NCT05871489

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).

Trial Health

58
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
800

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2020

Longer than P75 for all trials

Geographic Reach
3 countries

3 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 22, 2020

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

May 1, 2023

Completed
22 days until next milestone

First Posted

Study publicly available on registry

May 23, 2023

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2025

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

December 5, 2024

Status Verified

June 1, 2024

Enrollment Period

5.3 years

First QC Date

May 1, 2023

Last Update Submit

December 3, 2024

Conditions

Tuberculosis, Multidrug-ResistantHIV

Outcome Measures

Primary Outcomes (3)

  • 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

    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

    6-24 months after treatment completion

  • Adverse events of interest

    Assessed by a clinician based on symptomatology, subjective screening, and/or laboratory findings

    Tuberculosis treatment, an average of 9 months

Study Arms (3)

Lesotho Cohort

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

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

Peru Cohort

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

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

Kazakhstan Cohort

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

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)

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

Kazakhstan CohortLesotho CohortPeru Cohort
Bdq, Lzd, Lfx, Cfz, Cs (9-12 months)DRUG

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

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

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

Kazakhstan Cohort

Eligibility Criteria

Age0 Years - 120 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

This study will prospectively follow an observational cohort patients with confirmed MDR-TB who initiate one of the following MDR-TB regimens of interest: (1) an individualized 18-24 month all-oral regimen containing BDQ and/or DLM, designed according to 2019 WHO guidance (Lesotho); or (2) a standardized, shortened all-oral regimen containing BDQ or DLM.

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Partners In Health, Kazakhstan

Almaty, Kazakhstan

Location

Partners In Health, Lesotho

Maseru, Lesotho

Location

Socios En Salud

Lima, Lima Province, Peru

Location

Related Publications (1)

  • 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.

    PMID: 38833593DERIVED

MeSH Terms

Conditions

Tuberculosis, Multidrug-Resistant

Condition Hierarchy (Ancestors)

TuberculosisMycobacterium InfectionsActinomycetales InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfections

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Global Health and Social Medicine

Study Record Dates

First Submitted

May 1, 2023

First Posted

May 23, 2023

Study Start

September 22, 2020

Primary Completion

December 30, 2025

Study Completion

December 31, 2025

Last Updated

December 5, 2024

Record last verified: 2024-06

Locations

LE(1)KA(1)PE(1)