STEM-TB: Strengthening Evidence on Optimal Multidrug-resistant Tuberculosis Treatment Regimens Through Improved Epidemiologic Methods
Study Details
Study Description
Brief Summary
This is a multisite prospective cohort study of patients with multidrug- or rifampin-resistant tuberculosis who are treated with an all-oral shortened regimen under routine program conditions in one of three countries (Peru, Lesotho, Kazakhstan).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Lesotho Cohort 200 patients receiving an all-oral shorter regimen in Lesotho under routine program conditions. |
Drug: Bdq, Lzd, Lfx, Dlm, Cfz (9-12 months)
Bdq, Lzd, Lfx, Dlm, Cfz for nine months, with extension to 12 months as needed
|
| Peru Cohort 50 patients receiving an all-oral shorter regimen in Peru under routine program conditions. |
Drug: Bdq, Lzd, Lfx, Dlm, Cfz (9-12 months)
Bdq, Lzd, Lfx, Dlm, Cfz for nine months, with extension to 12 months as needed
|
| Kazakhstan Cohort 550 patients receiving an all-oral shorter regimen in Kazakhstan under routine program conditions. |
Drug: Bdq, Lzd, Lfx, Dlm, Cfz (9-12 months)
Bdq, Lzd, Lfx, Dlm, Cfz for nine months, with extension to 12 months as needed
Drug: Bdq, Lzd, Lfx, Cfz, Cs (9-12 months)
Bdq, Lzd, Lfx, Cfz, Cs for nine months, with extension to 12 months as needed
Drug: Bdq, Lzd, Lfx, Z, Dlm (9-12 months)
Bdq, Lzd, Lfx, Z, Dlm for nine months, with extension to 12 months as needed
|
Outcome Measures
Primary Outcome Measures
- End-of-treatment outcome [9-12 months after treatment initiation]
Number of individuals experiencing each tuberculosis treatment outcome (cure, completion, death, failure, lost-to-follow-up), assessed at the end of treatment by a clinician, based on culture results
- Final tuberculosis treatment outcome [6-24 months after treatment completion]
Final treatment outcome (cure, completion, death, failure, lost-to-follow-up, relapse), assessed at 6, 12, and 24 months by a clinician, based on culture results
- Adverse events of interest [Tuberculosis treatment, an average of 9 months]
Assessed by a clinician based on symptomatology, subjective screening, and/or laboratory findings
Eligibility Criteria
Criteria
Inclusion Criteria:
- We will include all patients with pulmonary tuberculosis that is resistant to rifampin (RIF) or to both RIF and isoniazid who initiate an all-oral treatment regimen (short or long) under routine or operational conditions, per local country guidance. All treatment decisions are determined locally.
Exclusion Criteria:
- Exclusions are based on local guidance in each country. Currently, individuals with fluoroquinolone resistant tuberculosis are excluded from all-oral shortened treatment.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Partners In Health, Kazakhstan | Almaty | Kazakhstan | ||
| 2 | Partners In Health, Lesotho | Maseru | Lesotho | ||
| 3 | Socios En Salud | Lima | Peru |
Sponsors and Collaborators
- Harvard Medical School (HMS and HSDM)
- National Institutes of Health (NIH)
- Partners in Health
- Socios En Salud Sucursal, Peru
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- R01AI146095