Oral Versus Topical Antibiotics for Chronic Rhinosinusitis Exacerbations

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

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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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
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