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Presumed Risk Factors and Biomarkers for Severe Respiratory Syncytial Virus Disease and Related Sequelae: Protocol for an Observational Multicenter, Case-Control Study From the Respiratory Syncytial Virus Consortium in Europe (RESCEU)

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@article{f667600a41c4488eaf1bb5495b3ac7fb,
title = "Presumed Risk Factors and Biomarkers for Severe Respiratory Syncytial Virus Disease and Related Sequelae: Protocol for an Observational Multicenter, Case-Control Study From the Respiratory Syncytial Virus Consortium in Europe (RESCEU)",
abstract = "Respiratory syncytial virus (RSV) is the leading viral pathogen associated with acute lower respiratory tract infection and hospitalization in children < 5 years of age worldwide. While there are known clinical risk factors for severe RSV infection, the majority of those hospitalized are previously healthy infants. There is consequently an unmet need to identify biomarkers that predict host response, disease severity, and sequelae. The primary objective is to identify biomarkers of severe RSV acute respiratory tract infection (ARTI) in infants. Secondary objectives include establishing biomarkers associated with respiratory sequelae following RSV infection and characterizing the viral load, RSV whole-genome sequencing, host immune response, and transcriptomic, proteomic, metabolomic and epigenetic signatures associated with RSV disease severity. Six hundred thirty infants will be recruited across 3 European countries: the Netherlands, Spain, and the United Kingdom. Participants will be recruited into 2 groups: (1) infants with confirmed RSV ARTI (includes upper and lower respiratory tract infections), 500 without and 50 with comorbidities; and (2) 80 healthy controls. At baseline, participants will have nasopharyngeal, blood, buccal, stool, and urine samples collected, plus complete a questionnaire and 14-day symptom diary. At convalescence (7 weeks ± 1 week post-ARTI), specimen collection will be repeated. Laboratory measures will be correlated with symptom severity scores to identify corresponding biomarkers of disease severity.CLINICAL TRIALS REGISTRATION: NCT03756766.",
keywords = "biomarkers, epigenetics, metabolomics, proteomics, respiratory syncytial virus, transcriptomics",
author = "Kimberley Jefferies and Drysdale, {Simon B} and Hannah Robinson and Clutterbuck, {Elizabeth Ann} and Luke Blackwell and Joseph McGinley and Gu-Lung Lin and Ushma Galal and Harish Nair and Jeroen Aerssens and Deniz {\"O}ner and Annefleur Langedijk and Louis Bont and Wildenbeest, {Joanne G} and Federico Martinon-Torres and {Rodr{\'i}guez-Tenreiro S{\'a}nchez}, Carmen and Simon Nadel and Peter Openshaw and Ryan Thwaites and Myra Widjojoatmodjo and Linong Zhang and Nguyen, {Thi Lien-Anh} and Carlo Giaquinto and Giuseppe Giordano and Eugenio Baraldi and Pollard, {Andrew J} and {RESCEU Investigators} and Fischer, {Thea K{\o}lsen}",
note = "{\textcopyright} The Author(s) 2020. Published by Oxford University Press for the Infectious Diseases Society of America. All rights reserved. For permissions, e-mail: journals.permissions@oup.com.",
year = "2020",
month = oct,
day = "7",
doi = "10.1093/infdis/jiaa239",
language = "English",
volume = "222",
pages = "S658--S665",
journal = "Journal of Infectious Diseases",
issn = "0022-1899",
publisher = "University of Chicago Press",
number = "Supplement_7",

}

RIS

TY - JOUR

T1 - Presumed Risk Factors and Biomarkers for Severe Respiratory Syncytial Virus Disease and Related Sequelae

T2 - Protocol for an Observational Multicenter, Case-Control Study From the Respiratory Syncytial Virus Consortium in Europe (RESCEU)

