Tuberculosis Clinical Trial
Official title:
Global Consortium for Drug-resistant Tuberculosis Diagnostics
The goal of this study is to evaluate time to diagnosis for three assays (line probe, pyrosequencing, and Microscopic Observation Drug Susceptibility Assay [MODS]) to detect resistance to first and second-line anti-tuberculosis (TB) drugs in Mycobacterium tuberculosis (Mtb) strains in 7 days or less, allowing for rapid diagnosis of extensively drug-resistant TB (XDR-TB).
The goals of this study are to test, fine tune, and compare three tests (line probe,
pyrosequencing, MODS assays) to rapidly detect Mycobacterium tuberculosis (Mtb) strains that
are resistant to first and second-line anti-tuberculosis (TB) drugs allowing for rapid
diagnosis of Extensively Drug-Resistant Tuberculosis (XDR-TB).
Primary Specific Aims
Aim 1: To reduce the average XDR-TB detection time from months to a week.
Aim 2: To determine agreement between rapid tests and standard drug susceptibility testing
(DST) results.
Aim 3: To identify the genetic basis of discordant results from Aim 2.
Aim 4: To characterize genotypic, phenotypic and epidemiological features, as well as
geographical relationships, of XDR-TB strains compared to other drug-resistant and
susceptible strains.
Secondary Aims Aim 1: Cost-effectiveness study. The costs associated with rapid-test
implementation will be compared with the performance of the new tests to rapidly and
accurately detect drug resistance and XDR-TB.
Aim 2: To determine the predictive value of resistance-associated mutations in determining
sputum culture conversion.
The investigators hypothesize that analysis of the genotypic basis of anti-TB drug
resistance will allow for the development of improved rapid molecular drug susceptibility
tests that will detect resistance to fluoroquinolones and injectable anti-TB drugs and
reduce the current XDR-TB diagnosis time of up to three months to less than seven days.
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Observational Model: Cohort, Time Perspective: Prospective
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