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Xpert MTB/XDR Clinical Evaluation Trial

NCT03728725 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 710

Last updated 2021-05-19

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Cepheid

    collaborator INDUSTRY

  • PD Hinduja Hospital and Medical Research Centre, Mumbai, India

    collaborator UNKNOWN

  • Phthisiopneumology Institute, Chisinau, Moldova

    collaborator UNKNOWN

  • National Institute of Tuberculosis and Respiratory Disease, New Delhi, India

    collaborator UNKNOWN

  • University of Witwatersrand, South Africa

    collaborator OTHER

  • Foundation for Innovative New Diagnostics, Switzerland

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-07-11
Primary Completion
2020-08-18
Completion
2020-08-18

Countries

  • Moldova

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03728725 on ClinicalTrials.gov