Strengthening Evidence on Optimal Multidrug-resistant Tuberculosis Treatment Regimens

Active, not recruiting

• Conditions: HIV; Tuberculosis, Multidrug-Resistant
• Interventions: 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)

• Registration Number: NCT05871489
• Lead Sponsor: Harvard Medical School (HMS and HSDM)

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2020-09-22
• Study First Submitted: 2023-05-01
• Study First Submitted QC: 2023-05-12
• Study First Posted: 2023-05-23
• Status Verified: 2024-06
• Last Update Submitted: 2024-12-03
• Last Update Posted: 2024-12-05
• Primary Completion: 2025-12-30
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 800

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Kazakhstan Cohort	Bdq, Lzd, Lfx, Cfz, Cs (9-12 months)	550 patients receiving an all-oral shorter regimen in Kazakhstan under routine program conditions.
Lesotho Cohort	Bdq, Lzd, Lfx, Dlm, Cfz (9-12 months)	200 patients receiving an all-oral shorter regimen in Lesotho under routine program conditions.
Peru Cohort	Bdq, Lzd, Lfx, Dlm, Cfz (9-12 months)	50 patients receiving an all-oral shorter regimen in Peru under routine program conditions.
Kazakhstan Cohort	Bdq, Lzd, Lfx, Dlm, Cfz (9-12 months)	550 patients receiving an all-oral shorter regimen in Kazakhstan under routine program conditions.
Kazakhstan Cohort	Bdq, Lzd, Lfx, Z, Dlm (9-12 months)	550 patients receiving an all-oral shorter regimen in Kazakhstan under routine program conditions.

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (3)

Partners In Health, Kazakhstan; 🇰🇿 Almaty, Kazakhstan

Partners In Health, Lesotho; 🇱🇸 Maseru, Lesotho

Socios En Salud; 🇵🇪 Lima, Peru