Oral Versus Topical Antibiotics for Chronic Rhinosinusitis Exacerbations

Phase 3

Completed

• Conditions: Chronic Rhinosinusitis
• Interventions: Drug: oral levofloxacin; Drug: nebulized levofloxacin

• Registration Number: NCT01988779
• Lead Sponsor: University of Rochester

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.

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study Start: 2013-10
• Study First Submitted: 2013-11-13
• Study First Submitted QC: 2013-11-13
• Study First Posted: 2013-11-20
• Primary Completion: 2017-09-11
• Results First Submitted: 2019-11-21
• Results First Submitted QC: 2019-11-21
• Results First Posted: 2019-12-11
• Study Completion: 2020-12-31
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-02
• Last Update Posted: 2021-03-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 33

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.

Read More

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.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
oral placebo with nebulized intranasal levofloxacin	oral levofloxacin	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	nebulized levofloxacin	Levofloxacin 500 mg by mouth once daily for 14 consecutive days, along with intranasal placebo solution twice daily for 14 consecutive days.
oral placebo with nebulized intranasal levofloxacin	nebulized levofloxacin	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	oral levofloxacin	Levofloxacin 500 mg by mouth once daily for 14 consecutive days, along with intranasal placebo solution twice daily for 14 consecutive days.

Primary Outcome Measures

Name	Time	Method
Change in Rhinosinusitis Disability Index (RSDI) Score	Baseline and 14 days after treatment	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

Name	Time	Method
Change in Sino-nasal Outcome Test (SNOT-22) Score	Baseline and 14 days after treatment	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	Baseline and 14 days after treatment	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	14 days after treatment	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	Baseline and 14 days after treatment	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.

Trial Locations

Locations (1)

University of Rochester Department of Otolaryngology Head and Neck Surgery; 🇺🇸 Rochester, New York, United States