Point-of-Care Immunoassay for Detection of Bacterial Sinusitis

April 10, 2023 updated by: ENTvantage Dx

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

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
800

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Sensitivity (positive predictive agreement) and specificity (negative predictive agreement) of the diagnostic device
Time Frame: 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.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Positive predictive value (PPV) and negative predictive value (NPV)
Time Frame: 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.
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-)
Time Frame: 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.
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
ENTvantage Dx

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Beaufort

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 12, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 9, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 10, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 19, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 29, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 12, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 12, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 10, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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