Clinical trial NCT03584737: Point-of-Care Immunoassay for Detection of Bacterial Sinusitis
Official title: Multi-Center Study of a Point-of-Care Immunoassay for the Detection of Bacterial Sinusitis
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Sinusitis Bacterial
Keywords: acute sinusitis
bacterial sinusitis
point-of-care
in vitro diagnostic device (IVD)
Lead sponsor: ENTvantage Dx
Sponsor class: INDUSTRY
Collaborators: name: Beaufort
First posted: 2018-07-12
Enrollment: 800
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients at least 18 years of age with symptoms of bacterial sinusitis from primary care clinics and otolaryngology clinics.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Sensitivity (positive predictive agreement) and specificity (negative predictive agreement) of the diagnostic device
timeFrame: Cumulation of one-time subject sample results obtained in 20-30 minutes for point-of-care test and 3-5 days for lab results
Secondary outcomes:
measure: Positive predictive value (PPV) and negative predictive value (NPV)
timeFrame: Cumulation of one-time subject sample results obtained in 20-30 minutes for point-of-care test and 3-5 days for lab results
measure: Positive likelihood ratio (LR+) and negative likelihood ratio (LR-)
timeFrame: Cumulation of one-time subject sample results obtained in 20-30 minutes for point-of-care test and 3-5 days for lab results
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: Northern California Research
state: California
city: DeLand
country: United States
facility: Hillcrest Medical Research
state: Florida
city: Port Saint Lucie
country: United States
facility: ENT Allergy & Associates of South Florida
state: Florida
city: Marrero
country: United States
facility: Tandem Clinical Research
state: Louisiana
city: New Hyde Park
country: United States
facility: Northwell Health
state: New York
city: Dublin
country: United States
facility: Optimed Research/Ohio Sinus Institute
state: Ohio
city: Houston
country: United States
facility: Kelsey-Seybold Clinic
state: Texas
Study officials:
affiliation: Beaufort
name: Karen Busch
role: STUDY_DIRECTOR
References: