TB-CAPT MTB/XDR Study
Overview
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.
Full Title of Study: “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”
Study Type
- Study Type: Observational
- Study Design
- Time Perspective: Cross-Sectional
- Study Primary Completion Date: June 30, 2024
Interventions
- Diagnostic Test: Xpert MTB/XDR
- Cepheid Xpert MTB/XDR assay for detection of resistance to INH, FQ and SLID
Clinical Trial Outcome Measures
Primary Measures
- 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 Measures
- 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
Participating in This Clinical Trial
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
Gender Eligibility: All
Minimum Age: N/A
Maximum Age: N/A
Are Healthy Volunteers Accepted: Accepts Healthy Volunteers
Investigator Details
- Lead Sponsor
- Foundation for Innovative New Diagnostics, Switzerland
- Collaborator
- University of Cape Town
- Provider of Information About this Clinical Study
- Sponsor
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