TY - JOUR
T1 - Respiratory Syncytial Virus Consortium in Europe (RESCEU) Birth Cohort Study
T2 - Defining the Burden of Infant Respiratory Syncytial Virus Disease in Europe
AU - Wildenbeest, Joanne G
AU - Zuurbier, Roy P
AU - Korsten, Koos
AU - van Houten, Marlies A
AU - Billard, Marie N
AU - Derksen-Lazet, Nicole
AU - Snape, Matthew D
AU - Drysdale, Simon B
AU - Robinson, Hannah
AU - Pollard, Andrew J
AU - Heikkinen, Terho
AU - Cunningham, Steve
AU - Leach, Amanda
AU - Martinón-Torres, Federico
AU - Rodríguez-Tenreiro Sánchez, Carmen
AU - Gómez-Carballa, Alberto
AU - Bont, Louis 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 - BACKGROUND: Respiratory syncytial virus (RSV) causes significant morbidity and mortality in infants worldwide. Although prematurity and cardiopulmonary disease are risk factors for severe disease, the majority of infants hospitalized with RSV are previously healthy. Various vaccines and therapeutics are under development and expected to be available in the near future. To inform the use of these new vaccines and therapeutics, it is necessary to determine the burden of RSV disease in Europe. We will prospectively follow-up a birth cohort to obtain incidence data on RSV acute respiratory tract infection (ARTI).METHODS: Multicenter prospective study of a birth cohort consisting of 10 000 healthy infants, recruited during 3 consecutive years. RSV associated hospitalization in the first year of life will be determined by questionnaires and hospital chart reviews. A nested cohort of 1000 infants will be actively followed. In case of ARTI, a respiratory sample will be collected for RSV molecular diagnosis.RESULTS: The primary outcome is the incidence rate of RSV-associated hospitalization in the first year of life. In the active cohort the primary outcome is RSV associated ARTI and MA-ARTI.CONCLUSIONS: We will provide key information to fill the gaps in knowledge about the burden of RSV disease in healthy infants.CLINICAL TRIALS REGISTRATION: NCT03627572.
AB - BACKGROUND: Respiratory syncytial virus (RSV) causes significant morbidity and mortality in infants worldwide. Although prematurity and cardiopulmonary disease are risk factors for severe disease, the majority of infants hospitalized with RSV are previously healthy. Various vaccines and therapeutics are under development and expected to be available in the near future. To inform the use of these new vaccines and therapeutics, it is necessary to determine the burden of RSV disease in Europe. We will prospectively follow-up a birth cohort to obtain incidence data on RSV acute respiratory tract infection (ARTI).METHODS: Multicenter prospective study of a birth cohort consisting of 10 000 healthy infants, recruited during 3 consecutive years. RSV associated hospitalization in the first year of life will be determined by questionnaires and hospital chart reviews. A nested cohort of 1000 infants will be actively followed. In case of ARTI, a respiratory sample will be collected for RSV molecular diagnosis.RESULTS: The primary outcome is the incidence rate of RSV-associated hospitalization in the first year of life. In the active cohort the primary outcome is RSV associated ARTI and MA-ARTI.CONCLUSIONS: We will provide key information to fill the gaps in knowledge about the burden of RSV disease in healthy infants.CLINICAL TRIALS REGISTRATION: NCT03627572.
KW - birth cohort
KW - disease severity
KW - Europe
KW - hospitalization
KW - infant
KW - respiratory syncytial virus
UR - http://www.scopus.com/inward/record.url?scp=85092749997&partnerID=8YFLogxK
U2 - 10.1093/infdis/jiaa310
DO - 10.1093/infdis/jiaa310
M3 - Journal article
C2 - 32794574
VL - 222
SP - S606-S612
JO - Journal of Infectious Diseases
JF - Journal of Infectious Diseases
SN - 0022-1899
IS - Supplement 7
ER -