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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