Oral Versus Topical Antibiotics for Chronic Rhinosinusitis Exacerbations
NCT ID: NCT01988779
Last Updated: 2021-03-24
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
33 participants
INTERVENTIONAL
2013-10-31
2020-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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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
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
Interventions
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oral levofloxacin
nebulized levofloxacin
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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University of Rochester
OTHER
Responsible Party
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Li-Xing Man
M.D.
Principal Investigators
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Li-Xing Man, MD, MPA, Msc
Role: PRINCIPAL_INVESTIGATOR
University of Rochester
Locations
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University of Rochester Department of Otolaryngology Head and Neck Surgery
Rochester, New York, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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45566
Identifier Type: -
Identifier Source: org_study_id
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