NCT03584737

Point-of-Care Immunoassay for Detection of Bacterial Sinusitis

Multi-Center Study of a Point-of-Care Immunoassay for the Detection of Bacterial Sinusitis

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 800 (actual)
• Sponsor: ENTvantage Dx · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Sinusitis Bacterial

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	rapid in vitro diagnostic test	IVD for qualitative detection of 3 bacterial pathogens (Haemophilus influenzae, Moraxella catarrhalis, and Streptococcus pneumoniae)
DIAGNOSTIC_TEST	bacterial culture	Quantitative bacterial culture assay with isolate identification by MALDI-TOF.
DIAGNOSTIC_TEST	PCR assay	Semiquantitative real-time PCR assay

Timeline

• Start date: 2021-11-12
• Primary completion: 2023-04-09
• Completion: 2023-04-10
• First posted: 2018-07-12
• Last updated: 2023-04-12

Locations

7 sites across 1 country: United States

Regulatory

• FDA-regulated device study