Point-of-Care Immunoassay for Detection of Bacterial Sinusitis

Stopped early

Conditions studied: Sinusitis Bacterial

In brief

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.

Key facts

Study ID

NCT03584737

Run by

ENTvantage Dx

People needed

800

Starts

2021-11-12

Expected to finish

2023-04-10

Last updated by the study team

2023-04-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Meets definition of acute sinusitis by Infectious Disease Society of America (2012)

You may not qualify if…

• 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.

Where it is running

• Northern California Research — Sacramento, California, United States
• Hillcrest Medical Research — DeLand, Florida, United States
• ENT Allergy & Associates of South Florida — Port Saint Lucie, Florida, United States
• Tandem Clinical Research — Marrero, Louisiana, United States
• Northwell Health — New Hyde Park, New York, United States
• Optimed Research/Ohio Sinus Institute — Dublin, Ohio, United States
• Kelsey-Seybold Clinic — Houston, Texas, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.