Evaluation of MDR-TB Treatment Strategies in Lima, Peru

简介（由申请人提供）：Sonya Shin，医学博士，在布莱根妇女医院和马萨诸塞州总医院完成了传染病研究。自1996年以来，她一直担任秘鲁耐多药结核病（MDR-TB）项目的临床顾问。Drs。Paul Farmer， Edward Nardell和Michael Hughes将担任本研究的导师。Shin博士计划发展她作为独立临床研究者的技能，同时在流行病学和决策分析研究方面接受进一步的正式培训。她最终希望在结核病临床试验和项目管理方面从事独立的职业。

DESCRIPTION (provided by applicant): Sonya Shin, M.D. has completed an Infectious Disease fellowship at Brigham and Women's and Massachusetts General Hospitals. She has served as a Clinical Consultant on a multidrug-resistant tuberculosis (MDR-TB) project in Peru since 1996. Drs. Paul Farmer, Edward Nardell, and Michael Hughes will serve as mentors for this study. Dr. Shin plans to develop her skills as an independent clinical investigator, while gaining further formal training in epidemiology and decision analysis research. She ultimately hopes to pursue an independent career in TB clinical trials and program management. Several sites at the Harvard Medical School will provide a research environment for the candidate. Both the Division of Social Justice and Health Inequalities at the Brigham and Women's Hospital and the Harvard School of Public Health, will provide ample environment for the candidate's professional development. Socios en Salud and the Ministry of Health in Lima, Peru will provide additional supervision and resources. MDR-TB remains a global health threat. Use of simple methods to rapidly identify multidrug-resistant tuberculosis strains will likely hasten treatment response. The specific aims of this study are to compare the sensitivity and specificity of two rapid drug susceptibility testing (DST) methods, the Luciferase Reporter Mycobacteriophage (LRM) method and a nitrate-reductase colorimetric (Griess) method, to conventional DST; and 2) to compare time to culture conversion among MDR-TB patients among high-risk cases randomized to receive individualized treatment based on either 1) a novel rapid DST method (Griess or Luciferase), 2) BACTEC or 3) conventional DST. Our hypotheses are that 1) the LRM and Griess methods will provide acceptably sensitive and specific alternatives to conventional drug susceptibility testing; and 2) use of rapid drug susceptibility testing compared with conventional DST to screen subjects at high risk for MDR-TB and guide individualized therapy will shorten time to culture-conversion among MDR-TB cases.