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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01988779
Other study ID # 45566
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date October 2013
Est. completion date December 31, 2020

Study information

Verified date March 2021
Source University of Rochester
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

See brief summary.


Recruitment information / eligibility

Status Completed
Enrollment 33
Est. completion date December 31, 2020
Est. primary completion date September 11, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
oral levofloxacin

nebulized levofloxacin


Locations

Country Name City State
United States University of Rochester Department of Otolaryngology Head and Neck Surgery Rochester New York

Sponsors (1)

Lead Sponsor Collaborator
University of Rochester

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
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
Baseline and 14 days after treatment
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
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.
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 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. Baseline and 14 days after treatment
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