Sinusitis Bacterial
Conditions
Keywords
acute sinusitis, bacterial sinusitis, point-of-care, in vitro diagnostic device (IVD)
Brief summary
This study is conducted to evaluate the performance of a rapid, point-of-care in vitro diagnostic device (Sinu-Test®) for the qualitative detection of the three most common pathogens responsible for causing bacterial sinusitis.
Detailed description
Mucous specimens will be collected from patients displaying symptoms of acute bacterial sinusitis enrolled by primary care and/or otolaryngology clinics in the United States. Health care professionals not having endoscopy certification will collect specimens using the Entvantage sample collection device. Health care professionals with nasal endoscopy certification or specialty training will collect comparator specimens using an endoscope. Untrained operators with a range of education and training (primary care physician, otolaryngologist, physician assistant, nurse practitioner, registered nurse or other healthcare professional), will perform the Sinu-Test® lateral flow assay in an outpatient setting. Mucous samples will be tested for the presence of 3 bacterial pathogens responsible for sinusitis using the Sinu-Test® in the clinic and by a composite comparator method comprised of standard quantitative bacterial culture with identification (matrix-assisted laser desorption/ionization-Time of Flight (MALDI-TOF) mass spectrometry instrument) and semiquantitative real-time polymerase chain reaction (real-time PCR) of the residual culture sample and the Sinu-Test® residual swab performed by a central laboratory.
Interventions
DIAGNOSTIC_TESTrapid in vitro diagnostic test
IVD for qualitative detection of 3 bacterial pathogens (Haemophilus influenzae, Moraxella catarrhalis, and Streptococcus pneumoniae)
DIAGNOSTIC_TESTbacterial culture
Quantitative bacterial culture assay with isolate identification by MALDI-TOF.
DIAGNOSTIC_TESTPCR assay
Semiquantitative real-time PCR assay
Sponsors
Beaufort
ENTvantage Dx
Study design
Observational model
COHORT
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Meets definition of acute sinusitis by Infectious Disease Society of America (2012)
Exclusion criteria
* Chronic sinusitis * Cystic fibrosis * Patients treated with antibiotics currently or within the previous 30 days. * Subjects with a prior history of sinus surgery will be excluded due to the modification of sinonasal anatomy. * Primary immunodeficiencies, as self-reported * Combined variable immunodeficiency * Immunodeficiency with reduced immunoglobulin G (IgG) and immunoglobulin A (IgA)-bearing cells * Kartagener Syndrome (ciliary dyskinesia) * Agammaglobulinemia * Sickle cell disease * Acquired immunodeficiencies, as self-reported * Chemotherapy * Radiation therapy * Transplantation * Asplenia * HIV * Poorly controlled Diabetes mellitus * Cognitive impairment resulting in the inability to provide informed consent. * Special groups, such as children under the age of 18, and men and women who are in prison will not participate in this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sensitivity (positive predictive agreement) and specificity (negative predictive agreement) of the diagnostic device | Cumulation of one-time subject sample results obtained in 20-30 minutes for point-of-care test and 3-5 days for lab results | Assessment of the true positive and true negative rate of the point-of-care test device relative to the composite reference standard for each of the 3 bacterial microorganisms. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Positive predictive value (PPV) and negative predictive value (NPV) | Cumulation of one-time subject sample results obtained in 20-30 minutes for point-of-care test and 3-5 days for lab results | Positive predictive value is the probability that subjects with a positive point-of-care test truly have the bacteria present. Negative predictive value is the probability that subjects with a negative point-of-care test truly do not have the bacteria present. |
| Positive likelihood ratio (LR+) and negative likelihood ratio (LR-) | Cumulation of one-time subject sample results obtained in 20-30 minutes for point-of-care test and 3-5 days for lab results | LR+ is equivalent to the probability of a true positive result divided by the probability of a false positive result. LR- is equivalent to the probability of a false negative result divided by the probability of a true negative result. |
Countries
United States
Outcome results
None listed