Clinical Evaluation of tNGS for Diagnosis of DR-TB

Launched by FOUNDATION FOR INNOVATIVE NEW DIAGNOSTICS, SWITZERLAND · Jan 20, 2020

Keywords

ClinConnect Summary

In recent years, tuberculosis (TB) control efforts have been complicated by the rise and spread of MDR-TB, or TB that is resistant to the first-line drugs isoniazid (INH) and rifampicin (RIF), and XDR-TB, or MDR-TB that has developed additional resistance to a fluoroquinolone (FQ) and any of the second-line injectable compounds (SLI) \[amikacin (AMK), kanamycin (KAN) and/or capreomycin (CAP)\] The rapid diagnosis and appropriate treatment of M/XDR-TB is essential to prevent significant morbidity, mortality and further transmission of disease. For treatment of uncomplicated MDR-TB, the World...

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Eligibility criteria

• Inclusion Criteria:
• • 1. A TB-positive result by Xpert MTB/RIF OR Xpert MTB/RIF Ultra (i.e. "MTB DETECTED") at or prior to enrollment, AND
• 2. At risk for drug resistant TB based on at least one of the following risk factors:
• • A. A positive RIF-resistance result by Xpert MTB/RIF OR Xpert MTB/RIF Ultra (i.e."RIF resistance DETECTED") OR B. Not responding TB treatment with positive sputum smear or culture after ≥ 3 months of standard TB treatment. OR C. Previously diagnosed with Rif-resistant/MDR-TB and failed TB treatment with positive sputum smear or culture after ≥ 3months of a standard MDR-TB regimen OR D. Previously received \>1 month of treatment for a prior TB episode OR E. Close contact with a known drug-resistant TB case AND
• • 3. Willing to provide sputum AND
• • 4. 18 years of age and older (or legal adult age corresponding to the site) AND
• • 5. Provision of signed informed consent
• Exclusion Criteria:
• • 1. Have started treatment for current TB episode more than 7 days prior to date of enrolment (i.e. must have been on treatment for less than 7 days for this TB treatment episode at enrolment) OR
• • 2. Institutionalized or imprisoned