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

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dc.contributor.authorHillery, Naomien_ZA
dc.contributor.authorGroessl, Erik J.en_ZA
dc.contributor.authorTrollip, Andreen_ZA
dc.contributor.authorCatanzaro, Donalden_ZA
dc.contributor.authorJackson, Lynnen_ZA
dc.contributor.authorRodwell, Timothy C.en_ZA
dc.contributor.authorGarfein, Richard S.en_ZA
dc.contributor.authorLin, S-Y. Graceen_ZA
dc.contributor.authorEisenach, Kathleenen_ZA
dc.contributor.authorGaniats, Theodore G.en_ZA
dc.contributor.authorPark, Danielen_ZA
dc.contributor.authorValafar, Faramarzen_ZA
dc.contributor.authorRodrigues, Camillaen_ZA
dc.contributor.authorCrudu, Valeriuen_ZA
dc.contributor.authorVictor, Thomas C.en_ZA
dc.contributor.authorCatanzaro, Antoninoen_ZA
dc.date.accessioned2015-07-23T14:28:43Z
dc.date.available2015-07-23T14:28:43Z
dc.date.issued2014-11
dc.date.updated2014-11-12T20:03:22Z
dc.descriptionCITATION: Hillery, N. et al. 2014. 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. Trials, 15(1):434, doi:10.1186/1745-6215-15-434.en_ZA
dc.descriptionThe original publication is available at http://www.trialsjournal.com/content/15/1/434en_ZA
dc.description.abstractBackground: 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.en_ZA
dc.description.sponsorshipjfl201601
dc.description.versionPublishers’ versionen_ZA
dc.format.extent13 pages
dc.identifier.citationHillery, N. et al. 2014. 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. Trials, 15(1):434, doi:10.1186/1745-6215-15-434.en_ZA
dc.identifier.issn1745-6215 (online)
dc.identifier.otherdoi:10.1186/1745-6215-15-434
dc.identifier.urihttp://hdl.handle.net/10019.1/97255
dc.language.isoen_ZAen_ZA
dc.publisherBioMed Centralen_ZA
dc.rights.holderNaomi Hillery et al.; licensee BioMed Central Ltd.en_ZA
dc.subjectMultidrug-resistant tuberculosis -- Diagnosisen_ZA
dc.titleThe 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 tuberculosisen_ZA
dc.typeArticleen_ZA
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