TB-CAPT MTB/XDR Study

NCT04567368 | Active Not Recruiting

• 1 other identifier: TB042
• Study Type: observational
• Target: 753
• Locations: 1 country
• Sites: 2

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.

Conditions

Tuberculosis; Resistance Bacterial; Diagnoses Disease

Outcome Measures

Primary Outcomes (1)

• Sensitivity and specificity of Xpert MTB/XDR assay

  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

  enrolment

Secondary Outcomes (1)

• Sensitivity and specificity of Xpert MTB/XDR assay compared to phenotypic anti-tuberculosis drug susceptibility testing and WGS separately

  enrolment

Interventions

Xpert MTB/XDR DIAGNOSTIC_TEST

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

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Respiratory specimens testing rifampicin-resistant Mtb positive on Xpert MTB/RIF Ultra. The proposed study procedures would not affect the usual care of patients as we will utilise specimens that would ordinarily be discarded. Similarly, the reference standard tests (next generation sequencing) are non-routine tests not currently utilised for patient care in South Africa. These tests will be performed post hoc with patient identifiers removed. For these reasons, we are proposing a waiver of informed consent for this diagnostic accuracy and feasibility study.

You may qualify if:

• Mtb-positive, rifampicin-resistant respiratory specimen identified on Xpert MTB/RIF Ultra

You may not qualify if:

• Residual SR-sputum mix not retained or not found
• Patient previously included in the study
• 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

Sponsors & Collaborators

• Foundation for Innovative New Diagnostics, Switzerland: lead
• University of Cape Town: collaborator
• Wits Health Consortium (Pty) Ltd: collaborator
• Ludwig-Maximilians - University of Munich: collaborator
• Ospedale San Raffaele: collaborator
• Swiss Tropical & Public Health Institute: collaborator
• Heidelberg University: collaborator
• African Society for Laboratory Medicine: collaborator

Study Sites (2)

University of Cape Town

Cape Town, South Africa

Location

University of the Witwatersrand

Johannesburg, South Africa

Location

MeSH Terms

Conditions

Tuberculosis

Condition Hierarchy (Ancestors)

Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 23, 2020
• First Posted: September 28, 2020
• Study Start: May 14, 2021
• Primary Completion: December 30, 2024
• Study Completion: December 30, 2024
• Last Updated: October 1, 2024

Record last verified: 2024-09

Locations

ZA (2)