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
| Verified date | November 2023 |
| Source | Foundation for Innovative New Diagnostics, Switzerland |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| 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 |
| Country | Name | City | State |
|---|---|---|---|
| South Africa | University of Cape Town | Cape Town | |
| South Africa | University of the Witwatersrand | Johannesburg |
| 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 |
South Africa,
| 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 |
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