Clinical Core
临床核心
基本信息
- 批准号:10430223
- 负责人:
- 金额:$ 41.64万
- 依托单位:
- 依托单位国家:美国
- 项目类别:
- 财政年份:2021
- 资助国家:美国
- 起止时间:2021-07-01 至 2026-04-30
- 项目状态:未结题
- 来源:
- 关键词:AftercareAgeAntitubercular AgentsBackBiological AssayBloodCaribbean regionCase Report FormCenter for Translational Science ActivitiesChemistryChestClinicClinicalClinical DataClinical ResearchClinical SciencesCollaborationsCollectionCommunitiesComputer softwareCountryCross-Sectional StudiesDNADataData SetData StoreDevelopmentDiagnosisDiseaseDrug KineticsDrug toxicityEnrollmentEquipmentFamilyFecesGeneticGenotypeGenus MycobacteriumGoalsGovernmentHIV SeronegativityHIV/TBHaitiHaitianHematologyImmunologicsImmunophenotypingIncidenceIndividualInfectionInstitutionInstitutional Review BoardsInternetLaboratoriesLaboratory ResearchLiquid substanceLongitudinal cohort studyLungMicrobiologyMolecularMulti-Drug ResistanceMycobacterium tuberculosisNational Institute of Allergy and Infectious DiseaseNew YorkNongovernmental OrganizationsNonprofit OrganizationsOutpatientsParticipantPatientsPersonsPlasmaPopulationProceduresQuality ControlRNARecurrenceRegimenRegulationRelapseResearchResearch PersonnelResearch SupportRetreatmentRetrievalRiskSamplingSampling StudiesSerologySerumServicesShippingShipsSiblingsSolidSputumSystemTestingTimeTrainingTuberculosisTuberculosis diagnosisUnited States National Institutes of HealthUrineVisitWhole Bloodchronic infectioncohortdata managementdrug sensitivitydrug-sensitiveexperiencefollow-uphigh riskmedical schoolsmicrobiome analysismonocytemortalitymycobacterialpatient populationperipheral bloodprogramsrecruitretention ratescreening programsextreatment centertuberculosis treatmentvolunteerwelfare
项目摘要
Abstract: The goal of the Clinical Core is to recruit and characterize patient cohorts in Haiti, and to collect and
ship clinical samples for studies of tuberculosis (TB) persistence in Projects 1- 3. Core activities will be performed
by the Groupe Haitien d'Etude du Sarcome de Kaposi et des Infections Opportunistes (GHESKIO) in Port au
Prince, Haiti. GHESKIO is a Haitian non-profit organization which was founded in 1982 and is dedicated to
research, service, and training in HIV and tuberculosis. It has conducted NIH supported clinical research for 38
years and has all the essential core components for the conduct of the proposed TBRU studies, including:
experienced research staff, out-patient clinics, access to large TB patient populations, a BSL-3 TB laboratory, a
data management center, and an institutional review board. In 2019, GHESKIO diagnosed and treated 1,456
patients with culture confirmed TB including 225 re-treatment patients with a second episode of TB, 15 families
with multiple siblings with TB, and 321 HIV-negative patients with pulmonary cavity disease and high sputum
bacillary load who are at high risk of recurrence after completion of TB treatment. A major focus of this Tri-I
TBRU is on post-treatment persistent infection (PTPI) and TB recurrence. Given that more than 1 million of the
world’s 10 million cases of TB diagnosed in 2018 were recurrent TB cases, understanding genetic, immunologic
and pharmacokinetic correlates for TB persistence and recurrence is critical.
The Specific Objectives of the Tri-I TBRU Clinical Core are:
1) Conduct a cross-sectional study of 250 HIV-negative patients with recurrent TB, 250 HIV-negative
controls with a single episode of TB, and 50 families with active TB in multiple siblings. Controls with
a single episode of TB and post-treatment follow-up will be matched to recurrent cases by age, sex, and time
since completion of first TB regimen. There will be a single study visit. Clinical samples including whole
blood for host DNA and RNA, serum, PBMCs, urine, and stool will be shipped to New York.
