Clinical Study to Improve Diagnosis and Treatment of Sinusitis
| Status: | Completed |
|---|---|
| Conditions: | Sinusitis |
| Therapuetic Areas: | Otolaryngology |
| Healthy: | No |
| Age Range: | 5 - 90 |
| Updated: | 4/29/2017 |
| Start Date: | August 2009 |
| End Date: | November 2013 |
Improving Patient Care Via Proteomics Based, Microbe-Specific Detection of Chronic Rhinosinusitis
Chronic rhinosinusitis (CRS) is the most common chronic medical condition that affects
Americans between 18-44 years of age. While significant advances have been made in the
understanding of the molecular pathogenesis underlying many subtypes of CRS, this has not
translated into widespread changes in how physicians manage adult or pediatric CRS. The
focus of this study is intended to develop testing methods to improve the objectivity and
specificity of diagnosis and allow for individualized therapy with less invasive, customized
treatments instead of the traditional, empiric based, and radically exenterative therapies
commonly employed in clinical practice. Specifically, it is now known that many patients
with CRS have a greater concentration of non-typeable Haemophilus influenzae (NTHI) in the
bacterial biofilms located within their sinus cavities compared to healthy patients. The
specific hypothesis behind the proposed research is that the presence of NTHI biofilms,
which are known to be highly recalcitrant, are positively correlated with the development of
CRS and that unique lipooligosaccharides and inflammatory byproducts obtained from
nasopharyngeal lavage fluids and/or swabs of sinus secretions may be used as a non-invasive
biomarker for CRS. As a result, patients with symptoms of CRS specifically associated with
NTHI biofilms could possibly obtain a non-invasive test in the physician's office that would
allow the clinician to make a more accurate diagnosis and objectively follow each patient's
responsiveness to customized therapy.
Americans between 18-44 years of age. While significant advances have been made in the
understanding of the molecular pathogenesis underlying many subtypes of CRS, this has not
translated into widespread changes in how physicians manage adult or pediatric CRS. The
focus of this study is intended to develop testing methods to improve the objectivity and
specificity of diagnosis and allow for individualized therapy with less invasive, customized
treatments instead of the traditional, empiric based, and radically exenterative therapies
commonly employed in clinical practice. Specifically, it is now known that many patients
with CRS have a greater concentration of non-typeable Haemophilus influenzae (NTHI) in the
bacterial biofilms located within their sinus cavities compared to healthy patients. The
specific hypothesis behind the proposed research is that the presence of NTHI biofilms,
which are known to be highly recalcitrant, are positively correlated with the development of
CRS and that unique lipooligosaccharides and inflammatory byproducts obtained from
nasopharyngeal lavage fluids and/or swabs of sinus secretions may be used as a non-invasive
biomarker for CRS. As a result, patients with symptoms of CRS specifically associated with
NTHI biofilms could possibly obtain a non-invasive test in the physician's office that would
allow the clinician to make a more accurate diagnosis and objectively follow each patient's
responsiveness to customized therapy.
Specific Aims:
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."
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."
Inclusion Criteria:
- Clinical diagnosis of chronic sinusitis
- Undergoing surgery for treatment of their disease
Exclusion Criteria:
We found this trial at
2
sites
Ohio State University The Ohio State University’s main Columbus campus is one of America’s largest...
Click here to add this to my saved trials
Ohio State University The Ohio State University’s main Columbus campus is one of America’s largest...
Click here to add this to my saved trials