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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04567368




Registration number
NCT04567368
Ethics application status
Date submitted
23/09/2020
Date registered
28/09/2020
Date last updated
1/10/2024

Titles & IDs
Public title
TB-CAPT MTB/XDR Study
Scientific title
Two-site Laboratory-based Diagnostic Accuracy and Feasibility Study of the Xpert MTB/XDR Assay for Detection of Isoniazid, Fluoroquinolone, Ethionamide and Second-line Injectable Anti-tuberculosis Drug Resistance
Secondary ID [1] 0 0
TB042
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Tuberculosis 0 0
Resistance Bacterial 0 0
Diagnoses Disease 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases
Infection 0 0 0 0
Studies of infection and infectious agents
Respiratory 0 0 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Diagnosis / Prognosis - Xpert MTB/XDR

Diagnosis / Prognosis: Xpert MTB/XDR
Cepheid Xpert MTB/XDR assay for detection of resistance to INH, FQ and SLID
Intervention code [1] 0 0
Diagnosis / Prognosis
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Sensitivity and specificity of Xpert MTB/XDR assay
Timepoint [1] 0 0
enrolment
Secondary outcome [1] 0 0
Sensitivity and specificity of Xpert MTB/XDR assay compared to phenotypic anti-tuberculosis drug susceptibility testing and WGS separately
Timepoint [1] 0 0
enrolment

Eligibility
Key inclusion criteria
* Mtb-positive, rifampicin-resistant respiratory specimen identified on Xpert MTB/RIF Ultra
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
* Residual SR-sputum mix not retained or not found
* Patient previously included in the study

Exclusion for diagnostic accuracy and time-to-result endpoints:

* Insufficient residual SR-sputum mix remaining for Xpert MTB/XDR (<2 ml)
* Xpert MTB/XDR unsuccessful
* No second / follow-up specimen received
* Second / follow-up specimen culture-negative, contaminated or not available
* Reference standard uninterpretable (phenotyping or WGS)

* Where phenotypic susceptibility testing results are uninterpretable, specimens will still be included in WGS comparison
* Where WGS results are uninterpretable, specimens will still be included in phenotypic susceptibility testing comparison

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
14/05/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/12/2024
Actual
Sample size
Target
Accrual to date
Final
753
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
South Africa
State/province [1] 0 0
Cape Town
Country [2] 0 0
South Africa
State/province [2] 0 0
Johannesburg

Funding & Sponsors
Primary sponsor type
Other
Name
Foundation for Innovative New Diagnostics, Switzerland
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
University of Cape Town
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Wits Health Consortium (Pty) Ltd
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
Ludwig-Maximilians - University of Munich
Address [3] 0 0
Country [3] 0 0
Other collaborator category [4] 0 0
Other
Name [4] 0 0
Ospedale San Raffaele
Address [4] 0 0
Country [4] 0 0
Other collaborator category [5] 0 0
Other
Name [5] 0 0
Swiss Tropical & Public Health Institute
Address [5] 0 0
Country [5] 0 0
Other collaborator category [6] 0 0
Other
Name [6] 0 0
Heidelberg University
Address [6] 0 0
Country [6] 0 0
Other collaborator category [7] 0 0
Other
Name [7] 0 0
African Society for Laboratory Medicine
Address [7] 0 0
Country [7] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
The Cepheid Xpert MTB/XDR cartridge, which runs on the same platform as Xpert MTB/RIF Ultra, has been developed to detect additional resistance to isoniazid, fluoroquinolones and second-line injectable anti-tuberculosis drugs and provides results within 2 hours and on primary samples. An evaluation of the the Xpert MTB/XDR assay is currently underway in clinical settings in South Africa, India and Moldova. The TB-CAPT MTB/XDR Study will add further diagnostic accuracy and feasibility data to the evidence base for the Xpert MTB/XDR assay.
Trial website
https://clinicaltrials.gov/study/NCT04567368
Trial related presentations / publications
Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT04567368