Clinical Study to Improve Diagnosis and Treatment of Sinusitis
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Improving Patient Care Via Proteomics Based, Microbe-Specific Detection of Chronic Rhinosinusitis|
|Actual Study Start Date:||August 2009|
|Study Completion Date:||November 2013|
|Primary Completion Date:||November 2013 (Final data collection date for primary outcome measure)|
Patients with chronic rhinosinusitis as defined by American Academy of Otolaryngology-Head and Neck Surgery and American Rhinologic Society guidelines
Patients undergoing endoscopic sinus surgery for diseases other than chronic rhinosinusitis (i.e., access to pituitary gland, etc)
Specific Aim 1 will test the hypothesis that a high throughput proteomics-based assay of nasopharyngeal lavage fluids and/or swabs of human sinus drainage material will be able to identify, with a high degree of sensitivity and specificity, patients with CRS specifically due to the presence of NTHI biofilms.
Specific Aim 2 will test the hypothesis that a priori assay for increased presence of phosphorylcholine-rich lipooligosaccharides in nasopharyngeal lavage fluids from chinchillas co-infected with adenovirus and biofilm forming NTHI will successfully predict, with a high degree of sensitivity and specificity, the development of CRS in this in vivo model.
Results from this project may: enable the design and conduct of a clinical trial to preoperatively identify patients with CRS earlier in their disease course (possibly prior to the initiation of long courses of empiric antibiotic therapy); aid in the development of non-surgical therapies to eradicate bacterial biofilms with the sinus cavities; result in the identification of an objective biomarker to monitor success with therapies; and ultimately lead to less morbidity and risk for complications compared to conventional surgical therapy. In addition, transforming this paradigm would make progress towards achieving the goals of the U.S. Department Health and Human Services Healthy People 2010 objective 14-19, which is "reducing the number of courses of antibiotics prescribed for the sole diagnosis of the common cold."
Please refer to this study by its ClinicalTrials.gov identifier: NCT00962689
|United States, Ohio|
|The Ohio State University|
|Columbus, Ohio, United States, 43210|
|Principal Investigator:||Subinoy Das, MD||Ohio State University|