Health Condition 1: A150- Tuberculosis of lung
Conditions
Interventions
Intervention1: BPaLM regimen: 6 month regimen
Control Intervention1: Short drug regimen: 9 month regimen
Sponsors
Dr jaydeep Jambukia
Eligibility
Inclusion criteria
Inclusion criteria: 1 Patient with age 18 years & above. 2 Newly diagnose MDR tuberculosis cases. 3 Patient present with laboratory conformation of TB positive or patients present with Xray Positive TB. 4 Non-lactating women, lactating women but not breast-feeding, non-pregnant women, pregnant women with less than 20 or less than 24 weeks gestation and who is willing for medical termination of pregnancy (as per latest MTP gazette notification, as applicable)
Exclusion criteria
Exclusion criteria: 1 Person with prescribed Lzd last 3 months. 2 Pt who are already on Anti-tubercular drug therapy. 3 A person with heart problems like AV Block, Arrhythmias, QT Prolongation. 4 Person with significant liver dysfunction [AST/ALT more than 3.0 x ULN and Total Bilirubin more than 2.0 x ULN.] 5 Drug sensitive TB, XDR-TB or disseminated TB (miliary TB or TB with multiorgan involvement). 6 Patient showing hypersensitivity reaction with BPaLM Regime drugs. 7 Severe anaemia, thrombocytopenia or leukopenia. Haemoglobin level less than 7.0 g/dL, Platelet count less than 75000/mm3, Absolute neutrophil count less than 750/mm3 8 Severe neuropathy [Peripheral neuropathy of grade 3 or grade 4].
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| increased treatment success rates, decreased mortality, treatment failure between bedaquiline-containing regimens and short drug regimens.Timepoint: Baseline and 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| 1 To evaluate the safety profile of newer regimen. 2 To assess patient adherence. 3 To identify factors influencing treatment outcome.Timepoint: 24 weeks | — |
Countries
India
Contacts
Public ContactDr Suraj Tripathi
Zydus medical College and Hospital
Outcome results
None listed