AU - Jefferies, Kimberley

AU - Drysdale, Simon B

AU - Robinson, Hannah

AU - Clutterbuck, Elizabeth Ann

AU - Blackwell, Luke

AU - McGinley, Joseph

AU - Lin, Gu-Lung

AU - Galal, Ushma

AU - Nair, Harish

AU - Aerssens, Jeroen

AU - Öner, Deniz

AU - Langedijk, Annefleur

AU - Bont, Louis

AU - Wildenbeest, Joanne G

AU - Martinon-Torres, Federico

AU - Rodríguez-Tenreiro Sánchez, Carmen

AU - Nadel, Simon

AU - Openshaw, Peter

AU - Thwaites, Ryan

AU - Widjojoatmodjo, Myra

AU - Zhang, Linong

AU - Nguyen, Thi Lien-Anh

AU - Giaquinto, Carlo

AU - Giordano, Giuseppe

AU - Baraldi, Eugenio

AU - Pollard, Andrew J

AU - RESCEU Investigators

A2 - Fischer, Thea Kølsen

N1 - © The Author(s) 2020. Published by Oxford University Press for the Infectious Diseases Society of America. All rights reserved. For permissions, e-mail: journals.permissions@oup.com.

PY - 2020/10/7

Y1 - 2020/10/7

N2 - Respiratory syncytial virus (RSV) is the leading viral pathogen associated with acute lower respiratory tract infection and hospitalization in children < 5 years of age worldwide. While there are known clinical risk factors for severe RSV infection, the majority of those hospitalized are previously healthy infants. There is consequently an unmet need to identify biomarkers that predict host response, disease severity, and sequelae. The primary objective is to identify biomarkers of severe RSV acute respiratory tract infection (ARTI) in infants. Secondary objectives include establishing biomarkers associated with respiratory sequelae following RSV infection and characterizing the viral load, RSV whole-genome sequencing, host immune response, and transcriptomic, proteomic, metabolomic and epigenetic signatures associated with RSV disease severity. Six hundred thirty infants will be recruited across 3 European countries: the Netherlands, Spain, and the United Kingdom. Participants will be recruited into 2 groups: (1) infants with confirmed RSV ARTI (includes upper and lower respiratory tract infections), 500 without and 50 with comorbidities; and (2) 80 healthy controls. At baseline, participants will have nasopharyngeal, blood, buccal, stool, and urine samples collected, plus complete a questionnaire and 14-day symptom diary. At convalescence (7 weeks ± 1 week post-ARTI), specimen collection will be repeated. Laboratory measures will be correlated with symptom severity scores to identify corresponding biomarkers of disease severity.CLINICAL TRIALS REGISTRATION: NCT03756766.

AB - Respiratory syncytial virus (RSV) is the leading viral pathogen associated with acute lower respiratory tract infection and hospitalization in children < 5 years of age worldwide. While there are known clinical risk factors for severe RSV infection, the majority of those hospitalized are previously healthy infants. There is consequently an unmet need to identify biomarkers that predict host response, disease severity, and sequelae. The primary objective is to identify biomarkers of severe RSV acute respiratory tract infection (ARTI) in infants. Secondary objectives include establishing biomarkers associated with respiratory sequelae following RSV infection and characterizing the viral load, RSV whole-genome sequencing, host immune response, and transcriptomic, proteomic, metabolomic and epigenetic signatures associated with RSV disease severity. Six hundred thirty infants will be recruited across 3 European countries: the Netherlands, Spain, and the United Kingdom. Participants will be recruited into 2 groups: (1) infants with confirmed RSV ARTI (includes upper and lower respiratory tract infections), 500 without and 50 with comorbidities; and (2) 80 healthy controls. At baseline, participants will have nasopharyngeal, blood, buccal, stool, and urine samples collected, plus complete a questionnaire and 14-day symptom diary. At convalescence (7 weeks ± 1 week post-ARTI), specimen collection will be repeated. Laboratory measures will be correlated with symptom severity scores to identify corresponding biomarkers of disease severity.CLINICAL TRIALS REGISTRATION: NCT03756766.

KW - biomarkers

KW - epigenetics

KW - metabolomics

KW - proteomics

KW - respiratory syncytial virus

KW - transcriptomics

UR - http://www.scopus.com/inward/record.url?scp=85092749987&partnerID=8YFLogxK

U2 - 10.1093/infdis/jiaa239

DO - 10.1093/infdis/jiaa239

M3 - Journal article

C2 - 32794560

VL - 222

SP - S658-S665

JO - Journal of Infectious Diseases

JF - Journal of Infectious Diseases

SN - 0022-1899

IS - Supplement_7

ER -

ID: 61038396