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RNA Biosignatures: A Paradigm Change for the Management of Young Febrile Infants

RNA 生物特征：低龄发热婴儿管理的范式变革

基本信息

批准号：
8945182
负责人：
NATHAN KUPPERMANN
金额：
$ 142.32万
依托单位：
WAYNE STATE UNIVERSITY
依托单位国家：
美国
项目类别：
财政年份：
2015
资助国家：
美国
起止时间：
2015-08-21 至 2020-04-30
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/8945182
关键词：
Accident and Emergency department Address Age Aliquot Antibiotics Applied Research Bacteremia Bacterial Infections Bacterial Meningitis Blood Blood specimen Body Fluids Cerebrospinal Fluid Child Childhood Clinical Complex Confidence Intervals Cross-Sectional Studies Decision Making Development Diagnosis Diagnostic Discrimination Disease Emergency Care Enrollment Evaluation Gene Expression Profile Genes Genetic Transcription Genome Genomics Goals Guidelines Hospitalization Hour Infection Inflammatory Informed Consent Interferons Investigation Laboratories Lead Meningitis Methods Mission Molecular Profiling National Institute of Child Health and Human Development Patients Pattern Procedures RNA RNA Stability Reference Standards Research Research Infrastructure Research Personnel Sampling Spinal Puncture Swab Technology Testing Time Urinary tract infection Urine Viral Virus Diseases Vulnerable Populations Whole Blood Work antipyretic base biosignature co-infection cost diagnostic accuracy disability experience febrile infant improved innovation multidisciplinary novel prospective public health relevance respiratory sample collection

项目摘要

DESCRIPTION (provided by applicant): Every year ~ 500,000 febrile infants = 60 days of age present to US emergency departments (ED). 6-10% of these febrile infants will have invasive bacterial infections (bacteremia, urinary tract infections or meningitis). Current approaches for the evaluation of young febrile infants are suboptimal because they include frequent invasive procedures, overuse of empirical antibiotics and unnecessary hospitalizations, which can lead to iatrogenic complications and have substantial cost implications. The primary cause of these problems is lack of highly accurate and short turn-around testing to reliably distinguish young febrile infants with and without bacterial infections. The long-term objective of our research is t investigate whole genome RNA expression profiles to define RNA biosignatures that allow precise diagnosis of isolated bacterial infections, isolated viral infections and bacterial-viral c-infections in febrile infants = 60 days of age. Our specific aims are to (1) define the RNA biosignatures in febrile infants = 60 days of age with isolated bacterial infections, isolated vira infections and viral-bacterial co-infections; (2) demonstrate the stability of the above defined RNA biosignatures over a 24-72 hour time period; and (3) validate the RNA biosignatures on a novel, PCR-based platform that has a rapid (2 - 4 hour) turnaround time. We will conduct a prospective, multi-center, cross-sectional study of febrile infants = 60 days of age who are being evaluated for bacterial infections. After obtaining informed consent from the guardian we will collect 2 ml of whole blood (1 ml for RNA expression analysis; 1 ml for comprehensive viral studies) and 1 nasopharyngeal (NP) swab for a comprehensive respiratory viral diagnosis. Additionally, in a selected group of febrile infants who are either hospitalized from the ED or those who return to the ED, we will obtain a second 1 ml blood sample for sequential RNA biosignature analysis at 24 - 72 hours after the initial sample collection. Using an aliquot of blood from the same sample we will validate RNA biosignatures on the PCR-based platform. Addressing the optimal evaluation and management of the febrile infant will assure that this vulnerable population of children have the chance to achieve their full potential for healthy and productive lives, free from disease or disability and is consistent with the mission of NICHD.