Clinical Trial

TB-CAPT MTB/XDR Study

Active, Not Recruiting
View on ClinicalTrials.gov →
Record status
This record was last updated October 1, 2024 (before its estimated December 30, 2024 completion). Its status may not reflect the trial's current state.
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.
Protocol Amendment History 5 amendments
This ClinicalTrials.gov record has been amended 5 times since 2020-09-23; most recent amendment 2024-09-30.
Status change: Recruiting → Active, Not Recruiting 2022-11-30
Status change: Not Yet Recruiting → Recruiting 2021-05-17
Trial Details
NCT Number NCT04567368
Lead Sponsor Foundation for Innovative New Diagnostics, Switzerland
Collaborators: University of Cape Town, Wits Health Consortium (Pty) Ltd, Ludwig-Maximilians - University of Munich, Ospedale San Raffaele, Swiss Tropical & Public Health Institute, Heidelberg University, African Society for Laboratory Medicine
Conditions Tuberculosis, Resistance Bacterial, Diagnoses Disease
Enrollment 753 participants
Start Date 2021-05-14
Primary Completion 2024-12-30 (estimated)
Study Completion 2024-12-30 (estimated)
Updated on ClinicalTrials.gov 2024-10-01