Bordetella InfectionsNCT02862262
A Multi-Site Clinical Evaluation of the ARIES Bordetella Assay in Symptomatic Patients
A study testing ARIES Bordetella Assay in people with Bordetella Infections and Bordetella Pertussis Infection, run by Luminex Molecular Diagnostics at 6 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Bordetella Infections, Bordetella Pertussis Infection, Bordetella Parapertussis Infection
- What is being tested?
- ARIES Bordetella Assay
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,052 participants
- Where
- 6 sitesin 2 countries
- Study dates
- Jul 2016to 14 Nov 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- The specimen is a nasopharyngeal swab collected using a cleared nasopharyngeal swab and transport medium.
- 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.
- The specimen is from a patient for whom a requisition has been made for B. pertussis and/or B. parapertussis testing.
- The specimen is from a patient exhibiting clinical signs and symptoms of respiratory tract infection consistent with B. pertussis or B. parapertussis.
- The specimen was received in good condition (no leakage or drying of the specimen).
- The specimen contains a minimum volume of 1000 μL.
Who cannot join
- The specimen is not a nasopharyngeal swab collected using a cleared nasopharyngeal swab and transport medium.
- The specimen was not properly collected, transported, processed or stored according to the instructions provided by the Sponsor in Section 10 below.
- The specimen volume is <1000 μL.
- Any specimen that was not tested per the complete testing algorithm provided by the Sponsor.
Trial locations and contacts
6 sites in 2 countries.
6 sites in 2 countries
United States5 sites
Tricore
Albuquerque, New Mexico, 87102
Nationwide Children's Hospital Laboratory
Columbus, Ohio, 43205
St. John Hospital and Medical Center
Grosse Pointe Woods, Michigan, 48230
Indiana University Health
Indianapolis, Indiana, 46202
Marshfield Labs
Marshfield, Wisconsin, 54449
About this study
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.
Read the 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.
- Being tested
- ARIES Bordetella Assay
- Medical subject headings
- Bordetella Infections, Whooping Cough
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ARIES Bordetella AssayDevice
| Study group | Role | What they receive |
|---|---|---|
| Blinded, Prospective Arm (1) | Experimental | 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. Receives: Device: ARIES Bordetella Assay |
| Blinded, Pre-selected Arm (2) | Experimental | 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. Receives: Device: ARIES Bordetella Assay |
| Blinded, Contrived Arm (3) | Experimental | 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. Receives: Device: ARIES Bordetella Assay |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 months
Secondary outcomes (3)
Clinical performance of the ARIES Bordetella Assay per clinical site.
Positive agreement and negative agreement values will be provided for each clinical site.
Measured: 5 months
Clinical performance of the ARIES Bordetella Assay per age group.
Positive agreement and negative agreement values will be provided for pediatric vs. adult patients.
Measured: 5 months
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).
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2016 (estimated)
- Study startJul 2016
- Primary completionNov 2016
- Study completion14 Nov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bordetella InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 1,052 participants (actual)
Sponsor and investigators
- Lead sponsor
- Luminex Molecular Diagnostics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ronald Dunn, Study director, Luminex Molecular DiagnosticsTimothy S Uphoff, PhD, Principal investigator, Marshfield LabsStephen Young, PhD, Principal investigator, Tricore Reference LabRyan Relich, PhD, Principal investigator, IU Health Pathology LaboratoryTed E Schutzbank, PhD, Principal investigator, St. John Hospital & Medical CenterAmy L Leber, PhD, Principal investigator, Nationwide Children's Hospital Laboratory
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02862262
- Sponsor's protocol ID
- LMA-BRD-01-CS-001
- Status last verified
- Oct 2018
- First submitted
- 12 Jul 2016
- Last updated
- 4 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 30518543
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Site Clinical Evaluation of the ARIES Bordetella Assay in Symptomatic Patients
- ClinicalTrials.gov ID
- NCT02862262
- Acronym / sponsor ID
- LMA-BRD-01-CS-001
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,052 participants (actual)
- Lead sponsor
- Luminex Molecular DiagnosticsIndustry (pharma, biotech, devices)
- Study start
- Jul 2016 (actual)
- Primary completion
- Nov 2016 (actual)
- Study completion
- 14 Nov 2016 (actual)
- First posted
- 11 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| Blinded, Prospective Arm (1) | Experimental | Device: ARIES Bordetella AssayClinical 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. |
| Blinded, Pre-selected Arm (2) | Experimental | Device: ARIES Bordetella AssayIn 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. |
| Blinded, Contrived Arm (3) | Experimental | Device: ARIES Bordetella AssayContrived 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- The specimen is a nasopharyngeal swab collected using a cleared nasopharyngeal swab and transport medium.
- 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.
- The specimen is from a patient for whom a requisition has been made for B. pertussis and/or B. parapertussis testing.
- The specimen is from a patient exhibiting clinical signs and symptoms of respiratory tract infection consistent with B. pertussis or B. parapertussis.
- The specimen was received in good condition (no leakage or drying of the specimen).
Key exclusion criteria (4 listed)
- The specimen is not a nasopharyngeal swab collected using a cleared nasopharyngeal swab and transport medium.
- The specimen was not properly collected, transported, processed or stored according to the instructions provided by the Sponsor in Section 10 below.
- The specimen volume is <1000 μL.
- Any specimen that was not tested per the complete testing algorithm provided by the Sponsor.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ARIES Bordetella Assay | Device | Blinded, Contrived Arm (3), Blinded, Pre-selected Arm (2), Blinded, Prospective Arm (1) |
Primary outcome
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.
3 secondary outcomes
Clinical performance of the ARIES Bordetella Assay per clinical site.
Time frame: 5 months
Clinical performance of the ARIES Bordetella Assay per age group.
Time frame: 5 months
Clinical performance of the ARIES Bordetella Assay per patient sub-population.
Time frame: 5 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2018.
- Derived from this study: PubMed 30518543Relich 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ronald Dunn study director
Luminex Molecular Diagnostics
Timothy S Uphoff, PhD principal investigator
Marshfield Labs
Stephen Young, PhD principal investigator
Tricore Reference Lab
6 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ARIES Bordetella Assay in people with Bordetella Infections and Bordetella Pertussis Infection, run by Luminex Molecular Diagnostics at 6 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02862262, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2018.