NCT03728725

Xpert MTB/XDR Clinical Evaluation Trial

Multicentre Clinical Trial to Assess the Performance of the Xpert MTB/XDR Assay for INH- and Second-line Resistance Detection

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 710 (actual)
• Sponsor: Foundation for Innovative New Diagnostics, Switzerland · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

FIND and partners intend to address the need for a multi- and extensively drug-resistant tuberculosis (M/XDR-TB) diagnostic solution for patients in settings with a high burden of drug-resistant tuberculosis (DR-TB) though the development, evaluation and introduction of an Xpert MTB/XDR assay

Conditions

• Tuberculosis, Pulmonary
• Tuberculosis, Multidrug-Resistant

Interventions

Type	Name	Description
DEVICE	Cepheid Gene Xpert MTB/XDR	The Xpert MTB/RIF assay (Cepheid, Sunnyvale, CA) is an integrated, automated, cartridge-based system for MDR-TB diagnosis that uses the GeneXpert instrument platform. WHO confirmed evidence to support the widespread use of the Xpert MTB/RIF assay in 2010 and the assay has since been widely used in TB programs, but it is only capable of identifying Mycobacterium tuberculosis (Mtb) and detecting RIF resistance. The Xpert MTB/XDR assay will be evaluated for INH and second-line resistance detection, and to recommend its use in diverse clinical settings. The focus of this protocol is the multicentre clinical evaluation.

Timeline

• Start date: 2019-07-11
• Primary completion: 2020-08-18
• Completion: 2020-08-18
• First posted: 2018-11-02
• Last updated: 2021-05-19

Locations

1 site across 1 country: Moldova