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TB-CAPT MTB/XDR Study | Clinical Trials | Clareo Health

ACTIVE_NOT_RECRUITING

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

NCT04567368•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.

Eligibility

Age

All ages

Sex

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

Locations (2)

University of Cape Town

Cape Town, South Africa

University of the Witwatersrand

Johannesburg, South Africa

Key Dates

Start Date

May 14, 2021

Primary Completion Date

December 30, 2024

Completion Date

December 30, 2024

Last Updated

October 1, 2024

Enrollment

753

ACTUAL participants

Conditions

TuberculosisResistance BacterialDiagnoses Disease

Interventions

Xpert MTB/XDR

DIAGNOSTIC_TEST

Trial of Novel Regimens for the Treatment of Pulmonary Tuberculosis

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Pulmonary Tuberculosis

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RECRUITINGPHASE2

Evaluating the Safety and Immunogenicity of MTBVAC

NCT05947890

HIV I InfectionTuberculosis

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RECRUITINGNA

Rapid Research in Diagnostics Development for TB Network (R2D2 Kids) and Assessing Diagnostics At POC for TB in Children (ADAPT for Kids)

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 1, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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TB-CAPT MTB/XDR Study

Inclusion Criteria

Exclusion Criteria

Trial of Novel Regimens for the Treatment of Pulmonary Tuberculosis

Evaluating the Safety and Immunogenicity of MTBVAC

Rapid Research in Diagnostics Development for TB Network (R2D2 Kids) and Assessing Diagnostics At POC for TB in Children (ADAPT for Kids)

A Study to Evaluate the Efficacy, Safety and Immunogenicity of MTBVAC in Adolescents and Adults Living in a TB Endemic Region.

Pharmacokinetic Study to Evaluate Anti-mycobacterial Activity of TMC207 in Combination With Background Regimen (BR) of Multidrug Resistant Tuberculosis (MDR-TB) Medications for Treatment of Children/Adolescents With Pulmonary MDR-TB

Rapid Research in Diagnostics Development for TB Network