Economic Evaluation of New MDR TB Regimens (PRACTECAL-EE)
Multi-drug Resistant Tuberculosis, Extensively Drug-Resistant Tuberculosis, Pulmonary Tuberculoses
About this trial
This is an interventional health services research trial for Multi-drug Resistant Tuberculosis focused on measuring Bedaquiline, Pretomanid, Linezolid, Clofazimine, Moxifloxacin, Economic Evaluation, Pharmacoeconomics
Eligibility Criteria
Inclusion Criteria:
- adults with Mycobacterium tuberculosis resistant to at least rifampicin by either molecular or phenotypic drug susceptibility test.
Exclusion Criteria:
-
Sites / Locations
- Republican Scientific and Practical Centre for Pulmonology and Tuberculosis hospitalRecruiting
- Helen Joseph HospitalRecruiting
- Doris Goodwin HospitalRecruiting
- THINK Clinical Trial Unit, HillcrestRecruiting
- King DinuZulu HospitalRecruiting
- Republican TB Hospital No. 2Recruiting
- Sh Alimov Republican Specialised Scientific-Practical Medical Centre for Phthysiology and Pulmonology HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Experimental
Experimental
Active Comparator
Regimen 1: Bedaquiline, Pretomanid, Linezolid, Moxifloxacin
Regimen 2: Bedaquiline, Pretomanid, Linezolid, Clofazimine
Regimen 3: Bedaquiline, Pretomanid, Linezolid
Control regimen
Bedaquiline: 400 mg once daily for 2 weeks followed by 200 mg 3 times per week for 22 weeks Pretomanid: 200mg once daily for 24 weeks Moxifloxacin: 400 mg once daily for 24 weeks Linezolid: 600mg daily for 16 weeks then 300mg daily (or 600mg x3/wk) for the remaining 8 weeks or earlier when moderately tolerated Drug: Bedaquiline Bedaquiline is a diarylquinoline class antimicrobial which blocks the proton pump for ATP synthase of mycobacteria. This in turn blocks the ATP production required for cellular energy production and leading to cell death.
Bedaquiline: 400 mg once daily for 2 weeks followed by 200 mg 3 times per week for 22 weeks Pretomanid: 200mg once daily for 24 weeks Linezolid: 600mg daily for 16 weeks then 300mg daily (or 600mg x3/wk) for the remaining 8 weeks or earlier when moderately tolerated Clofazimine: 50 mg (less than 33 kg), 100 mg (more than 33 kg) for 24 weeks
Bedaquiline: 400 mg once daily for 2 weeks followed by 200 mg 3 times per week for 22 weeks Pretomanid: 200mg once daily for 24 weeks Linezolid: 600mg daily for 16 weeks then 300mg daily (or 600mg x3/wk) for the remaining 8 weeks or earlier when moderately tolerated)
Locally accepted standard of care which is consistent with the WHO recommendations for the treatment of M/XDR-TB