Tuberculosis
Conditions
Interventions
Bedaquiline Based All Oral Shorter Regimens BPaLM
Sponsors
Jimma University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Bacteriologically confirmed rifampicin-resistant TB positive result by Xpert MTB/RIF OR Xpert MTB/RIF Ultra (i.e. “MTB DETECTED” and RIF resistance-DETECTED) - Patients should have undergone baseline drug susceptibility testing to confirm the absence of resistance to second-line anti-TB drugs at the start of the treatment. - Patient should be eligible to receive bedaquiline-based, all-oral shorter regimens as part of their MDR/RR-TB treatment. - Patients (or their legal guardian/parents) must provide written informed consent and/or assent - Willing and able to provide written informed consent
Exclusion criteria
Exclusion criteria: - Patients with known severe or uncontrolled co-morbidities (e.g., severe liver, kidney, or heart disease) unless medically managed. - Extrapulmonary TB patients - Has a known allergy to any of the drugs in the MDR/RR-TB regimen - Who has been on medications contraindicated with the medicines in the all-oral shorter regimens.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Prevalence of acquired resistance to any second-line drugs SLD (bedaquiline, fluoroquinolones, linezolid, clofazimine, etc.) | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence rate of newly detected resistance to second-lined drugs (SLD);Treatment success (cured + treatment completed);Proportion of patients with =90% dose adherence;Incidence rate of grade =2 adverse events;Median time to culture conversion ;Prevalence of newly detected second-line drug- SLD resistance after treatment completion;Prevalence of Post-TB lung disease (PTLD);Number of stock-out events per drug per facility | — |
Countries
Ethiopia
Contacts
Public ContactZerihun Assefa
Research Director and Associate Professor at Biomedical Sciences Department Jimma University
Outcome results
None listed