2) Conduct a longitudinal cohort study of 500 HIV-negative drug-sensitive TB patients with pulmonary
cavities on chest radiograph, high sputum bacillary load and high risk for recurrent TB. Participants
will be enrolled at initiation of anti-tuberculosis therapy (2HRZE/4HR) and followed for 24 months after
completion of therapy (30 months total). We estimate that 40 - 50 participants will develop recurrent TB (4-
5 recurrences/100 patient years). M. tuberculosis isolates will be genotyped to determine if recurrence is
from relapse of prior infection (estimated 85% of cases) or reinfection with new strain (15%). We will quantify
M. tuberculosis in sputum at weeks 1, 2, 3, 4, 8 and 24 weeks during therapy using BACTEC time-to-
positivity. We will collect samples including blood, PBMCs, urine, and stool at enrollment, week 2, 4, 8, at the
completion of therapy and 3 and 6 months after therapy for analyses by TBRU Projects 1- 3 and PIP Core.
翻译后摘要:临床核心的目标是招募和表征患者队列在海地,并收集和
为项目1- 3中结核病持久性研究运送临床样本。将开展核心活动
由Au港的海地卡波西肉瘤和传染病研究小组(GHESKIO)
海地王子GHESKIO是一个海地非营利组织,成立于1982年,致力于
艾滋病毒和结核病的研究、服务和培训。它已经进行了38年的NIH支持的临床研究
年,并拥有进行拟议TBRU研究的所有基本核心组成部分,包括:
经验丰富的研究人员、门诊诊所、接触大量结核病患者群体、BSL-3结核病实验室、
数据管理中心和机构审查委员会。2019年,GHESKIO诊断和治疗了1,456例
培养确诊结核病患者,包括225例复治结核病患者,15个家庭
321例HIV阴性肺空洞病高痰患者
完成结核病治疗后复发风险高的患者的细菌负荷。本次三一的一个主要焦点是
TBRU是治疗后持续感染(PTPI)和TB复发。鉴于超过100万的
2018年全球确诊的1000万例结核病病例是复发性结核病病例,了解遗传、免疫学、
和药代动力学与结核病持续和复发的相关性是至关重要的。
Tri-I TBRU临床核心的具体目标是:
1)对250例HIV阴性的复发性结核病患者进行横断面研究,
对照组为单次结核病发作,50个家族中有多个兄弟姐妹患有活动性结核病。控件与
单次结核病发作和治疗后随访将按年龄、性别和时间与复发病例相匹配
自从完成第一个结核病治疗方案以来。将进行一次研究访视。临床样本,包括全血
用于检测宿主DNA和RNA的血液、血清、PBMC、尿液和粪便将被运送到纽约。
2)对500例HIV阴性药物敏感性肺结核患者进行纵向队列研究,
胸部X光片上有空洞,痰菌量高,结核病复发的风险高。参与者
将在开始抗结核治疗(2 HRZE/4 HR)时入组,并在治疗后随访24个月
完成治疗(共30个月)。我们估计,40 - 50名参与者将发展为复发性结核病(4-
5例复发/100患者年)。M.将对结核病分离株进行基因分型,以确定是否复发。
既往感染复发(估计占病例的85%)或新菌株再次感染(15%)。我们将量化
M.在使用BACTEC的治疗期间第1、2、3、4、8和24周痰结核的时间-
积极性我们将在入组时、第2周、第4周、第8周、第10周、第12周和第14周采集样本,包括血液、PBMC、尿液和粪便。
治疗完成后以及治疗后3个月和6个月,通过TBRU项目1- 3和PIP核心进行分析。
项目成果
期刊论文数量(0)
专著数量(0)
科研奖励数量(0)
会议论文数量(0)
专利数量(0)
数据更新时间:{{ journalArticles.updateTime }}
{{
item.title }}
{{ item.translation_title }}
- DOI:
{{ item.doi }} - 发表时间:
{{ item.publish_year }} - 期刊:
- 影响因子:{{ item.factor }}
- 作者:
{{ item.authors }} - 通讯作者:
{{ item.author }}
数据更新时间:{{ journalArticles.updateTime }}
{{ item.title }}
- 作者:
{{ item.author }}
数据更新时间:{{ monograph.updateTime }}
{{ item.title }}
- 作者:
{{ item.author }}
数据更新时间:{{ sciAawards.updateTime }}
