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Tuberculosis Epidemiologic Studies Consortium (TBESC)Task Order 8: An analysis of molecular epidemiology of multi-drug resistant M. tuberculosis in the United StatesThe purpose of the Task Order 8 research project is to develop a comprehensive national tuberculosis (TB) genotyping registry for TB case-patients with multidrug-resistant M. tuberculosis (MDR-TB ) and to assess the molecular epidemiology of MDR-TB in the United States (U.S.). It is anticipated that this ongoing surveillance of MDR-TB cases through collection of genotyping data and epidemiologic investigations will help clarify the dynamics of MDR-TB transmission, factors contributing to spread, and identify and evaluate potential areas for appropriate interventions. SitesAmerican Lung Association of Metropolitan Chicago, California Department of Health Services, Denver Health and Hospital, Emory University (Atlanta, GA), Maryland Department of Health, Massachusetts Department of Health, New York City Department of Health, New York State Department of Health, Seattle-King County Department of Public Health, Tennessee Department of Health, Texas Department of State Health Services, University of Medicine and Dentistry, and University of North Texas Health Science Center at Fort Worth. Study Objectives
Study DesignThis project will be a 3-year cross-sectional population based study design where the recruitment and data collection are handled prospectively. It will include a large representation of MDR-TB cases located in 14 U.S. sites selected from the TBESC consortium. Cluster investigations will be completed for both MDR-TB and non MDR-TB cases who have a matching genotype to a MDR-TB case, who are named as a contact (in Public Health records) or found on a contact roster of a MDR-TB and are Isoniazid or Rifampin mono-resistant. Clinical culture negative pediatric TB cases (under age 5) who were identified as an exposed contact by the MDR-TB case during the interview or were already listed as a contact to a MDR-TB case by the public health department will also be a part of the cluster investigations. Genotyping will be completed for isolates submitted for MDR-TB and non MDR-TB cases. For this study, isolates from MDR-TB cases in the U.S. will be sent to two regional DNA genotyping laboratories for both spoligotyping and MIRU genotyping followed by IS6110-based RFLP analysis as part of the CDC Universal Genotyping program. In addition to spoligotyping and MIRU typing for all cases, IS6110-based RFLP typing will be completed for all MDR-TB and non MDR-TB cases clustered with MDR-TB cases in order to further differentiate between TB strains and identify clusters. Study ProgressPiloting was conducted in five sites and the pilot data led to significant changes to the protocol, questionnaire and data abstraction forms. Questionnaires and consent forms have been translated in Tagalog, Chinese, Spanish, Vietnamese and Hindi. Official enrollment began at some sites in April 2007 and there are still some sites that are waiting for final IRB approval. Last Modified: 07/25/2007 Last Reviewed: 05/18/2008 |
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Centers for Disease Control & Prevention |