Xpert MTB/XDR Clinical Evaluation Trial

Tuberculosis, Pulmonary Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03728725
• Other study ID #: 7162-02/2
• Status: Completed
• Start date: July 11, 2019
• Est. completion date: August 18, 2020

Study information

• Verified date: April 2020
• Source: Foundation for Innovative New Diagnostics, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 710
• Est. completion date: August 18, 2020
• Est. primary completion date: August 18, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Tuberculosis
• Tuberculosis, Multidrug-Resistant
• Tuberculosis, Pulmonary

Intervention

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.

Locations

Country	Name	City	State
Moldova, Republic of	Institute of Pthisiopenumology	Chisinau

Sponsors (6)

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

Country where clinical trial is conducted

Moldova, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Estimate the diagnostic accuracy of the Xpert MTB/XDR assay for INH and ETH resistance detection	Sensitivity and specificity estimates for INH and ETH resistance detection	Day 1
Primary	Estimate the diagnostic accuracy of the Xpert MTB/XDR assay for fluoroquinolone resistance detection	Sensitivity and specificity estimates for fluoroquinolone resistance detection	Day 1
Primary	Estimate the diagnostic accuracy of the Xpert MTB/XDR assay for second-line injectable resistance detection	Sensitivity and specificity estimates for second-line injectable resistance detection	Day 1