TB-CAPT MTB/XDR Study

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Tuberculosis, Resistance Bacterial, Diagnoses Disease

Intervention / Treatment
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* Diagnostic Test: Xpert MTB/XDR


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |