Xpert MTB/XDR Clinical Evaluation Trial

Foundation for Innovative New Diagnostics (FIND)

Status: Completed

Conditions: Tuberculosis, Multidrug-Resistant; Tuberculosis, Pulmonary

Treatments: Device: Cepheid Gene Xpert MTB/XDR

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT03728725

7162-02/2

Details and patient eligibility

About

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

Enrollment: 710 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

710 participants in 2 patient groups

TB case detection Group

Description:

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.

Treatment:

Device: Cepheid Gene Xpert MTB/XDR

RIF-resistance MTB Group

Description:

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.

Treatment:

Device: Cepheid Gene Xpert MTB/XDR