None listed
Conditions
Interventions
Control Intervention1: Lab tests: one or more of the following....AFB Smear--Sputum staining
and microscopy [Ziehl
Neelsen/Fluorescence] Liquid
Culture and DST -Molecular test
(CB-NAAT or TrueNat or
G
Sponsors
HealthSeq Precision Medicine Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: (a) Age 18 and above (b) Treatment-naive patients at zero week (c) Sputum positive for AFB or GenXpert/ Truenat/ CBNAAT TB test positive, with the diagnosis confirmed by a clinician (d) completing 24 weeks or recommended duration of ATT.
Exclusion criteria
Exclusion criteria: a) Individuals on alternate treatment forms - e.g. Ayurveda, homeopathy, etc (b) Individuals with comorbidities such as HIV, proven malignancy, COVID-19 (c) Pregnancy or lactation (d) are on Immunosuppressants
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| (a)To demonstrate the effectiveness of the host-based biomarker panel and the associated HTT test (HealSeq TB Test) in diagnosis of PTB and EPTB (b)To demonstrate the effectiveness of the host-based biomarker panel and the associated HTT test in identifying non-responders at 2 weeks after treatment in DS TB (c)To demonstrate the effectiveness of the host-based biomarker panel and the associated HTT test in identifying non-responders (and determining optimal time point for testing) in EPTB cases (Extra pulmonary TB) (d)To demonstrate the effectiveness of the host-based biomarker panel and the associated HTT test in identifying â??curedâ?? and â??treatment failureâ?? cases at 24 weeks of ATT (Anti Tuberculosis drugs)Timepoint: 2 weeks and 24 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| (a)To demonstrate the effectiveness of the host-based biomarker panel and the associated HTT test in identifying non-responders (and determining optimal time point for testing) in DR TB cases (b) To demonstrate the effectiveness of the host-based biomarker panel and the associated HTT test in identifying non-responders at other time points upto 24 weeks in DS (Drug Sensitive)and DR (Drug resistant) TB (c) To demonstrate correlation of HTT score with disease severity in all cases (d) To test the prognostic potential of the biomarker panel and the score for predicting treatment outcome at diagnosis.Timepoint: 24 weeks | — |
Countries
India
Contacts
Public ContactDr Pramila Tata
HealthSeq Precision Medicine Pvt Ltd
Outcome results
None listed