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Trials
Published in: Trials 1/2014

Open Access 01-12-2014 | Research

The Global Consortium for Drug-resistant Tuberculosis Diagnostics (GCDD): design of a multi-site, head-to-head study of three rapid tests to detect extensively drug-resistant tuberculosis

Authors: Naomi Hillery, Erik J Groessl, Andre Trollip, Donald Catanzaro, Lynn Jackson, Timothy C Rodwell, Richard S Garfein, S-Y Grace Lin, Kathleen Eisenach, Theodore G Ganiats, Daniel Park, Faramarz Valafar, Camilla Rodrigues, Valeriu Crudu, Thomas C Victor, Antonino Catanzaro

Published in: Trials | Issue 1/2014

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Abstract

Background

Drug-resistant tuberculosis (DR-TB) remains a threat to global public health, owing to the complexity and delay of diagnosis and treatment. The Global Consortium for Drug-resistant Tuberculosis Diagnostics (GCDD) was formed to develop and evaluate assays designed to rapidly detect DR-TB, so that appropriate treatment might begin more quickly. This paper describes the methodology employed in a prospective cohort study for head-to-head assessment of three different rapid diagnostic tools.

Methods

Subjects at risk of DR-TB were enrolled from three countries. Data were gathered from a combination of patient interviews, chart reviews, and laboratory testing from each site’s reference laboratory. The primary outcome of interest was reduction in time from specimen arrival in the laboratory to results of rapid drug susceptibility tests, as compared with current standard mycobacterial growth indicator tube (MGIT) drug susceptibility tests.

Results

Successful implementation of the trial in diverse multinational populations is explained, in addition to challenges encountered and recommendations for future studies with similar aims or populations.

Conclusions

The GCDD study was a head-to-head study of multiple rapid diagnostic assays aimed at improving accuracy and precision of diagnostics and reducing overall time to detection of DR-TB. By conducting a large prospective study, which captured epidemiological, clinical, and biological data, we have produced a high-quality unique dataset, which will be beneficial for analyzing study aims as well as answering future DR-TB research questions. Reduction in detection time for XDR-TB would be a major public health success as it would allow for improved treatment and more successful patient outcomes. Executing successful trials is critical in assessment of these reductions in highly variable populations.

Trial registration

ClinicalTrials.gov NCT02170441.
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Metadata
Title
The Global Consortium for Drug-resistant Tuberculosis Diagnostics (GCDD): design of a multi-site, head-to-head study of three rapid tests to detect extensively drug-resistant tuberculosis
Authors
Naomi Hillery
Erik J Groessl
Andre Trollip
Donald Catanzaro
Lynn Jackson
Timothy C Rodwell
Richard S Garfein
S-Y Grace Lin
Kathleen Eisenach
Theodore G Ganiats
Daniel Park
Faramarz Valafar
Camilla Rodrigues
Valeriu Crudu
Thomas C Victor
Antonino Catanzaro
Publication date
01-12-2014
Publisher
BioMed Central
Published in
Trials / Issue 1/2014
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/1745-6215-15-434

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