Strengthening Evidence on Optimal Multidrug-resistant Tuberculosis Treatment Regimens

HIV Clinical Trial

— STEM-TB  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05871489
• Other study ID #: R01AI146095
• Secondary ID: R01AI146095
• Status: Active, not recruiting
• Start date: September 22, 2020
• Est. completion date: October 30, 2025

Study information

• Verified date: June 2024
• Source: Harvard Medical School (HMS and HSDM)
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 800
• Est. completion date: October 30, 2025
• Est. primary completion date: October 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 0 Years to 120 Years

Eligibility

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.

Related Conditions & MeSH terms

• HIV
• Tuberculosis
• Tuberculosis, Multidrug-Resistant

Intervention

Drug:
• Bdq, Lzd, Lfx, Dlm, Cfz (9-12 months)
Bdq, Lzd, Lfx, Dlm, Cfz for nine months, with extension to 12 months as needed
• Bdq, Lzd, Lfx, Cfz, Cs (9-12 months)
Bdq, Lzd, Lfx, Cfz, Cs for nine months, with extension to 12 months as needed
• Bdq, Lzd, Lfx, Z, Dlm (9-12 months)
Bdq, Lzd, Lfx, Z, Dlm for nine months, with extension to 12 months as needed

Locations

Country	Name	City	State
Kazakhstan	Partners In Health, Kazakhstan	Almaty
Lesotho	Partners In Health, Lesotho	Maseru
Peru	Socios En Salud	Lima

Sponsors (4)

Lead Sponsor	Collaborator
Harvard Medical School (HMS and HSDM)	National Institute of Allergy and Infectious Diseases (NIAID), Partners in Health, Socios En Salud Sucursal, Peru

Countries where clinical trial is conducted

Kazakhstan,  Lesotho,  Peru, 

Outcome

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