An observational study in Tuberculosis, Multidrug-Resistant and HIV, sponsored by Harvard Medical School (HMS and HSDM). Active, not recruiting at 3 sites in 3 countries. Open to participants aged 0 Years to 120 Years. Per ClinicalTrials.gov, last updated 2024-12-05.
Sponsored by Harvard Medical School (HMS and HSDM) · Observational
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).
132 studies on the registry are indexed under Tuberculosis, Multidrug-Resistant; 25 are open to participants now.
This study's planned enrollment of 800 is above the median of 410 across 42 observational studies indexed under Tuberculosis, Multidrug-Resistant.
Browse Tuberculosis, Multidrug-Resistant studies →Harvard Medical School (HMS and HSDM) is the lead sponsor of 55 studies on the registry; 14 are open to participants now.
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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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Exclusion Criteria:
200 patients receiving an all-oral shorter regimen in Lesotho under routine program conditions.
Drug: Bdq, Lzd, Lfx, Dlm, Cfz (9-12 months)
50 patients receiving an all-oral shorter regimen in Peru under routine program conditions.
Drug: Bdq, Lzd, Lfx, Dlm, Cfz (9-12 months)
550 patients receiving an all-oral shorter regimen in Kazakhstan under routine program conditions.
Drug: Bdq, Lzd, Lfx, Dlm, Cfz (9-12 months) · Drug: Bdq, Lzd, Lfx, Cfz, Cs (9-12 months) · Drug: Bdq, Lzd, Lfx, Z, Dlm (9-12 months)
Bdq, Lzd, Lfx, Dlm, Cfz for nine months, with extension to 12 months as needed
Bdq, Lzd, Lfx, Cfz, Cs for nine months, with extension to 12 months as needed
Bdq, Lzd, Lfx, Z, Dlm for nine months, with extension to 12 months as needed
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
Time frame: 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
Time frame: 6-24 months after treatment completion
Adverse events of interest
Assessed by a clinician based on symptomatology, subjective screening, and/or laboratory findings
Time frame: Tuberculosis treatment, an average of 9 months
Plan to share: Undecided
No publications or documents are linked to this record.
Started Sep 2020 (actual). Primary completion is estimated for Dec 2025, 63 months after the start.
Of 19 observational studies under Tuberculosis, Multidrug-Resistant, half reached primary completion within 53 months of starting (the median), counting those still running; a quarter within 32 and three quarters within 90. This study's planned 63 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is active, not recruiting, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.
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Tuberculosis, Multidrug-Resistant →
Harvard Medical School (HMS and HSDM)