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Oral Versus Topical Antibiotics for Chronic Rhinosinusitis Exacerbations

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ClinicalTrials.gov Identifier: NCT01988779
Recruitment Status : Recruiting
First Posted : November 20, 2013
Last Update Posted : October 27, 2017
Sponsor:
Information provided by (Responsible Party):
Li-Xing Man, University of Rochester

Study Description
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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
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 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
Study Start Date : October 2013
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : January 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics

Arms and Interventions
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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
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Primary Outcome Measures :
  1. Change in Rhinosinusitis Disability Index (RSDI) scores [ Time Frame: 14 days after treatment ]

Secondary Outcome Measures :
  1. Endoscopy findings using POSE scores [ Time Frame: 14 days after treatment ]
  2. Change in the total bacterial community following treatment as determined by RNA pyrosequencing. [ Time Frame: 14 days after treatment ]
  3. Change in aerobic bacterial cultures performed via traditional microbiology plating techniques [ Time Frame: 14 days after treatment ]

Eligibility Criteria
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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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01988779


Contacts
Contact: Li-Xing Man, MD 585-758-5700 Li-Xing_Man@urmc.rochester.edu

Locations
United States, New York
University of Rochester Department of Otolaryngology Head and Neck Surgery Recruiting
Rochester, New York, United States, 14642
Sub-Investigator: Alexis Strohl, MD         
Principal Investigator: Li-Xing Man, MSc, MD, MPA         
Sponsors and Collaborators
University of Rochester
Investigators
Principal Investigator: Li-Xing Man, MD, MPA, Msc University of Rochester
More Information
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Responsible Party: Li-Xing Man, M.D., University of Rochester
ClinicalTrials.gov Identifier: NCT01988779     History of Changes
Other Study ID Numbers: 45566
First Posted: November 20, 2013    Key Record Dates
Last Update Posted: October 27, 2017
Last Verified: October 2017

Additional relevant MeSH terms:
Levofloxacin
Ofloxacin
Sinusitis
Paranasal Sinus Diseases
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Anti-Bacterial Agents
Antibiotics, Antitubercular
Anti-Infective Agents
 Antitubercular Agents
Anti-Infective Agents, Urinary
Renal 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