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

Bordetella Parapertussis Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02862262
• Other study ID #: LMA-BRD-01-CS-001
• Status: Completed
• Phase: N/A
• Start date: July 2016
• Est. completion date: November 14, 2016

Study information

• Verified date: October 2018
• Source: Luminex Molecular Diagnostics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1052
• Est. completion date: November 14, 2016
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Bordetella Infections
• Bordetella Parapertussis Infection
• Bordetella Pertussis Infection
• Communicable Diseases
• Infection
• Whooping Cough

Intervention

Device:
• ARIES Bordetella Assay

Locations

Country	Name	City	State
Canada	Luminex Molecular Diagnostics	Toronto	Ontario
United States	Tricore	Albuquerque	New Mexico
United States	Nationwide Children's Hospital Laboratory	Columbus	Ohio
United States	St. John Hospital and Medical Center	Grosse Pointe Woods	Michigan
United States	Indiana University Health	Indianapolis	Indiana
United States	Marshfield Labs	Marshfield	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
Luminex Molecular Diagnostics

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Specificity and sensitivity of the ARIES Bordetella Assay in patients suspected of having respiratory infection attributable to B. pertussis or B. parapertussis.	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	Clinical performance of the ARIES Bordetella Assay per clinical site.	Positive agreement and negative agreement values will be provided for each clinical site.	5 months
Secondary	Clinical performance of the ARIES Bordetella Assay per age group.	Positive agreement and negative agreement values will be provided for pediatric vs. adult patients.	5 months
Secondary	Clinical performance of the ARIES Bordetella Assay per patient sub-population.	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