Effects of newer drugs, Bedaquiline and Delamanid in Drug Resistant Tuberculosis
- Conditions
- Health Condition 1: A159- Respiratory tuberculosis unspecified
- Registration Number
- CTRI/2023/11/059452
- Lead Sponsor
- Dr Seema Gogoi
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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.
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
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method (1)To observe QT prolongation, its severity and outcome in Indian scenario. <br/ ><br>(2)Culture conversion time as per liquid culture. <br/ ><br>Timepoint: 0, 2nd week, 3rd month, 4th month, 5th month, 6th month <br/ ><br>
- Secondary Outcome Measures
Name Time Method Adverse Drug ReactionsTimepoint: 0, 2nd week, 3rd month, 4th month, 5th month, 6th month