Economic Evaluation of New MDR TB Regimens

• Status: Recruiting
• Trial end date: 2022-07-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Medecins Sans Frontieres, Netherlands
• Collaborators: Clinical HIV Reserach Unit, Wits Health Consortium; Liverpool School of Tropical Medicine; London School of Hygiene and Tropical Medicine; LSHTM Clinical Research Department; Ministry of Health, Belarus; Ministry of Health, Republic of Uzbekistan; Ministry of Public Health, Republic of Belarus; TB & HIV Investigative Network (THINK); THINK TB & HIV Investigative Network; University of Liverpool; Wits Health Consortium (Pty) Ltd
• Treatments: Bedaquiline; Clofazimine; Diarylquinolines; Linezolid; Moxifloxacin; Norgestimate, ethinyl estradiol drug combination

Criteria

Inclusion Criteria:

• adults with Mycobacterium tuberculosis resistant to at least rifampicin by either molecular or phenotypic drug susceptibility test.

Exclusion Criteria:

-