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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes

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
NA
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
NA
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)

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

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
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
[email protected]
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT06392451