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Point-of-Care Immunoassay for Detection of Bacterial Sinusitis

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ClinicalTrials.gov Identifier: NCT03584737
Recruitment Status : Recruiting
First Posted : July 12, 2018
Last Update Posted : October 31, 2018
Sponsor:
Collaborators:
Beaufort
Clinical Network Services (CNS) Pty Ltd
Entvantage Diagnostics Australia Pty Ltd
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Sinusitis Bacterial 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 and Australia. 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 the comparator method, standard quantitative bacterial culture with identification (matrix-assisted laser desorption/ionization-Time of Flight (MALDI-TOF) mass spectrometry instrument) by the central laboratory. Qualitative real-time polymerase chain reaction (real-time PCR) of the residual assay specimen will also be performed by the central laboratory.

An additional cohort of individuals not displaying symptoms of acute bacterial sinusitis or illness will be included in the study to establish performance of the device with respect to colonizing bacteria.


Study Type : Observational
Estimated Enrollment : 1400 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Multi-Center Study of a Point-of-Care Immunoassay for the Detection of Bacterial Sinusitis
Actual Study Start Date : July 30, 2018
Estimated Primary Completion Date : February 2019
Estimated Study Completion Date : February 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sinusitis

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 Name: Sinu-Test™

Diagnostic Test: bacterial culture
Quantitative bacterial culture assay with isolate identification by MALDI-TOF.

Diagnostic Test: PCR assay
Qualitative real-time PCR assay

Healthy - no symptoms of sinusitis
Samples from healthy participants showing no symptoms of 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 Name: Sinu-Test™

Diagnostic Test: bacterial culture
Quantitative bacterial culture assay with isolate identification by MALDI-TOF.

Diagnostic Test: PCR assay
Qualitative real-time PCR assay




Primary Outcome Measures :
  1. Sensitivity and specificity of the diagnostic device [ Time Frame: One time subject sample result 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 lab culture reference standard for each of the 3 bacterial microorganisms.


Secondary Outcome Measures :
  1. Positive predictive value (PPV) and negative predictive value (NPV) [ Time Frame: One time subject sample result 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.


Other Outcome Measures:
  1. Discordant results [ Time Frame: One time subject sample result in 20-30 minutes for point-of-care test and 3-5 days for lab results ]
    Comparison of discordant results from point-of-care test device and lab culture with results from qualitative real-time PCR assay.


Biospecimen Retention:   Samples Without DNA
nasal mucus in buffer solution


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03584737


Contacts
Contact: Elisa Maldonado-Holmertz 866-406-3688 info@ent-dx.com

Locations
United States, Alabama
Achieve Clinical Research Recruiting
Birmingham, Alabama, United States, 35216
Contact: Study Coordinator    205-757-8212 ext 412      
Principal Investigator: Hayes Williams, MD         
United States, California
Empire Clinical Research Recruiting
Upland, California, United States, 91786
Contact: Study Coordinator    909-981-5321      
Principal Investigator: Natee Poopat, MD         
United States, Florida
Avail Clinical Research Recruiting
DeLand, Florida, United States, 32720
Contact: Study Coordinator    386-785-2400      
Principal Investigator: Bruce Rankin, DO         
Avail Clinical Research Recruiting
Orange City, Florida, United States, 32763
Contact: Study Coordinator    386-785-2400 ext 304      
Principal Investigator: John Hill, MD         
South Coast Ear, Nose & Throat Recruiting
Port Saint Lucie, Florida, United States, 34952
Contact: Study Coordinator    772-777-2132      
Principal Investigator: John Lanza, MD         
Asclepes Research Recruiting
Weeki Wachee, Florida, United States, 34607
Contact: Study Coordinator    352-364-9401      
Principal Investigator: Dan Pulsipher, DO         
United States, Louisiana
Tandem Clinical Research Recruiting
Marrero, Louisiana, United States, 70072
Contact: Study Coordinator    504-934-8424      
Principal Investigator: Adil Fatakia, MD         
United States, New York
Northwell Health Recruiting
New Hyde Park, New York, United States, 11042
Contact: Study Coordinator    718-470-7974      
Principal Investigator: Todd Schaeffer, MD         
ENT and Allergy Associates Recruiting
New Windsor, New York, United States, 12553
Contact: Study Coordinator    845-562-5941      
Principal Investigator: Eric Munzer, DO         
United States, Ohio
Optimed Research Recruiting
Dublin, Ohio, United States, 43016
Contact: Study Coordinator    614-430-3030      
Principal Investigator: Boris Karanfilov, MD         
United States, Texas
ARC Clinical Research Recruiting
Austin, Texas, United States, 78731
Contact: Study Coordinator    512-632-3403      
Principal Investigator: Anurekha Chadha, MD         
Hillcrest Family Health Center Recruiting
Waco, Texas, United States, 76710
Contact: Study Coordinator    254-202-2645      
Principal Investigator: Crawford Allison, MD         
Australia, New South Wales
Paratus Clinical Blacktown Clinic Recruiting
Blacktown, New South Wales, Australia, 2148
Contact: Study Coordinator    0468 351 401      
Principal Investigator: Peter Clyne         
Paratus Clinical Kanwal Clinic Recruiting
Kanwal, New South Wales, Australia, 2259
Contact: Study Coordinator    02 4393 3852      
Principal Investigator: James Vandeleur         
Australia, Queensland
Paratus Clinical Kippa Ring Clinic Recruiting
Kippa-Ring, Queensland, Australia, 4021
Contact: Study Coordinator    07 3883 2615      
Principal Investigator: Sheetal Bull         
Australia, Western Australia
Captain Stirling Medical Centre Recruiting
Nedlands, Western Australia, Australia, 6009
Contact: Study Coordinator    93861858      
Principal Investigator: Michael Benson         
Sponsors and Collaborators
ENTvantage Dx
Beaufort
Clinical Network Services (CNS) Pty Ltd
Entvantage Diagnostics Australia Pty Ltd
Investigators
Study Director: Jodi L Crutchleo, BS Beaufort

Responsible Party: ENTvantage Dx
ClinicalTrials.gov Identifier: NCT03584737     History of Changes
Other Study ID Numbers: 1001
First Posted: July 12, 2018    Key Record Dates
Last Update Posted: October 31, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by ENTvantage Dx:
acute sinusitis
bacterial sinusitis
point-of-care
in vitro diagnostic device (IVD)

Additional relevant MeSH terms:
Sinusitis
Paranasal Sinus Diseases
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases