Trials / Active Not Recruiting
Active Not RecruitingNCT04567368
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
- Status
- Active Not Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 753 (actual)
- Sponsor
- Foundation for Innovative New Diagnostics, Switzerland · Academic / Other
- Sex
- All
- Age
- —
- Healthy volunteers
- Accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| DIAGNOSTIC_TEST | Xpert MTB/XDR | Cepheid Xpert MTB/XDR assay for detection of resistance to INH, FQ and SLID |
Timeline
- Start date
- 2021-05-14
- Primary completion
- 2024-12-30
- Completion
- 2024-12-30
- First posted
- 2020-09-28
- Last updated
- 2024-10-01
Locations
2 sites across 1 country: South Africa
Source: ClinicalTrials.gov record NCT04567368. Inclusion in this directory is not an endorsement.