Evaluation of novel tuberculosis LAM assays among people living with HIV and sepsis
HIV 感染者和败血症患者中新型结核病 LAM 检测的评估
基本信息
- 批准号:10548256
- 负责人:
- 金额:$ 24.72万
- 依托单位:
- 依托单位国家:美国
- 项目类别:
- 财政年份:2022
- 资助国家:美国
- 起止时间:2022-07-21 至 2024-06-30
- 项目状态:已结题
- 来源:
- 关键词:AIDS/HIV problemAccountingAcquired Immunodeficiency SyndromeAddressAffinityAfrica South of the SaharaAntigensAntitubercular AgentsBiological AssayBloodCD4 Lymphocyte CountCase Fatality RatesCause of DeathCell WallCessation of lifeCharacteristicsClinicalCoupledCritical IllnessDevelopmentDiagnosisDiagnosticDiagnostic testsDiseaseDoseEpidemiologyEtiologyEvaluationFunctional disorderGenus MycobacteriumGoalsHIVHIV/TBHospitalizationImmunologic Deficiency SyndromesInfrastructureInterventionIntervention TrialLifeLipopolysaccharidesLungMethodsMicrobiologyMonoclonal AntibodiesMycobacterium tuberculosisOrganOutcomeParentsPatientsPerformancePersonsPharmaceutical PreparationsPopulationProcessProtocols documentationRandomizedRandomized Clinical TrialsRandomized Controlled TrialsReference StandardsReportingResearchSensitivity and SpecificitySepsisSilverSiteSpecificitySpecimenSpecimen HandlingSputumSymptomsSyndromeTanzaniaTechnologyTestingTimeTuberculosisTuberculosis diagnosisUgandaUndifferentiatedUnited States National Institutes of HealthUrineVulnerable PopulationsWorkWorld Health Organizationaccurate diagnosisbaseclinical implementationclinical practiceclinically relevantcomparativedesigndiagnostic accuracyearly phase clinical trialimprovedinsightlateral flow assaylipoarabinomannanmortalitymultiplex assaynovelparticlepathogenperformance testspoint of careprospectiverandomized trialrapid teststandard of caresurvival outcometreatment armtrial designtuberculosis diagnosticstuberculosis treatmentuptakeurinary
项目摘要
PROJECT SUMMARY/ABSTRACT
Mycobacterium tuberculosis is a leading cause of sepsis and the leading killer among people living with HIV
(PLWH) in sub-Saharan Africa. The diagnosis of tuberculosis (TB) is challenging to confirm in this population
due to the paucibacillary and disseminated disease state, coupled with a frequent inability to produce sputum
even among those with a pulmonary focus of TB. There is a pressing need for improved TB diagnostics,
particularly those that rely on readily-available specimens such as urine. One example of this is the AlereLAM
assay, which detects a TB cell-wall fragment (lipoarabinomannan, or “LAM”) from urine. The AlereLAM has been
endorsed by the World Health Organization (WHO) since 2015 and performs relatively well among people with
advanced HIV/AIDS, however the sensitivity is still modest at 56%. The Fujifilm SILVAMP is a newer urinary
LAM assay that uses high affinity monoclonal antibodies and a silver amplification step to aid interpretation. Early
studies have demonstrated improved sensitivity at 71% among PLWH, but the assay has not yet been tested
among a subset of PLWH who present with undifferentiated sepsis. There is room for improvement in the
accuracy of these assays. Therefore, we will evaluate the ability for a ~30 minute urine processing step, using
the Ceres Nanotrap, to augment the yield of these rapid urinary LAM assays. This project serves as a substudy
of the ATLAS Trial, a randomized controlled trial using a 2x2 factorial design of immediate empiric anti-TB
therapy initiation and sepsis-specific doses of anti-TB therapy along with standard of care among people living
with HIV who present with sepsis to our collaborative sites in Tanzania and Uganda. We will compare the
performance between the AlereLAM and SILVAMP assays before and after processing the urine with the Ceres
Nanotrap which concentrates urinary LAM and removes interfering substances within the urine. We will also
evaluate the diagnostic accuracy and incremental yield of rapid assays to detect urinary LAM as compared to
robust diagnostic reference standards (including blood/sputum culture for TB, sputum smear and TB-PCR
testing, bacterial culture of blood/sputum/urine, as well as a novel multiplex PCR assay to identify the etiology of
sepsis from blood and TB-PCR testing of urine) that are designed to identify TB and non-TB etiologies of sepsis,
as well as a clinical reference standard that is partly informed by the ATLAS Trial interventions and outcomes.
