A Multi-Site Clinical Evaluation of the ARIES Bordetella Assay in Symptomatic Patients

October 2, 2018 updated by: Luminex Molecular Diagnostics
A three-arm, multi-site clinical evaluation of the ARIES Bordetella Assay for the detection and identification of Bordetella pertussis (B. pertussis) and Bordetella parapertussis (B. parapertussis) nucleic acids in prospectively collected, de-identified, left-over clinical specimens; banked, pre-selected clinical specimens; and contrived specimens.

Study Overview

Status

Status

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

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

The ARIES Bordetella Assay is a real-time polymerase chain reaction (PCR) based qualitative in vitro diagnostic test for the direct detection and identification of Bordetella pertussis (B. pertussis) and Bordetella parapertussis (B. parapertussis) nucleic acid in nasopharyngeal swabs (NPS) specimens obtained from individuals suspected of having a respiratory tract infection attributable to B. pertussis or B. parapertussis.

Clinical nasopharyngeal swab specimens collected using nasopharyngeal swab in transport media will be processed according to the routine procedure followed at the clinical collection site and as ordered by the referring physician. The leftover specimen will be blinded and assigned a unique clinical study specimen number. In order to preserve the confidentiality of subjects, the following procedures will be implemented at each site:

  • Clinical specimens will be individually numbered by an honest broker who is not involved in investigational testing so that the identity of the subject may not be readily ascertained by the investigator, investigational testing staff, or study Sponsor.
  • Available clinical information accompanying the specimens will be provided in such a way that it does not make the specimen source identifiable to the investigator or any other individuals associated with investigational testing, including the Sponsor.
  • No personal identifier (protected health information) will be included on the case report form (CRF) so that the confidentiality of each subject is protected.

Multiple aliquots of each left-over specimen will be generated. One aliquot of each specimen will be shipped to a laboratory where the reference method (two validated real-time PCR methods for each, B. pertussis and B. parapertussis) will be performed. A second aliquot of each specimen will be used by the clinical sites for ARIES Bordetella Assay testing. Additional aliquots of each specimen will be stored frozen (-65 to -95°C) at the clinical sites and sent separately on dry ice to the Sponsor upon Sponsor's request.

The prospective data set will be supplemented with banked, pre-selected clinical specimens and contrived specimens that tested positive by a comparator method for B. pertussis and B. parapertussis. If contrived specimens are required, these specimens will be prepared then blinded, aliquoted, randomized and frozen (-65 to -95°C) until distributed to the clinical testing sites by the Sponsor.

The clinical data will be automatically generated from the ARIES System software. The system will report the specimen as B. pertussis and B. parapertussis positive (Co-infection), B. pertussis positive, B. parapertussis positive, B. pertussis and B. parapertussis negative or Invalid. Invalid results will be retested and both the original data and the retest data will be reported. The clinical data will be compared to the reference data and recorded in the clinical study reports.

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.
Interventional

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.
1052

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

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

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G 1Y8
        • Luminex Molecular Diagnostics
  • United States
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Indiana University Health
    • Michigan
      • Grosse Pointe Woods, Michigan, United States, 48230
        • St. John Hospital and Medical Center
    • New Mexico
      • Albuquerque, New Mexico, United States, 87102
        • TriCore
    • Ohio
      • Columbus, Ohio, United States, 43205
        • Nationwide Children's Hospital Laboratory
    • Wisconsin
      • Marshfield, Wisconsin, United States, 54449
        • Marshfield Labs

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. The specimen is a nasopharyngeal swab collected using a cleared nasopharyngeal swab and transport medium.
  2. The specimen is from an adult or pediatric, male or female subject who is either hospitalized, admitted to a hospital emergency department, visiting an outpatient clinica or resident of a long term care facility.
  3. The specimen is from a patient for whom a requisition has been made for B. pertussis and/or B. parapertussis testing.
  4. The specimen is from a patient exhibiting clinical signs and symptoms of respiratory tract infection consistent with B. pertussis or B. parapertussis.
  5. The specimen was received in good condition (no leakage or drying of the specimen).
  6. The specimen contains a minimum volume of 1000 μL.

Exclusion Criteria:

  1. The specimen is not a nasopharyngeal swab collected using a cleared nasopharyngeal swab and transport medium.
  2. The specimen was not properly collected, transported, processed or stored according to the instructions provided by the Sponsor in Section 10 below.
  3. The specimen volume is <1000 μL.
  4. Any specimen that was not tested per the complete testing algorithm provided by the Sponsor.

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

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
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.
Experimental: Blinded, Prospective Arm (1)
Clinical performance of the ARIES Bordetella Assay for the detection of B. pertussis and B. parapertussis will be evaluated in prospectively collected, de-identified, left-over, clinical specimens.
Device: ARIES Bordetella Assay
Experimental: Blinded, Pre-selected Arm (2)
In the event that an insufficient number of positive specimens are acquired for B. pertussis / B. parapertussis in Arm 1, clinical performance of the ARIES Bordetella Assay will be tested using banked, pre-selected, positive clinical specimens.
Device: ARIES Bordetella Assay
Experimental: Blinded, Contrived Arm (3)
Contrived specimens will be tested using the ARIES Bordetella Assay to evaluate detection of B. parapertussis in the event that an insufficient number of positive specimens are acquired in Arm 2.
Device: ARIES Bordetella 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
Specificity and sensitivity of the ARIES Bordetella Assay in patients suspected of having respiratory infection attributable to B. pertussis or B. parapertussis.
Time Frame: 5 months
Estimates of positive percent agreement and negative percent agreement for each target will be calculated based on a two-by-two table (reference method result vs. result from ARIES Bordetella Assay) for each target. In addition, 95% two sided confidence intervals will be provided. Positive agreement and negative agreement values will be provided for the entire prospective data set.
5 months

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
Clinical performance of the ARIES Bordetella Assay per clinical site.
Time Frame: 5 months
Positive agreement and negative agreement values will be provided for each clinical site.
5 months
Clinical performance of the ARIES Bordetella Assay per age group.
Time Frame: 5 months
Positive agreement and negative agreement values will be provided for pediatric vs. adult patients.
5 months
Clinical performance of the ARIES Bordetella Assay per patient sub-population.
Time Frame: 5 months
Positive agreement and negative agreement values will be provided for each patient sub population (e.g., immuno-competent vs. immuno-compromised patients, and hospitalized vs. outpatient vs. long-term care facility).
5 months

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.
Luminex Molecular Diagnostics

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Ronald Dunn, Luminex Molecular Diagnostics
  • Principal Investigator: Timothy S Uphoff, PhD, Marshfield Labs
  • Principal Investigator: Stephen Young, PhD, Tricore Reference Lab
  • Principal Investigator: Ryan Relich, PhD, IU Health Pathology Laboratory
  • Principal Investigator: Ted E Schutzbank, PhD, St. John Hospital & Medical Center
  • Principal Investigator: Amy L Leber, PhD, Nationwide Children's Hospital Laboratory

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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.
July 1, 2016

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.
November 1, 2016

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.
November 14, 2016

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).
July 12, 2016

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.
August 5, 2016

First Posted (Estimate)

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.
August 11, 2016

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.
October 4, 2018

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.
October 2, 2018

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.
October 1, 2018

More Information

Terms related to this study

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.
  • LMA-BRD-01-CS-001

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.

No

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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings