TB-CAPT MTB/XDR Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

753 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-05-14

Study Completion Date

2024-12-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Tuberculosis Resistance Bacterial Diagnoses Disease

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Interventions

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Xpert MTB/XDR

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes