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TB-CAPT MTB/XDR Study
Sponsor: Foundation for Innovative New Diagnostics, Switzerland
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
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