TB diagnosis and treatment response evaluatio
Not Applicable
- Registration Number
- CTRI/2022/12/047991
- Lead Sponsor
- HealthSeq Precision Medicine Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
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
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
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method (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 <br/ ><br>(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 <br/ ><br>(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) <br/ ><br>(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 Outcome Measures
Name Time Method (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 <br/ ><br>(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 <br/ ><br>(c)To demonstrate correlation of HTT score with disease severity in all cases <br/ ><br>(d)To test the prognostic potential of the biomarker panel and the score for predicting treatment outcome at diagnosis.Timepoint: 24 weeks