolones |
| D015363 | Quinolones |
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| nebulized levofloxacin |
| Drug |
|
| 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 |
Levofloxacin 500 mg by mouth once daily for 14 consecutive days, along with intranasal placebo solution twice daily for 14 consecutive days. oral levofloxacin nebulized levofloxacin |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Levofloxacin 500 mg by mouth once daily for 14 consecutive days, along with intranasal placebo solution twice daily for 14 consecutive days. oral levofloxacin nebulized levofloxacin |
|
|
|
| Secondary | 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 | Posted | Mean | Standard Deviation | units on a scale | Baseline and 14 days after treatment |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | units on a scale | Baseline and 14 days after treatment |
|
|
|
|
| Secondary | 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 | Posted | Count of Participants | Participants | 14 days after treatment |
|
|
|
|
| Secondary | 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. | Data was only collected on the first consecutive 8 randomized participants and had equal numbers in each group | Posted | Mean | Standard Deviation | operational taxonomic units | Baseline and 14 days after treatment |
|
|
|
| 0 |
| 12 |
| 0 |
| 12 |
| 5 |
| 12 |
| EG001 | Oral Antibiotics With Nebulized Intranasal Placebo | Levofloxacin 500 mg by mouth once daily for 14 consecutive days, along with intranasal placebo solution twice daily for 14 consecutive days. oral levofloxacin nebulized levofloxacin | 0 | 13 | 0 | 13 | 9 | 13 |
| Fever | General disorders | Non-systematic Assessment |
|
| diarrhea | Gastrointestinal disorders | Non-systematic Assessment |
|
| joint pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| bad taste | Gastrointestinal disorders | Non-systematic Assessment |
|
| nausea/vomiting | Gastrointestinal disorders | Non-systematic Assessment |
|
| dizziness | General disorders | Non-systematic Assessment |
|
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| D011804 |
| Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |