Active — Not RecruitingNot Applicable

TB-CAPT MTB/XDR Study

South Africa753 participantsStarted 2021-05-14

Plain-language 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.

Who can participate

SexALL

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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

What they're measuring

Sensitivity and specificity of Xpert MTB/XDR assay

Timeframe: enrolment

Trial details

NCT IDNCT04567368

SponsorFoundation for Innovative New Diagnostics, Switzerland

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2024-12-30

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