search
Back to results

Oral Versus Topical Antibiotics for Chronic Rhinosinusitis Exacerbations

Primary Purpose

Chronic Rhinosinusitis

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
oral levofloxacin
nebulized levofloxacin
Sponsored by
University of Rochester
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Rhinosinusitis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Rochester Department of Otolaryngology Head and Neck Surgery

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

oral placebo with nebulized intranasal levofloxacin

oral antibiotics with nebulized intranasal placebo

Arm Description

Placebo oral tablet by mouth daily for 14 consecutive days along with nebulized levofloxacin 125 mg twice daily for 14 consecutive days

Levofloxacin 500 mg by mouth once daily for 14 consecutive days, along with intranasal placebo solution twice daily for 14 consecutive days.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
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.
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
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.

Full Information

First Posted
November 13, 2013
Last Updated
March 2, 2021
Sponsor
University of Rochester
search

1. Study Identification

Unique Protocol Identification Number
NCT01988779
Brief Title
Oral Versus Topical Antibiotics for Chronic Rhinosinusitis Exacerbations
Official Title
Oral Versus Topical Antibiotic Therapy for Treatment of Chronic Rhinosinusitis Exacerbations
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
October 2013 (Actual)
Primary Completion Date
September 11, 2017 (Actual)
Study Completion Date
December 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Rochester

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed Description
See brief summary.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Rhinosinusitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
33 (Actual)

8. Arms, Groups, and Interventions

Arm Title
oral placebo with nebulized intranasal levofloxacin
Arm Type
Active Comparator
Arm Description
Placebo oral tablet by mouth daily for 14 consecutive days along with nebulized levofloxacin 125 mg twice daily for 14 consecutive days
Arm Title
oral antibiotics with nebulized intranasal placebo
Arm Type
Active Comparator
Arm Description
Levofloxacin 500 mg by mouth once daily for 14 consecutive days, along with intranasal placebo solution twice daily for 14 consecutive days.
Intervention Type
Drug
Intervention Name(s)
oral levofloxacin
Intervention Type
Drug
Intervention Name(s)
nebulized levofloxacin
Primary Outcome Measure Information:
Title
Change in Rhinosinusitis Disability Index (RSDI) Score
Description
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 Outcome Measure Information:
Title
Change in Sino-nasal Outcome Test (SNOT-22) Score
Description
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
Title
Change in Bilateral Endoscopy Findings Using POSE Score
Description
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
Title
Number of Participants With Post-treatment Culture Negativity
Description
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
Title
Mean Change in the Total Bacterial Community
Description
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.
Time Frame
Baseline and 14 days after treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Li-Xing Man, MD, MPA, Msc
Organizational Affiliation
University of Rochester
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Rochester Department of Otolaryngology Head and Neck Surgery
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Oral Versus Topical Antibiotics for Chronic Rhinosinusitis Exacerbations

We'll reach out to this number within 24 hrs