Oral Versus Topical Antibiotics for Chronic Rhinosinusitis Exacerbations

• ClinicalTrials.gov Identifier: NCT01988779
• Recruitment Status: Active, not recruiting
• First Posted: November 20, 2013
• Results First Posted: December 11, 2019
• Last Update Posted: March 11, 2020
• Sponsor: University of Rochester
• Information provided by (Responsible Party): Li-Xing Man, University of Rochester

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.

Condition or disease	Intervention/treatment	Phase
Chronic Rhinosinusitis	Drug: oral levofloxacin; Drug: nebulized levofloxacin	Phase 3

Detailed Description:

See brief summary.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 33 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Oral Versus Topical Antibiotic Therapy for Treatment of Chronic Rhinosinusitis Exacerbations
• Actual Study Start Date: October 2013
• Actual Primary Completion Date: September 11, 2017
• Estimated Study Completion Date: December 31, 2020

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: 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	Drug: oral levofloxacin; Drug: nebulized levofloxacin
Active Comparator: 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.	Drug: oral levofloxacin; Drug: nebulized levofloxacin

Outcome Measures

Primary Outcome Measures :

1. Change in Rhinosinusitis Disability Index (RSDI) Scores [ Time Frame: 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 :

1. Change in Sino-nasal Outcome Test (SNOT-22) Score [ Time Frame: 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

2. Change in Bilateral Endoscopy Findings Using POSE Scores [ Time Frame: 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.

3. Post-treatment Culture Negativity [ Time Frame: 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
4. Change in the Total Bacterial Community Following Treatment as Determined by DNA Sequencing. [ Time Frame: 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 operational taxonomic units in each subject sample. The scale is bounded at zero with an increasing score indicating a larger number of distinct bacterial species.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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.

Contacts and Locations

Locations

United States, New York

University of Rochester Department of Otolaryngology Head and Neck Surgery

Rochester, New York, United States, 14642

Sponsors and Collaborators

University of Rochester

Investigators

• Principal Investigator: Li-Xing Man, MD, MPA, Msc; University of Rochester

  Study Documents (Full-Text)

Documents provided by Li-Xing Man, University of Rochester:

Study Protocol and Statistical Analysis Plan  [PDF] March 7, 2019

More Information

• Responsible Party: Li-Xing Man, M.D., University of Rochester
• ClinicalTrials.gov Identifier: NCT01988779
• Other Study ID Numbers: 45566
• First Posted: November 20, 2013
• Results First Posted: December 11, 2019
• Last Update Posted: March 11, 2020
• Last Verified: February 2020

Additional relevant MeSH terms:

Levofloxacin; Ofloxacin; Sinusitis; Paranasal Sinus Diseases; Nose Diseases; Respiratory Tract Diseases; Respiratory Tract Infections; Otorhinolaryngologic Diseases; Anti-Infective Agents, Urinary; Anti-Infective Agents; Renal Agents; Anti-Bacterial Agents; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Cytochrome P-450 CYP1A2 Inhibitors; Cytochrome P-450 Enzyme Inhibitors