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Oral Versus Topical Antibiotics for Chronic Rhinosinusitis Exacerbations

NCT01988779 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 33

Last updated 2021-03-24

Study results available
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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.

Conditions

  • Chronic Rhinosinusitis

Interventions

DRUG

oral levofloxacin

DRUG

nebulized levofloxacin

Sponsors & Collaborators

  • University of Rochester

    lead OTHER

Principal Investigators

  • Li-Xing Man, MD, MPA, Msc · University of Rochester

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-10-31
Primary Completion
2017-09-11
Completion
2020-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01988779 on ClinicalTrials.gov