NCT05871489

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
• Phase: —
• Study type: Observational
• Enrollment: 800 (estimated)
• Sponsor: Harvard Medical School (HMS and HSDM) · Academic / Other
• Sex: All
• Age: 0 Years – 120 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Tuberculosis, Multidrug-Resistant
• HIV

Interventions

Type	Name	Description
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

Timeline

• Start date: 2020-09-22
• Primary completion: 2025-12-30
• Completion: 2025-12-31
• First posted: 2023-05-23
• Last updated: 2024-12-05

Locations

3 sites across 3 countries: Kazakhstan, Lesotho, Peru