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| ID | Type | Description | Link |
|---|---|---|---|
| R01AI153213 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| University of Stellenbosch | OTHER |
| National Health Laboratory Service (NHLS), South Africa | UNKNOWN |
| National Institute for Communicable Diseases, South Africa | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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) |
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| 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 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Targeted next-generation sequencing | Diagnostic 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | At the anticipated completion of prescribed treatment, up to 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| 12-month relapse-free survival | Length of time after treatment ends that the patient survives without TB recurrence | From completion of prescribed treatment to death or TB recurrence, up to 12 months |
| Exposure time to ineffective drugs |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with clinical uptake of sequencing intervention results | The number of sequencing intervention results with treatment regimen adjustment where appropriate treatment change is indicated | At the anticipated completion of prescribed treatment, up to 18 months |
| Cost-effectiveness of the sequencing intervention |
Inclusion Criteria:
Exclusion Criteria:
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.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| John Z Metcalfe, MD, PhD | Contact | +14152068314 | john.metcalfe@ucsf.edu | |
| Rob Warren, PhD | Contact |
| Name | Affiliation | Role |
|---|---|---|
| John Z Metcalfe, MD, PhD | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| South African National Health Laboratory Service | Recruiting | Cape Town | South Africa |
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| ID | Term |
|---|---|
| D018088 | Tuberculosis, Multidrug-Resistant |
| D015658 | HIV Infections |
| ID | Term |
|---|---|
| D014376 | Tuberculosis |
| D009164 | Mycobacterium Infections |
| D000193 | Actinomycetales Infections |
| D016908 | Gram-Positive Bacterial Infections |
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| National Institute of Allergy and Infectious Diseases (NIAID) |
| NIH |
| Find | OTHER |
| Translational Genomics Research Institute | OTHER |
| University Hospital Heidelberg | OTHER |
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Cumulative length of time on individual drugs to which Mtb is found to be resistant, per participant
| 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 | 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 | 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 | 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 | From diagnosis to stable culture conversion, up to 9 months |
Costs of necessary personnel, consumables, facility, logistics, and per unit tests |
| At the anticipated completion of prescribed treatment, up to 18 months |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |