Tuberculosis, Multidrug-ResistantSTEM-TBNCT05871489
Strengthening Evidence on Optimal Multidrug-resistant Tuberculosis Treatment Regimens
An observational study of Tuberculosis, Multidrug-Resistant and HIV, run by Harvard Medical School (HMS and HSDM) at 3 sites in 3 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 0 to 120 years
- Conditions the study is for
- Tuberculosis, Multidrug-Resistant, HIV
- What is being tested?
- Bdq, Lzd, Lfx, Dlm, Cfz (9-12 months), Bdq, Lzd, Lfx, Cfz, Cs (9-12 months) and Bdq, Lzd, Lfx, Z, Dlm (9-12 months)
- Type of treatment
- Pill or oral medicine
- How many people
- 800 participants
- Where
- 3 sitesin 3 countries
- Study dates
- 22 Sep 2020to 31 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 120 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Exclusions are based on local guidance in each country. Currently, individuals with fluoroquinolone resistant tuberculosis are excluded from all-oral shortened treatment.
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
About this study
Official title: Strengthening Evidence on Optimal Multidrug-resistant Tuberculosis Treatment Regimens Through Improved Epidemiologic Methods
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).
- Conditions
- Tuberculosis, Multidrug-Resistant, HIV
- Being tested
- Bdq, Lzd, Lfx, Dlm, Cfz (9-12 months), Bdq, Lzd, Lfx, Cfz, Cs (9-12 months), Bdq, Lzd, Lfx, Z, Dlm (9-12 months)
- Medical subject headings
- Tuberculosis, Multidrug-Resistant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| Lesotho Cohort | 200 patients receiving an all-oral shorter regimen in Lesotho under routine program conditions. Receives: 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. Receives: 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. Receives: 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) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 6-24 months after treatment completion
Adverse events of interest
Assessed by a clinician based on symptomatology, subjective screening, and/or laboratory findings
Measured: Tuberculosis treatment, an average of 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2023
- Study start22 Sep 2020
- Primary completion30 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Tuberculosis, Multidrug-ResistantStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Harvard Medical School (HMS and HSDM)
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID), Partners in Health, Socios En Salud Sucursal, Peru
- Responsible party
- Principal investigator, Molly Franke, Harvard Medical School (HMS and HSDM)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05871489
- Sponsor's protocol ID
- R01AI146095
- Other IDs
- R01AI146095
- Acronym
- STEM-TB
- Status last verified
- Jun 2024
- First submitted
- 1 May 2023
- Last updated
- 5 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 38833593
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Strengthening Evidence on Optimal Multidrug-resistant Tuberculosis Treatment Regimens Through Improved Epidemiologic Methods
- ClinicalTrials.gov ID
- NCT05871489
- Acronym / sponsor ID
- STEM-TB / R01AI146095
- Conditions
- Tuberculosis, Multidrug-Resistant, HIV
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- Harvard Medical School (HMS and HSDM)University, hospital or other
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID), Partners in Health, Socios En Salud Sucursal, Peru
- Study start
- 22 Sep 2020 (actual)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 23 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Lesotho Cohort | – | Drug: Bdq, Lzd, Lfx, Dlm, Cfz (9-12 months)200 patients receiving an all-oral shorter regimen in Lesotho under routine program conditions. |
| Peru Cohort | – | Drug: Bdq, Lzd, Lfx, Dlm, Cfz (9-12 months)50 patients receiving an all-oral shorter regimen in Peru under routine program conditions. |
| Kazakhstan Cohort | – | 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)550 patients receiving an all-oral shorter regimen in Kazakhstan under routine program conditions. |
Who may qualify
- Ages
- 0 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- Exclusions are based on local guidance in each country. Currently, individuals with fluoroquinolone resistant tuberculosis are excluded from all-oral shortened treatment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bdq, Lzd, Lfx, Dlm, Cfz (9-12 months)Bdq, Lzd, Lfx, Dlm, Cfz for nine months, with extension to 12 months as needed | Drug | Kazakhstan Cohort, Lesotho Cohort, Peru Cohort |
| Bdq, Lzd, Lfx, Cfz, Cs (9-12 months)Bdq, Lzd, Lfx, Cfz, Cs for nine months, with extension to 12 months as needed | Drug | Kazakhstan Cohort |
| Bdq, Lzd, Lfx, Z, Dlm (9-12 months)Bdq, Lzd, Lfx, Z, Dlm for nine months, with extension to 12 months as needed | Drug | Kazakhstan Cohort |
Primary outcome
End-of-treatment outcome
Time frame: 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
Time frame: 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
Time frame: Tuberculosis treatment, an average of 9 months
Assessed by a clinician based on symptomatology, subjective screening, and/or laboratory findings
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2024.
- Derived from this study: PubMed 38833593Rashitov 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tuberculosis, Multidrug-Resistant and HIV, run by Harvard Medical School (HMS and HSDM) at 3 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Kazakhstan, Lesotho, Peru. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
End-of-treatment outcome (time frame: 9-12 months after treatment initiation). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05871489, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2024.