Point-of-Care Immunoassay for Detection of Bacterial Sinusitis

Terminated

• Conditions: Sinusitis Bacterial
• Interventions: Diagnostic Test: rapid in vitro diagnostic test; Diagnostic Test: bacterial culture; Diagnostic Test: PCR assay

• Registration Number: NCT03584737
• Lead Sponsor: ENTvantage Dx

Brief 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.

Study Timeline

• Study First Submitted: 2018-06-19
• Study First Submitted QC: 2018-06-29
• Study First Posted: 2018-07-12
• Study Start: 2021-11-12
• Status Verified: 2023-04
• Primary Completion: 2023-04-09
• Study Completion: 2023-04-10
• Last Update Submitted: 2023-04-10
• Last Update Posted: 2023-04-12

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 800

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Sensitivity (positive predictive agreement) and specificity (negative predictive agreement) of the diagnostic device	Cumulation of one-time subject sample results obtained in 20-30 minutes for point-of-care test and 3-5 days for lab results	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.

Secondary Outcome Measures

Name	Time	Method
Positive predictive value (PPV) and negative predictive value (NPV)	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 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.
Positive likelihood ratio (LR+) and negative likelihood ratio (LR-)	Cumulation of one-time subject sample results obtained in 20-30 minutes for point-of-care test and 3-5 days for lab results	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.

Trial Locations

Locations (7)

Kelsey-Seybold Clinic; 🇺🇸 Houston, Texas, United States

Optimed Research/Ohio Sinus Institute; 🇺🇸 Dublin, Ohio, United States

Hillcrest Medical Research; 🇺🇸 DeLand, Florida, United States

Tandem Clinical Research; 🇺🇸 Marrero, Louisiana, United States

Northern California Research; 🇺🇸 Sacramento, California, United States

ENT Allergy & Associates of South Florida; 🇺🇸 Port Saint Lucie, Florida, United States

Northwell Health; 🇺🇸 New Hyde Park, New York, United States