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NCT04567368

TB-CAPT MTB/XDR Study

Sponsor: Foundation for Innovative New Diagnostics, Switzerland

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

Any - Any

Study Type

OBSERVATIONAL

Enrollment

753

Start Date

2021-05-14

Completion Date

2024-12-30

Last Updated

2024-10-01

Healthy Volunteers

Yes

Interventions

DIAGNOSTIC_TEST

Xpert MTB/XDR

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

Locations (2)

University of Cape Town

Cape Town, South Africa

University of the Witwatersrand

Johannesburg, South Africa