Clinical trial NCT02862262: A Multi-Site Clinical Evaluation of the ARIES Bordetella Assay in Symptomatic Patients
Official title: A Multi-Site Clinical Evaluation of the ARIES Bordetella Assay in Symptomatic Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bordetella Infections
Bordetella Pertussis Infection
Bordetella Parapertussis Infection
Lead sponsor: Luminex Molecular Diagnostics
Sponsor class: INDUSTRY
First posted: 2016-08-11
Enrollment: 1052
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study is comprised of three arms:

Arm 1: Blinded, Prospective Arm Primary arm comprised of prospectively collected, de-identified, left-over nasopharyngeal swab specimens.

Arm 2: Blinded, Pre-selected Arm Because both B. pertussis and B. parapertussis exhibited low prevalence rates in the prospective study cohort, the prospective sample set was supplemented with banked (pre-selected) positive specimens collected at selected sites.

Arm 3: Contrived Specimens Because the number of B. parapertussis positive clinical specimens tested in Arm 1 and Arm 2 of the study was insufficient for accurate estimate of positive percent agreement (PPA) for this target, fifty (50) contrived specimens spiked with relevant B. parapertussis strains at different levels were also prepared. The analyte concentrations covered clinically relevant titers.
Primary purpose: DIAGNOSTIC

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Specificity and sensitivity of the ARIES Bordetella Assay in patients suspected of having respiratory infection attributable to B. pertussis or B. parapertussis.
timeFrame: 5 months
Secondary outcomes:
measure: Clinical performance of the ARIES Bordetella Assay per clinical site.
timeFrame: 5 months
measure: Clinical performance of the ARIES Bordetella Assay per age group.
timeFrame: 5 months
measure: Clinical performance of the ARIES Bordetella Assay per patient sub-population.
timeFrame: 5 months
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Indiana University Health
state: Indiana
city: Grosse Pointe Woods
country: United States
facility: St. John Hospital and Medical Center
state: Michigan
city: Albuquerque
country: United States
facility: Tricore
state: New Mexico
city: Columbus
country: United States
facility: Nationwide Children's Hospital Laboratory
state: Ohio
city: Marshfield
country: United States
facility: Marshfield Labs
state: Wisconsin
city: Toronto
country: Canada
facility: Luminex Molecular Diagnostics
state: Ontario
Study officials:
affiliation: Luminex Molecular Diagnostics
name: Ronald Dunn
role: STUDY_DIRECTOR
affiliation: Marshfield Labs
name: Timothy S Uphoff, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Tricore Reference Lab
name: Stephen Young, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: IU Health Pathology Laboratory
name: Ryan Relich, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: St. John Hospital & Medical Center
name: Ted E Schutzbank, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Nationwide Children's Hospital Laboratory
name: Amy L Leber, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Relich RF, Leber A, Young S, Schutzbank T, Dunn R, Farhang J, Uphoff TS. Multicenter Clinical Evaluation of the Automated Aries Bordetella Assay. J Clin Microbiol. 2019 Jan 30;57(2):e01471-18. doi: 10.1128/JCM.01471-18. Print 2019 Feb.