TB-CAPT MTB/XDR Study

Active, not recruiting

• Conditions: Resistance Bacterial; Diagnoses Disease; Tuberculosis

• Registration Number: NCT04567368
• Lead Sponsor: Foundation for Innovative New Diagnostics, Switzerland

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-09-23
• Study First Submitted QC: 2020-09-23
• Study First Posted: 2020-09-28
• Study Start: 2021-05-14
• Status Verified: 2024-09
• Last Update Submitted: 2024-09-30
• Last Update Posted: 2024-10-01
• Primary Completion: 2024-12-30
• Study Completion: 2024-12-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 753

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Sensitivity and specificity of Xpert MTB/XDR assay	enrolment	Sensitivity and specificity of Xpert MTB/XDR assay vs. the composite reference standard for detection of resistance to Isoniazid, Fluoroquinolones, Ethionamide, Second-line injectable anti-tuberculosis drugs

Secondary Outcome Measures

Name	Time	Method
Sensitivity and specificity of Xpert MTB/XDR assay compared to phenotypic anti-tuberculosis drug susceptibility testing and WGS separately	enrolment	Sensitivity and specificity of Xpert MTB/XDR assay for detection of resistance to Isoniazid, Fluoroquinolones, Ethionamide, Second-line injectable anti-tuberculosis drugs compared to phenotypic anti-tuberculosis drug susceptibility testing and WGS separately

Trial Locations

Locations (2)

University of Cape Town; 🇿🇦 Cape Town, South Africa

University of the Witwatersrand; 🇿🇦 Johannesburg, South Africa