drugset / Trial / NCT04207112
Economic Evaluation of New MDR TB Regimens
Phase 2/3
Completed
73 enrolled
Medecins Sans Frontieres, Netherlands
London School of Hygiene and Tropical Medicine · collabMinistry of Health, Republic of Uzbekistan · collabMinistry of Public Health, Republic of Belarus · collabTHINK TB & HIV Investigative Network · collabUniversity of Liverpool · collabWits Health Consortium (Pty) Ltd · collab
RandomizedParallel-groupOpen-labelHealth-services research
Summary
The current treatment regimen for MDR-TB has poor outcomes and costs of treating MDR-TB are greater than treating drug susceptible TB, both in terms of health service and patient-incurred costs. Urgent action is needed to Identify short, effective and tolerable treatments for people with MDR-TB. The PRACTECAL economic evaluation sub-study (PRACTECAL-EE) will take place alongside the TB PRACTECAL trial, aiming to assess the costs to patients and providers of such regimens and to estimate the cost-effectiveness and poverty impact of an introduction of new MDR-TB regimens in the three countries participating in the main study.
Timeline
- Start
- 2020-10-20
- Primary completion
- 2022-08-25
- Completion
- 2022-08-25
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bedaquiline | Small molecule | 200 mg | — |
| Subject | Clofazimine | Small molecule | 50 mg | — |
| Subject | Clofazimine | Small molecule | 100 mg | — |
| Subject | Linezolid | Other / unclassified | 300 mg | — |
| Subject | Linezolid | Other / unclassified | 600 mg | — |
| Subject | Moxifloxacin | Small molecule | 400 mg | — |
| Subject | Pretomanid | Small molecule | 200 mg | — |