TB-CAPT MTB/XDR 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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04567368

Enrollment

753

Registered

2020-09-28

Start date

2021-05-14

Completion date

2024-12-30

Last updated

2024-10-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diagnoses Disease, Resistance Bacterial, Tuberculosis

Brief summary

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.

Interventions

DIAGNOSTIC_TESTXpert MTB/XDR

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

Study design

Observational model

CASE_ONLY

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Sensitivity and specificity of Xpert MTB/XDR assay	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

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

Countries

South Africa

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026