{{ item.title }}
- 作者:
{{ item.author }}
数据更新时间:{{ conferencePapers.updateTime }}
{{ item.title }}
- 作者:
{{ item.author }}
数据更新时间:{{ patent.updateTime }}
Daniel W Fitzgerald其他文献
Inpatient mortality of HIV-infected adults in sub-Saharan Africa and possible interventions: a mixed methods review
- DOI:
10.1186/s12913-014-0627-9 - 发表时间:
2014-12-01 - 期刊:
- 影响因子:3.000
- 作者:
Bahati MK Wajanga;Lauren E Webster;Robert N Peck;Jennifer A Downs;Kedar Mate;Luke R Smart;Daniel W Fitzgerald - 通讯作者:
Daniel W Fitzgerald
Daniel W Fitzgerald的其他文献
{{
item.title }}
{{ item.translation_title }}
- DOI:
{{ item.doi }} - 发表时间:
{{ item.publish_year }} - 期刊:
- 影响因子:{{ item.factor }}
- 作者:
{{ item.authors }} - 通讯作者:
{{ item.author }}
{{ truncateString('Daniel W Fitzgerald', 18)}}的其他基金
Tri-Institutional Tuberculosis Research Advancement Center (TRAC)
三机构结核病研究促进中心 (TRAC)
- 批准号:
10430737 - 财政年份:2022
- 资助金额:
$ 41.64万 - 项目类别:
Tri-Institutional TRAC Clinical Science Core
三机构 TRAC 临床科学核心
- 批准号:
10675740 - 财政年份:2022
- 资助金额:
$ 41.64万 - 项目类别:
Tri-Institutional TRAC Clinical Science Core
三机构 TRAC 临床科学核心
- 批准号:
10430740 - 财政年份:2022
- 资助金额:
$ 41.64万 - 项目类别:
Tri-Institutional Tuberculosis Research Advancement Center (TRAC)
三机构结核病研究促进中心 (TRAC)
- 批准号:
10675723 - 财政年份:2022
- 资助金额:
$ 41.64万 - 项目类别:
Mwanza-Tanzania Research Training Program in HIV Clinical Investigation
姆万扎-坦桑尼亚艾滋病毒临床研究研究培训项目
- 批准号:
10374941 - 财政年份:2021
- 资助金额:
$ 41.64万 - 项目类别:
Mwanza-Tanzania Research Training Program in HIV Clinical Investigation
姆万扎-坦桑尼亚艾滋病毒临床研究研究培训项目
- 批准号:
10592325 - 财政年份:2021
- 资助金额:
$ 41.64万 - 项目类别:
Post-Doctoral Fellowship Training in HIV Clinical Investigation
艾滋病毒临床研究博士后培训
- 批准号:
10649986 - 财政年份:2021
- 资助金额:
$ 41.64万 - 项目类别:
相似国自然基金
靶向递送一氧化碳调控AGE-RAGE级联反应促进糖尿病创面愈合研究
- 批准号:JCZRQN202500010
- 批准年份:2025
- 资助金额:0.0 万元
- 项目类别:省市级项目
对香豆酸抑制AGE-RAGE-Ang-1通路改善海马血管生成障碍发挥抗阿尔兹海默病作用
- 批准号:2025JJ70209
- 批准年份:2025
- 资助金额:0.0 万元
- 项目类别:省市级项目
AGE-RAGE通路调控慢性胰腺炎纤维化进程的作用及分子机制
- 批准号:
- 批准年份:2024
- 资助金额:0 万元
- 项目类别:面上项目
甜茶抑制AGE-RAGE通路增强突触可塑性改善小鼠抑郁样行为
- 批准号:2023JJ50274
- 批准年份:2023
- 资助金额:0.0 万元
- 项目类别:省市级项目
蒙药额尔敦-乌日勒基础方调控AGE-RAGE信号通路改善术后认知功能障碍研究
- 批准号:
- 批准年份:2022
- 资助金额:33 万元
- 项目类别:地区科学基金项目
补肾健脾祛瘀方调控AGE/RAGE信号通路在再生障碍性贫血骨髓间充质干细胞功能受损的作用与机制研究
- 批准号:
- 批准年份:2022
- 资助金额:52 万元
- 项目类别:面上项目
LncRNA GAS5在2型糖尿病动脉粥样硬化中对AGE-RAGE 信号通路上相关基因的调控作用及机制研究
- 批准号:n/a
- 批准年份:2022
- 资助金额:10.0 万元
- 项目类别:省市级项目
围绕GLP1-Arginine-AGE/RAGE轴构建探针组学方法探索大柴胡汤异病同治的效应机制
- 批准号:81973577
