Trial Review

ANZCTR is currently experiencing a technical issue. Thank you for your patience while we work on it and apologies for any inconvenience caused.


Reset your password and enable multi-factor authentication (MFA)


For ANZCTR account holders: to help ensure the cyber safety of your account, you’ll need to reset your password and set-up multi-factor authentication (MFA) as per the instructions below.


  1. Go to the Login page, click ‘reset password’ and follow the instructions.
  2. Check your email for the link to set a new password.
  3. Create a new password that meets requirements.
  4. Return to the Login page and enter your new password. A verification code will be sent to your email.
  5. Check your email for the code and enter it on the Login page. If the code is entered incorrectly, you can re-enter the correct one or request a new one.

Learn more about MFA and its importance on the Australian Signals Directorate website.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
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
Date last updated
2/08/2021

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
Assessment method [1] 0 0
Proportion of samples where mNGS detects a pathogenic micro-organism that has been identified by the standard diagnostic pathway.
Timepoint [1] 0 0
Within 1 week of sampling.
Primary outcome [2] 0 0
Specificity of mNGS compared to standard pathway
Assessment method [2] 0 0
Proportion of samples where mNGS does not detect a micro-organism where the standard diagnostic pathway has also not detected a micro-organism.
Timepoint [2] 0 0
Within 1 week of sampling.
Primary outcome [3] 0 0
Level of agreement between mNGS and standard pathway
Assessment method [3] 0 0
Proportion of samples where the two methods produce the same result.
Timepoint [3] 0 0
Within 1 week of sampling.
Primary outcome [4] 0 0
Changes to patient management in response to mNGS result
Assessment method [4] 0 0
The microbiologists involved in the project will assess whether there was a change in treatment or other clinical management in response to the mNGS result. This would include binary outcomes such as a change in antibiotic treatment or whether further investigations (e.g. laboratory or diagnostic radiology) were undertaken.
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
Not applicable
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
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Wellington Southern Community Laboratories
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Institute of Environmental Science and Research
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
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
Email 0 0
maxim.bloomfield@ccdhb.org.nz
Contact person for scientific queries

Data sharing statement


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