Health Condition 1: A150- Tuberculosis of lung
Conditions
Interventions
Intervention1: Bedaquiline containing shorter oral regimen: Bedaquiline containing shorter oral regimen as Anti-Tubercular Treatment will be given as per Programmatic Management of drug-resistant TB (
Sponsors
Government Medical College, Patiala
Eligibility
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse drug reaction profile in multi-drug resistant pulmonary tuberculosis patients on Bedaquiline containing shorter oral regimenTimepoint: Visit 1 Day 0 Enrollment & Treatment initiation Visit 2 1 month since initiation of bedaquiline as part of regimen Visit 3 4 months since initiation of bedaquiline as part of regimen Visit 4 6 months since initiation of bedaquiline as part of regimen Visit 5 1 month post completion of bedaquiline as part of regimen | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 Visit 2 1 month since initiation of bedaquiline as part of regimen Visit 3 4 months since initiation of bedaquiline as part of regimen Visit 4 6 months since initiation of bedaquiline as part of regimen Visit 5 1 month post completion of bedaquiline as part of regimen | — |
Countries
India
Contacts
Public ContactDr Anjleen Kaur
Government Medical College, Patiala
Outcome results
None listed