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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
2,500
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.
South African National Health Laboratory Service
Cape Town, South Africa
RECRUITINGNumber 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 months
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 months
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 months
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 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
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
Length of time from diagnosis to treatment initiation with at least four effective drugs to which M.tuberculosis is susceptible
Time frame: From diagnosis to treatment initiation with at least four effective drugs, up to 18 months
Rob Warren, PhD
CONTACT
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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
Time frame: From diagnosis to stable culture conversion, up to 9 months