Xpert MTB/XDR Clinical Evaluation Trial

Completed

• Conditions: Tuberculosis, Multidrug-Resistant; Tuberculosis, Pulmonary
• Interventions: Device: Cepheid Gene Xpert MTB/XDR

• Registration Number: NCT03728725
• Lead Sponsor: Foundation for Innovative New Diagnostics, Switzerland

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-10-05
• Study First Submitted QC: 2018-11-01
• Study First Posted: 2018-11-02
• Study Start: 2019-07-11
• Status Verified: 2020-04
• Primary Completion: 2020-08-18
• Study Completion: 2020-08-18
• Last Update Submitted: 2021-05-17
• Last Update Posted: 2021-05-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 710

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
TB case detection Group	Cepheid Gene Xpert MTB/XDR	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.
RIF-resistance MTB Group	Cepheid Gene Xpert MTB/XDR	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.

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Institute of Pthisiopenumology; 🇲🇩 Chisinau, Moldova, Republic of