Oral Versus Topical Antibiotics for Chronic Rhinosinusitis Exacerbations

This study is currently recruiting participants. (see Contacts and Locations)

Verified August 2016 by Li-Xing Man, University of Rochester

Sponsor:

Information provided by (Responsible Party):

Li-Xing Man, University of Rochester

ClinicalTrials.gov Identifier:

NCT01988779

First received: November 13, 2013

Last updated: August 25, 2016

Last verified: August 2016

History of Changes

Purpose

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	Intervention	Phase
Chronic Rhinosinusitis	Drug: oral levofloxacin Drug: nebulized levofloxacin	Phase 3


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Participant, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Oral Versus Topical Antibiotic Therapy for Treatment of Chronic Rhinosinusitis Exacerbations

Resource links provided by NLM:

MedlinePlus related topics: Antibiotics

Drug Information available for: Ofloxacin Levofloxacin Ofloxacin hydrochloride

U.S. FDA Resources

Further study details as provided by Li-Xing Man, University of Rochester:

Primary Outcome Measures:

Change in Rhinosinusitis Disability Index (RSDI) scores [ Time Frame: 14 days after treatment ]

Secondary Outcome Measures:

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


Estimated Enrollment:	70
Study Start Date:	October 2013
Estimated Study Completion Date:	January 2020
Estimated Primary Completion Date:	January 2020 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Detailed Description:

See brief summary.

Eligibility


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

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.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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


Responsible Party:	Li-Xing Man, M.D., University of Rochester
ClinicalTrials.gov Identifier:	NCT01988779 History of Changes
Other Study ID Numbers:	45566
Study First Received:	November 13, 2013
Last Updated:	August 25, 2016

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

ClinicalTrials.gov processed this record on May 25, 2017

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