Health Condition 1: A159- Respiratory tuberculosis unspecified
Conditions
Interventions
Intervention1: Nil: Nil
Sponsors
Dr Seema Gogoi
Eligibility
Inclusion criteria
Inclusion criteria: TB patient diagnosed by CBNAAT(Cartridge Based Nucleic Acid Amplification Test) or 1st line LPA (Line Probe Assay), who are resistant to Rifampicin and Isoniazid; to any Fluoroquinolones like Moxifloxacin, Levofloxacin or any Group A drugs like (Linezolid) : MDR/Pre-XDR/XDR- TB cases are only taken. Patients who are willing to take part in the study with signed and written informed consent.
Exclusion criteria
Exclusion criteria: Patients who are not willing to sign in after informed consent. Pregnant and breast-feeding mother. Having uncontrolled and controlled cardiac arrhythmia that requires medication. Having any of the following QTcF interval characteristics at screening. QTcF > 500 at baseline & normal electrolytes, ECG to be repeated after 6 hours and if both ECGs show QTcF >500 then the patient should not be challenged with cardiotoxic drugs; History of additional risk factors for Torsade de Pointes, e.g. heart failure, hypokalemia, family history of long QT syndrome
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| (1)To observe QT prolongation, its severity and outcome in Indian scenario. (2)Culture conversion time as per liquid culture. Timepoint: 0, 2nd week, 3rd month, 4th month, 5th month, 6th month | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse Drug ReactionsTimepoint: 0, 2nd week, 3rd month, 4th month, 5th month, 6th month | — |
Countries
India
Contacts
Public ContactDr Seema Gogoi
Gajra Raja Medical College
Outcome results
None listed