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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT06392451




Registration number
NCT06392451
Ethics application status
Date submitted
26/04/2024
Date registered
30/04/2024
Date last updated
30/04/2024

Titles & IDs
Public title
LIAISON NES Influenza (FLU) A/B, Respiratory Syncytial Virus (RSV), & Coronavirus Disease 2019 (COVID-19) in Symptomatic Patients in Australia
Scientific title
A Multi-Site Clinical Evaluation of the LIAISON NES FLU A/B, RSV, & COVID-19 and LIAISON PLEX Respiratory (RSP) Flex Assays in Symptomatic Patients in Australia
Secondary ID [1] 0 0
DSM-PROT-005190
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Influenza A 0 0
Influenza Type B 0 0
Coronavirus Disease 2019 0 0
Respiratory Syncytial Virus (RSV) 0 0
Adenovirus 0 0
Enterovirus 0 0
Para Influenza 0 0
Bordetella Parapertussis Infection 0 0
Bordetella Pertussis Infection, Respiratory 0 0
Chlamydia Pneumonia 0 0
Mycoplasma Pneumonia 0 0
Condition category
Condition code
Infection 0 0 0 0
Studies of infection and infectious agents
Infection 0 0 0 0
Other infectious diseases
Infection 0 0 0 0
Sexually transmitted infections
Respiratory 0 0 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Diagnosis / Prognosis - LIAISON NES FLU A/B, RSV, & COVID-19
Diagnosis / Prognosis - LIAISON PLEX Respiratory Flex Assay

Other: Blinded, Prospective Arm - Clinical specimens shall be collected prospectively from patients with signs or symptoms of respiratory tract infection. Nasal swab (NS) in Copan universal transport media (UTM) 3 milliliters for comparator testing should be collected by a healthcare professional. Where subjects are willing and able, up to 40% of NS for the investigational device will be self-collected under the guidance and supervision of a healthcare professional.
Nasopharyngeal (NPS) specimens (optional) should only be collected by a healthcare professional. All specimens collected from children 13 years or younger should only be collected by a trained healthcare professional. Follow the Centers for Disease Control and Prevention guidelines for collecting NPS swabs, unless otherwise specified by the sponsor.


Diagnosis / Prognosis: LIAISON NES FLU A/B, RSV, & COVID-19
The LIAISON® NES FLU A/B, RSV & COVID-19 real-time (RT) PCR assay is a Point of Care (POC) system that enables the extraction, amplification, detection and differentiation of influenza A, Influenza B, respiratory syncytial virus (RSV) and SARS-CoV-2 viral RNA from dry nasal swabs (NS). The system consists of the LIAISON® NES FLU A/B, RSV & COVID-19 cartridge, the LIAISON® NES system (with LIAISON® NES Software), and associated accessories. In the LIAISON® NES FLU A/B, RSV & COVID-19 cartridge, extraction reagents and lyophilized fluorescent probes are used together with corresponding forward and reverse primers to extract and amplify influenza A, influenza B, RSV, SARS-CoV-2 and internal control RNA targets.

Diagnosis / Prognosis: LIAISON PLEX Respiratory Flex Assay
The LIAISON PLEX® (also known as VERIGENE® II) RSP Flex Assay is an automated test for the detection and identification of common viruses and bacteria, including severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) RNA, from upper respiratory specimens. The VERIGENE® II Respiratory Flex (RSP Flex) Assay is performed on the VERIGENE® II System. The VERIGENE® II System is an automated platform that performs sample preparation and is capable of polymerase chain reaction (PCR) for the detection of target-specific nucleic acids. The VERIGENE® II System is a fully automated, bench-top "sample-to-answer" device. The test reagents are supplied in a single, disposable test cartridge.
Intervention code [1] 0 0
Diagnosis / Prognosis
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Diagnostic accuracy
Timepoint [1] 0 0
Samples will be tested on LIAISON NES within one hour of collection.

Eligibility
Key inclusion criteria
- Human patients with active signs and symptoms of respiratory tract infection at time
of collection

- Specimens collected within 7 days of symptom onset for the initial collection

- Patient consents to participate in the study

- Availability of age, gender, race, ethnicity, collection dates, collection time,
routine respiratory testing method, routine respiratory result, signs and symptoms
(e.g., fever), date of symptom onset for each symptom, vaccination status (Flu and
COVID-19, as applicable), pre-existing medical conditions (as applicable), medications
(e.g., COVID-19 antivirals), etc. for each subject
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Incorrect swab type

- Incorrect transport media

- Incorrect specimen handling (specimens not stored at recommended temperature)

- Samples collected >7 days from symptom onset

- Subject does not provide informed consent or subject withdraws informed consent

Study design
Purpose of the study
Diagnosis
Allocation to intervention
N/A
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
6/05/2024
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/10/2024
Actual
Sample size
Target
1000
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
Key Health - Bondi - Bondi Junction
Recruitment hospital [2] 0 0
Key Health - CBD South - Sydney
Recruitment hospital [3] 0 0
Key Health - Pagewood - Sydney
Recruitment hospital [4] 0 0
Maxwell Medical Group - Melbourne
Recruitment postcode(s) [1] 0 0
2022 - Bondi Junction
Recruitment postcode(s) [2] 0 0
2000 - Sydney
Recruitment postcode(s) [3] 0 0
2036 - Sydney
Recruitment postcode(s) [4] 0 0
3019 - Melbourne

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
DiaSorin Molecular LLC
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
To establish the relative accuracy of the LIAISON® NES Flu A/B, RSV & COVID-19 assay for
viral nucleic acid targets from professionally collected or patient self-collected dry nasal
(NS) swabs and to establish the relative accuracy of the LIAISON PLEX® RSP Flex assay from NS
and nasopharyngeal swabs (NPS) in applicable transport media from human patients exhibiting
clinical signs and symptoms of a respiratory tract infection.
Trial website
https://clinicaltrials.gov/ct2/show/NCT06392451
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Janet Farhang, PhD
Address 0 0
DiaSorin Molecular/Luminex Corporation
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Rachel Behounek, PhD
Address 0 0
Country 0 0
Phone 0 0
512-336-3554
Fax 0 0
Email 0 0
rbehounek@luminexcorp.com
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT06392451