Pragmatic Use of Next-generation Sequencing for Management of Drug-resistant Tuberculosis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorUniversity of California, San Francisco
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
Patient expects to relocate/move residence outside of the study region
Patient does not agree to participate in the study
Trial design
Design model
Parallel
Treatments tested in this trial
Targeted next-generation sequencing
Diagnostic testDuring 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.
Treatment groups
2,500 Participants
are divided into 2 treatment groupsGroup A: Sequencing Intervention in addition to standard of careExperimental treatment 1 intervention
Group B: Standard of CareNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
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.
Time frame
At the anticipated completion of prescribed treatment, up to 18 monthsSecondary outcomes
1
12-month relapse-free survival
Length of time after treatment ends that the patient survives without TB recurrence
Time frame
From completion of prescribed treatment to death or TB recurrence, up to 12 months2
Exposure time to ineffective drugs
Cumulative length of time on individual drugs to which Mtb is found to be resistant, per participant
Time frame
At the anticipated completion of prescribed treatment, up to 18 months3
Number of participants with acquired drug resistance
Number of participants with M.tuberculosis acquiring additional drug resistance during treatment
Time frame
At the anticipated completion of prescribed treatment, up to 18 months4
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
Time frame
From diagnosis to treatment initiation with at least three effective drugs, up to 18 monthsOther outcomes
1
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
Time frame
At the anticipated completion of prescribed treatment, up to 18 months2
Cost-effectiveness of the sequencing intervention
Costs of necessary personnel, consumables, facility, logistics, and per unit tests
Time frame
At the anticipated completion of prescribed treatment, up to 18 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of California, San Francisco
Lead sponsor
University of Stellenbosch
Collaborator
National Health Laboratory Service (NHLS), South Africa
Collaborator
National Institute for Communicable Diseases, South Africa
Collaborator
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborator
Find
Collaborator
Translational Genomics Research Institute
Collaborator
University Hospital Heidelberg
Collaborator
Source ClinicalTrials.gov