Xpert MTB/XDR Clinical Evaluation Trial

Sponsor

Foundation for Innovative New Diagnostics, Switzerland (Other)

Overall Status

Completed

CT.gov ID

NCT03728725

Collaborator

Cepheid (Industry), PD Hinduja Hospital and Medical Research Centre, Mumbai, India (Other), Phthisiopneumology Institute, Chisinau, Moldova (Other), National Institute of Tuberculosis and Respiratory Disease, New Delhi, India (Other), University of Witwatersrand, South Africa (Other)

710

Enrollment

Location

13.3

Actual Duration (Months)

53.5

Patients Per Site Per Month

Study Details

Study Description

Brief 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

Condition or Disease	Intervention/Treatment	Phase
Tuberculosis, Pulmonary Tuberculosis, Multidrug-Resistant	Device: Cepheid Gene Xpert MTB/XDR

Study Design

Study Type:

Observational

Actual Enrollment :

710 participants

Observational Model:

Cohort

Time Perspective:

Cross-Sectional

Official Title:

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

Actual Study Start Date :

Jul 11, 2019

Actual Primary Completion Date :

Aug 18, 2020

Actual Study Completion Date :

Aug 18, 2020

Arms and Interventions

Arm	Intervention/Treatment
TB case detection Group Patients with pulmonary TB symptoms and at least one DR-TB risk factor will be screened by Xpert MTB/RIF or Ultra. Patients with a clear TB-positive and RIF-resistant or RIF-sensitive result by Xpert MTB/RIF or Ultra and who consent to study procedures will be tested by Xpert MTB/XDR.	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.
RIF-resistance MTB Group An anticipated 316 additional RIF-resistant patients, as detected by Xpert MTB. /RIF, will be enrolled in this study to evaluate sensitivity and specificity of the Xpert MTB/XDR test against strains with other potential drug-resistance mutations.	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.

Arm

Intervention/Treatment

TB case detection Group

Patients with pulmonary TB symptoms and at least one DR-TB risk factor will be screened by Xpert MTB/RIF or Ultra. Patients with a clear TB-positive and RIF-resistant or RIF-sensitive result by Xpert MTB/RIF or Ultra and who consent to study procedures will be tested by Xpert MTB/XDR.

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.

RIF-resistance MTB Group

An anticipated 316 additional RIF-resistant patients, as detected by Xpert MTB. /RIF, will be enrolled in this study to evaluate sensitivity and specificity of the Xpert MTB/XDR test against strains with other potential drug-resistance mutations.

Device: Cepheid Gene Xpert MTB/XDR

Outcome Measures

Primary Outcome Measures

Estimate the diagnostic accuracy of the Xpert MTB/XDR assay for INH and ETH resistance detection [Day 1]
Sensitivity and specificity estimates for INH and ETH resistance detection
Estimate the diagnostic accuracy of the Xpert MTB/XDR assay for fluoroquinolone resistance detection [Day 1]
Sensitivity and specificity estimates for fluoroquinolone resistance detection
Estimate the diagnostic accuracy of the Xpert MTB/XDR assay for second-line injectable resistance detection [Day 1]
Sensitivity and specificity estimates for second-line injectable resistance detection

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Institute of Pthisiopenumology	Chisinau		Moldova, Republic of

Sponsors and Collaborators

Foundation for Innovative New Diagnostics, Switzerland
Cepheid
PD Hinduja Hospital and Medical Research Centre, Mumbai, India
Phthisiopneumology Institute, Chisinau, Moldova
National Institute of Tuberculosis and Respiratory Disease, New Delhi, India
University of Witwatersrand, South Africa

Investigators

None specified.

Study Documents (Full-Text)

More Information

Publications

None provided.

Responsible Party:

Foundation for Innovative New Diagnostics, Switzerland

ClinicalTrials.gov Identifier:

NCT03728725

Other Study ID Numbers:

7162-02/2

First Posted:

Nov 2, 2018

Last Update Posted:

May 19, 2021

Last Verified:

Apr 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Tuberculosis

Tuberculosis, Pulmonary

Tuberculosis, Multidrug-Resistant

Study Results

No Results Posted as of May 19, 2021