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Completed

NCT Number: NCT01988779

Oral Versus Topical Antibiotics for Chronic Rhinosinusitis Exacerbations

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

University of Rochester Department of Otolaryngology Head and Neck Surgery

Rochester, New York, 14642, United States

About this study

See brief summary.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

oral levofloxacin

Drug

nebulized levofloxacin

Drug

Primary outcomes

  1. Change in Rhinosinusitis Disability Index (RSDI) Score

    Time frame: Baseline and 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 outcomes

  1. Change in Sino-nasal Outcome Test (SNOT-22) Score

    Time frame: Baseline and 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 Score

    Time frame: Baseline and 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. Number of Participants With 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. Mean Change in the Total Bacterial Community

    Time frame: Baseline and 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 number of operational taxonomic units in each subject sample. The count has a minimum of zero with an increasing score indicating a larger number of distinct bacterial species.

Sponsors and collaborators

Lead sponsor

University of Rochester

Other

Registry information

Official study title

Oral Versus Topical Antibiotic Therapy for Treatment of Chronic Rhinosinusitis Exacerbations

Important dates

Study start
2013
Primary completion
2017
Study completion
2020
First posted
Nov 20, 2013
Registry last updated
Mar 24, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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