Strengthening Evidence on Optimal Multidrug-resistant Tuberculosis Treatment Regimens

N/AActive Not RecruitingNCT05871489

Harvard Medical School (HMS and HSDM)800 enrolled

Overview

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).

Study Type

OBSERVATIONAL

Enrollment

800

Conditions

Tuberculosis, Multidrug-Resistant HIV

Interventions

Bdq, Lzd, Lfx, Dlm, Cfz (9-12 months)DRUG

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

Bdq, Lzd, Lfx, Cfz, Cs (9-12 months)DRUG

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

Bdq, Lzd, Lfx, Z, Dlm (9-12 months)DRUG

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

Eligibility

Sex: ALLMin age: 0 YearsMax age: 120 Years

Medical Language ↔ Plain English

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.

Locations (3)

Partners In Health, Kazakhstan

Almaty, Kazakhstan

Partners In Health, Lesotho

Maseru, Lesotho

Socios En Salud

Lima, Lima Province, Peru

Outcomes

Primary Outcomes

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

Data from ClinicalTrials.gov

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