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Strengthening Evidence on Optimal Multidrug-resistant Tuberculosis Treatment Regimens

NCT ID: NCT05871489

Last Updated: 2024-12-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

800 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-09-22

Study Completion Date

2025-12-31

Brief Summary

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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

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Conditions

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Tuberculosis, Multidrug-Resistant HIV

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Lesotho Cohort

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

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

Intervention Type DRUG

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

Peru Cohort

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

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

Intervention Type DRUG

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

Kazakhstan Cohort

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

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

Intervention Type DRUG

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

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

Intervention Type DRUG

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

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

Intervention Type DRUG

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

Interventions

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

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

Intervention Type DRUG

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

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

Intervention Type DRUG

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

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

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

0 Years

Maximum Eligible Age

120 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Allergy and Infectious Diseases (NIAID)

NIH

Sponsor Role collaborator

Partners in Health

OTHER

Sponsor Role collaborator

Socios En Salud Sucursal, Peru

OTHER

Sponsor Role collaborator

Harvard Medical School (HMS and HSDM)

OTHER

Sponsor Role lead

Responsible Party

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Molly Franke

Associate Professor of Global Health and Social Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Partners In Health, Kazakhstan

Almaty, , Kazakhstan

Site Status

Partners In Health, Lesotho

Maseru, , Lesotho

Site Status

Socios En Salud

Lima, Lima Province, Peru

Site Status

Countries

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Kazakhstan Lesotho Peru

References

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Rashitov M, Franke MF, Trevisi L, Bekbolatova G, Shalimova J, Eshmetov G, Bektasov S, LaHood A, Arlyapova N, Osso E, Yedilbayev A, Korotych O, Ciobanu A, Skrahina A, Mitnick CD, Seung KJ, Algozhin Y, Rich ML. Safety and Effectiveness of 3 Novel All-Oral Shortened Regimens for Rifampicin- or Multidrug-Resistant Tuberculosis in Kazakhstan. Clin Infect Dis. 2024 Oct 15;79(4):1046-1053. doi: 10.1093/cid/ciae305.

Reference Type DERIVED
PMID: 38833593 (View on PubMed)

Other Identifiers

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R01AI146095

Identifier Type: NIH

Identifier Source: secondary_id

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R01AI146095

Identifier Type: NIH

Identifier Source: org_study_id

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