Point-of-Care Immunoassay for Detection of Bacterial Sinusitis

Entvantage Dx

Status: Terminated

Conditions: Sinusitis Bacterial

Treatments: Diagnostic Test: rapid in vitro diagnostic test; Diagnostic Test: bacterial culture; Diagnostic Test: PCR assay

Study type: Observational

Funder types: Industry; Other

Identifiers

NCT03584737

1001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 800 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

800 participants in 1 patient group

Symptomatic for bacterial sinusitis

Description:

Samples from participants showing symptoms of bacterial sinusitis tested by rapid in vitro diagnostic test, bacterial culture, and PCR assay

Treatment:

Diagnostic Test: PCR assay

Diagnostic Test: bacterial culture

Diagnostic Test: rapid in vitro diagnostic test