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| ID | Type | Description | Link |
|---|---|---|---|
| R01AI146095 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Allergy and Infectious Diseases (NIAID) | NIH |
| Partners in Health | OTHER |
| Socios En Salud Sucursal, Peru | OTHER |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lesotho Cohort | 200 patients receiving an all-oral shorter regimen in Lesotho under routine program conditions. |
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| Peru Cohort | 50 patients receiving an all-oral shorter regimen in Peru under routine program conditions. |
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| Kazakhstan Cohort | 550 patients receiving an all-oral shorter regimen in Kazakhstan under routine program conditions. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bdq, Lzd, Lfx, Dlm, Cfz (9-12 months) | Drug | Bdq, Lzd, Lfx, Dlm, Cfz for nine months, with extension to 12 months as needed |
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| Measure | Description | Time Frame |
|---|---|---|
| End-of-treatment outcome | 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 | 9-12 months after treatment initiation |
| Final tuberculosis treatment outcome | Number of individuals experiencing each final tuberculosis 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 | 6-24 months after treatment completion |
| Adverse events of interest | Assessed by a clinician based on symptomatology, subjective screening, and/or laboratory findings | Tuberculosis treatment, an average of 9 months |
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Inclusion Criteria:
Exclusion Criteria:
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This study will prospectively follow an observational cohort patients with confirmed MDR-TB who initiate one of the following MDR-TB regimens of interest: (1) an individualized 18-24 month all-oral regimen containing BDQ and/or DLM, designed according to 2019 WHO guidance (Lesotho); or (2) a standardized, shortened all-oral regimen containing BDQ or DLM.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Partners In Health, Kazakhstan | Almaty | Kazakhstan | ||||
| Partners In Health, Lesotho |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38833593 | Derived | Rashitov M, Franke MF, Trevisi L, Bekbolatova G, Shalimova J, Eshmetov G, Bektasov S, LaHood A, Arlyapova N, Osso E, Yedilbayev A, Korotych O, Ciobanu A, Skrahina A, Mitnick CD, Seung KJ, Algozhin Y, Rich ML. Safety and Effectiveness of 3 Novel All-Oral Shortened Regimens for Rifampicin- or Multidrug-Resistant Tuberculosis in Kazakhstan. Clin Infect Dis. 2024 Oct 15;79(4):1046-1053. doi: 10.1093/cid/ciae305. |
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| Bdq, Lzd, Lfx, Cfz, Cs (9-12 months) | Drug | Bdq, Lzd, Lfx, Cfz, Cs for nine months, with extension to 12 months as needed |
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| Bdq, Lzd, Lfx, Z, Dlm (9-12 months) | Drug | Bdq, Lzd, Lfx, Z, Dlm for nine months, with extension to 12 months as needed |
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| Maseru |
| Lesotho |
| Socios En Salud | Lima | Lima Province | Peru |
| ID | Term |
|---|---|
| D018088 | Tuberculosis, Multidrug-Resistant |
| ID | Term |
|---|---|
| D014376 | Tuberculosis |
| D009164 | Mycobacterium Infections |
| D000193 | Actinomycetales Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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