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TB-CAPT MTB/XDR Study

NCT04567368 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 753

Last updated 2024-10-01

No results posted yet for this study

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

DIAGNOSTIC_TEST

Xpert MTB/XDR

Cepheid Xpert MTB/XDR assay for detection of resistance to INH, FQ and SLID

Sponsors & Collaborators

  • University of Cape Town

    collaborator OTHER

  • Wits Health Consortium (Pty) Ltd

    collaborator OTHER

  • Ludwig-Maximilians - University of Munich

    collaborator OTHER

  • Ospedale San Raffaele

    collaborator OTHER

  • Swiss Tropical & Public Health Institute

    collaborator OTHER

  • Heidelberg University

    collaborator OTHER

  • African Society for Laboratory Medicine

    collaborator UNKNOWN

  • Foundation for Innovative New Diagnostics, Switzerland

    lead OTHER

Eligibility

Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-05-14
Primary Completion
2024-12-30
Completion
2024-12-30

Countries

  • South Africa

Study Locations

More Related Trials

Entities

Diseases

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 NCT04567368 on ClinicalTrials.gov