Drug-resistant TuberculosisTSELiOTNCT05553236
Pragmatic Use of Next-generation Sequencing for Management of Drug-resistant Tuberculosis
A study testing Targeted next-generation sequencing in people with Drug-resistant Tuberculosis and HIV Coinfection, run by University of California, San Francisco at 1 site in South Africa.
Trial summary
TS ELiOT is a stepped-wedge, cluster randomized trial assessing the effect of a next-generation sequencing-based strategy on rifampin-resistant tuberculosis management and patient outcomes. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Drug-resistant Tuberculosis, HIV Coinfection, Cost-Benefit Analysis
- What is being tested?
- Targeted next-generation sequencing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,500 participants
- Where
- 1 siteSouth Africa
- Study dates
- 1 Aug 2024to Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Active RR-TB diagnosed at a study facility during the study period
- Positive Mtb culture, smear, or specimen derivative (e.g., GenoLyse remnant, Xpert cartridge extract)
Who cannot join
- Patient expects to relocate/move residence outside of the study region
- Patient does not agree to participate in the study
- In addition, participants later found to have isolates with rifamycin susceptibility on at least two additional tests (e.g., phenotypic DST, LPA, or sequencing) will be considered late exclusions.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Rob Warren, PhD contact
South Africa1 site, 1 recruiting
- Recruiting
South African National Health Laboratory Service
Cape Town
Robin M Warren, PhD
Nabila Ismail, PhD, nabilai@sun.ac.za
About this study
Official title: Targeted Sequencing to Enhance, Liberate, and Optimize Treatment of Drug-resistant Tuberculosis
TS ELiOT is a stepped-wedge, cluster randomized trial assessing the effect of a next-generation sequencing-based strategy on rifampin-resistant tuberculosis management and patient outcomes.
- Being tested
- Targeted next-generation sequencing
- Medical subject headings
- Tuberculosis, Multidrug-Resistant, HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Targeted next-generation sequencingDiagnostic test
During intervention periods, an additional patient sample derived from routinely collected specimens will be processed by a local technician. Extracted DNA extracted from these samples will be batched on a regular basis for targeted deep sequencing. Sequencing results will be regularly transmitted to a clinical advisory committee.
| Study group | Role | What they receive |
|---|---|---|
| Sequencing Intervention in addition to standard of care | Experimental | Batched targeted deep sequencing in addition to the locally accepted standard of care drug susceptibility determination of multidrug/extensively drug-resistant tuberculosis (M/XDR-TB) Receives: Diagnostic Test: Targeted next-generation sequencing |
| Standard of Care | No intervention | Locally accepted standard of care which is consistent with the WHO recommendations for the drug susceptibility determination of M/XDR-TB |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with prespecified end of treatment outcomes
The number of participants with each of the following prespecified end of treatment outcomes will be reported: cure, treatment completed, loss to follow up, treatment failure, death, transfer, and still on treatment.
Measured: At the anticipated completion of prescribed treatment, up to 18 months
Secondary outcomes (6)
12-month relapse-free survival
Length of time after treatment ends that the patient survives without TB recurrence
Measured: From completion of prescribed treatment to death or TB recurrence, up to 12 months
Exposure time to ineffective drugs
Cumulative length of time on individual drugs to which Mtb is found to be resistant, per participant
Measured: At the anticipated completion of prescribed treatment, up to 18 months
Number of participants with acquired drug resistance
Number of participants with M.tuberculosis acquiring additional drug resistance during treatment
Measured: At the anticipated completion of prescribed treatment, up to 18 months
Time to effective treatment initiation with three drugs
Length of time from diagnosis to treatment initiation with at least three effective drugs to which M.tuberculosis is susceptible
Measured: From diagnosis to treatment initiation with at least three effective drugs, up to 18 months
Time to effective treatment initiation with four drugs
Length of time from diagnosis to treatment initiation with at least four effective drugs to which M.tuberculosis is susceptible
Measured: From diagnosis to treatment initiation with at least four effective drugs, up to 18 months
Time to culture conversion
Length of time from diagnosis to stable culture conversion, defined as the first of two (consecutive or non-consecutive) negative sputum cultures without an intervening positive culture, and/or visits wherein the participant is unable to produce sputum and has no signs of active TB, up to 9 months
Measured: From diagnosis to stable culture conversion, up to 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 Sep 2022
- Study start1 Aug 2024
