Oral Versus Topical Antibiotics for Chronic Rhinosinusitis Exacerbations

Chronic Rhinosinusitis Clinical Trial

Official title:

Oral Versus Topical Antibiotic Therapy for Treatment of Chronic Rhinosinusitis Exacerbations

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01988779
• Other study ID #: 45566
• Status: Completed
• Phase: Phase 3
• 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
• 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.

Related Conditions & MeSH terms

• Chronic Rhinosinusitis
• Sinusitis

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