NCT02170441

Global Consortium for Drug-resistant Tuberculosis Diagnostics

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 1,128 (actual)
• Sponsor: University of California, San Diego · Academic / Other
• Sex: All
• Age: 5 Years
• Healthy volunteers: Not accepted

Summary

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).

Detailed description

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.

Conditions

• Tuberculosis
• Tuberculosis, Multidrug-Resistant

Timeline

• Start date: 2012-04-01
• Primary completion: 2014-06-01
• Completion: 2014-06-01
• First posted: 2014-06-23
• Last updated: 2014-06-23

Locations

3 sites across 3 countries: India, Moldova, South Africa