Strengthening Evidence on Optimal Multidrug-resistant Tuberculosis Treatment Regimens (STEM-TB)

Harvard Medical School (HMS and HSDM)

Status: Active, not recruiting

Conditions: HIV; Tuberculosis, Multidrug-Resistant

Treatments: Drug: Bdq, Lzd, Lfx, Cfz, Cs (9-12 months); Drug: Bdq, Lzd, Lfx, Dlm, Cfz (9-12 months); Drug: Bdq, Lzd, Lfx, Z, Dlm (9-12 months)

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT05871489

R01AI146095

Details and patient eligibility

About

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).

Enrollment: 800 estimated patients

Sex: All

Ages: Under 120 years old

Volunteers: No 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.

Trial design

800 participants in 3 patient groups

Lesotho Cohort

Description:

200 patients receiving an all-oral shorter regimen in Lesotho under routine program conditions.

Treatment:

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

Peru Cohort

Description:

50 patients receiving an all-oral shorter regimen in Peru under routine program conditions.

Treatment:

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

Kazakhstan Cohort

Description:

550 patients receiving an all-oral shorter regimen in Kazakhstan under routine program conditions.

Treatment:

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

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

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