Point-of-Care Immunoassay for Detection of Bacterial Sinusitis

Sinusitis Bacterial Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03584737
• Other study ID #: 1001
• Status: Terminated
• Start date: November 12, 2021
• Est. completion date: April 10, 2023

Study information

• Verified date: April 2023
• Source: ENTvantage Dx
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 800
• Est. completion date: April 10, 2023
• Est. primary completion date: April 9, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Sinusitis
• Sinusitis Bacterial

Intervention

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

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
ENTvantage Dx	Beaufort

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sensitivity (positive predictive agreement) and specificity (negative predictive agreement) of the diagnostic device	Assessment of the true positive and true negative rate of the point-of-care test device relative to the composite reference standard for each of the 3 bacterial microorganisms.	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	Positive predictive value (PPV) and negative predictive value (NPV)	Positive predictive value is the probability that subjects with a positive point-of-care test truly have the bacteria present. Negative predictive value is the probability that subjects with a negative point-of-care test truly do not have the bacteria present.	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	Positive likelihood ratio (LR+) and negative likelihood ratio (LR-)	LR+ is equivalent to the probability of a true positive result divided by the probability of a false positive result. LR- is equivalent to the probability of a false negative result divided by the probability of a true negative result.	Cumulation of one-time subject sample results obtained in 20-30 minutes for point-of-care test and 3-5 days for lab results