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Completed

NCT Number: NCT03728725

Xpert MTB/XDR Clinical Evaluation Trial

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

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Key information

Conditions

Tuberculosis, Pulmonary Actinomycetales Infections Bacterial Infections Bacterial Infections and Mycoses Gram-Positive Bacterial Infections Infections Lung Diseases Mycobacterium Infections Respiratory Tract Diseases Respiratory Tract Infections Tuberculosis Tuberculosis, Multidrug-Resistant

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Institute of Pthisiopenumology

Chisinau, Moldova

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • • Age 18 years or above;
  • Symptoms suggesting pulmonary TB, i.e. persistent cough (generally ≥3 weeks or as per local definition of TB suspect), and at least one of the following:
  • Previously received >1 month of treatment for a prior TB episode or
  • Failing TB treatment with positive sputum smear or culture after ≥3 months of a standard TB treatment or
  • Had close contact with a known drug-resistant TB case or
  • Newly diagnosed with MDR-TB within the last 30 days or
  • Previously diagnosed with MDR-TB and failed TB treatment with positive sputum smear or culture after ≥3 months of a standard MDR-TB treatment regimen

Patients meeting the above criteria will be screened by Xpert MTB/RIF or Xpert MTB/RIF Ultra. TB patients meeting the following criteria will be included in the study:

  • A clear Mtb-positive and RIF-resistant or RIF-sensitive result by Xpert MTB/RIF or Xpert MTB/RIF Ultra
  • Provision of informed consent;
  • Production of an adequate quantity (>3mL) of sputum

Exclusion criteria

  • Participants will be excluded from the study if informed consent is not provided.

Treatment and study plan

Cepheid Gene Xpert MTB/XDR

Device

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.

Primary outcomes

  1. Estimate the diagnostic accuracy of the Xpert MTB/XDR assay for INH and ETH resistance detection

    Time frame: Day 1

    Sensitivity and specificity estimates for INH and ETH resistance detection

  2. Estimate the diagnostic accuracy of the Xpert MTB/XDR assay for fluoroquinolone resistance detection

    Time frame: Day 1

    Sensitivity and specificity estimates for fluoroquinolone resistance detection

  3. Estimate the diagnostic accuracy of the Xpert MTB/XDR assay for second-line injectable resistance detection

    Time frame: Day 1

    Sensitivity and specificity estimates for second-line injectable resistance detection

Sponsors and collaborators

Lead sponsor

Foundation for Innovative New Diagnostics, Switzerland

Other

Collaborators

  • Cepheid
  • National Institute of Tuberculosis and Respiratory Diseases, New Delhi
  • PD Hinduja Hospital and Medical Research Centre, Mumbai, India
  • Phthisiopneumology Institute, Chisinau, Moldova
  • University of Witwatersrand, South Africa

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Nov 2, 2018
Registry last updated
May 19, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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