Strengthening Evidence on Optimal Multidrug-resistant Tuberculosis Treatment Regimens

Strengthening Evidence on Optimal Multidrug-resistant Tuberculosis Treatment Regimens Through Improved Epidemiologic Methods

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05871489

Acronym

STEM-TB

Enrollment

800

Registered

2023-05-23

Start date

2020-09-22

Completion date

2025-12-31

Last updated

2024-12-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV, Tuberculosis, Multidrug-Resistant

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).

Interventions

DRUGBdq, Lzd, Lfx, Dlm, Cfz (9-12 months)

Bdq, Lzd, Lfx, Dlm, Cfz for nine months, with extension to 12 months as needed

DRUGBdq, Lzd, Lfx, Cfz, Cs (9-12 months)

Bdq, Lzd, Lfx, Cfz, Cs for nine months, with extension to 12 months as needed

DRUGBdq, Lzd, Lfx, Z, Dlm (9-12 months)

Bdq, Lzd, Lfx, Z, Dlm for nine months, with extension to 12 months as needed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

0 Years to 120 Years

Healthy volunteers

Inclusion criteria

* 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, will be included.

Exclusion criteria

* Exclusions are based on local guidance in each country. Currently, individuals with fluoroquinolone resistant tuberculosis are excluded from all-oral shortened treatment.

Design outcomes

Primary

Measure	Time frame	Description
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	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
Adverse events of interest	Tuberculosis treatment, an average of 9 months	Assessed by a clinician based on symptomatology, subjective screening, and/or laboratory findings

Countries

Kazakhstan, Lesotho, Peru

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026