TB-CAPT MTB/XDR Study

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Tuberculosis Actinomycetales Infections Bacterial Infections Bacterial Infections and Mycoses Diagnoses Disease Gram-Positive Bacterial Infections Infections Mycobacterium Infections Resistance Bacterial

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Cape Town, Cape Town, South Africa

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Xpert MTB/XDR

Diagnostic Test

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

Primary outcomes

Sensitivity and specificity of Xpert MTB/XDR assay

Time frame: enrolment

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

Secondary outcomes

Sensitivity and specificity of Xpert MTB/XDR assay compared to phenotypic anti-tuberculosis drug susceptibility testing and WGS separately

Time frame: enrolment

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

Sponsors and collaborators

Lead sponsor

Foundation for Innovative New Diagnostics, Switzerland

Other

Collaborators

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

Registry information

Official study 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

Important dates

Study start: 2021
Primary completion: 2024
Study completion: 2024
First posted: Sep 28, 2020
Registry last updated: Oct 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed