Health Condition 1: J988- Other specified respiratory disorders
Conditions
Interventions
Intervention1: Bedaquiline, Linezolid, Pretomanid: Bedaquiline (400mg) once daily orally for 2 weeks followed by 200 mg thrice weekly for 24 weeks, Pretomanid (200mg) once daily orally for 26 weeks, L
Sponsors
International Union Against Tuberculosis and Lung Disease
Indian Council of Medical Research
Eligibility
Inclusion criteria
Inclusion criteria: . Adults aged between 18 years â?? 65 years 2. Pulmonary XDR-TB, MDRFQ, or SLI patients [with documented evidence of resistance to rifampicin with or without isoniazid resistance AND additional resistance to fluoroquinolones or SLIs by conventional DST (culture-based1) or rapid DST (Xpert MTB/RIF or LPA) from a certified laboratory] OR MDR-TBTI/NR patients [with documented intolerance or non-response to MDR TB treatment regimen for 6-months or more when the participant was adherent to the treatment regimen] 3. Bodyweight of >=30 kg (in light clothing and no shoes) 4. Provide written, informed consent before all study-related procedures 5. Provide consent to HIV testing2 (if an HIV test was performed within 1 month before the study start, it should not be repeated as long as documentation can be provided [ELISA and/or Western Blot]). 6. Aspartate aminotransferase (AST) or Alanine aminotransferase (ALT) 7. QTcF less than or equal to 450 at baseline 8. Female patients should not be pregnant or should be using a birth control method. They should be willing to continue practicing birth control methods (barrier or non-barrier contraceptive methods including oral contraceptives) throughout the treatment period, or history of post-menopausal for the past 12 months.
Exclusion criteria
Exclusion criteria: Non-DST based criteria 1. Intolerance or risk of toxicity from medicine in the treatment regimens (e.g. drug-drug interactions) 2. Patient who has received more than 2 weeks of Bedaquiline or Linezolid before the first dose of BPaL regimen 3. Pregnancy or Lactating women 4. All forms of Extrapulmonary TB (Lymph node TB associated with Pulmonary DR-TB and pleural effusion associated with pulmonary TB can be considered for inclusion ) . HIV infected patient having a CD4+ cell count of 6. Currently having an uncontrolled cardiac arrhythmia that requires medication 7. Have any of the following QTcF interval characteristics
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients with favorable treatment outcomes. Favorable treatment outcome is defined as Sustained Treatment success at 12 months after successful TB treatment, who is alive and free of TB. Successful TB treatment includes Cure and Treatment Completed. Timepoint: Favorable Outcome at end of 72 weeks (18 months) | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of serious adverse events among patients in the study occurring during the treatment and follow-up period Proportion of patients with Unfavourable Outcome while on treatment regimens. HRQoL scores at baseline, end of treatment, and 48-weeks post-treatment and the percentage change in score over the treatment period between the regimens Timepoint: At 72 weeks (18 months) | — |
Countries
India
Contacts
Public ContactC Padmapriyadarsini
ICMR-National Institute for Research in Tuberculosis
Outcome results
None listed