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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04567368
Other study ID # TB042
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date May 14, 2021
Est. completion date June 30, 2024

Study information

Verified date November 2023
Source Foundation for Innovative New Diagnostics, Switzerland
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 753
Est. completion date June 30, 2024
Est. primary completion date June 30, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - Mtb-positive, rifampicin-resistant respiratory specimen identified on Xpert MTB/RIF Ultra 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


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
Xpert MTB/XDR
Cepheid Xpert MTB/XDR assay for detection of resistance to INH, FQ and SLID

Locations

Country Name City State
South Africa University of Cape Town Cape Town
South Africa University of the Witwatersrand Johannesburg

Sponsors (8)

Lead Sponsor Collaborator
Foundation for Innovative New Diagnostics, Switzerland African Society for Laboratory Medicine, Heidelberg University, Ludwig-Maximilians - University of Munich, Ospedale San Raffaele, Swiss Tropical & Public Health Institute, University of Cape Town, Wits Health Consortium (Pty) Ltd

Country where clinical trial is conducted

South Africa, 

Outcome

Type Measure Description Time frame Safety issue
Primary Sensitivity and specificity of Xpert MTB/XDR assay Sensitivity and specificity of Xpert MTB/XDR assay vs. the composite reference standard for detection of resistance to Isoniazid, Fluoroquinolones, Ethionamide, Second-line injectable anti-tuberculosis drugs enrolment
Secondary Sensitivity and specificity of Xpert MTB/XDR assay compared to phenotypic anti-tuberculosis drug susceptibility testing and WGS separately Sensitivity and specificity of Xpert MTB/XDR assay for detection of resistance to Isoniazid, Fluoroquinolones, Ethionamide, Second-line injectable anti-tuberculosis drugs compared to phenotypic anti-tuberculosis drug susceptibility testing and WGS separately enrolment
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