Point-of-Care Immunoassay for Detection of Bacterial Sinusitis

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

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.

Study Overview

• Status: Terminated
• Conditions: Sinusitis Bacterial
• Intervention / Treatment: Diagnostic test: rapid in vitro diagnostic test; Diagnostic test: bacterial culture; Diagnostic test: PCR assay

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.

• Study Type: Observational
• Enrollment (Actual): 800

Contacts and Locations

• Study Contact: Name: Elisa Maldonado-Holmertz; Phone Number: +1-512-431-6069; Email: elisa@entvantagedx.com

Study Locations

• United States
  • California
    • Sacramento, California, United States, 95821
      • Northern California Research
  • Florida
    • DeLand, Florida, United States, 32720
      • Hillcrest Medical Research
    • Port Saint Lucie, Florida, United States, 34952
      • ENT Allergy & Associates of South Florida
  • Louisiana
    • Marrero, Louisiana, United States, 70072
      • Tandem Clinical Research
  • New York
    • New Hyde Park, New York, United States, 11042
      • Northwell Health
  • Ohio
    • Dublin, Ohio, United States, 43016
      • Optimed Research/Ohio Sinus Institute
  • Texas
    • Houston, Texas, United States, 77025
      • Kelsey-Seybold Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients at least 18 years of age with symptoms of bacterial sinusitis from primary care clinics and otolaryngology clinics.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Symptomatic for bacterial sinusitis; Samples from participants showing symptoms of bacterial sinusitis tested by rapid in vitro diagnostic test, bacterial culture, and PCR assay	Diagnostic test: rapid in vitro diagnostic test; IVD for qualitative detection of 3 bacterial pathogens (Haemophilus influenzae, Moraxella catarrhalis, and Streptococcus pneumoniae); Other Names: Sinu-Test®; Diagnostic test: bacterial culture; Quantitative bacterial culture assay with isolate identification by MALDI-TOF.; Diagnostic test: PCR assay; Semiquantitative real-time PCR assay

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: ENTvantage Dx
• Collaborators: Beaufort

Study record dates

Study Major Dates

• Study Start (Actual): November 12, 2021
• Primary Completion (Actual): April 9, 2023
• Study Completion (Actual): April 10, 2023

Study Registration Dates

• First Submitted: June 19, 2018
• First Submitted That Met QC Criteria: June 29, 2018
• First Posted (Actual): July 12, 2018

Study Record Updates

• Last Update Posted (Actual): April 12, 2023
• Last Update Submitted That Met QC Criteria: April 10, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: acute sinusitis; point-of-care; bacterial sinusitis; in vitro diagnostic device (IVD)
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Paranasal Sinus Diseases; Nose Diseases; Sinusitis
• Other Study ID Numbers: 1001 (Registro Nacional Estudios Clinicos (RNEC))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes