Monitoring side effects of bedaquiline containing regimen in multi-drug resistant pulmonary tuberculosis patients
- Conditions
- Health Condition 1: A150- Tuberculosis of lung
- Registration Number
- CTRI/2023/06/053848
- Lead Sponsor
- Government Medical College, Patiala
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
1)Patients above the age of 18 years
2)Patients diagnosed with Multidrug resistant pulmonary tuberculosis (Rifampicin resistance detected/inferred; MDR-TB with H resistance detected/inferred based on InhA mutation only or based on KatG mutation only (not both); MDR-TB with FQ resistance not detected)
3)Those who will understand the purpose of the study, ready to provide information regarding their health status and written informed consent for participation in the study.
1)Pregnant and lactating women
2)History of exposure for more than 1 month to Bedaquiline, Levofloxacin, Ethionamide or Clofazimine
3)Patients with H resistance detected with both KatG and InhA mutation; and patients with FQ resistance detected
4)Confirmed resistance to a medicine in the shorter oral Bedaquiline- containing MDR-TB regimen
5)History of Torsade de Pointes, congenital long QT syndrome, uncompensated heart failure, and cardio ventricular arrythmias
6)Intolerance to any drug in the regimen or risk of toxicity from a drug in shorter oral Bedaquiline- containing MDR-TB regimen
7)Extra-pulmonary TB disease
8)Extensive TB disease found in presence of bilateral cavitary disease or extensive parenchymal damage on chest radiography
9)Reactive Serology for HIV
Study & Design
- Study Type
- PMS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Adverse drug reaction profile in multi-drug resistant pulmonary tuberculosis patients on Bedaquiline containing shorter oral regimenTimepoint: Visit 1 Day 0 Enrollment & Treatment initiation <br/ ><br>Visit 2 1 month since initiation of bedaquiline as part of regimen <br/ ><br>Visit 3 4 months since initiation of bedaquiline as part of regimen <br/ ><br>Visit 4 6 months since initiation of bedaquiline as part of regimen <br/ ><br>Visit 5 1 month post completion of bedaquiline as part of regimen
- Secondary Outcome Measures
Name Time Method Severity & causal relationship of adverse drug reactions in multi-drug resistant pulmonary tuberculosis patients on Bedaquiline containing shorter oral regimenTimepoint: Visit 1 Day 0 Enrollment & Treatment initiation <br/ ><br>Visit 2 1 month since initiation of bedaquiline as part of regimen <br/ ><br>Visit 3 4 months since initiation of bedaquiline as part of regimen <br/ ><br>Visit 4 6 months since initiation of bedaquiline as part of regimen <br/ ><br>Visit 5 1 month post completion of bedaquiline as part of regimen