Health Condition 1: J709- Respiratory conditions due to unspecified external agent
Conditions
Interventions
Control Intervention1: Liquid culture DST and First line & second line line probe assay.: Diagnostic evaluation of the tNGS assays will be done in comparison with the existing diagnostics assays.
Sponsors
Foundation for Innovative New Diagnostics FIND
Eligibility
Inclusion criteria
Inclusion criteria: 1. A clear TB-positive result by Xpert MTB/RIF OR Xpert MTB/RIF Ultra prior to enrolment, irrespective of RIF-resistance status, AND 2. At risk for drug resistant TB based on at least one of the following risk factors: A.Not responding TB treatment with positive sputum smear or culture after >= 3 months of standard TB treatment. OR B.Previously diagnosed with Rif-resistant/MDR-TB and failed TB treatment with positive sputum smear or culture after >= 3months of a standard MDR-TB regiment OR C.Previously received >1 month of treatment for a prior TB episode OR D.Close contact with a known drug-resistant TB case AND 3.Willing to provide sputum AND 4.Over 18 years of age (or legal adult age corresponding to the site) 5.Provision of signed informed consent
Exclusion criteria
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. Are pregnant or institutionalized or imprisoned
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Point estimates, with 95% confidence intervals, of sensitivity and specificity for rifampicin, isoniazid, fluoroquinolones, second-line injectables, and pyrazinamide resistance detection for up to 3 tNGS solutionsTimepoint: Sputum samples will be collected from patient on the day of enrolment and the following day (Day 1 and Day 2) and pooled together to generate sediment. Frozen sediments will be processed using end-to-end targeted sequencing solutions no later than 1 month after collection. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Detecting sensitivity and specificity (95%) for second-line resistance detection (bedaquiline, linezolid, clofazamine, streptomycin). 2. Performance of overall test success rate against Xpert MTB/RIF and Hain MTBDRplus/sl. 3. Performance characteristics including invalid and indeterminate rates, ease of use metrics, and other operational characteristics. Timepoint: 12 months | — |
Countries
Georgia, India, South Africa
Contacts
Public ContactDr Camilla Rodrigues
P D Hinduja National Hospital and MRC
Outcome results
None listed