TB-CAPT MTB/XDR Study

Tuberculosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04567368
• Other study ID #: TB042
• Status: Active, not recruiting
• Start date: May 14, 2021
• Est. completion date: June 30, 2024

Study information

• Verified date: November 2023
• Source: Foundation for Innovative New Diagnostics, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 753
• Est. completion date: June 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Diagnoses Disease
• Resistance Bacterial
• Tuberculosis

Intervention

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

Locations

Country	Name	City	State
South Africa	University of Cape Town	Cape Town
South Africa	University of the Witwatersrand	Johannesburg

Sponsors (8)

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

Country where clinical trial is conducted

South Africa, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Sensitivity and specificity of Xpert MTB/XDR assay compared to phenotypic anti-tuberculosis drug susceptibility testing and WGS separately	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	enrolment