FEND for TB

FEND 防治结核病

• 批准号: 10180898
• 负责人: David Alland
• 金额: $ 395.47万
• 依托单位: RBHS-NEW JERSEY MEDICAL SCHOOL
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-06-04 至 2025-05-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10180898
• 关键词: Address; Adult; Age; Algorithms; Bacille Calmette-Guerin vaccination; Biological Assay; Caring; Cause of Death; Characteristics; Child; Childhood; China; Clinical Research; Clinical Sciences; Collaborations; Communicable Diseases; Costs and Benefits; Country; Data; Detection; Diabetes Mellitus; Diagnosis; Diagnostic; Diagnostic tests; Diagnostics Research; Drug resistance; Drug resistance in tuberculosis; Economics; Enrollment; Ensure; Evaluation; Exposure to; Feedback; Foundations; Funding; Genus Mycobacterium; Good Clinical Practice; HIV Infections; Health; Health Benefit; Health system; India; Laboratories; Leadership; Lung; Malnutrition; Modeling; Multi-Drug Resistance; Mycobacterium tuberculosis; Outcome; Patient Care; Patients; Performance; Peru; Pharmaceutical Preparations; Policies; Predisposition; Pulmonary Tuberculosis; Readiness; Reference Standards; Research; Research Design; Research Personnel; Resistance; Science Policy; Site; South Africa; Specific qualifier value; Specimen; Sputum; Technology; Testing; Triage; Tuberculosis; Uganda; United States National Institutes of Health; Work; base; clinical diagnostics; clinical research site; comorbidity; cost; cost effectiveness; design; diagnostic accuracy; diagnostic technologies; economic evaluation; experience; field study; good laboratory practice; improved; innovation; interest; low and middle-income countries; mathematical model; novel; novel diagnostics; point of care; population health; programs; prospective; recruit; response; sample collection; statistics; transmission process; tuberculosis diagnostics; tuberculosis treatment

ABSTRACT In response to RFA-AI-19-030, Feasibility of Novel Diagnostics for TB in Endemic Countries (FEND-TB) the leadership team has brought together a consortium of experienced investigators and clinical sites and developed a research plan to address critical unmet TB diagnostic needs. This program benefits from experience gained during the successful 7-year tenure of the NIH DMID-funded TB-Clinical Diagnostics Research Consortium (TB-CDRC), with overlap in leadership, investigators and sites. This program has been adapted in several ways to further enhance capacity to meet the current challenges in the field -- the successful collaboration with the Foundation for Innovative New Diagnostics (FIND) has been strengthened to now a full partnership that will facilitate access to cutting edge technologies and alignment of FEND-TB work with global stakeholder priorities; clinical study sites in India and Peru have been added to accelerate recruitment and augment capacity to enroll patients with co-morbidities and drug- resistance; inclusion of a mature analytic laboratory and revised technology evaluation strategy that together allow for rational, nimble, step-wise evaluation of early-stage diagnostics; and inclusion of mathematical modeling capacity to inform optimal diagnostic strategies in TB endemic settings. This proposal will test two main hypotheses: A. Novel early stage TB diagnostics, that target bacterial and/or host targets and will be ready for evaluation in the next five years, will have performance characteristics suitable for point of care (POC)/near-care use for TB detection, triage, or drug susceptibility testing. B. Rapid non-sputum diagnostics will provide ancillary support as components of algorithms for the diagnosis of childhood TB as well as paucibacillary pulmonary TB and extrapulmonary TB in adults. Specific Aims are: 1. To evaluate the diagnostic accuracy of early stage diagnostic tests for tuberculosis. 2. To identify new early stage diagnostics for evaluation, and to develop and implement for each a stepwise evaluation plan. 3. To use economic analysis and transmission modelling to design optimal diagnostic algorithms.

摘要