TB-CAPT MTB/XDR Study

N/AActive Not RecruitingNCT04567368

Foundation for Innovative New Diagnostics, Switzerland753 enrolled

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.

Study Type

OBSERVATIONAL

Enrollment

753

Conditions

Tuberculosis Resistance Bacterial Diagnoses Disease

Interventions

Xpert MTB/XDRDIAGNOSTIC_TEST

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

Eligibility

Sex: ALLHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (2)

University of Cape Town

Cape Town, South Africa

University of the Witwatersrand

Johannesburg, South Africa

Outcomes

Primary Outcomes

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

Time frame: enrolment

Secondary Outcomes

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

Time frame: enrolment