- Primary completionJan 2027 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Drug-resistant TuberculosisStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- University of Stellenbosch, National Health Laboratory Service (NHLS), South Africa, National Institute for Communicable Diseases, South Africa, National Institute of Allergy and Infectious Diseases (NIAID), Find, Translational Genomics Research Institute, University Hospital Heidelberg
- Responsible party
- Sponsor
- Investigators
- John Z Metcalfe, MD, PhD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05553236
- Sponsor's protocol ID
- AI153213
- Other IDs
- R01AI153213
- Acronym
- TSELiOT
- Status last verified
- Jan 2026
- First submitted
- 12 Sep 2022
- Last updated
- 26 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Targeted Sequencing to Enhance, Liberate, and Optimize Treatment of Drug-resistant Tuberculosis
- ClinicalTrials.gov ID
- NCT05553236
- Acronym / sponsor ID
- TSELiOT / AI153213
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 2,500 participants (estimated)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- University of Stellenbosch, National Health Laboratory Service (NHLS), South Africa, National Institute for Communicable Diseases, South Africa, National Institute of Allergy and Infectious Diseases (NIAID), Find, Translational Genomics Research Institute, University Hospital Heidelberg
- Study start
- 1 Aug 2024 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 23 Sep 2022 (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.
TS ELiOT is a stepped-wedge, cluster randomized trial assessing the effect of a next-generation sequencing-based strategy on rifampin-resistant tuberculosis management and patient outcomes.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sequencing Intervention in addition to standard of care | Experimental | Diagnostic Test: Targeted next-generation sequencingBatched targeted deep sequencing in addition to the locally accepted standard of care drug susceptibility determination of multidrug/extensively drug-resistant tuberculosis (M/XDR-TB) |
| Standard of Care | No intervention | –Locally accepted standard of care which is consistent with the WHO recommendations for the drug susceptibility determination of M/XDR-TB |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Active RR-TB diagnosed at a study facility during the study period
- Positive Mtb culture, smear, or specimen derivative (e.g., GenoLyse remnant, Xpert cartridge extract)
Key exclusion criteria (3 listed)
- Patient expects to relocate/move residence outside of the study region
- Patient does not agree to participate in the study
- In addition, participants later found to have isolates with rifamycin susceptibility on at least two additional tests (e.g., phenotypic DST, LPA, or sequencing) will be considered late exclusions.
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 |
|---|---|---|
| Targeted next-generation sequencingDuring intervention periods, an additional patient sample derived from routinely collected specimens will be processed by a local technician. Extracted DNA extracted from these samples will be batched on a regular basis for targeted deep sequencing. Sequencing results will be regularly transmitted to a clinical advisory committee. | Diagnostic test | Sequencing Intervention in addition to standard of care |
Primary outcome
Number of participants with prespecified end of treatment outcomes
Time frame: At the anticipated completion of prescribed treatment, up to 18 months
The number of participants with each of the following prespecified end of treatment outcomes will be reported: cure, treatment completed, loss to follow up, treatment failure, death, transfer, and still on treatment.
6 secondary outcomes
12-month relapse-free survival
Time frame: From completion of prescribed treatment to death or TB recurrence, up to 12 months
Exposure time to ineffective drugs
Time frame: At the anticipated completion of prescribed treatment, up to 18 months
Number of participants with acquired drug resistance
Time frame: At the anticipated completion of prescribed treatment, up to 18 months
Time to effective treatment initiation with three drugs
Time frame: From diagnosis to treatment initiation with at least three effective drugs, up to 18 months
Time to effective treatment initiation with four drugs
Time frame: From diagnosis to treatment initiation with at least four effective drugs, up to 18 months
Time to culture conversion
Time frame: From diagnosis to stable culture conversion, up to 9 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2026.
- Individual participant dataSharing planned: No
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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.
Rob Warren, PhD contact
John Z Metcalfe, MD, PhD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Targeted next-generation sequencing in people with Drug-resistant Tuberculosis and HIV Coinfection, run by University of California, San Francisco at 1 site in South Africa.
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 2 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 26 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Africa. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact John Z Metcalfe, MD, PhD (+14152068314, john.metcalfe@ucsf.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with prespecified end of treatment outcomes (time frame: At the anticipated completion of prescribed treatment, up to 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Jan 2026.