- 批准年份:2019
- 资助金额:55.0 万元
- 项目类别:面上项目
AGE/RAGE通路microRNA编码基因多态性与2型糖尿病并发冠心病的关联研究
- 批准号:81602908
- 批准年份:2016
- 资助金额:18.0 万元
- 项目类别:青年科学基金项目
高血糖激活滑膜AGE-RAGE-PKC轴致骨关节炎易感的机制研究
- 批准号:81501928
- 批准年份:2015
- 资助金额:18.0 万元
- 项目类别:青年科学基金项目
相似海外基金
Collaborative Research: Resolving the LGM ventilation age conundrum: New radiocarbon records from high sedimentation rate sites in the deep western Pacific
合作研究:解决LGM通风年龄难题:西太平洋深部高沉降率地点的新放射性碳记录
- 批准号:
2341426 - 财政年份:2024
- 资助金额:
$ 41.64万 - 项目类别:
Continuing Grant
Collaborative Research: Resolving the LGM ventilation age conundrum: New radiocarbon records from high sedimentation rate sites in the deep western Pacific
合作研究:解决LGM通风年龄难题:西太平洋深部高沉降率地点的新放射性碳记录
- 批准号:
2341424 - 财政年份:2024
- 资助金额:
$ 41.64万 - 项目类别:
Continuing Grant
PROTEMO: Emotional Dynamics Of Protective Policies In An Age Of Insecurity
PROTEMO:不安全时代保护政策的情绪动态
- 批准号:
10108433 - 财政年份:2024
- 资助金额:
$ 41.64万 - 项目类别:
EU-Funded
The role of dietary and blood proteins in the prevention and development of major age-related diseases
膳食和血液蛋白在预防和发展主要与年龄相关的疾病中的作用
- 批准号:
MR/X032809/1 - 财政年份:2024
- 资助金额:
$ 41.64万 - 项目类别:
Fellowship
Atomic Anxiety in the New Nuclear Age: How Can Arms Control and Disarmament Reduce the Risk of Nuclear War?
新核时代的原子焦虑:军控与裁军如何降低核战争风险?
- 批准号:
MR/X034690/1 - 财政年份:2024
- 资助金额:
$ 41.64万 - 项目类别:
Fellowship
Walkability and health-related quality of life in Age-Friendly Cities (AFCs) across Japan and the Asia-Pacific
日本和亚太地区老年友好城市 (AFC) 的步行适宜性和与健康相关的生活质量
- 批准号:
24K13490 - 财政年份:2024
- 资助金额:
$ 41.64万 - 项目类别:
Grant-in-Aid for Scientific Research (C)
Discovering the (R)Evolution of EurAsian Steppe Metallurgy: Social and environmental impact of the Bronze Age steppes metal-driven economy
发现欧亚草原冶金的(R)演变:青铜时代草原金属驱动型经济的社会和环境影响
- 批准号:
EP/Z00022X/1 - 财政年份:2024
- 资助金额:
$ 41.64万 - 项目类别:
Research Grant
ICF: Neutrophils and cellular senescence: A vicious circle promoting age-related disease.
ICF:中性粒细胞和细胞衰老:促进与年龄相关疾病的恶性循环。
- 批准号:
MR/Y003365/1 - 财政年份:2024
- 资助金额:
$ 41.64万 - 项目类别:
Research Grant
Doctoral Dissertation Research: Effects of age of acquisition in emerging sign languages
博士论文研究:新兴手语习得年龄的影响
- 批准号:
2335955 - 财政年份:2024
- 资助金额:
$ 41.64万 - 项目类别:
Standard Grant
Shaping Competition in the Digital Age (SCiDA) - Principles, tools and institutions of digital regulation in the UK, Germany and the EU
塑造数字时代的竞争 (SCiDA) - 英国、德国和欧盟的数字监管原则、工具和机构
- 批准号:
AH/Y007549/1 - 财政年份:2024
- 资助金额:
$ 41.64万 - 项目类别:
Research Grant