We will leverage the interventional ATLAS trial design and pursue exploratory analyses to understand the
epidemiologic impact of a more accurate, rapid, TB diagnostic as well as the clinical impact of timelier initiation
of anti-TB treatment on mortality. Our work within this unique trial infrastructure can inherently hasten the
implementation of improved urinary TB diagnostics into clinical practice in settings with high TB/HIV burden for
critically ill people.
项目总结/文摘
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)
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Tania A Thomas其他文献
Leveraging nutritional rehabilitation and tuberculosis programmes to tackle tuberculosis and severe acute malnutrition in children
利用营养康复和结核病方案来解决儿童结核病和严重急性营养不良问题
- DOI:
10.1016/s2352-4642(25)00062-8 - 发表时间:
2025-05-01 - 期刊:
- 影响因子:15.500
- 作者:
Bryan J Vonasek;Olivier Marcy;Jasmine Armour-Marshall;Martina Casenghi;Cécile Cazes;Mohammod Jobayer Chisti;Marc d’Elbée;Helena Huerga;Cathy Hewison;Christina L Lancioni;Patrick S Lungu;Eric D McCollum;Victor Musiime;Tisungane Mvalo;James A Seddon;Andrew P Steenhoff;Tania A Thomas;Marco Tovar;Anca Vasiliu;Anthony Garcia-Prats;Chishala Chabala - 通讯作者:
Chishala Chabala
Tania A Thomas的其他文献
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{{ truncateString('Tania A Thomas', 18)}}的其他基金
Evaluation of novel tuberculosis LAM assays among people living with HIV and sepsis
HIV 感染者和败血症患者中新型结核病 LAM 检测的评估
- 批准号:
10669787 - 财政年份:2022
- 资助金额:
$ 24.72万 - 项目类别:
Effects of TB and TB treatment on the pediatric intestinal microbiome
结核病和结核病治疗对儿童肠道微生物组的影响
- 批准号:
10042944 - 财政年份:2020
- 资助金额:
$ 24.72万 - 项目类别:
Effects of TB and TB treatment on the pediatric intestinal microbiome
结核病和结核病治疗对儿童肠道微生物组的影响
- 批准号:
10196992 - 财政年份:2020
- 资助金额:
$ 24.72万 - 项目类别:
Non-respiratory biomarkers to diagnose and monitor response in pediatric TB
用于诊断和监测儿童结核病反应的非呼吸生物标志物
- 批准号:
9116648 - 财政年份:2015
- 资助金额:
$ 24.72万 - 项目类别:
Non-respiratory biomarkers to diagnose and monitor response in pediatric TB
用于诊断和监测儿童结核病反应的非呼吸生物标志物
- 批准号:
8952359 - 财政年份:2015
- 资助金额:
$ 24.72万 - 项目类别:
Improving Pediatric Tb Diagnosis and Management in Tanzania
改善坦桑尼亚儿童结核病诊断和管理
- 批准号:
8374149 - 财政年份:2012
- 资助金额:
$ 24.72万 - 项目类别:
Improving Pediatric Tb Diagnosis and Management in Tanzania
改善坦桑尼亚儿童结核病诊断和管理
- 批准号:
8660027 - 财政年份:2012
- 资助金额:
$ 24.72万 - 项目类别:
Improving Pediatric Tb Diagnosis and Management in Tanzania
改善坦桑尼亚儿童结核病诊断和管理
- 批准号:
9061576 - 财政年份:2012
- 资助金额:
$ 24.72万 - 项目类别:
Improving Pediatric Tb Diagnosis and Management in Tanzania
改善坦桑尼亚儿童结核病诊断和管理
- 批准号:
8492026 - 财政年份:2012
- 资助金额:
$ 24.72万 - 项目类别:
Improving Pediatric Tb Diagnosis and Management in Tanzania
改善坦桑尼亚儿童结核病诊断和管理
- 批准号:
8849821 - 财政年份:2012
- 资助金额:
$ 24.72万 - 项目类别:
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