Multi-drug Resistant Tuberculosis Clinical Trial
— PRACTECAL-EEOfficial title:
Economic Evaluation of New MDR TB Regimens (PRACTECAL EE)
Verified date | January 2024 |
Source | Medecins Sans Frontieres, Netherlands |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 73 |
Est. completion date | August 25, 2022 |
Est. primary completion date | August 25, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - adults with Mycobacterium tuberculosis resistant to at least rifampicin by either molecular or phenotypic drug susceptibility test. Exclusion Criteria: - |
Country | Name | City | State |
---|---|---|---|
Belarus | Republican Scientific and Practical Centre for Pulmonology and Tuberculosis hospital | Minsk | |
South Africa | King DinuZulu Hospital | Durban | KwaZulu-Natal |
South Africa | THINK Clinical Trial Unit, Hillcrest | Durban | KwaZulu-Natal |
South Africa | Helen Joseph Hospital | Johannesburg | Gauteng |
South Africa | Doris Goodwin Hospital | Pietermaritzburg | KwaZulu Natal |
Uzbekistan | Republican TB Hospital No. 2 | Nukus | Karakalpakstan |
Uzbekistan | Sh Alimov Republican Specialised Scientific-Practical Medical Centre for Phthysiology and Pulmonology Hospital | Tashkent |
Lead Sponsor | Collaborator |
---|---|
Medecins Sans Frontieres, Netherlands | London School of Hygiene and Tropical Medicine, Ministry of Health, Republic of Uzbekistan, Ministry of Public Health, Republic of Belarus, THINK TB & HIV Investigative Network, University of Liverpool, Wits Health Consortium (Pty) Ltd |
Belarus, South Africa, Uzbekistan,
Sweeney S, Gomez G, Kitson N, Sinha A, Yatskevich N, Staples S, Moodliar R, Motlhako S, Maloma M, Rassool M, Ngubane N, Ndlovu E, Nyang'wa BT. Cost-effectiveness of new MDR-TB regimens: study protocol for the TB-PRACTECAL economic evaluation substudy. BMJ Open. 2020 Oct 10;10(10):e036599. doi: 10.1136/bmjopen-2019-036599. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Incremental cost incurred per disability adjusted life year (DALY) averted: Societal Perspective | Incremental cost incurred per disability adjusted life year (DALY) averted with the intervention regimen compared to the standard of care from societal perspective. DALYs will be modelled up to a life time horizon using a markov model. | 108 weeks post randomisation | |
Primary | Incremental cost per disability adjusted life year (DALY) averted: Provider Perspective | Incremental cost per disability adjusted life year (DALY) averted with the intervention regimen compared to the standard of care from provider perspective. DALYs will be modelled up to a life time horizon using a markov model. | 108 weeks post randomisation | |
Secondary | Mean cost per month of treatment | Mean cost per month of treatment for different regimens and type of patient (MDR-TB, pre-XDR-TB (resistant to fluoroquinolone) and XDR-TB) | 108 weeks post randomisation | |
Secondary | Mean cost per course of treatment for different types of patients | Mean cost per course of treatment for different types of patients (MDR-TB, pre-XDR-TB (resistant to fluoroquinolone), XDR-TB) and by category (training, monitoring, service delivery and drugs) | 108 weeks post randomisation | |
Secondary | Incremental total cost of intervention for the trial population | Incremental total cost of intervention for the trial population, over the trial duration | 108 weeks post randomisation | |
Secondary | Incremental total cost of intervention for the modelling cohort | Incremental total cost of intervention for the modelling cohort, over a life time horizon | 108 weeks post randomisation |
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