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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04864873




Registration number
NCT04864873
Ethics application status
Date submitted
21/04/2021
Date registered
29/04/2021

Titles & IDs
Public title
Evaluation of a mNGS Workflow for Infection Diagnosis Using Oxford Nanopore Sequencing.
Scientific title
An External Evaluation of a Metagenomic Next Generation Sequencing Workflow for Infection Diagnosis Using Oxford Nanopore Sequencing.
Secondary ID [1] 0 0
MNGS001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Bacterial Infections 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

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Diagnosis / Prognosis - Metagenomic next generation sequencing using Oxford Nanopore
Diagnosis / Prognosis - Standard microbiological diagnostic pathway

Active comparator: Standard diagnostic pathway - Part of each patient sample will be tested using current standard microbiological techniques.

Experimental: mNGS pathway - Part of each sample will be testing using mNGS methodology, which will be compared to the standard diagnostic pathway.


Diagnosis / Prognosis: Metagenomic next generation sequencing using Oxford Nanopore
See previous.

Diagnosis / Prognosis: Standard microbiological diagnostic pathway
See previous.
Intervention code [1] 0 0
Diagnosis / Prognosis
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Sensitivity of mNGS compared to standard pathway
Timepoint [1] 0 0
Within 1 week of sampling.
Primary outcome [2] 0 0
Specificity of mNGS compared to standard pathway
Timepoint [2] 0 0
Within 1 week of sampling.
Primary outcome [3] 0 0
Level of agreement between mNGS and standard pathway
Timepoint [3] 0 0
Within 1 week of sampling.
Primary outcome [4] 0 0
Changes to patient management in response to mNGS result
Timepoint [4] 0 0
Within 1 month of sampling.

Eligibility
Key inclusion criteria
* All samples received by the WSCL microbiology laboratory for testing for the purposes of diagnosing infection will be eligible.
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Use of residual sample for mNGS testing may leave too little remaining sample and compromise standard diagnostic testing.
* Patients who have requested that their residual samples be returned to them.

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
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
UNKNOWN
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/05/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/05/2022
Actual
Sample size
Target
400
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Wellington

Funding & Sponsors
Primary sponsor type
Government body
Name
Capital and Coast District Health board
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Wellington Southern Community Laboratories
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Institute of Environmental Science and Research
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Maxim G Bloomfield, MBChB
Address 0 0
Wellington Southern Community Laboratories, Capital and Coast District Health Board
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Maxim G Bloomfield, MBChB
Address 0 0
Country 0 0
Phone 0 0
+64272089584
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
No plans at this stage.


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/NCT04864873