Point-of-Care Immunoassay for Detection of Bacterial Sinusitis

  • STATUS
    Recruiting
  • End date
    Mar 10, 2023
  • participants needed
    1500
  • sponsor
    ENTvantage Dx
Updated on 10 December 2021

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.

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.

Details
Condition Sinusitis Bacterial, bacterial sinusitis
Treatment rapid in vitro diagnostic test, bacterial culture, PCR assay
Clinical Study IdentifierNCT03584737
SponsorENTvantage Dx
Last Modified on10 December 2021

Eligibility

Yes No Not Sure

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
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